Coronavirus Updates January 1, 2022

[missy]

Wow two years into the pandemic.
Here we are.
Definitely much further along and better off despite a surge at the moment.

"

COVID-19, Sure, but What Else Will We Remember 2021 For?​

Damian McNamara, MA


The ongoing COVID-19 pandemic was the biggest medical news or event of 2021, according to an overwhelming 84% of 987 of our readers who answered a recent Medscape Medical News poll. Perhaps no surprise there.

Coming in distant second, at 26%, was the new law requiring that patients be granted electronic access to clinical notes. The controversial FDA approval of aducanumab (Aduhelm, Biogen/Eisai) to treat Alzheimer's disease was next, cited by almost 16% when asked what they would remember most about 2021.

Coming in at 10% or less were the permanent end to the Step 2 Clinical Skills test, the JAMA deputy editor resignation over controversial comments, and an "other" option that allowed for write-in responses.

It should be noted respondents could choose up to three answers to this and other questions in this survey, except for questions about profession and specialty.

Exciting News in 2021​

Widespread availability of COVID-19 vaccines was the number one response ― chosen by 85% ― when asked what medical news or events excited them in 2021.


FDA clearance of a 5-minute test for early dementia was selected by 22%, followed by almost 16% citing approval in October 2021 of abemaciclib(Verzenio, Lilly) "described as the first advance for early breast cancer in 20 years."

The resignation of JAMA editors over a podcast on race rounded out the list of exciting medical news or events ― coming in fourth at 11%. A total 5% of readers chose "other" and were asked to specify what news or events excited them in 2021.

A Frustrating Year?​

Medscape also asked readers what medical news or events frustrated them in 2021. A majority, 81%, chose COVID-19 vaccine hesitancy or refusal. Almost one third, 31%, chose the effect of climate change on health worldwide.

Some of the most memorable news or events of 2021 were also selected as frustrating by readers. For example, 22% were frustrated by the law requiring that patients be granted electronic access to clinical notes, followed by 19% who referred to the aducanumab approval in June. Furthermore, about 12% selected the JAMA resignations.

A Shocking Survey Question​

Asked what medical news or event from 2021 shocked readers, COVID-19 vaccine hesitancy or refusal was the most common answer, at 69%.


The US Preventive Services Task Force ruling out aspirin in people over age 60 for primary prevention of cardiovascular disease shocked 36% of respondents.


Coming in third and fourth on the survey were the two JAMA editors resigning after a podcast on race, chosen by 19%, and the demise of the Step 2 Clinical Skills test, selected by 18%.


Interestingly, almost 96% of respondents were physicians. Less than 1% were residents, physician assistants, or nurses. Respondents also represented a wide range of specialties. From a list of 29 possible specialties, including "other," family medicine, internal medicine, and psychiatry were the most common.


For more on the year that was 2021, see the Medscape Year in Medicine 2021: News That Made a Difference slideshow. Read Medscape's full Year in Medicine report.


Wondering what stood out most to our readers in 2020? Here is a story about the results of a similar survey 1 year ago.

"

 

[missy]

New Year, new uncertainty.​

As 2021 closed out, Omicron drove coronavirus cases to record highs, upended air travel and left staffing holes at hospitals. The highly contagious variant is still racing across the country, and teachers, parents and workplaces are bracing for the impact. Many wonder whether life will ever be normal again.​

The U.S. is averaging more than 386,000 cases a day, likely a vast undercount. Hospitalizations are growing at a much slower rate, but the death rate is falling. Puerto Rico is facing a 4,600-percent increase in cases in recent weeks.​

Scientists say that Omicron may peak in the U.S. in mid-January. New estimates suggest that the country’s cases could peak by Jan. 9 at around 2.5 million cases per week, though that number may go as high as 5.4 million. Still, the enormous numbers of people getting infected could greatly strain hospitals, especially in places with lower vaccination rates.​

A vaccination site in East New York.Anna Watts for The New York Times​

Despite the dizzying pace of cases, there was a bit of good news from the latest scientific reports.​

People infected with Omicron were about half as likely to be hospitalized as those with the Delta variant, according to a report from British health officials, and they were only one-third as likely to need emergency care. A laboratory study from South African scientists suggested that people who have recovered from an Omicron infection might be able to repel infections from the Delta variant. Several studies have offered a possible explanation for Omicron’s milder effects: It often concentrates in the nose, throat and windpipe rather than damaging the lungs, as previous variants did.

 

[dk168]

In England, I can't get hold of further supply of free-issue lateral flow test kits via the post, and all the local pharmacies posted a notice to indicate they don't have any on their doors.

