Coronavirus updates December 2021

[MMtwo]

Australia is wild! We went from locking down playgrounds to being reasonable about Omicron. I suspect they think public goodwill is going to expire soon if they lock us up again.

Omicron ‘five times less severe’ than Delta

NSW Premier Dominic Perrottet says early signs indicate Omicron is “five times less severe” than Delta.

www.news.com.au

That said I REALLY REALLY REALLY trust Dr Chant and I do everything she tells me (seriously I ate dodgy supermarket bread for that lady because she said not to go into cramped bakeries) so if she's going to hang her hat on Omicron being milder, I believe her.

I saw that! Talk about a complete and utter about face in policy.

I have also been following along with the more encouraging reports out of countries that have data on hospitalization and severity and am so hopeful that this is a pivotal point for everyone.

 

[missy]

From one of my doctors. Her latest update to all her patients.

"

Omicron Addendum
12/22/2021


Much has changed since I sent my last newsletter a few weeks ago. The big news is the spread of the Omicron variant, of course. I still maintain that there is no need to panic, but Omicron is forcing a lot of us (including me) to rethink our upcoming plans for travel and socializing. It can be hard to keep up with all the rapid developments, so I’m sharing some updates:

In just a few weeks, Omicron has become the dominant variant in New York State. Almost every case being diagnosed now is Omicron. The new variant is highly transmissible, much more so than Delta. Some reports say Omicron is 70 times as transmissible.

Case numbers have skyrocketed, both locally and nationally, but hospitalizations and deaths have not risen much at all. Omicron seems to cause milder illness than Delta. Also, many more people are vaccinated now than when Delta first emerged. This is all good news, because fewer people will get severely ill and die. But because Omicron symptoms are so mild (especially in vaccinated individuals), people are often not responding to the symptoms with isolation, thereby spreading the virus to many people.

A lot of healthcare staff will be lost to quarantine and isolation, spreading the healthcare workforce very thin over this holiday week and weeks to come.

For most people, an Omicron covid infection starts as a scratchy throat and a headache. If you have any symptoms—no matter how mild—err on the side of caution. Isolate and test immediately. Most of the transmission so far has happened in household, workplace, and social gatherings.

Here are the CDC guidelines to Isolation and Quarantine:
https://www.cdc.gov/coronavirus/2019-ncov/your-health/quarantine-isolation.html

They have not yet been updated to reflect Omicron’s increased transmissibility. Since I am mostly seeing illness in vaccinated patients, I would recommend quarantine in people who have had a significant exposure, regardless of their vaccination status.

Some common-sense Omicron health guidelines:

Keep your holiday gatherings small. Friends and family who have had a known exposure should be excluded from your events. Same day, rapid testing should be encouraged if possible. Anyone who has any symptoms, regardless of test results, should be excluded. I am hearing many, many reports of patients testing negative for days in a row before their results turn positive.

I recommend against indoor dining or drinking, going to the gym, going to the movies or shows, etc, until this latest Covid wave has calmed down.

If you are traveling via public transportation, going to school, or doing anything in which you do not know the status of every person present then you should wear an N94, KN95 or N95 mask. It’s a small precaution to take for a big benefit.

Cloth and surgical masks protect other people from you but they do not protect you from other people.

I have diagnosed more Covid in the past week than during the entire pandemic before now. Almost every one of my patients with Covid is fully vaccinated and received a booster. Proceed with caution, my friends.

I will be out of the office from December 24th until January 3rd, but I will be available for emergencies on my cell phone as always.

I wish you a safe and healthy holiday week! And for those of you already in isolation or in quarantine for the holidays, I will keep you in my heart.
"

 

[missy]

CityMD Temporarily Closes 3 NJ Clinics As COVID Surges​

The chain of urgent care clinics is also closing 13 New York City locations "to preserve our ability to staff our sites."​

NEW JERSEY — CityMD is temporarily closing three clinics in New Jersey and 13 in New York as COVID-19 continues to surge.
"As so many of you are aware, most CityMD locations are operating at full capacity, doing our best to meet the urgent care needs of the people of New York and New Jersey," according to CityMD. "Continuing to provide these services to the community is a top priority; however, our physicians and teammates are also a priority."
The demand for a COVID-19 test has been high with many New Jersey residents lining the streets at local clinics ahead of the holidays.

In order to preserve CityMD's ability to staff their sites, they announced they are temporarily closing certain locations effective Wednesday, Dec. 22.
"It is our hope that closing sites now will best allow us to avoid future closures as this surge continues," according to CityMD.

​

See below for a list of temporary closures in New Jersey with suggestions of nearby clinics:

• CityMD Jersey City - 340 Grove Street (visit CityMD Jersey City- Journal Square)
• CityMD Raritan - 503 Route 202 North (visit CityMD East Brunswick)
• CityMD Wayne - 76 Willowbrook Blvd Unit C2 (visit CityMD Clifton)

As of Wednesday, New Jersey hit a new record Wednesday with 9,711 new COVID-19 cases reported in one day. There were also 28 new deaths. This is the most amount of cases ever to be reported throughout the almost two-year pandemic. ecord COVID Cases In NJ As Holidays Near
Gov. Phil Murphy offered alternative ways for residents to get tested before gathering for the holidays.

 

[Asscherhalo_lover]

NYC is in a very bad spot right now. It's spreading like wild fire in the schools. We had a related service provider test positive. The "situation room" is so overwhelmed with calls that they're not responding and shutting down schools. My admin took it into their own hands and called every family to warn them. We had 12/55 students yesterday and are expecting far less today. Staff still has to report since they won't shut the school. This is all across the city at this point. If you can stay home, stay home.

 

[missy]

Biden: 'It's Your Patriotic Duty' to Get Vaccinated This Holiday Season

Federal government setting up more vaccination and testing sites, boosting hospital supplies

www.medpagetoday.com

"https://www.medpagetoday.com/infect...&utm_term=NL_Gen_Int_Daily_News_Update_active

Biden addressed concerns about the Omicron variant of COVID, which appears to be spreading very rapidly.

"If you're not fully vaccinated, you have good reason to be concerned," he said. "Unvaccinated people have a significantly higher risk of ending up in the hospital, or even dying."

But for those who are vaccinated -- and especially those who also have received a booster shot -- "they have much less reason to worry," because they'll be much more protected from severe disease, hospitalization, and death, he added. And although there will certainly be breakthrough cases among the vaccinated and boosted, "those cases are highly unlikely to lead to serious illness," he said.

Those who are vaccinated and boosted "can enjoy the holiday season," Biden continued. But he added, "All of you who have not been vaccinated, you have an obligation to yourselves, your family, and quite frankly -- and I know I'll get criticized for this -- to your country" to get vaccinated. "Honest to God, I believe it's your patriotic duty."



Biden said many people have asked him whether the country is going back to the situation it was in during March 2020, when the pandemic really began. The answer is "No," for three reasons, Biden said. First of all, "more than 200 million Americans have been fully vaccinated," which wasn't true in March 2020; that means if they get sick, their cases are likely to be less severe.

Second, the country wasn't physically prepared for the epidemic, "and today, we have stockpiled enough masks, gowns, and ventilators to deal with a surge of COVID among the unvaccinated," he said. And finally, "we know a lot more today than we did in March 2020. For example, last year, we thought the only way to keep children safe was to close our schools... Today we know more to keep schools open," and don't close down a school if a single case of COVID is detected.



"We should all be concerned about Omicron, but not panicked," said Biden. "And no, this is not March 2020."

The president outlined several steps his administration was taking to combat the coronavirus:

Increasing vaccination and booster efforts. "We've added 10,000 new vaccination sites on top of the 80,000 sites we already had in place, and even more will open in January," Biden said. "Starting this week, we are deploying hundreds more vaccinators at more sites; I've ordered FEMA [the Federal Emergency Management Agency] to stand up new vaccination pop-up clinics all across the country." FEMA vaccination sites are opening in Washington state and New Mexico, and "I'm directing FEMA to stand up new sites in areas where there is high demand," Biden said. "These steps will help us add more booster appointments in the next few weeks."

Increasing access to testing. "We have over 20,000 free testing sites, and I've used the Defense Production Act and spent $3 billion to greatly expand the amount of tests available for purchase online and at local pharmacies," Biden said. He reminded the audience that, as he announced earlier this month, starting in January private insurers will be required to reimburse patients for home testing, "so you can order a test online and get reimbursed ... We're also offering free home testing for those who may not have insurance."



However, the government still needs to do better, he added.

"Starting this week, the federal government will set up additional testing sites," starting with a few in New York City that will be open before Christmas, Biden said. "That will reduce time in waiting lines ... We're going to continue to add federal testing sites where needed, so if you want an immediate test, there is a place where you can go get it." To find testing nearby, patients will soon be able to Google "COVID testing near me" and locations will pop up, he added.

During a background briefing for the press on Monday, MedPage Today asked a senior administration official whether anything was being done to alleviate the shortage of at-home tests in many geographic areas.

"The biggest thing we're doing, to get to your point, is buying half a billion tests -- at-home tests -- to be able to give to the American people for free," the official said.



Getting hospitals ready for a surge. With 40 million as-yet-unvaccinated adults who still have a chance of getting very sick, the administration is taking several steps to get ready, including having masks, gowns, and ventilators on hand to send to hospitals that need them, Biden said. In addition, "I've directed the Pentagon to mobilize 1,000 troops" of doctors, nurses, and medics to be deployed to hospitals that need them, he said, adding that some of those troops landed in Wisconsin and Indiana this week.

The president also has activated FEMA's National Response Center to begin preparing hospital beds to be moved to hospitals that run out of bed capacity. FEMA also will be deploying ambulances and ambulance crews to transport patients elsewhere when a hospital fills up.

"This week, we will send dozens of ambulances to New York and Maine -- because COVID is spreading very rapidly -- to help transport patients," he said. "Our doctors, nurses, hospital staff have gone above and beyond during this pandemic. Thestrain, the stress is real ... We have to let them know we have their backs."



Keeping schools and businesses open. Biden noted that last week, a federal court reinstated his "vaccine or test" mandate for businesses with 100 or more employees. "These rules will keep workers safe and help keep businesses open," he said. "I know that vaccination requirements aren't popular for many ... But my administration has put them in place not to control your life, but to save your life and the lives of others. Four hundred thousand Americans died from COVID this calendar year and almost all were unvaccinated, almost all were preventable. The rule is legal and effective, and it's going to save thousands of American lives."

As for schools, "K-12 schools should be open, and safety is increased if schools require all adults who work in the school to get vaccinated and take the safety measures that the CDC is recommending, including masking," he said. "I got Congress to pass billions of dollars in school improvements -- ventilation and social distancing -- and just Friday, the CDC issued 'test to stay' guidelines so schools can stay open and kids can stay in class, even when a classmate tests positive."

"We all want this to be over, but we're still in it," Biden concluded. "This is a critical moment. But we have more tools than we ever had before. We're ready, and we'll get through this."



"

 

[missy]

Pandemic Uncertainty Makes Life Difficult for Healthcare Workers​

— "You just don't know what will happen next. The ebb and flow makes it difficult."​

by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today

Holy Name Medical Center in Teaneck, New Jersey, was once the epicenter of the state's first COVID-19 outbreak. MedPage Today spoke with its chief of infectious diseases, Suraj Saggar, DO, in mid-March 2020, when doctors were still struggling to understand this novel pathogen and figuring out how best to care for patients.

MedPage caught up with Saggar earlier this week, to see how things have changed on the front lines in the last 20 months, and to understand how hospitalists are preparing for the new unknowns of the Omicron variant.



After the spring of 2020, Saggar said, the work went "from a sprint to a marathon." Things calmed down over the summer of 2020, and then there was a bit of a surge in the fall of that year and into the winter of 2021.

Soon enough, the vaccine brought "encouragement and hope," Saggar said, with "vaccine euphoria" taking over into the spring and early summer as cases fell to all-time lows.

Then, Delta hit. The surges were "uneven," Saggar said. "Our area wasn't affected as much ... as other parts of the country with lower vaccination rates."

The nation's Delta surge calmed down by mid-fall. But now, Omicron threatens to disrupt the peace yet again.

"It's unclear if that will definitively equate to an increase in hospitalizations," Saggar told MedPage Today. "We're seeing hospitalizations mainly in the unvaccinated population. We are seeing breakthroughs, but these patients are not as sick."



"Even being fully vaccinated, including boosters, we know people may still get illness," he said. "But [vaccines] still have good protection against moderate to severe to critical disease."

At the moment, Saggar said, the hospital is doing just fine: "We're keeping ahead of it. We're in a much better place than we ever were before."

Holy Name didn't have to re-open its extra COVID wards after the first surge, he said, but this remains an option if they're needed.

"The hospital retrofit a lot of regular floors with negative pressure rooms" during the first surge, Saggar said. "The hope is to not have to use those. Having said that, it's always in the back of our minds, and we're being vigilant about case numbers and staying one step ahead of this pandemic."

The bigger challenge, he said, would be staffing those units if they're needed, especially in terms of nurses and respiratory techs and therapists.



"We've seen a lot of older nurses who have taken early retirement, and younger nurses have decided this isn't for them," he said. There's also the lure of higher pay by doing locum tenens nursing work. Some nurses can make enough money working just a few months, and then take some time off, he said.