Hopefully, I could get further supply soon before my current supply runs out in 3 weeks' time.

The number of cases is at record high, with increased hospital admissions. However, the number deaths does not appear to follow the high number of cases.

The NHS is straining due to frontline staff shortages related to Covid-19.

The booster programme has been extended to all adults over 18.

I am limiting myself from unnecessary social mixing, so no going out to pubs and restaurants etc. and other indoor venues such as shops at peak times if I can help it.

Still carrying and wearing mask indoors and on public transport.

I have close friends who went down with C19 in the last 2-3 weeks of December, some of them still isolating as a result.

I went to a small house party on 26 December, and one of the attendees who is a close friend tested positive on a LFT on 30 December after a negative test on 27 December.

I tested negative on a LFT on 28 December, and took another test on 30 December which was negative.

This is my closest C19 scare to date.

I have not been out since 29 December except to walk the dog around the neighbourhood, and cancelled my plan to go out to celebrate on New Year's Eve.

Yes I am concerned about Omicron being more transmittable, however, life goes on and am living it the best way I can.

Stay safe everyone!

DK

 

[missy]

How effective are vaccines on omicron?​

In this week's edition of the Covid Q&A, we look at omicron’s power at escaping vaccines. In hopes of making this very confusing time just a little less so, each week Bloomberg Prognosis is picking one question sent in by readers and putting it to experts in the field. This week's question comes to us from Sara. She asks: Is the omicron variant resistant to current vaccines and boosters? It seems like every other incoming text message these days is from someone sharing the news that they, too, have a breakthrough infection. It can make the vaccines start to feel like some sort of broken promise. We waited for them to arrive so that we could all get back to normal without fear of contracting Covid-19. Then the highly transmissible omicron variant showed up, and, well, you know what happened. But rest assured. The vaccines still appear to be doing their most important job: preventing hospitalizations and deaths. The reason we’re seeing more breakthrough cases as people travel for the holidays is that omicron is very good at getting past a vaccine’s first line of defense, antibodies, which bind to the surface of the virus to prevent infection. But the reason we aren’t seeing many severe infections among those who are vaccinated is that omicron is still easily defeated by a vaccine’s second line of defense, T cells and B cells, which begin to work once an infection occurs. In most cases, that immune response helps kill off Covid before the disease has the chance to progress toward anything more than mild symptoms. “Although antibodies, our main line of defense for upper respiratory tract symptoms, can wane over time or be affected by mutations along the spike protein, we know now that T cells from the vaccine still work against omicron,” says Monica Gandhi, an infectious disease expert at University of California, San Francisco. “B cells generated by the vaccines also adapt the new antibodies they produce to work against variants.” A line outside a mobile testing site in New York City, where the omicron variant is spreading rapidly. Photographer: Angus Mordant/Bloomberg And a booster shot, says Gandhi, makes your immune system even better at fighting off infection. Depending on how quickly and efficiently your T cells and B cells get to work, you may not even feel sick. That’s why the U.S. Centers for Disease Control and Prevention currently says that if you’re vaccinated and boosted, it’s not necessary to quarantine after exposure to someone infected, as long as you have no virus symptoms and are careful about masking indoors. That said, infections are on the rise around the globe and more cases will always mean more hospitalizations and deaths, no matter how well the vaccines prevent severe infection. That’s just what happens when case numbers surge. And sticking closer to home does help prevent spread, whether you’re vaccinated, boosted, or none of the above. So if you’ve been meaning to learn to knit or rewatch all the Harry Potter movies, or master the French omelet, now is a great time to opt for fun at home. Thanks to all of you for writing in this week! Next Sunday, we'll be answering the best question we receive again. So if you have any, we want to hear from you. Write to us at [email protected]—Kristen V. Brown

​ ​ ​ ​ Track the virus​

Kids’ Covid Hospitalizations Rising​ Pediatric Covid-19 hospitalizations have risen to record levels in the U.S., amplifying the urgency to get boosters and vaccines cleared for children. New hospital admissions of kids with coronavirus increased 66% to 378 a day on average in the latest week’s figures. The previous peak occurred in early September at a daily count of 342. Read the full story here.

 

[lissyflo]

In England, I can't get hold of further supply of free-issue lateral flow test kits via the post, and all the local pharmacies posted a notice to indicate they don't have any on their doors.

Hopefully, I could get further supply soon before my current supply runs out in 3 weeks' time.

DK

If you’ve got 3 weeks’ supply then I guess you’re not in dire need soon, but walk-in testing centres are the best place to get lateral flows at the moment. We were given two boxes of 20 (so 40 tests in total) on NYE when we passed a site on a dog walk, whilst nhs online delivery and chemists were out of stock at the time. The number given was for us as a family of 4. Hopefully online deliveries will become easier again once children are back at school and receiving their test packs there.