As for treatments, there are now good options for early disease, Saggar said. Monoclonal antibodies can be helpful, "though we have to adjust which ones we're using in real-time based on variants. But given early, they are highly effective," he said.

The promise of having an oral antiviral in the near future is reassuring, he said. While Merck's data on molnupiravir are "a little disappointing," Pfizer's data on Paxlovid (nirmatrelvir + ritonavir) are better.

Still, both therapies have a high pill burden. Pfizer's drug, for example, is six pills per day for 5 days, for a total of 30 pills, he said. That requires high compliance -- especially when stopping short could increase the risk of resistance.



Patients also need to take antivirals within 5 days of symptom onset for optimal efficacy, he said, so there's a "smaller window of opportunity."

"Based on all that, you feel much better about early COVID," Saggar said. "The issue is when people get to the severe or critical level, and there, we're really out of options."

Saggar said for these severely ill patients, specialists will treat with a range of therapies, including anticoagulation, steroids like dexamethasone, and other immunosuppressants like the IL-6 antagonist tocilizumab (Actemra) and the JAK inhibitor baricitinib (Olumiant).

"Those have varying degree of success," he said. "Once you get to critical-level hypoxia -- they're on six liters or more -- or they're [otherwise] progressed, and once they're vented, that's a really big problem," Saggar said. "We really have very few effective options at that point."

While these patients account for a small proportion of COVID-19 cases overall, Saggar notes that a "small percentage of a large number is still going to equate to an absolute number that's not palatable," referencing the more than 800,000 deaths from COVID-19 in the U.S.



Holy Name is preparing for a "significant surge in the next few weeks to months," he said. The question is, how long will it last?

"Will it turn out that it's truly more infectious but less virulent?" he questioned. "What does that mean in terms of hospitalizations? Maybe we'll have people taking time off of work and school, but not necessarily flooding the hospitals."

"You just don't know what will happen next," he said. And that's been the hardest part of the pandemic: "The ebb and flow makes it difficult."

"Do you plan a vacation, or do you not plan a vacation? How are things going to be in March and April? Will it be a lot worse? Will it be like this every year, whe
e spring and summer are better, then we get to fall and winter and we have a new variant, and new concerns?"

"The uncertainty," he said, "is what makes it difficult."

 

[missy]

New York City’s miscalculation on testing​

New Yorkers are used to waiting in lines, for everything from bagels to discount tickets for Broadway shows. But not for three hours or more. The arrival of the omicron variant caught city officials off guard, overwhelming testing capacity just as residents of the biggest U.S. city were getting set to travel for the winter holidays. In addition to spending hours in the cold for a test, many are waiting days to receive their results. “It is disappointing,” says Jessica Justman, an associate professor of medicine in epidemiology at Columbia Mailman School of Public Health. “Especially because we’ve been there before in the first part of this pandemic.” The seven-day average of testing across the city has more than tripled since a low in July, to about 90,000 molecular and 30,000 rapid antigen tests on Dec. 19. Meanwhile, test results returned within one day fell to 54.8% on Dec. 11, down from 76% in July, according to the latest data available from the city. The omicron variant has overwhelmed New York City’s testing capacity, forcing residents to wait in lines for hours. Photographer: Angus Mordant/Bloomberg So what went wrong? Mayor Bill de Blasio said the city had seen demand drop at some test sites before the current surge, and it moved instead to focus on mobile testing vans. When the highly transmissible omicron variant arrived earlier this month, the city was caught flat-footed. “We did not expect omicron to move quite this quickly,” de Blasio said at a briefing this week. New York shifted two sites to mobile testing in November, and in December it did the same at sites at JFK and LaGuardia airports before the omicron surge, says Adam Shrier, a spokesman for the city’s Test & Trace Corps. The city had previously closed 18 sites in the spring and summer as the facilities hosting them returned to other functions, Shrier says. Caught off guard, the city is now ramping up capacity, adding 30 mobile and brick-and-mortar sites this week, bringing the total to 119. New York state and the federal government are also trying to add capacity and distribute at-home tests. But it may be too little, too late. The additions are lagging demand and are “really not enough,” Justman of Columbia says. “We need to be talking about hundreds of hundreds of testing sites that need to pop up.”—Elaine Chen

​ ​ ​ ​ Track the virus​

Positive Studies Start to Roll In Weeks after it was first identified, the highly-mutated, highly contagious omicron variant appears much less likely to land patients in the hospital with Covid-19 than the delta strain, or to have them need to stay overnight, according to preliminary data from a trio of studies from South Africa, Scotland and the U.K. Read the full story here. Lining up for Covid vaccinations in London. Photographer: Chris Ratcliffe/Bloomberg

What you should read​

New Risks to Unvaccinated Pregnant Women Confusing messages, widespread misinformation add up to danger. Sinovac Failed to Aid Against Omicron in Study Two doses and a booster of China's main vaccine didn't cut it. Masks Return to Australia Ahead of Christmas Sydney, Melbourne roiled by new surge of omicron-led Covid cases.

 

[House Cat]

We just had to fire our son’s therapist of 8 years because she is unvaccinated and doesn’t wear a mask. When she wasn’t wearing a mask WITH MY KID in the room, I assumed she was (decent enough to be) vaccinated. She revealed to my son in his last session that she was not. Buh bye.

it’s terrible, my son put in many years of work with her. Now he has to start over with someone new.

 

[Calliecake]

We just had to fire our son’s therapist of 8 years because she is unvaccinated and doesn’t wear a mask. When she wasn’t wearing a mask WITH MY KID in the room, I assumed she was (decent enough to be) vaccinated. She revealed to my son in his last session that she was not. Buh bye.

it’s terrible, my son put in many years of work with her. Now he has to start over with someone new.

I would be livid that she didn’t disclose this to you as soon as vaccines became available for her age group. She knew then she wasn’t going to be vaccinated. She should have been honest and upfront with those she was treating.

 

[missy]

Update on the home Covid tests.

Types of COVID-19 Tests

There are basically two types of tests for the coronavirus that causes COVID-19:

Virus test
This test detects the virus (SARS-CoV-2) to determine if you have an active infection and are infectious, i.e., you can spread the virus. Although you can be infectious before showing any symptoms, the virus is best detected during the first week of symptoms (which is about two weeks after becoming infected from exposure) (Sethuraman, JAMA 2020).

The virus test is best done by collecting a sample of mucous from a swab (typically from the nasopharynx or nostril) or saliva. There are two type of virus tests: the PCR and antigen test. Both tests need to be analyzed in a laboratory or with a special rapid, portable machine.

The PCR test uses a technique that amplifies genetic material (RNA) from the virus. This can take as little as a few minutes or several hours. The FDA has begun allowing some at-home sampling kits to be sold by which you can collect your own sample and drop it off or mail it to a lab, which will report the results back to you.

An analysis of tests performed among symptomatic and asymptomatic patients at Vanderbilt University Medical Center showed that the proportion of samples testing positive on PCR tests were twice as high at 2 pm than in the morning, decreasing later in the afternoon and evening. Researchers proposed this may indicate that test accuracy varies by time of day and could have public health implications (McNaughton, medRxiv 2021 -- preprint).

The other type of virus test is the antigen test. It identifies a protein (or "antigen") that is specifically found on the virus. Advantages of the antigen test are that it can provide results in just 15 minutes and can be produced at lower cost, lending itself to wider use in screening. In addition, only a nasal swab is needed from the nostrils, not a much deeper, nasopharyngeal swab. The downside with antigen tests is that they are more likely to provide a false negative result than a gene amplification test, that is, it's more likely to identify your sample as negative when you are actually positive. Consequently, negative results from an antigen test may need to be confirmed with a gene amplification test — but a positive result is highly likely to be accurate.

Antibody test
This test detects antibodies to the virus and requires blood — either a drop or a vial — to determine if you have been infected in the past and have developed some level of immunity. This test (also called a serology test) can be run in a laboratory or on a test strip, although even test strips must be used in an authorized facility, not at home.

As it takes time to develop antibodies that can be detected, antibody tests are most accurate when performed at least 20 days after the first disease symptoms and may be most accurate (in terms of not missing antibodies that are present) 4 months or longer after a positive virus test. This was shown in study of 486 COVID patients in California in which the likelihood of a positive antibody (IgG) test result increased with time after a positive virus test. Antibody tests were most accurate (~80%) among those ages 40 to 59 years and least accurate (~65%) among those 70+ or under 40. The tests were more accurate for men than women (79% vs 72%) (Vashisht, JAMA Netw Open 2021).

Tests focus on levels of the antibody IgG, which persists without much decline for several weeks, but may include levels of IgM which fall off more rapidly (Sethuraman, JAMA 2020). These tests look for antibodies to specific parts of the virus, namely its spike proteins (proteins on the outside of the virus that can bind to receptors on human cells) or nucleocapsid proteins (proteins inside the virus). An advantage to testing for antibodies to the nucleocapsid is that these antibodies can be easier to detect, however, antibodies to the spike proteins are believed to be more important in conferring immunity against the virus, as these antibodies may block viral entry into cells — although antibodies to nucleocapsid proteins may still serve as proxies for immunity. See Finding the Best COVID-19 Test — Antibody Test to learn which marketed tests target each protein.

Note: Avoid taking large doses of the B-vitamin biotin (10,000 mcg or more) for several days before an antibody test, as biotin may skew results. Tests that may be affected by biotin interference include Abbott Alinity i SARS-CoV-2 IgG, Abbott Architect SARS-CoV-2 IgG, Babson Diagnostics aC19G1 (IgG), Elecsys Anti-SARS-CoV-2 Antibody test, Ortho-Clinical Diagnostics VITROS (IgG), Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 IgG (COV2G), Wadsworth New York SARS-CoV Antibody Detection (IgG), and other ELISA-based equipment that uses biotin-streptavidin technology.

Another way our bodies fight the virus is with T cells. Preliminary research suggests that even if antibody levels are too low to be detected, people previously infected with the virus may produce enough T cell response to provide immunity (Sekine, MediRxiv 2020). However, currently authorized tests do not measure this type of immunity, and one should still apply distancing and health precautions regardless of test results.

Some labs may provide you with an index value that reflects the strength of the antibody signal produced from your test. Higher antibody levels generate higher signals and higher index values. The interpretation of these index values depends on the test used. For example, for a particular test the cut-offs could be "less than 1.01" for negative, "1.01 to less than 1.21" for indeterminate, and "greater than or equal to 1.21" for positive (Theel, J Clin Microbio 2020). Or, there could just be a single cut-off index value of, say, 1.40 for positive, with anything below being negative (Example: Abbott Alinity -- https://www.fda.gov/media/137910/download). If you would like to know your index value, be sure to check that the lab you use provides the value.

Who is checking these tests?
To speed the availability of tests, rather than put these through its normal approval process, the FDA has provided a special emergency use allowance (EUA) for tests that, although imperfect, may be useful at this time. So there are actually no FDA "approved" SARS-CoV-2 virus tests, but a list of "FDA authorized" tests. The FDA authorizations are based on data submitted by the test manufacturers, but the National Institutes of Health (NIH) and other government laboratories are now conducting independent tests of these tests and the FDA has been making the results public (see results in the Finding the Best COVID-19 Test section and watch for further announcements in our newsletter.) Be aware that on October 5, 2021, the maker of one home COVID test, "Ellume," recalled certain lots of the test as they were found to provide inaccurate results (see detailsbelow).

Several other organizations around the world have been testing the test and/or certifying virus and antibody tests. The European Union's has been certifying tests, conferring on them its CE (Conformité Européenne) mark, and the Chinese National Medical Products Administration (NMPA) has been doing the same. Researchers in California, Denmark, and elsewhere have been testing the antibody tests.

Be aware that in June 2020 the FDA warned consumers about at-home antibody tests being sold without FDA clearance or approval and issued warning letters to three companies selling these tests. Some of these tests were falsely labeled as FDA approved.

Finding the Best COVID-19 Test

Virus Test
So long as they are performed at the right time, any FDA-allowed virus test based on gene amplification (PCR) can be "incredibly accurate," according to the FDA. However, as noted above, the reliability of results has been called into question with the smallest and fastest system, Abbott ID NOW, which, compared to some larger and slower systems, appears to be less sensitive in detecting the virus, resulting in higher levels of false negative results (Basu, bioRxiv 2020 preprint). For example, tests by the Cleveland Clinic showed the sensitivity of Abbott ID NOW to be only 85.2% as compared to 98.2% and 96.5%, respectively, for Cepheid Xpert Xpress and Roche Cobas, as reported by NPR on April 21, 2020. In addition, the FDA reported that Becton, Dickinson and Company's BD Max System using BD SARS-CoV-2 reagents had a higher false positive rate than believed: A study showed that approximately 3% of results were false positives. The FDA suggested that any positive result should be confirmed with another test (FDA, July 6, 2020).

A saliva-based test developed at Yale, which has been used on NBA players, can be run on existing PCR-based systems but does not require some of their reagents. It makes sample collection easier and less expensive, but is no quicker (taking about 3 hours) and not quite as sensitive as standard PCR tests (missing about 5% of specimens other systems identify as positive) (Vogels, MedRxiv 2020). Additional research at Yale showed that self-collected saliva samples were just as good as nasopharyngeal samples collected by healthcare workers in detecting the SARS-CoV-2 virus in PCR tests. In fact, saliva samples tended to contain higher amounts of viral RNA, and a higher percentage of the saliva samples were positive up to 10 days after diagnosis (Wyllie, Correspondence in JAMA, 2020).

Aside from concern about the Abbott ID NOW and BD MAX virus tests, from a consumer perspective, the brand of FDA-authorized test is likely less important than how quickly results can be obtained and provided, i.e., same day or several days. Often this is less a function of the equipment used than whether or not that equipment is on-site or off-site, so you'll need to ask your testing group. As noted above, some places can get results the same day, while others may take days.

The FDA-authorized at-home PCR self-tests, the Lucira Check It COVID-19 Test Kit and the Lucira COVID-19 All-In-One-Test Kit, take 30 minutes to run, achieved a 94% positive percent agreement and a 98% negative percent agreement with a lab-based PCR test for patients with signs and symptoms of COVID-19 infection (i.e., people likely to have high levels of virus). If virus levels are low, it may miss cases that a lab-based test would catch.

With regard to antigen tests that must be performed in a clinical setting, based on information provided by the companies themselves and published by the FDA, the Sofia antigen test and the BD antigen test appear to be among the most specific, with both tests correctly identifying 100% of tests negative by PCR, but Sofia is more sensitive, correctly identified 96.7% of samples known to be positive with PCR testing missing just 1 out of 30 positives), compared to BD which missed 5 out of 31 positives, getting only 83.9% of them correct. The LumiraDx SARS-CoV-2 Ag Test is more sensitive than the BD test but slightly less specific.



At-home tests
The FDA has authorized several fully self-administered virus tests for use at home (FDA Antigen Diagnostic Tests for SARS-CoV-2). There are two types, antigen test and PCR test, each with pros and cons.




Home antigen tests:
These provide results within 15 minutes. They can be used on symptomatic individuals (using a single test) or for surveillance — testing people with or without symptoms, although this requires taking the test twice over three days at least 36 hours apart.

If used to check if you have been infected due to close contact but you are not symptomatic, the CDC recommends getting tested about 5 days after exposure, but it may be appropriate to test even sooner. For instance, an Omicron outbreak in Norway showed the average time between exposure and symptom development to be only 3 days (with a range of 2 to 5 days), which is shorter than the 4.3-day incubation period for Delta and 5-day incubation period for other variants (Brandal, Eurosurveillance 2021). For this reason, it may be wise to consider testing 2 or 3 days after exposure (rather than 5), although you should still follow up with a second test 2 to 3 days later even if your test results are negative.

Advantages:

• Can be purchased over-the-counter without a prescription.
• Relatively inexpensive at this time (costing about $7 to $12 per test). Beginning sometime in January, the cost may be reimbursable through private insurance, including Affordable Care Act plans, as announced by U.S. President Biden. Although details have not yet been announced, CNBC reported that some short-term or health-care sharing plans may not provide reimbursement and, for people who are uninsured or on Medicaid and Medicare, free at-home tests may become more widely available at clinics, health centers and some pharmacies, but these individuals will not be eligible for reimbursement for purchased at-home tests.
• Very rapid.
• Most antigen tests should be able to detect the Omicron variant because mutations appear to have little impact on the nucleocapsid protein, which is the target of most antigen tests in the U.S. The Omicron mutations predominantly affect the spike protein, which is not the target of most antigen tests. Tests by the NIH show that the Abbott BinaxNOW and Quidel QuickVue tests detect the Omicron variant as effectively as other variants. Evaluations of other brands of antigen tests are ongoing (FDA, SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests).

Disadvantages:

• Not as sensitive as a PCR tests, so may miss early and later phases of infection.
• More likely than PCR tests to miss some variants if they affect virus proteins on which the tests focus. Fortunately, most antigen tests (including the two currently available for home use — below) focus on nucleocapsid proteins, which are less subject to variation than spike proteins, so they should be able to detect most variants, which have mutations that affect spike proteins. Some less-common variants, however, have mutations affecting nucleocapsid proteins. (PCR tests generally have multiple targets to detect the virus, such that even if a mutation impacts one of the targets, the other targets will still work.)

If positive on an antigen test, you may be highly infectious and should self-isolate and contact your healthcare provider. False negatives can occur if steps are not followed properly. False positives can also occur, sometimes due to mishandling the test (see FDA warning). If negative, you could still be infectious — either at an early or late stage of infection or with a variant.

Here is how the home antigen tests compare. In short, several good home antigen tests (BinaxNow Self Test, QuickVue, and Flowflex) are available that have been shown to correctly identify at least 90% of positive samples and 99% of negative samples, and there are others that fall below that mark (iHealth, BD Veritor, On/Go, AccessBio CareStart, and InteliSwab). Note that all antigen tests should be used within the first six days of symptoms, and all focus on the nucleocapsid antigen, so should be able to pick up the Omicron variant, as well as Delta.

Among these tests, our Top Pick is QuickVue, as it appears to be slightly better than the others at correctly identifying positive specimens, based on results submitted to the FDA by each brand. Its cost ($23.99 for two tests) is the same as that of the BinaxNow (although, at Walmart, you can get the BinaxNOW for less than QuickVue -- just $14 for two tests). Flowflex is a similar type of test (with one extra step) that is a little less expensive ($9.99 for a single test), but is somewhat more likely to miss positive samples than QuickVue.

iHealth picks up slightly more positives that Flowflex but also reports more false negatives than most of the tests -- which can be a problem, particularly as most people taking tests are actually negative. On/Go has the distinction of reporting the most false negatives and is the most expensive test on Amazon, although it is also sold at half the price on Target under the name AccessBio CareStart. BD Veritor is also on the more costly side but is not among the most accurate, and requires an app (which does not work on all phones) to interpret the results. InteliSwab is among the least expensive but is also the least accurate and only seems to be available online. Ellume no longer seems to be on the market since it announced a massive recall in October, although it had appeared to be a very accurate test.

• Quidel QuickVue is an antigen test available over-the-counter and that provides results within 15 minutes on a test strip that gets dipped in a small tube of solution. It has been shown to correctly identify 96.6% of positive samples and 99.3% of negative samples collected from people within five days of symptom onset (FDA). Like the BinaxNOW COVID-19 Self Test, positive results are most accurate within the first six days of symptoms; it includes two tests for serial testing; and samples can be self-collected by nasal swab (from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult). Regarding the Omicron variant, Quidel has stated "While our studies are ongoing, the early data give us confidence that our American-made PCR and rapid antigen tests can detect COVID-19 caused by the Omicron variant." QuickVue is available for $23.99 (providing two tests) at CVS, Walgreens, Walmart and other retail and online vendors.
• Abbott BinaxNOW COVID-19 Antigen Tests:
  
  -- BinaxNOW COVID-19 Self Test (includes 2 tests for serial testing) is an antigen test (focusing on nucleocapsid antigens) available over-the-counter (it is similar to a BinaxNow antigen test introduced for use at point-of-care settings in 2020, which was shown to correctly identify 91.7% of positive samples and 100% of negative samples in samples collected from people with symptoms within the past seven days) (FDA). It uses nasal swab sample that can be self-collected by people age 15 or older (or collected by an adult for children age 4 or older). The swab is inserted into a card to which you apply a solution from an included small dropper bottle. If the first test is negative, the second test should be conducted within three days, but at least 36 hours later. If the first test is positive, you should self-isolate and contact your healthcare provider. It's available online and in stores at CVS and Walgreens for $23.99, and at Walmart for $14.00. Abbot has indicated that it is confident that its rapid and PCR tests can detect this variant.
  
  Be aware that the Abbott antigen test, when evaluated in a real-world setting in Germany in early 2021, was much less accurate than noted above, particularly for patients who had no symptoms. Overall, it was only able to correctly identify 56.8% of positive samples (i.e., its sensitivity). Among people with symptoms, the sensitivity was 75.2%, particularly when the symptom was elevated body temperature (91.7% sensitivity), but this fell to just 31.9% among those without symptoms. Sensitivity was also lower with Alpha variant samples, the predominant variant at the time. On a positive note, the test was more than 99% specific, i.e., able to correctly identify negative samples. (Note: In Germany the test is called Panbio rather than BinaxNOW). The study found similar results with Roche's antigen test (SD Biosensor COVID-19 Ag), which is not currently available in the U.S. As expected, the antigen tests performed better when viral loads were relatively high, as during the acute phase of illness (Wertenauer, medRxiv 2021 preprint). These results highlight limitations of antigen tests, and reinforce the importance of the 2nd test at least 36 hours later (as required with the Self Test) and other measures noted above. Interestingly, earlier real-world testing of the Abbott antigen test in San Francisco in late 2020 found better results than those above, correctly identifying 98.5% of positives (including 100% of positives in people with symptom onset within seven days of testing and 97.5% of positives in people who were asymptomatic or experienced symptom onset more than seven days before testing) (Pilarowski, Clin Infect Dis 2020).
  
  -- Abbott BinaxNOW COVID-19 Antigen Home Test (includes 1 test per package) is the same test as the Self Test but includes the ability to get a digital pass (Navica) that can be used at selected events and on some airlines (the list of airlines accepting Navica is very limited -- perhaps only United flights to Jamaica; other forms of proof of testing are more commonly accepted by airlines). However, unlike the Self-Test, it is not sold over-the-counter -- it must be ordered through eMed.com, which can FedEx the test to you the next day (except weekends) and is only sold in packs of 6. You get 6 individual tests for $150, plus shipping and taxes. When you are ready to take the test, you perform the test while online with an eMed representative. You'll also need to create a free account on the Navica app. If the test is negative, eMed issues you a temporary pass on Navica, which usually takes 15 minutes but can take up to 24 hours to issue. That pass is valid for 72 hours if negative, or 7 days if positive. So, unfortunately, you cannot simply go into a pharmacy, buy a test, test negative, and get a pass. You'll need to spend $150+ and wait for your test to arrive before you get potentially get a pass.
• Flowflex (from ACON Laboratories) is an antigen test available over-the-counter and that provides results within 15 minutes on a test cassette after applying drops of solution made from swirling a swab in solution in a test tube. It has been shown to correctly identify 93% of positive samples and 100% of negative samples collected from people within seven days of symptom onset (FDA). Flowflex is available for $9.99 (for one test) from CVS.
• iHealth COVID-19 Antigen Rapid Test is available over-the-counter and provides results within 15 minutes on a test cassette after applying drops of solution made from swirling a swab in solution in a test tube. It has been shown to correctly identify 94.3% of positive samples and 98.1% of negative samples collected from people within seven days of symptom onset (FDA 2021). An app is also available to upload results and create a "iHealth Pass," although it is questionable if this is electronic pass would be accepted as proof of a negative test since the test is not witnessed by an independent party. iHealth is available for $13.98 plus shipping (for two tests) at ihealthlabs.com or for $17.98 on Amazon.
• BD Veritor At-Home COVID-19 Test (from Beckton Dickenson) is an antigen test available over-the-counter and that provides results within 15 minutes on a test cassette after applying drops of solution made by swirling a swab in solution in a test tube. An app is required to then interpret the results and this works only on iPhones 7 or higher or Samsung or Pixel phones. It has been shown to correctly identify 85.7% of positive samples and 99.8% of negative samples collected from people within seven days of symptom onset (FDA 2011). BD Veritor only seems to be available online and sells for $26.50 (providing two tests) on Amazon.
• On/GO which is also sold as AccessBio CareStart (the name under which it is authorized by the FDA) is an over-the-counter test and that provides results within 10 to 15 minutes on a test cassette after applying drops of solution made by swirling a swab in solution in a test tube. It has been shown to correctly identify 87% of positive samples and 98% of negative samples collected from people within seven days of symptom onset (FDA 2021). On/Go is available for $34.99 (providing two tests) on Amazon but also sold for just $15.79 at Target.
• InteliSwab COVID-19 Rapid Antigen Test (from OraSure) is an antigen test available over-the-counter and that provides results within 15 minutes on a test cassette after applying drops of solution made by swirling a swab in solution in a test tube. It has been shown to correctly identify 84% of positive samples and 98% of negative samples collected from people within seven days of symptom onset (FDA). InteliSwab is available for $14.00 (providing two tests) at Walmart online.
• Ellume COVID-19 Home Test was the first antigen test available over-the-counter in the U.S., but is not widely available. It provides results within 15 minutes at home via a smartphone app. It has been shown to correctly identify 96% of positive samples and 100% of negative samples collected from people with six days of symptom onset, and 91% of positive samples and 96% of negative samples in people without symptoms. Positive results are most accurate within the first six days of symptoms. Samples can be self-collected by nasal swab, except for children ages 2 to 16 for whom an adult must collect the sample. [Update: On October 1, 2021, Ellume announced a recall of almost 200,000 Ellume COVID-19 home test kits due to a manufacturing defect that can cause false positive results (i.e., indicating that someone has COVID-19 when they do not). As many as one-quarter of positive tests with these kits may be inaccurate, according to a New York Times interview with Dr. Sean Parson, Ellume's chief executive officer. The affected products were distributed to retailers and distributors from April 2021 through August 2021. You can check if your product was recalled on Ellume's website. Individuals who attempt to use the recalled tests will be notified in the Ellume COVID-19 Home Test app. Ellume will be directly contacting customers who used an affected product before 09/17/2021 and tested positive. The FDA advised consumers who had a positive result not to assume they have developed immunity to COVID-19, and they should continue taking precautions, including vaccination, to avoid COVID-19 infection. The test does not appear to be currently available for sale on CVS.com, where it was previously sold. Prior to the recall, Ellume had been available for $39 from CVS locations as well as on CVS.com.]