 

[dk168]

If you’ve got 3 weeks’ supply then I guess you’re not in dire need soon, but walk-in testing centres are the best place to get lateral flows at the moment. We were given two boxes of 20 (so 40 tests in total) on NYE when we passed a site on a dog walk, whilst nhs online delivery and chemists were out of stock at the time. The number given was for us as a family of 4. Hopefully online deliveries will become easier again once children are back at school and receiving their test packs there.

Indeed not too concerned right now as I have 6 tests in hand, and I am using 2 a week.

Fingers firmly crossed that I would be able to get more in a couple of weeks' time.

DK

 

[AprilBaby]

The lines here for testing are now outrageously long. We are staying firmly inside. Our daughter was due in last night for the first time in 4 years but she went to her boyfriends family first in Nebraska. They got a call right before they boarded the plane that a family member tested positive so they have to stay there. Thank goodness they never made it onto the plane and came here.

 

[Vanilla Bling]

I’ve been hearing that Omicron will replace Delta and that’s a good thing because with Omicron you can’t get the Delta that infects the lungs so bad and Omicron is milder .

 

[dk168]

Another person I know has been tested positive today 02 January 2022.

I last worked with her in a local charity shop on Thursday 23 December.

She had been back to work since (she is the manager of the shop) to re-organise the shop in readiness for the re-opening next Wednesday or Thursday, and worked alongside a coupe of others.

She has been triple vaccinated as well!

DK

 

[Vanilla Bling]

Another person I know has been tested positive today 02 January 2022.

I last worked with her in a local charity shop on Thursday 23 December.

She had been back to work since (she is the manager of the shop) to re-organise the shop in readiness for the re-opening next Wednesday or Thursday, and worked alongside a coupe of others.

She has been triple vaccinated as well!

DK

What I heard was you can catch the Omicron even if you had the Delta Variant but if you have had the Omicron you can’t catch the Delta . I watch John Campbell on YouTube and he was reading a medical paper that came out of South Africa where the Omicron originated .

 

[dk168]

Luckily, none of those I know who have C19 after being triple vaccinated required hospitalisation - just very bad colds as they would describe their symptoms.

DK

 

[Vanilla Bling]

Luckily, none of those I know who have C19 after being triple vaccinated required hospitalisation - just very bad colds as they would describe their symptoms.

DK

That’s really good to hear !!

 

[dk168]

I managed to order a further supply of LFTs for home delivery this morning.

DK

 

[missy]

snip...data from the U.K. suggests that protection against Omicron infection provided by the Pfizer booster might wane over time. Among those who received the two-dose series of the Pfizer vaccine followed by the Pfizer booster, vaccine effectiveness against symptomatic disease caused by the Omicron variant was around 70% at one week after the booster but decreased to about 45% at 10 weeks or more after the booster. For those vaccinated with Pfizer who received the Moderna booster, vaccine effectiveness against symptomatic disease caused by Omicron stayed around 70% to 75% for up to 9 weeks after the booster. It was not possible to estimate booster vaccine effectiveness against Omicron among those who were initially vaccinated with two doses of Moderna due to the low number of cases of infection (UK Health Security Agency, Technical briefing 33).

Having had COVID-19 appears to reduce the chance of getting infected by Omicron compared with never having been infected, but it is less protective than it had been against earlier variants. For example, in South Africa, people previously infected by the original variant had a 71% lower risk of reinfection from September to October 2021 but only a 27% lower risk of being reinfected during the Omicron wave. Similarly, data from the U.K. study found that the Omicron variant was associated with a more than 5-fold higher risk of reinfection compared with Delta (Imperial College London Report 49, 12-16-21).




Infectiousness and transmission:
Despite showing less replication in the lung tissue in the study above, the Omicron variant's ability to replicate (multiply) in tissue from the bronchus (the tubes that carry air from the windpipe to the lungs) was 70 times greater than the Delta and original variants, which may help the Omicron variant be more infectious and transmit faster than earlier variants (HKUMed Press Release, 12-15-21). This theory is supported by a cell-based laboratory study that found Omicron to be four times as infectious (better at binding to and entering cells) than the original variant, and twice as infectious as the Delta variant, which may be a contributing factor to the rapid spread of the Omicron variant (Garcia-Beltran, medRxiv 2021 – preprint).