Home PCR tests:
These take 30 minutes and are more accurate than antigen tests and more likely to pick up variants.

• Lucira Check It COVID-19 Test Kit, which uses PCR, can be purchased by consumers directly from Lucira's website. It does not require a prescription. It is a single-use test that works by swirling a self-collected nasal swab sample (from the inside walls of both nostrils) in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit's light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus (see below for accuracy). According to Lucira, the test is also able to detect alpha, beta, delta, gamma, lambda, mu and omicron variants of the virus. The test is authorized for self-collection for individuals aged 14 or older and adult collection for children aged 2-13. The test costs $75, which may be reimbursed by insurance (see Lucira's website and check with your insurance for details). Online orders are processed within two business days, and ground shipping is free (expedited shipping available at additional cost). It is the same test as the Lucira COVID-19 All-In-One-Test Kit, which requires a prescription and is available to healthcare providers.

At-home sample collection

• Pixel from LabCorp allows users to collect their own nasal swab samples and mail them to LabCorp for testing. Pixel was initially only available to healthcare workers and first responders but is now generally available. The test is currently available for purchase online through Walgreen's Find Care program at a cost of $119 if used for basic screening purposes, but is also available for no upfront cost to consumers (and billed to consumers' health insurance or paid by federal funding for uninsured) who are experiencing symptoms, have been exposed to someone who is infected, or if directed to test by their healthcare provider. It is also available through CVS.com and for over-the-counter purchase and at select CVS Pharmacy locations. No prescription is necessary.
• Everlywell COVID-19 Test Home Collection Kit ($109) is sent to users after completing an online eligibility questionnaire. The kit allows users to collect their own nasal swab samples. Samples are then sent directly to an accredited laboratory. The company promises online results within 3-5 days from purchase and results are reviewed by a physician.
• Kroger Health COVID-19 Test Home Collection Kit is currently available to Kroger employees and will soon be available to non-employees. Based on results of an online screening, a healthcare professional will issue a prescription and the home collection kit is shipped to the home within 24-48 hours. The home collection kit includes a nasal swab, transport vial, instruction sheet, prepaid shipping label, and packing materials for return shipment of the sample to the laboratory. Upon receipt of the home collection kit, a healthcare professional guides the home collection process via video chat. The patient will then ship their sample overnight to Gravity Diagnostics, which has developed an FDA authorized virus test yielding results 96.8% and 100% in agreement with the CDC's own tests, respectively, on positive and negative samples. Results are provided online or by phone within 24-48 hours.
• Rutgers Clinical Genomics Laboratory allows users to collect their own saliva sample using a special collection device and return it for testing at Rutgers. This test requires a prescription.
• Quest Diagnostics Self-Collection Kit for COVID-19 +Flu received FDA authorization in December 2020 and allows users to collect their own nasal swab sample and return it to Quest Diagnostics laboratory for analysis for the SARS-CoV-2 virus as well as influenza A and B. Compared to nasopharyngeal samples collected by healthcare professionals, results using this kit have an extremely high percent agreement (99.6+%) for influenza samples and somewhat less but still fairly high agreement for SARS-CoV-2 (96.4% positive agreement and 98% negative agreement). This test requires a prescription.

Antibody Test
There are significant differences in the accuracy of antibody tests based on their "sensitivity," or their ability to identify those with antibodies to SARS-CoV-2 (true positive rate), and their "specificity," or their ability to identify those without antibodies to SARS-CoV-2 (true negative rate).

As noted earlier, the tests also differ as to whether they look for antibodies to the virus spike proteins (proteins on the outside of the virus that can bind to receptors on human cells), nucleocapsid proteins (proteins inside the virus), or both. An advantage to testing for antibodies to the nucleocapsid is that these antibodies can be easier to detect; however, antibodies to the spike proteins are believed to be more important in conferring immunity against the virus, as these antibodies may block viral entry into cells — although antibodies to nucleocapsid proteins may still serve as proxies for immunity.

Although it is not recommended that antibody tests be relied upon to determine the effectiveness of vaccines, be aware that only tests that focus on antibodies to spike protein would be useful for this purpose because the authorized vaccines generate antibodies only to spike proteins. A negative result on a nucleocapsid antibody test provides no information about the effectiveness of a vaccine although it would suggest that a person has not had COVD-19. The list of authorized antibody tests below indicates whether a test focuses on spike, nucleocapsid, or both types of proteins.

If, at some point, tests for spike protein antibodies are indicated for assessing antibody response to COVID-19 vaccines, those that provide a quantitative or semi-quantitative measurement, will be more useful than those that provide only a yes/no answer. As shown below, several authorized antibody tests focus on the spike protein and are semi-quantitative.

An example of a semi-quantitative test for spike protein antibodies is the Roche Elecsys Anti-SARS-CoV-2 S (IgG) (note the "S" for "spike"), which is available from LabCorp where it is listed as test number 164090 (this specific test must be requested when ordered, otherwise the more common, nucleocapsid test, may be run, which will not provide useful results.) This test is 96.6% sensitive and 100% specific, as shown in the table below. A result of 0.8 U/mL or greater with this test indicates detectable antibodies, although results will typically be much higher. Antibody levels 3 to 4 weeks after the 2nd dose of the Pfizer vaccine were shown to generally range from about 30 U/mL up as much as 9,000 U/mL in a group of 185 people ages 70 to 89 in England, although most were in the 100 — 1,300 U/mL range. Even higher results were seen among those who previously had COVID (Subbarao, Eurosurveil 2021). The implications of these values in terms of protection, however, has not yet been determined. (Quantifiable results for this test are normally up to 250 U/mL, but when results are higher, labs may perform dilutions to obtain a quantifiable value).

Quest Diagnostics also offers a semi-quantitative lab-based test for spike protein antibodies (listed as test number 34499) which is manufactured by Siemens as its SARS-CoV-2 IgG (COV2G) test. It has a sensitivity of 100% (somewhat better than the test at LabCorp) and specificity of 99.9%. Values are reported based on an index, with results of 1.00 or greater indicating a positive result. The semi-quantitative reportable range is 1.00 to 20.00 (Quest, FAQ, Question 9). However, the implications of these values in terms of protection has not yet been determined.

Siemens makes several similar tests, which are more sensitive, although it not clear which labs in the U.S. offer these tests. Abbott has developed a quantitative/semi-quantitative spike protein antibody test (SARS-CoV-2 IgG II Quant) but this test is not yet authorized for use in the U.S., although it has received certification in Europe.

Agencies within the U.S. government, such as the NIH, have been evaluating the FDA-authorized antibody tests. Ongoing evaluations of the 29 currently authorized tests (see table below) show that sensitivity ranges from 88% to 100% and specificity ranges from 94.4% to 100%. Only three tests provide 100% on both measures: Babson Diagnostics and InBios SCoV-2 Detect IgG (which improved since its original release), both of which are run on high-throughput systems, and Hangzhou Biotest, a rapid test. Babson is offering its antibody test for free to COVID-19 patients and front-line workers in the Austin, Texas area. The Hangzhou Biotest product is being marketed in the U.S. by Premier Biotech. (Note: Rapid test strip products cannot be purchased for home use, but must be performed in an authorized laboratory or, in some instances, a point-of-care facility, such as a pharmacy.)

The next best performing products, all of which require high throughput systems run on laboratory devices, are Abbott Alinity, Abbott Architect, Roche Elecsys, and four tests from Siemens — its ADVIA Centaur, ADVIA Atellica, Dimension EXL, and Dimension Vista, each providing 100% sensitivity and, respectively, 99%, 99.6%, 99%, 99.8%, 99.8, 99.9%, and 99.8% specificity. These tests are offered in many hospitals and commercial laboratories, including the two largest commercial labs in the U.S., Quest Diagnostics (uses Abbott Architect and another test) and LabCorp (uses Roche Elecsys as well as other tests). A doctor can order these specific tests.

The first rapid antibody test to be authorized by the FDA for use in point-of-care settings is the Assure COVID-19 IgG/IgM Rapid Test, which is available for $25 without at prescription at Krogerlocations using blood from a fingerprick. It has 100% sensitivity and 98.8% specificity and the indicator on the test stick shows results for both IgM (antibodies that last only a few weeks) and IgG (more persisting antibodies) to the virus spike or nucleocapsid.

Note that in a population where few people (e.g., 5%) actually have antibodies, positive results on a test that is not at 100% specific (such as the test from Healgen that provides 97.56% specificity and 100% sensitivity) may only be correct 67.8% the time, although a negative result would nearly always be correct.

 

[missy]

Part 2.

Selected Antibody Tests Authorized by the FDA

PRODUCT	VIRAL TARGET1	SENSITIVITY	SPECIFICITY
ELISA-based Equipment:
Abbott Alinity i SARS-CoV-2 IgG	Nucleocapsid	100%	99%
Abbott Architect SARS-CoV-2 IgG	Nucleocapsid	100%	99.6%
Babson Diagnostics aC19G1 (IgG)	Spike	100%	100%
Beckman Coulter Access SARS-CoV-2 IgG	Spike	96.8%	99.6%
Bio-Rad Platelia SARS-CoV-2 Total Ab (IgG)	Nucleocapsid	92.2%	96.6%
DiaSorin LIASON SARS-CoV-2 S1/S2 IgG	Spike	97.6%	99.3%
Diazyme Laboratories Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit	Spike and Nucleocapsid	100%	97.4%
Emory Medical Laboratories SARS-CoV-2 RBD IgG	Spike	100%	96.4%
EUROIMMUN SARS-COV-2 ELISA (IgG)	Spike	90%	100%
InBios SCoV-2 Detect IgG	Spike	100%	100%
InBios SCoV-2 Detect IgM ELISA	Spike	96.7%	98.8%
Luninex xMAP SARS-CoV-2 Multi-Antigen IgG	Spike and Nucleocapsid	Not posted by FDA	Not posted by FDA
Mount Sinai Hospital Clinical Laboratory COVID-19 ELISA Antibody Test (IgG/IgM)	Spike	92.5% *	100% *
Ortho-Clinical Diagnostics VITROS (IgG)†	Spike	90%	100%
Roche Elecsys Anti-SARS-CoV-2 (IgG)	Nucleocapsid	100%	99.8%
Roche Elecsys Anti-SARS-CoV-2 S (IgG)	Spike (Semi-quantitative)	96.6%	100%
Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 IgG (COV2G)	Spike (Semi-quantitative)	100%	99.9%
Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 IgG (COV2G)	Spike (Semi-quantitative)	100%	99.9%
Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 Total (COV2T) (IgG)	Spike	100% *	99.8% *
Siemens Healthcare Diagnostics ADVIA Atellica IM SARS-CoV-2 Total (COV2T) (IgG)	Spike	100%	99.8%
Siemens Healthcare Diagnostics Dimension EXL SARS-CoV-2 Total antibody assay	Spike	100% *	99.9% *
Siemens Healthcare Diagnostics Dimension Vista SARS-CoV-2 Total antibody assay	Spike	100% *	99.8% *
Vibrant America Clinical Labs COVID-19 Ab	Spike and Nucleocapsid	98.1% *	98.6% *
Wadsworth New York SARS-CoV Antibody Detection (IgG)	Nucleocapsid	88%	98.8%
Rapid Test Strip**:
Assure Tech. Assure COVID-19 IgG/IgM Rapid Test [Also authorized for Point-of-Care settings]	Spike and Nucleocapsid	100% *	98.8% *
Beijing Wantai Biological Pharmacy Enterprise	Spike	100% *	98.8% *
Biohit Healthcare (Hefei) SARS-CoV-2 IgM/IgG	Nucleocapsid	96.7% *	95% *
Cellex qSARS-CoV-2 IgG/IgM Rapid Test	Spike and Nucleocapsid	93.8% *	96% *
Healgen COVID-19 IgG/IgM Rapid Test Cassette	Spike	100%	97.5%*
Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM	Spike	100% *	100% *
Hangzhou Laihe Biotech LYHER Novel Coronavirus IgM/IgG (Colloidal Gold)	Spike	100% *	98.8% *
Megna Health Rapid COVID-19 IgM/IgG Combo Test	Nucleocapsid	Not posted by FDA	Not posted by FDA
Salofa Oy Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test	Spike	Not posted by FDA	Not posted by FDA

Bold text indicates higher accuracy compared to most other tests.
*Combined IgG and IgM performance.
** Rapid test strips are known as "lateral flow" tests. Currently, may only be performed in an
authorized or certified clinical laboratory.
† Ortho's reagent pack and calibrator have also been evaluated and authorized
†† Requires separate reader device.
1 Viral Target refers to the viral proteins targeted by the antibodies found in the test. Antibodies to spike proteins likely play a greater role in immunity, although antibodies to nucleocapsid proteins may serve as a proxy for immunity.



A project in California involving researchers at universities and biology institutes, including the Chan Zuckerberg Biohub, tested ten rapid test strip products — none of which were approved by the FDA. Six had CE certification from Europe and four had no certification. A preliminary reportindicated that many of the rapid tests were less effective at correctly identifying COVID-19 antibodies than previously claimed. The results also highlighted the importance of waiting at least 21 days after symptom onset to detect antibodies and after symptoms have subsided, as the proportion of correct positive diagnoses (or sensitivity) was extremely low in blood samples from people who had virus for less than two weeks. For example, the sensitivity of the BioMedomics "COVID-19 IgM/IgG Rapid Test" increased from just 31% (5 days or less), to 64% (6 to 10 days), 76% (11-15 days), 81% (16-20 days), and 82% for over 20 days.

What Does a Negative Antibody Test Mean?
If you took a coronavirus antibody test and it came back negative, it can mean one of several things:

• The test was not sensitive enough to detect antibodies that existed. This is more likely if the test had a sensitivity of less than 100% (see Finding the Best COVID-19 Test — Antibody Test for sensitivities of FDA-authorized tests);
• You may have never had COVID-19;
• You took the test too early -- generally less than 20 days after first disease symptoms, although, according to the CDC, some people may take longer; or
• You didn't develop levels of antibodies high enough to be detected by tests -- which preliminary research suggests may happen in mild and asymptomatic cases (Long, Nature Med 2020).

There is currently not enough data to know if a negative result could result from taking the test too late. More research is needed to determine how long significant levels of antibodies to SARS-CoV-2 persist.

The CDC cautions, "Regardless of whether you test positive or negative, the results do not confirm whether or not you are able to spread the virus that causes COVID-19. Until we know more, continue to take steps to protect yourself and others."

Can COVID-19 Tests Identify Which Variant Caused an Infection?
Although COVID-19 tests can identify if you've been infected by SARS-CoV-2, the standard tests cannot identify which variant caused your infection although, if a PCR test is negative for the spike protein gene but positive for other genes of the virus, this is suggestive of infection with the Omicron strain. . Special genomic sequencing tests can make variant identification, but this is not available for individual diagnostic purposes. It is used for surveillance purposes: The CDC and public health partners characterizes variants from 750 SARS-CoV-2 samples each week, and commercial diagnostic laboratories contracted by the CDC sequence about 20,000 samples per week to estimate the prevalence of variants in the general population (CDC's Role in Tracking Variants, Updated June 17, 2021).

[You can see a list of all current, FDA-authorized virus and antibody tests on the FDA website. Virus tests are listed as "Molecular" or "Antigen" tests, while antibody tests are listed as "Serology" tests. A medical diagnostics industry website, 360dx.com, has also been tracking tests that have been given FDA-allowance and/or the "CE mark" for conforming to European standards. On that site, most virus tests are denoted as "PCR" (the scientific term for the method of genetic amplification), while most antibody tests denoted as "serological."

 

[missy]

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Significant Increase' in Protection vs Omicron From MRNA Boosters, Study Says​

By Reuters Staff
December 24, 2021

COPENHAGEN (Reuters) - Getting a third dose of either Pfizer-BioNTech's or Moderna's COVID-19 vaccine offers a "significant increase" in protection against the Omicron variant in elderly people, according to a Danish study published on Wednesday.
The study, published ahead of peer review on medRxiv, investigated the effectiveness of COVID-19 vaccines that use so-called mRNA technology against the Delta variant and the new, more infectious Omicron variant.
"Our study contributes to emerging evidence that BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) primary vaccine protection against Omicron decreases quickly over time, with booster vaccination offering a significant increase in protection," the authors wrote in the study.
The study was conducted by researchers at Denmark's top infectious disease authority, Statens Serum Institut (SSI). It analysed data from three million Danes gathered between Nov. 20 and Dec. 12.

Among those who recently had their second vaccine dose, effectiveness against Omicron was measured at 55.2% for Pfizer-BioNTech and 36.7% for Moderna, compared to unvaccinated people.

But that protection quickly waned over the course of five months, the researchers said.
"We see that the protection is lower and decreases faster against Omicron than against the Delta variant after a primary vaccination course," study author Palle Valentiner-Branth said.
However, a third dose of Pfizer-BioNTech's vaccine restored protection to 54.6% in people aged 60 or more who had been inoculated 14 to 44 days earlier, compared to those with only two doses.
The study confirms the findings of a recent British study, which also showed a rapid decline in protection against Omicron over time and an increase following a booster with Pfizer-BioNTech's vaccine.
"In light of the exponential rise in Omicron cases, these findings highlight the need for massive rollout of vaccinations and booster vaccinations," the researchers said.

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[missy]

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France Cancels Order for Merck's COVID-19 Antiviral Drug​

By Reuters Staff
December 23, 2021

PARIS (Reuters) - France has cancelled its order for Merck & Co's COVID-19 antiviral drug following disappointing trial data and hopes instead to receive Pfizer's competing drug before the end of January, the health minister said on Wednesday.
France is the first country to publicly say it has cancelled an order for the Merck treatment after the company released data in late November suggesting its drug was markedly less effective than previously thought, reducing hospitalisations and deaths in its clinical trial of high-risk individuals by about 30%.
"The latest studies weren't good," Olivier Veran told BFM TV.
Merck did not immediately respond to Reuters' request for comment.

While vaccines are the main weapons against COVID-19 for governments, there are hopes Merck and Pfizer's experimental pills could be a game-changer in reducing the chances of dying or hospitalisation for those most at risk of severe illness.

France had placed an early order for 50,000 doses of the nucleoside analogue drug molnupiravir developed by Merck and Ridgeback Biotherapeutics.
The cancellation would not incur a cost, Veran said.
In Italy, the office of the special commissioner for the COVID emergency said on Nov 18 it had received a mandate from the health ministry to buy 50,000 courses of Merck's pill and another 50,000 of Pfizer's. "The contract has not yet been finalised, but is in progress," a spokesperson for the commissioner told Reuters on Tuesday.

Italian drug regulator Aifa's head Nicola Magrini told a Senate committee on Dec. 9 the two treatments could be available in Italy from the end of January.
However, regardless of the availability of the drugs, there will be assessments of their use, two top government scientific advisers told Reuters.
"There must and will be an evaluation, independently of the assessments of regulatory bodies," Walter Ricciardi, top adviser of health minister Roberto Speranza, told Reuters.
Germany has already bought Merck's antiviral treatment, health minister Karl Lauterbach told Reuters on Wednesday.

"This is a binding order," he said, adding Berlin was also in talks with Pfizer about buying its antiviral drug.

The European Medicines Agency is expected to decide whether to approve the Merck and Pfizer pills in the new year.

Pfizer's Paxlovid, a protease inhibitor, has shown near 90% efficacy in preventing COVID-19 hospitalisations and deaths in high-risk patients.

France had purchased that drug instead, Veran said, without saying how many doses it had secured.

"France is lined up to get it before the end of January," Veran continued. It has not yet been decided whether the drug would be available over the counter in pharmacies, the minister said.
"

 

[missy]

"

Epicentre of Omicron Outbreak in S.Africa Passes Peak: Scientists​

By Emma Rumney and Estelle Shirbon





JOHANNESBURG (Reuters) - COVID-19 cases appear to have peaked in South Africa's Gauteng province about a month after the Omicron variant was first detected there and the impact of surging infections has been less severe than previous waves, scientists said on Wednesday.
Scientists from the National Institute of Communicable Diseases (NICD) said that while more study was needed, the data from South Africa - whose experience is being closely watched around the world - told a "positive story" about the variant's severity.
Gauteng, South Africa's commercial hub, home to one of the continent's busiest airports and the region where Omicron first emerged, is now seeing a fall in daily cases and the percentage of positive tests, the NICD's Michelle Groome told a news briefing.
"Really we feel that this has persisted for over a week and that we are past the peak in Gauteng," she said.

There had been a "levelling off" in three other provinces - Limpopo, North West and Mpumalanga, she added, though cases were still increasing elsewhere.

NICD data showed that the seven-day moving average of daily cases - which the scientists say is more reliable than daily confirmed cases - was on a downward trajectory in Gauteng.
A graph showed a steep rise in cases from close to zero in mid-November to an average of 10,000 daily cases early in December. That had since fallen sharply to around 5,000 per day on average.
LOWER DEATH TOLL
Groome cautioned that some of the lower case numbers could be due to lower levels of testing during the holiday period.
South Africa, now maintaining the lowest level of a five-tier system of restrictions despite a rapid surge in infections, is monitoring hospitalisation levels very closely.
While these have also risen, they have so far remained far below the levels seen during previous waves of the pandemic, with deaths also lower than seen in the past and people staying in hospital for shorter periods, the NICD's Waasila Jassat said, warning however that relevant data tended to lag.
Infections in the first four weeks of the fourth coronavirus wave, driven by Omicron, rose well above those seen in the previous three waves, NICD data showed, but the proportion of people admitted to hospital stood at 5.7%, compared to above 13% in the other waves.

The proportion of people admitted to hospital who later died meanwhile dropped to 5.6%, compared with 19% or above in the first, second or third waves.

Some 87% of COVID-19 deaths seen in South Africa between Nov. 7 and Dec. 18 were of people who were unvaccinated or not fully vaccinated, the data showed.



"

 

[missy]

"

US Testing Struggles to Keep Up With Omicron​

By Carl O'Donnell and Ahmed Aboulenein




NEW YORK/WASHINGTON (Reuters) - A surge in U.S. COVID-19 cases from the Omicron variant is overwhelming testing capacity in high-infection areas like New York City due in part to staffing shortages among healthcare workers and the limited number of open test sites, according to interviews with more than a dozen officials, health providers, and testmakers.
Some testing centers, such as the New York area's CityMD, have had to shut sites due to a lack of workers, causing long lines in others, they say. The demand is exacerbated by a months-long shortage of at-home rapid tests in pharmacies that has worsened in hardest-hit regions.
The highly contagious Omicron variant has become the dominant coronavirus strain in the United States in the past 10 days. U.S. infections have doubled since early November to a seven-day average of more than 150,000 cases per day, according to a Reuters tally. One national lab company said testing has increased more than 30% in the past week. States where infections are climbing such as Ohio and Texas also said they were struggling to keep up with demand.
"The issue... in our community is with access," said Dr. John D'Angelo, who heads emergency medicine at Northwell Health, a health system in New York. "The demand for rapid testing is driving long lines at our testing sites."

A spokesperson for XpresCheck, which provides COVID-19 tests at 11 U.S. airports, said recent staffing shortages have worsened the impact of rising infections, resulting in longer wait times for airport testing.

The United States has a shortage of workers across industries with about 11 million available jobs going unfilled, according to the Bureau of Labor Statistics.
In healthcare and social work, about 8.3% of jobs are vacant based on October federal data, about 1.5 percentage points above the overall rate.
"Our big one-two punch is an Omicron surge... with unprecedented depletion of our health care workers," said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.
Demand for tests will likely increase until January based on current models of the virus's spread, said Mark Stevenson, chief operations officer at Thermo Fisher Scientific, a testmaker.
The White House has invested $3 billion since September with the aim of quadrupling U.S. production of rapid at-home tests to 200 million per month by December.


Several testmakers told Reuters they have more than doubled capacity in recent months putting tens of millions more tests on the market each month.

That would still fall far short of the number of rapid at-home tests that health experts say are needed for the country's 330 million residents.


The White House on Tuesday said it will open testing centers across the country, starting with one in New York City before Christmas. It also plans to provide 500 million rapid at-home tests for free directly to consumers starting January.


"By the time these tests are rolled out, we will very likely be right in the middle of the peak, if not past it," said Sam Scarpino, managing director of pathogen surveillance at the Rockefeller Foundation's Pandemic Prevention Institute.


Thermo Fisher said it is boosting its supply from around 5 million COVID-19 tests per week in October to as much as 20 million by the end of the year. Quidel Corp says it has increased its test production to a run-rate of around 70 million per month, up from around 20 million earlier this year.


Testmaker InBios International, one of 11 FDA-approved at home tests, expects to supply up to 5 million tests monthly starting in January.


Experts caution that the White House's purchases of 500 million rapid tests could divert supplies from retailers and some healthcare providers.


A report by the Kaiser Health Foundation assessing the availability of four rapid home COVID-19 tests at six major U.S. online retailers found that tests were unavailable 73% of the time in November, compared to 95% in September.


"Test manufacturers can only make a finite number of tests," said Lindsey Dawson, an associate director of healthcare policy at the Kaiser Family Foundation.


"Whether what's leftover...is enough for consumers looking to pick up tests at their drugstore (or) community health center, is something that we'll have to watch."

"

 

[missy]

From the NEJM​

Protection against Covid-19 by BNT162b2 Booster across Age Groups​

List of authors.

• Yinon M. Bar-On, M.Sc.,
• Yair Goldberg, Ph.D.,
• Micha Mandel, Ph.D.,
• Omri Bodenheimer, M.Sc.,
• Laurence Freedman, Ph.D.,
• Sharon Alroy-Preis, M.D.,
• Nachman Ash, M.D.,
• Amit Huppert, Ph.D.,
• and Ron Milo, Ph.D.

Abstract​

BACKGROUND​

After promising initial results from the administration of a third (booster) dose of the BNT162b2 messenger RNA vaccine (Pfizer–BioNTech) to persons 60 years of age or older, the booster campaign in Israel was gradually expanded to persons in younger age groups who had received a second dose at least 5 months earlier.