Despite showing less replication in the lung tissue in the study above, the Omicron variant's ability to replicate (multiply) in tissue from the bronchus (the tubes that carry air from the windpipe to the lungs) was 70 times greater than the Delta and original variants, which may help the Omicron variant be more infectious and transmit faster than earlier variants (HKUMed Press Release, 12-15-21). This theory is supported by a cell-based laboratory study that found Omicron to be four times as infectious (better at binding to and entering cells) than the original variant, and twice as infectious as the Delta variant, which may be a contributing factor to the rapid spread of the Omicron variant (Garcia-Beltran, medRxiv 2021 – preprint).


The CDC now advises that fully vaccinated people who are in areas with "substantial" or "high" community transmission wear a mask in public indoor settings.


How the Vaccines Compare

Comparison of FDA-Authorized or Approved Vaccines

Pfizer / BioNTech (mRNA)	Moderna (mRNA)	J&J (Janssen) (adenovirus)
Efficacy
After 1st dose: 52% After 2nd dose: 95%	After 1st dose: Not known After 2nd dose: 94% Efficacy in those 65 and older is a little lower, about 86%; however, overall, some evidence of greater protection against severe disease.	After 1st dose: 72% (moderate and severe COVID-19) Similar efficacy in people 65 and older vs. younger people based on clinical data. Lower effectiveness in people 50 and older compared to those younger than 50 (75% vs. 83%) based on real-world data
Most Common Side Effects
Injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever; more common after 2nd dose. Side effects noted to be lower in people 56 and older.	Injection site pain, fatigue, headache, muscle pain, joint pain, chills, nausea / vomiting, fever; more common after 2nd dose. Side effects after 2nd dose more common with Moderna than Pfizer (swelling/redness at injection site in about 12.5% with Moderna vs. 6% with Pfizer).	Injection site pain, headache, fatigue, muscle pain, nausea, fever Side effects similar in people 65 and older vs. younger people
Duration of Side Effects
Can last several days	Typically one day, but can last up to one week	One or two days
Serious Reactions
Low rate of rate of severe allergic reactions (4.7 cases per million doses) but nearly double the rate for Moderna. Treatable with epinephrine. Affected people should not receive 2nd dose.	Low rate of rate of severe allergic reactions (2.5 cases per million doses). Treatable with epinephrine. Affected people should not receive 2nd dose.	Rare cases of very serious blood clotting. Low rate of severe allergic reactions (only 1 case of anaphylaxis in an ongoing trial in South Africa). Treatable with epinephrine. One case of severe hypersensitivity (not anaphylaxis) per 21,895 doses in pre-authorization trial.
Age Requirements
Approved: 16 and older Authorized: 5 and older	Authorized: 18 years and older	Authorized: 18 years and older
Where to Get
Ultra-low temperature freezer storage is preferred. As an alternative, undiluted, frozen vials can be transported and stored at freezer temperatures for up to 2 weeks, which may make it available to more vaccine sites. Once thawed, the vials can be stored in the refrigerator for up to 1 month.	Requires only regular freezer storage, so may be more broadly available, such as in doctor's offices, clinics, rural locations.	Requires only regular refrigeration (DNA is more stable than mRNA) and single dose, so may be available in widest variety of settings
Ingredients (per dose)
30 mcg nucleoside-modified mRNA for people 12 and older (10 mcg for children 5-11) Lipids (fatty substances) (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) 2[PEG 2000]-N,N-ditetradecylacetamide 1,2-distearoyl-sn-glycero-3-phosphocholine Cholesterol Phosphate buffered saline for people 12 and older (Tris buffer for children 5-11) Potassium chloride Monobasic potassium phosphate Sodium chloride Dibasic sodium phosphate dihydrate Sucrose (sugar)	100 mcg nucleoside-modified mRNA (Booster is a half dose: 50 mcg) Lipids (fatty substances) SM-102 PEG 2000 dimyristoyl glycerol (DMG) Cholesterol 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) Tromethamine Tromethamine hydrochloride Acetic acid Sodium acetate Sucrose (sugar)	5 x 1010 viral DNA particles Polysorbate-80 2-hydroxypropyl-beta-cyclodextrin Citric acid monohydrate Trisodium citrate dihydrate Ethanol Sodium chloride

 

[Vanilla Bling]

snip...data from the U.K. suggests that protection against Omicron infection provided by the Pfizer booster might wane over time. Among those who received the two-dose series of the Pfizer vaccine followed by the Pfizer booster, vaccine effectiveness against symptomatic disease caused by the Omicron variant was around 70% at one week after the booster but decreased to about 45% at 10 weeks or more after the booster. For those vaccinated with Pfizer who received the Moderna booster, vaccine effectiveness against symptomatic disease caused by Omicron stayed around 70% to 75% for up to 9 weeks after the booster. It was not possible to estimate booster vaccine effectiveness against Omicron among those who were initially vaccinated with two doses of Moderna due to the low number of cases of infection (UK Health Security Agency, Technical briefing 33).