METHODS​

We extracted data for the period from July 30 to October 10, 2021, from the Israel Ministry of Health database regarding 4,696,865 persons 16 years of age or older who had received two doses of BNT162b2 at least 5 months earlier. In the primary analysis, we compared the rates of confirmed coronavirus disease 2019 (Covid-19), severe illness, and death among those who had received a booster dose at least 12 days earlier (booster group) with the rates among those who had not received a booster (nonbooster group). In a secondary analysis, we compared the rates in the booster group with the rates among those who had received a booster 3 to 7 days earlier (early postbooster group). We used Poisson regression models to estimate rate ratios after adjusting for possible confounding factors.

RESULTS​

The rate of confirmed infection was lower in the booster group than in the nonbooster group by a factor of approximately 10 (range across five age groups, 9.0 to 17.2) and was lower in the booster group than in the early postbooster group by a factor of 4.9 to 10.8. The adjusted rate difference ranged from 57.0 to 89.5 infections per 100,000 person-days in the primary analysis and from 34.4 to 38.3 in the secondary analysis. The rates of severe illness in the primary and secondary analyses were lower in the booster group by a factor of 17.9 (95% confidence interval [CI], 15.1 to 21.2) and 6.5 (95% CI, 5.1 to 8.2), respectively, among those 60 years of age or older and by a factor of 21.7 (95% CI, 10.6 to 44.2) and 3.7 (95% CI, 1.3 to 10.2) among those 40 to 59 years of age. The adjusted rate difference in the primary and secondary analyses was 5.4 and 1.9 cases of severe illness per 100,000 person-days among those 60 years of age or older and 0.6 and 0.1 among those 40 to 59 years of age. Among those 60 years of age or older, mortality was lower by a factor of 14.7 (95% CI, 10.0 to 21.4) in the primary analysis and 4.9 (95% CI, 3.1 to 7.9) in the secondary analysis. The adjusted rate difference in the primary and secondary analyses was 2.1 and 0.8 deaths per 100,000 person-days.

CONCLUSIONS​

Across the age groups studied, rates of confirmed Covid-19 and severe illness were substantially lower among participants who received a booster dose of the BNT162b2 vaccine than among those who did not.







...snip

Discussion
We sought to determine whether the booster dose had a similar effect across different age groups and have indeed found that the booster dose reduced the rate of confirmed infection and severe illness by a similar factor in the age groups studied (although in the youngest age group, a larger reduction factor against confirmed infections was observed). The temporal pattern of the rate ratio between the booster group and the nonbooster group after booster vaccination was also similar across age groups. These findings are consistent with those of the phase 2–3 clinical trial of the BNT162b2 vaccine,11 in which vaccine efficacy was similar across age groups.
Although in our primary analysis we attempted to address confounding and detection bias, some sources of bias may not have been measured or corrected adequately. These biases might include differences between booster recipients and those who chose not to receive the booster with respect to risk-avoidance behaviors and coexisting conditions, neither of which are recorded in the national database. Moreover, participants’ risk-avoidance behavior and propensity to perform PCR tests are probably modified after receipt of the booster dose. In our secondary analysis, we tried to reduce the extent of confounding bias between the booster group and the nonbooster group by focusing solely on persons who received the booster dose and comparing rates during a period in which the booster was expected to have a small effect (days 3 to 7 after vaccination) with those during a period in which it had become effective (≥12 days after vaccination).
Although this type of analysis reduces confounding bias, because all participants potentially contribute days at risk to both groups, estimates of the rate ratio during the first days after vaccination could include the effect of transient biases. These potential biases include the “healthy vaccinee” bias,12 in which people who feel ill tend not to get vaccinated in the following days, leading to a lower number of infections in the booster group during the first days after vaccination. Moreover, one would expect that detection bias due to behavioral changes such as the tendency to perform fewer PCR tests after booster vaccination is more pronounced just after receiving the dose (days 3 to 7) and that this bias declines over time. Thus, potential behavioral biases under this approach are expected to underestimate the true rate ratio. The secondary analysis showed a decrease in the rate of confirmed infection across age groups by a factor of approximately 5. Although the primary and secondary analyses were exposed to different biases and resulted in somewhat different estimates, both suggested a notable reduction in the rate of confirmed infections. With respect to severe illness in the booster group as compared with the nonbooster group (Table 3), the analysis shows decreased rates of severe Covid-19 in both age groups considered, but with wider confidence intervals owing to the lower number of cases of severe illness in those 40 to 59 years of age.
As compared with our previous analysis of the elderly population,2 we made two methodologic modifications in the current analysis. First, instead of including indicators for calendar dates in order to adjust for exposure risk, we calculated a spatial–temporal index of risk according to the number of infections in each area of residence. This method better measures the exposure risk for each participant. Second, in our secondary analysis, we compared the rates 12 or more days after receipt of the booster with the rates 3 to 7 days after its receipt, instead of 4 to 6 days. This change was made to increase the number of person-days at risk in the early postbooster group and enabled us to apply the secondary analysis to severe Covid-19 as well.
Understanding the protective effect of the booster dose in younger age groups is key for forming public health policy. Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant delta variant in persons 16 years of age or older. Future studies will help determine the longer-term effectiveness of the booster dose against current and emerging variants.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Mr. Bar-On and Dr. Goldberg and Drs. Huppert and Milo contributed equally to this article.
This article was published on December 8, 2021, at NEJM.org.
We thank Ronen Fluss for productive feedback on an earlier version of the manuscript.

 

[missy]

"
What is the best way to use rapid tests?

As many of us consider the best way to gather safely for the holidays, odds are this question has come up a lot. We’re in a weird place in the pandemic. The virus is surging once again, with the more contagious omicron variant on the loose. Slowing the spread is essential to preventing health systems from becoming overwhelmed and protecting vulnerable populations, including people with less access to vaccines.

If you’re vaccinated, early data suggest omicron presents very little threat of severe illness, yet there’s still a risk of infection. That's where rapid tests can come in particularly handy: They aren’t fool-proof, but they’re a good way to detect Covid, even when people don't have symptoms. As such, rapid testing offers a potential middle ground between locking down entirely and abandoning all caution.

But rapid tests can also be confusing. For a little clarity on best practices, we turn to two of our favorite Sunday Covid Q&A experts.

Jessica Justman, a Columbia University Medical Center epidemiologist, says it’s critical to set ground rules for testing and stick to them. She says that anyone who tests positive should leave a gathering immediately, and that everyone should keep their masks on until they test negative. The testing location is also important.

“Outdoors is great, but not if it’s cold or windy,” she says. “If it is cold or windy, find a quiet indoor corner away from the main gathering. You will need a space with enough horizontal surfaces (table tops, countertops) to set up the test kits during the incubation time.”

A QuickVue at-home Covid-19 test made by Quidel Corp.

Photographer: John Tully/Bloomberg

Organizing the testing process ahead of time can help prevent mistakes like sample mix-ups, Justman says. So she suggests keeping a permanent marker on hand to label test kits and lots of hand sanitizer to prevent contamination throughout the testing process. Also, she says, be sure to read the instructions carefully and use a timer with an alarm to know when the results are ready.

“You can’t wing this and hope for the best,” she says. “Pay attention to the description of which parts you can touch with your fingers and which parts you should not touch. Move slowly and carefully to avoid dropping the test kit components on the ground. Open up each component when you need it, not before.”

Rapid tests are best used as a screening tool for people without any symptoms of illness, says Vanderbilt University infectious-disease specialist William Schaffner. While faster than PCR tests, they’re not quite as accurate. So if you don’t feel well or know you’ve been exposed to the virus, it’s best to opt for a PCR test and stay home until you have a negative result.

But if you’re vaccinated, feel fine and have had no known Covid exposure, rapid testing is a great way to add another layer of protection to holiday gatherings.

”Rapid tests can add a level of reassurance to allow us to move to this new normal,” Schaffner says.

"

 

[missy]

Coronavirus Can Persist for Months After Traversing Body​

By
Jason Gale


The coronavirus that causes Covid-19 can spread within days from the airways to the heart, brain and almost every organ system in the body, where it may persist for months, a study found.

In what they describe as the most comprehensive analysis to date of the SARS-CoV-2 virus’s distribution and persistence in the body and brain, scientists at the U.S. National Institutes of Health said they found the pathogen is capable of replicating in human cells well beyond the respiratory tract.

The results, released online Saturday in a manuscript under review for publication in the journal Nature, point to delayed viral clearance as a potential contributor to the persistent symptoms wracking so-called long Covid sufferers. Understanding the mechanisms by which the virus persists, along with the body’s response to any viral reservoir, promises to help improve care for those afflicted, the authors said.


“This is remarkably important work,” said Ziyad Al-Aly, director of the clinical epidemiology center at the Veterans Affairs St. Louis Health Care System in Missouri, who has led separate studies into the long-term effects of Covid-19. “For a long time now, we have been scratching our heads and asking why long Covid seems to affect so many organ systems. This paper sheds some light, and may help explain why long Covid can occur even in people who had mild or asymptomatic acute disease.”

The findings and the techniques haven’t yet been reviewed by independent scientists, and mostly relate to data gathered from fatal Covid cases, not patients with long Covid or “post-acute sequelae of SARS-CoV-2,” as it’s also called.

Contentious Findings​

The coronavirus’s propensity to infect cells outside the airways and lungs is contested, with numerous studies providing evidence for and against the possibility.

The research undertaken at the NIH in Bethesda, Maryland, is based on extensive sampling and analysis of tissues taken during autopsies on 44 patients who died after contracting the coronavirus during the first year of the pandemic in the U.S.

The burden of infection outside the respiratory tract and the time taken to clear the virus from infected tissues aren’t well characterized, particularly in the brain, wrote Daniel Chertow, who runs the NIH’s emerging pathogens section, and his colleagues.

The group detected persistent SARS-CoV-2 RNA in multiple parts of the body, including regions throughout the brain, for as long as 230 days following symptom onset. This may represent infection with defective virus particles, which has been described in persistent infection with the measles virus, they said.

“We don’t fully understand long Covid, but these changes could explain ongoing symptoms,” said Raina MacIntyre, professor of global biosecurity at the University of New South Wales in Sydney. MacIntyre wasn’t involved with the research, which she said “provides a warning about being blasé about mass infection in children and adults.”

Precautionary Approach​

“We don’t yet know what burden of chronic illness will result in years to come,” she said. “Will we see young-onset cardiac failure in survivors, or early onset dementia? These are unanswered questions which call for a precautionary public health approach to mitigation of the spread of this virus.”

In contrast to other Covid autopsy research, the NIH team’s post-mortem tissue collection was more comprehensive and typically occurred within about a day of the patient’s death.


The researchers also used a variety of tissue preservation techniques to detect and quantify viral levels, as well as grow the virus collected from multiple tissues, including lung, heart, small intestine and adrenal gland from deceased Covid patients during their first week of illness.

“Our results collectively show that while the highest burden of SARS-CoV-2 is in the airways and lung, the virus can disseminate early during infection and infect cells throughout the entire body, including widely throughout the brain,” the authors said.

The study provides pathologic data that support findings of previous research showing, for example, that SARS-CoV-2 directly kills heart muscle cells, and that those who survive an infection suffer cognitive deficits, said MacIntyre at the University of New South Wales.

‘Viremic’ Phase​

The latest Covid updates

Make sense of the headlines and the outbreak's global response with the Coronavirus Daily.




The N.I.H. researchers posit that infection of the pulmonary system may result in an early “viremic” phase, in which the virus is present in the bloodstream and is seeded throughout the body, including across the blood-brain barrier, even in patients experiencing mild or no symptoms. One patient in the autopsy study was a juvenile who likely died from unrelated seizure complications, suggesting infected children without severe Covid-19 can also experience systemic infection, they said.


The less-efficient viral clearance in tissues outside the pulmonary system may be related to a weak immune response outside the respiratory tract, the authors said.


SARS-CoV-2 RNA was detected in the brains of all six autopsy patients who died more than a month after developing symptoms, and across most locations evaluated in the brain in five, including one patient who died 230 days after symptom onset.

The focus on multiple brain areas is especially helpful, said Al-Aly at the Veterans Affairs St. Louis Health Care System.

“It can help us understand the neurocognitive decline or ‘brain fog’ and other neuropsychiatric manifestations of long Covid,” he said. “We need to start thinking of SARS-CoV-2 as a systemic virus that may clear in some people, but in others may persist for weeks or months and produce long Covid -- a multifaceted systemic disorder.”

 

[missy]

Flight cancellations that disrupted U.S. travel over the Christmas weekend stretched into Monday, with winter storms further pressuring carriers that were already short-staffed because of spreading Covid-19 cases. With a monstrous surge of infections tied to the omicron variant forcing U.S. airlines to scrap about 2,800 flights over the holiday, President Joe Biden’s chief medical adviser said a domestic travel rule requiring vaccinations to fly should be seriously considered. —David E. Rovella

Bloomberg is tracking the coronavirus pandemic and the progress of global vaccination efforts.

Here are today’s top stories​

The Biden administration is seeking to expand pop-up sites and the availability of at-home Covid-19 test kits. The U.K. government won’t introduce stricter restrictions in England before the end of the year despite the rapid spread of omicron there. And in France, working from home three days a week is about to become compulsory. The global infection rate is now close to matching that of the worst wave of the coronavirus. Here’s the latest on the pandemic.

As one of Wall Street’s staunchest advocates of making employees return to their desks, Goldman Sachs is bucking the trend among banks to loosen work-from-home rules in the face of omicron.

Photos of the aftermath of a Christmas Eve massacre in Myanmar that reportedly left more than 30 people dead, including women and children burned inside vehicles, have triggered outrage against the military junta there that’s already killed more than 1,300 civilians since February.


Smokes and flames billow from vehicles in Hpruso township, Myanmar, on Dec. 24. Source: Karenni Nationalities Defense Force/AP Photo
There’s little reason to fear that the rally that catapulted U.S. stocks to successive records this year will end soon, according to JPMorgan strategists. In fact, it may get broader they say: “The market has taken the hawkish central bank and bearish omicron narratives too far.” On Monday, U.S. stocks rose for a fourth day amid thin trading as investors evaluated prospects for a year-end rally amid spiking coronavirus cases. Oil gained and the Treasury curve flattened. Here’s your markets wrap.

As a blockbuster year for cryptocurrencies ticks to a close, some of the smallest players are having a moment. Polkadot and Cardano were among coins posting the biggest moves on Monday, with each up more than 6%.

Some 72% of chief executive officers are worried about losing their jobsnext year because of business disruptions like the labor market and supply chain crunches.

India has barred the Catholic religious order and philanthropic organization started by Mother Teresa from accessing foreign donations.

 

[missy]

New CDC guidance recommends that vaccinated and boosted healthcare staff no longer quarantine after high-risk exposures and shortens the isolation time for those testing positive, if asymptomatic.

New York state saw a fourfold increase in COVID-19 hospitalizations among children over the past 3 weeks, about half of which involved kids under 5 years of age. (NBC News)

Meanwhile, New York Magazine explores the "infuriating wait" for a vaccine for children under 5.

Why did the Biden Administration reject a plan for scaling up free rapid tests ahead of the holidays? (Vanity Fair)
British researchers found the risk of hospitalization with Omicron to be 40-45% lower than with the Delta variant. (Reuters)

The FDA authorized Merck's molnupiravir for adults at high risk of serious COVID-19, though only in cases where other authorized treatment options "are not accessible or clinically appropriate" -- a far more narrow indication than for Pfizer's pill.

In either case, experts warned that careful monitoring for both of these antivirals is needed as they may interact with commonly used medications. (NBC News)

FDA also approved secukinumab (Cosentyx) for treating enthesitis-related arthritis and psoriatic arthritis in children and adolescents, Novartis announced.

As of Monday at 8 a.m. EST, the unofficial U.S. COVID toll is 52,283,401 cases and 816,610, increases of 1,436,560 cases and 10,172 deaths versus this time a week ago.

Protection from symptomatic COVID with the Omicron variant appears to lessen within 10 weeks of a booster, British research suggests. (New York Times)

Medical experts are pressing the government for action to ensure boosters reach nursing home residents. (New York Times)

Roughly 2,100 more flights were canceled globally on Monday as the Omicron variant continues to sicken airline crews. (New York Times)

"We're sailing on a petri dish," said a passenger of the Carnival Freedom cruise ship that was turned away from its port because of COVID infections on board -- at least six other cruises were similarly forced to alter course. (Washington Post)

Across the pond, France witnessed more than 100,000 daily COVID-19 cases for the first time on Sunday. (AP)

Despite Australia's first Omicron-related death, officials there appear committed to the country's reopening plan. (Reuters)

Researchers took a look at how kids exposed to the Zika virus are developing 5 years later. (NPR)

Could the conviction of a Harvard scientist with ties to China have a chilling effecton international research? (STAT)
E.O. Wilson, a pioneering evolutionary biologist and Harvard professor, died at age 92 on Sunday. (New York Times)

While city dwellers in Brazil were getting their boosters, here's how medical teams delivered first and second shots to the hard-to-reach riverine people, or ribeirinhos. (Science)

Mehmet Oz, MD, the Republican celebrity physician running for a Senate seat in Pennsylvania, promoted chloroquine and hydroxychloroquine for treating COVID-19 in 25 separate appearances on Fox in the spring of 2020. (New York Times)

 

[missy]

Here’s the latest news from the pandemic. China starts to disinfect city of 13 million people after delta outbreak Fauci warns of complacency with virus set to fill hospitals Singapore to require vaccinations for foreigners working in city

Pregnant women come last​

The omicron variant is heightening risks for this little-talked-about demographic: pregnant women. Left out of early vaccine trials and faced with confusing messages and misinformation on the dangers to their unborn children, a disproportionately large number of pregnant women have steered clear of Covid shots. About 75% of expectant mothers in the U.K. and about 65%in the U.S. remain unvaccinated, making them among the groups most at risk of getting infected and being exposed to severe forms of the diseaseas the fast-spreading omicron strain sweeps the globe. At least 17 pregnant women and four babies have died from Covid-19 in England between May and October, figures published last week show. Over that period, 98% of pregnant women admitted to intensive care were unvaccinated. Also, since July, one in five Covid patients receiving treatment in England through a special lung-bypass machine was an unvaccinated expectant mother. A nurse helps a pregnant woman during the Covid-19 pandemic. Photographer: Martin Bureau/AFP/Getty Images “The uptake of vaccination in pregnant women is depressingly low, and significant numbers of women have come to serious harm as a result of this,” Chris Whitty, the U.K.’s chief medical adviser, told lawmakers on Dec. 16. “Pregnancy’s a period of vulnerability. We really should have made that point even clearer earlier on.” Take Antonia, for instance. The London lawyer, who’s seven months pregnant, got her first jab before she was pregnant but struggled over her second, post-pregnancy inoculation. Vaccine centers didn’t have reassuring answers to her questions, and she got the shot with a lot of trepidation. “I was so nervous I booked the vaccination so many times and canceled it,” says Antonia, 38, who’s having her second child and didn’t want to reveal her last name. “I just thought, ‘It’s not my life here, it’s somebody else’s life I’m making decisions about.’” Many maternal-care specialists saw the problem coming when women weren’t included in clinical trials. At least one drugmaker tried. In February, Pfizer initiated a mid-stage study in pregnant women before moving to advanced-stage testing in June. But low enrollment and the ethical dilemma of giving placebos to expectant mothers when vaccines were already recommended saw the trial halted with less than 10% of its target 4,000 volunteers. Peter Marks, head of the U.S. Food and Drug Administration’s vaccine program, says if the agency could start over, it would do things differently. “If we weren’t in such a pandemic ‘all-out’ mode, we probably could have started a trial early on in pregnant women,” Marks said in an interview. If he could go back, Marks said he’d likely initiate a test for pregnant women “within a few months after we had safety data flowing in from the phase 3 clinical trials.”—Suzi Ring

 

[missy]

Stats as of today....NJ 21.4% positivity rate

Positive Covid 19 tests by state.

States ranked by COVID-19 test positivity rates: Dec. 23​

States ranked by COVID-19 test positivity rates - Becker's Hospital Review | Healthcare News & Analysis

Here are the rates of positive COVID-19 tests in each state, along with the number of new cases most recently reported and number of tests conducted per 1,000 people.

www.beckershospitalreview.com

"
Here are the rates of positive COVID-19 tests in each state, along with the number of new cases most recently reported and number of tests conducted per 100,000 people.
Data points were last updated Dec. 23. Data for positivity rates and tests are seven-day moving averages. New cases are daily counts as reported by states and the District of Columbia. The information cited is from the Johns Hopkins Coronavirus Resource Center. States are arranged in descending order of test positivity rates.
For user-friendly data on current COVID-19 hospitalizations and death rates, please refer to The New York Times' presentation of HHS data here.

District of Columbia: 108.6%
New Daily Cases: 1524
Tests per 100k: 148
Kansas: 53.4%
New Daily Cases: 5074
Tests per 100k: 110.5
Vermont: 51.8%
New Daily Cases: 651
Tests per 100k: 132.2
New Jersey: 48.5%
New Daily Cases: 11906
Tests per 100k: 160.5
Pennsylvania: 48.2%
New Daily Cases: 9838
Tests per 100k: 107.5
Wisconsin: 47.2%
New Daily Cases: 5726
Tests per 100k: 127.3
Colorado: 34.1%
New Daily Cases: 3723
Tests per 100k: 104.7
Nevada: 25.%
New Daily Cases: 1165
Tests per 100k: 106.6
Idaho: 23.1%
New Daily Cases: 355
Tests per 100k: 63.6
Ohio: 20.7%
New Daily Cases: 12864
Tests per 100k: 367.2
Oklahoma: 16.7%
New Daily Cases: 1482
Tests per 100k: 148.9
Michigan: 16.6%
New Daily Cases: 16216
Tests per 100k: 441.1
Missouri: 13.7%
New Daily Cases: 3675
Tests per 100k: 295.9
Iowa: 13.4%
New Daily Cases: 0
Tests per 100k: 255.8
Texas: 13.1%
New Daily Cases: 10121
Tests per 100k: 259.4
New Hampshire: 12.%
New Daily Cases: 1304
Tests per 100k: 745.2
Tennessee: 11.8%
New Daily Cases: 3669
Tests per 100k: 230.4
Georgia: 11.5%
New Daily Cases: 7610
Tests per 100k: 298.2
Indiana: 11.3%
New Daily Cases: 4778
Tests per 100k: 605.4
Virginia: 11.%
New Daily Cases: 5972
Tests per 100k: 300.5
Kentucky: 10.6%
New Daily Cases: 2894
Tests per 100k: 369.4
Delaware: 10.4%
New Daily Cases: 673
Tests per 100k: 243.1
Connecticut: 10.3%
New Daily Cases: 3366
Tests per 100k: 478.7
Arkansas: 9.2%
New Daily Cases: 897
Tests per 100k: 183.7
Utah: 9.%
New Daily Cases: 1406
Tests per 100k: 275.3
Nebraska: 8.7%
New Daily Cases: 1269
Tests per 100k: 469.2
New York: 8.6%
New Daily Cases: 28924
Tests per 100k: 1345.9
New Mexico: 8.4%
New Daily Cases: 905
Tests per 100k: 581.9
Mississippi: 8.3%
New Daily Cases: 873
Tests per 100k: 140.2
Maine: 8.2%
New Daily Cases: 1462
Tests per 100k: 541.4
Minnesota: 8.2%
New Daily Cases: 2804
Tests per 100k: 526.5
North Carolina: 8.2%
New Daily Cases: 4889
Tests per 100k: 360
Florida: 8.1%
New Daily Cases: 0
Tests per 100k: 474.5
Arizona: 7.5%
New Daily Cases: 2806
Tests per 100k: 452
West Virginia: 7.3%
New Daily Cases: 1149
Tests per 100k: 625.1
South Dakota: 7.1%
New Daily Cases: 466
Tests per 100k: 309.7
Hawaii: 6.9%
New Daily Cases: 961
Tests per 100k: 638.2
North Dakota: 6.9%
New Daily Cases: 383
Tests per 100k: 392.4
Massachusetts: 6.8%
New Daily Cases: 8602
Tests per 100k: 1340.9
South Carolina: 6.8%
New Daily Cases: 1330
Tests per 100k: 338
Illinois: 6.%
New Daily Cases: 16581
Tests per 100k: 1514.8
Alabama: 5.8%
New Daily Cases: 1460
Tests per 100k: 226.2
Oregon: 5.4%
New Daily Cases: 1163
Tests per 100k: 528.6
Rhode Island: 5.4%
New Daily Cases: 1811
Tests per 100k: 1691.3
Louisiana: 5.3%
New Daily Cases: 2205
Tests per 100k: 384.9
Alaska: 3.4%
New Daily Cases: 232
Tests per 100k: 697.8
Wyoming: 3.%
New Daily Cases: 156
Tests per 100k: 298.4
Montana: 2.8%
New Daily Cases: 246
Tests per 100k: 318
California: 2.7%
New Daily Cases: 10903
Tests per 100k: 778.6
Maryland: -8.%
New Daily Cases: 4072
Tests per 100k: -701.9
Washington: N/A
New Daily Cases: 2071
Tests per 100k: 0
%MCEPASTEBIN%

"

Coronavirus disease 2019 (COVID-19) - Symptoms and causes

www.mayoclinic.org

 

[missy]

COVID Concerns Reemerge After Months of Rebounding Heart Care​

— What does Omicron have in store for heart patients?​

by Nicole Lou, Staff Writer, MedPage Today December 27, 2021

On Jan. 12, 2021, MedPage Today reported on early studies describing COVID-19's indirect effects on cardiovascular testing and deaths around the world. As a review of the year's top stories, we report on the ongoing challenges in closing the backlog of routine heart care.
While COVID-19 vaccines were authorized late last year, 2021 was the year that vaccination finally became available to most Americans, many of whom had had cardiovascular care disrupted the previous year -- whether for fear of contracting SARS-CoV-2 in healthcare facilities, because their elective procedures were cancelled, or other reasons.

With widespread COVID vaccination in place by the spring of 2021, there was hope that more patients would return to the medical care that they had gone without for months.
For example, the sharp reduction of U.S. adult cardiac surgery volumes starting in April 2020, along with high procedural mortality, were documented in a study of the Society of Thoracic Surgeons Adult Cardiac Surgery Database. By July 2020, heart surgery volumes reportedly bounced back to approximately pre-pandemic levels -- although still not enough to make up for the pile-up of missed operations accrued in the first year of the pandemic.
However, by May 2021, things appeared to be back to normal. Hospitals were no longer bursting at the seams and more than half of the U.S. adult population was at least partially vaccinated against COVID-19. Interventional cardiologists said their cath labs had been back to business as usual for months. In Israel, where more adults were vaccinated, operators were working longer hours to catch up on in a backlog of catheterizations.




Yet the recent wave of Omicron infections around the world has some concerned that systems of cardiovascular care are about to be tested again.
"Our services for patients with heart disease at the Royal Infirmary of Edinburgh are unchanged currently. The main challenge for cardiology services will be to maintain staffing levels over the winter period. We are already stretched and with more community transmission of coronavirus, colleagues will have to be flexible and cover staff absences to maintain these services," said cardiologist Nicholas Mills, MBChB, PhD, of his institution in Scotland.
The importance of staffing was highlighted when an interventional cardiologist was recorded as Israel's first Omicron COVID-19 patient in late November. He reported extreme fatigue for 72 hours and was back working at the cath lab, still weak, 10 days after his diagnosis.
"The most important message for our patients is that they should continue to seek help for acute cardiac care despite the pandemic and emergence of Omicron," Mills told MedPage Today in mid-December.

"At present we are taking care of patients the way we've been doing, but of course are concerned about patients and staff getting COVID in this wave. Contingency planning is the key and just making sure that everyone tries to stay as safe as possible and is fully boosted with vaccinations is key," said interventional cardiologist Ajay Kirtane, MD, SM, of Columbia University Irving Medical Center/NewYork-Presbyterian in New York City.
In the U.S., more than 72% of adults are fully vaccinated -- the gaps in vaccination arising in part due to fears of side effects.
Fanning the flames were alarming reports of myocarditis after COVID vaccination throughout the year, which were countered by studies suggesting a favorable clinical course for those affected, even in a diverse population. There was general consensus that post-vaccination myocarditis is rare, even if some estimates are higher than others.

For clinicians, the larger worry was the suffering in store for heart patients in the long run in light of their weight gain, lifestyle changes, and deferred healthcare during the pandemic. Even the American Heart Association announced that it was backing away from its Impact Goal for 2020-2023 to increase life expectancy around the world; its new focus toward 2024 would be on health equity projects instead.
"The United States is facing an oncoming wave of death and disability from CCDs [common chronic diseases], especially cardiometabolic diseases ... The fight against COVID-19 has given us a glimpse of what is possible. If we act now, we can significantly reduce the damage from the impending tsunami," wrote former FDA commissioner (and current nominee for a return tenure) Robert Califf, MD, of Verily Life Sciences, in a commentary published in April.
In a recent guidance statement tailored to the pandemic, the European Society of Cardiology reminded people with cardiovascular disease to continue maintaining a healthy lifestyle, taking their prescribed heart medications, and staying on top of their cardiac follow-up appointments.

 

[MaisOuiMadame]

Thank you Missy !!

 

[missy]

CDC Cuts Isolation Time for COVID-Affected Americans to 5 Days

"
U.S. health authorities on Monday shortened the recommended time for isolation for asymptomatic Americans with COVID-19 to five days from the previous guidance of 10 days.

​

The Centers for Disease Control and Prevention also said the people who test positive after quarantining should follow five days of wearing a mask when around others.

Omicron accounts for 73% of U.S. coronavirus infections, the federal CDC had said last week.

Breakthrough infections are rising among the fully vaccinated population, including those who have had a third booster shot. However, Omicron appears to be causing milder symptoms in those people, some of whom have no symptoms at all.


Reducing the CDC's 10-day quarantine recommendation would help asymptomatic people return to work or school, with proper precautions, White House medical adviser Anthony Fauci had told CNN last week.


The CDC on Monday also gave guidance for people who are unvaccinated or are more than six months out from their second mRNA dose or more than two months after the Johnson & Johnson (JNJ.N) vaccine and not yet boosted. It recommended quarantine for them for five days followed by strict mask use for an additional six days.


Individuals who have received their booster shot do not need to quarantine following an exposure should wear a mask for 10 days, the CDC said.
"

 

[missy]

Surging NYC Coronavirus Spread Brings Warnings for Children​

Larry Neumeister, Associated Press

"

NEW YORK (AP) — The spiraling coronavirus outbreak numbers in New York state are coming with a new warning of a disturbing rise in pediatric hospitalizations — particularly of unvaccinated children — even as the state touts a high vaccination rate among adults.
The New York State Department of Health's warning Friday of a "striking increase" in new hospital admissions for children was being publicized a day later as many coronavirus testing centers in New York City were closed for Christmas.
A health advisory said the recent fourfold increase in admissions that began the week of Dec. 5 are concentrated in New York City and the surrounding area, where the highly contagious omicron variant was spreading rapidly.

"The risks of COVID-19 for children are real," acting State Health Commissioner Dr. Mary T. Bassett said in a release.

"We are alerting New Yorkers to this recent striking increase in pediatric COVID-19 admissions so that pediatricians, parents and guardians can take urgent action to protect our youngest New Yorkers. We must use all available safe and effective infection control, prevention and mitigation strategies," she said.
Basset said parents should protect children who are 5 and older by getting them fully vaccinated while children under 5 are protected by ensuring those around them have been vaccinated and gotten boosters while adhering to other protective measures including mask-wearing, avoiding crowds and testing.
On Friday, Gov. Kathy Hochul boasted at a cheerful coronavirus update briefing of the state's high vaccination rate, saying that 95% of New York adults over age 18 have had at least one vaccine dose.

She also disclosed that the number of new infections had soared above 44,000 on Thursday to a new single-day record. Still, the rising numbers had not translated to a corresponding rise in hospitalizations or deaths, though those statistics tend to be lagging indicators.
Her words came as New Yorkers continued struggling to get tested for the coronavirus, with many sites closed on Saturday, and testing kits in short supply. The desperation was apparent at a free giveaway of home coronavirus test kits in a Brooklyn neighborhood where police had to be called to quell a crowd of angry people who were disappointed when the supply ran out.
The state health department advisory later Friday provided a grimmer picture for children.
For the week ending last Sunday, no 5- to 11-year-old child admitted to a hospital for COVID-19 treatment was fully vaccinated, it said.

And only a quarter of 12- to 17-year-olds who were admitted to the hospital were fully vaccinated, it said.

"These startling trends underscore the critical importance of protecting our children from COVID-19. The Department urges parents and guardians of all children five years and older to get their kids fully vaccinated as soon as possible," the advisory stated.



"

 

[dk168]

No further restrictions in England for the time being, and I shall have a (scheduled twice weekly) lateral flow test before I go out in the evening on 31 December.

Likely to be the last time I shall go to the pub that I frequent for a while as they have decided to close the whole of January when it is quiet and with punters doing "Dry January" etc., etc...

DK

 

[dk168]

The NYE event at the pub has been cancelled due to staff shortage as both of them have to self-isolate.

One of them is a close friend, double-vaccinated and boosted, and was tested positive on a home LFT this morning, having tested negative on Monday 27 December; and he and I attended the same small gathering at a friend's house on Sunday 26 December!

I was tested negative on a home LFT on Tuesday 28 December.

Although I am not planning to test again until tomorrow, on hearing my friend has tested positive on a LFT this morning, and I did sit next to me at the house party on Sunday 26 December; and have a medical appointment early afternoon today; I decided to take a test a day early than scheduled.

The result of today's test is negative, PHEW!

This is the closest Covid-19 scare for me to date.

DK

 

[missy]

The Centers for Disease Control and Prevention shortened the recommended isolation time for people infected with the coronavirus. The new guidance issued this week says you need only isolate for five days instead of 10 — if you're asymptomatic at the end of that period. After that, you should wear a mask around others for an additional five days, according to the CDC. Officials said the change was primarily driven by concerns that tens of thousands of police officers, firefighters and other essential workers could be sidelined with minor infections as the omicron variant pushes caseloads to new heights. But it's been met with skepticism. Some high-profile health experts said the move was premature and faulted the CDC for not requiring a negative test to end isolation, while some labor leaders argued that the guidance seemed more aligned with business interests than public health.

The outlook on omicron is still a mixed bag. Healthy people who have been vaccinated — particularly those with booster shots — appear unlikely to get severely sick from omicron, according to medical experts who have been tracking the new pathogen. Early data from U.S. hospitals seems to line up with international studies indicating omicron may lead to fewer hospitalizations than the delta variant. But the jury is still out on older, boosted patients or people with underlying conditions. And even if their risks are lowered, the sheer transmissibility of omicron still threatens to overwhelm the nation's beleaguered hospital systems, experts say.

The seven-day average for new cases reached record levels in the United States this week, surpassing a previous high set in January and climbing above 266,000 on Wednesday, less than a month after omicron was first detected in the country. The previous high was seen in mid-January, before the vaccines were widely available. The District of Columbia is leading the surge, facing some of the country's highest per capita infection and hospitalizations.

Across the country, people who did their best to avoid the virus are getting infected. The protections so many Americans have taken the last two years haven't been enough to prevent some transmission of the highly contagious omicron variant, and as a consequence even the strictest followers of public health guidance have tested positive. It's a sobering reality for some. "You’re probably going to get covid," one expert said, "but it’s okay."

Amid the variant's lightning fast spread, political leaders and public health experts are urging Americans to scrap their New Year's Eve plansand stay home a second year in a row. “Omicron and delta are coming to your party,” Illinois Gov. J.B. Pritzker (D) said. Flight disruptions continued, with more than 800 cancellations in the United States Wednesday, though cancellations were down overall from the thousands seen last week.

Other important news​

A federal court denied the Oklahoma governor's attempt to halt the military vaccine mandate. The requirements are important to maintaining a healthy force, the judge said.

The coronavirus is spreading on cruise ships again. But there's no shutdown in sight for the industry.

Nursing homes are woefully understaffed as the pandemic enters its third year. It's worsening problems at overwhelmed hospitals.

Parents hoped this school year might be "normal." It hasn’t turned out that way.

 

[missy]

And yet another (of so many) casualty indirectly caused by Covid.
And this is why those who refused to get vaccinated who are medically cleared to do so are selfish, irresponsible and contributing to innocent people's deaths. Yes that is right. You decide not to get vaccinated? And this is the result.

"He died after waiting 15 days for a hospital bed. His family blames unvaccinated covid-19 patients.​

Dale Weeks, center, died last month in Iowa. His family blames the surge in unvaccinated covid-19 patients in the state for him not getting the treatment he needed. (Jenifer Owenson)
By Timothy Bella
December 28, 2021|Updated December 28, 2021 at 4:30 p.m. EST


Throughout his life, Dale Weeks was characterized by family and friends in Iowa as “a good neighbor,” someone who would do anything for anyone. So when he was diagnosed with sepsis last month, the retired schools superintendent and his family hoped he would get immediate care and be okay to reunite with them for the holidays.

But at a time when unvaccinated covid-19 patients have again overwhelmed hospitals because of the fast-spreading omicron variant, finding an available bed at a large medical center able to give him the treatment he needed proved to be difficult. Weeks was being treated at a small, rural hospital. He had waited 15 days to be transferred to a larger hospital with better treatment options, because facilities throughout Iowa did not have an open bed for him as a result of the latest hospital surge of unvaccinated patients, his children told The Washington Post.
“It was terribly frustrating being told, ‘There’s not a bed yet,’ ” Jenifer Owenson, one of his four children, said Tuesday. “All of us were talking multiple times a day, ‘Why can’t we get him a bed?’ There was this logjam to get him in anywhere.”


When Weeks was finally able to have surgery more than two weeks later, his condition from sepsis had worsened. Weeks died Nov. 28 of complications after surgery. He was 78.
Anthony Weeks, his son, said that the family believes their vaccinated and boosted father was the latest indirect victim of the pandemic — and that he would have survived his sepsis diagnosis if he was immediately admitted to a larger medical center that had an open bed.
“The frustrating thing was not that we wanted him to get care that others weren’t getting, but that he didn’t get care when he needed it. And when he did get it, it was too late,” he said. “The question comes up of: ‘Who was in those beds?’ If it’s people who are unvaccinated with covid, then that’s the part where it really hurts.”
Owenson added: “The thing that bothers me the most is people’s selfish decision not to get vaccinated and the failure to see how this affects a greater group of people. That’s the part that’s really difficult to swallow.”



Marcy Peterson, a spokeswoman with MercyOne, the hospital system that cared for Dale Weeks in Newton, Iowa, did not get into the specifics of his case, but she acknowledged the frustration surrounding hospitals that are again overwhelmed with unvaccinated patients. She said in a statement to The Post that “a large percentage” of covid-19 patients at MercyOne hospitals are unvaccinated.
“In addition to an increased number of covid-19 cases and spread of the delta and omicron variants, hospitals across the country are dealing with traumas and experiencing multiple types of illness,” Peterson said. “This demand is coupled with a reduced number of staff to care for patients. These challenges can strain available resources and contribute to delays in care or other complications for patients.”

"