Having had COVID-19 appears to reduce the chance of getting infected by Omicron compared with never having been infected, but it is less protective than it had been against earlier variants. For example, in South Africa, people previously infected by the original variant had a 71% lower risk of reinfection from September to October 2021 but only a 27% lower risk of being reinfected during the Omicron wave. Similarly, data from the U.K. study found that the Omicron variant was associated with a more than 5-fold higher risk of reinfection compared with Delta (Imperial College London Report 49, 12-16-21).




Infectiousness and transmission:
Despite showing less replication in the lung tissue in the study above, the Omicron variant's ability to replicate (multiply) in tissue from the bronchus (the tubes that carry air from the windpipe to the lungs) was 70 times greater than the Delta and original variants, which may help the Omicron variant be more infectious and transmit faster than earlier variants (HKUMed Press Release, 12-15-21). This theory is supported by a cell-based laboratory study that found Omicron to be four times as infectious (better at binding to and entering cells) than the original variant, and twice as infectious as the Delta variant, which may be a contributing factor to the rapid spread of the Omicron variant (Garcia-Beltran, medRxiv 2021 – preprint).


Despite showing less replication in the lung tissue in the study above, the Omicron variant's ability to replicate (multiply) in tissue from the bronchus (the tubes that carry air from the windpipe to the lungs) was 70 times greater than the Delta and original variants, which may help the Omicron variant be more infectious and transmit faster than earlier variants (HKUMed Press Release, 12-15-21). This theory is supported by a cell-based laboratory study that found Omicron to be four times as infectious (better at binding to and entering cells) than the original variant, and twice as infectious as the Delta variant, which may be a contributing factor to the rapid spread of the Omicron variant (Garcia-Beltran, medRxiv 2021 – preprint).


The CDC now advises that fully vaccinated people who are in areas with "substantial" or "high" community transmission wear a mask in public indoor settings.


How the Vaccines Compare

Comparison of FDA-Authorized or Approved Vaccines

Pfizer / BioNTech (mRNA)	Moderna (mRNA)	J&J (Janssen) (adenovirus)
Efficacy
After 1st dose: 52% After 2nd dose: 95%	After 1st dose: Not known After 2nd dose: 94% Efficacy in those 65 and older is a little lower, about 86%; however, overall, some evidence of greater protection against severe disease.	After 1st dose: 72% (moderate and severe COVID-19) Similar efficacy in people 65 and older vs. younger people based on clinical data. Lower effectiveness in people 50 and older compared to those younger than 50 (75% vs. 83%) based on real-world data
Most Common Side Effects
Injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever; more common after 2nd dose. Side effects noted to be lower in people 56 and older.	Injection site pain, fatigue, headache, muscle pain, joint pain, chills, nausea / vomiting, fever; more common after 2nd dose. Side effects after 2nd dose more common with Moderna than Pfizer (swelling/redness at injection site in about 12.5% with Moderna vs. 6% with Pfizer).	Injection site pain, headache, fatigue, muscle pain, nausea, fever Side effects similar in people 65 and older vs. younger people
Duration of Side Effects
Can last several days	Typically one day, but can last up to one week	One or two days
Serious Reactions
Low rate of rate of severe allergic reactions (4.7 cases per million doses) but nearly double the rate for Moderna. Treatable with epinephrine. Affected people should not receive 2nd dose.	Low rate of rate of severe allergic reactions (2.5 cases per million doses). Treatable with epinephrine. Affected people should not receive 2nd dose.	Rare cases of very serious blood clotting. Low rate of severe allergic reactions (only 1 case of anaphylaxis in an ongoing trial in South Africa). Treatable with epinephrine. One case of severe hypersensitivity (not anaphylaxis) per 21,895 doses in pre-authorization trial.
Age Requirements
Approved: 16 and older Authorized: 5 and older	Authorized: 18 years and older	Authorized: 18 years and older
Where to Get
Ultra-low temperature freezer storage is preferred. As an alternative, undiluted, frozen vials can be transported and stored at freezer temperatures for up to 2 weeks, which may make it available to more vaccine sites. Once thawed, the vials can be stored in the refrigerator for up to 1 month.	Requires only regular freezer storage, so may be more broadly available, such as in doctor's offices, clinics, rural locations.	Requires only regular refrigeration (DNA is more stable than mRNA) and single dose, so may be available in widest variety of settings
Ingredients (per dose)
30 mcg nucleoside-modified mRNA for people 12 and older (10 mcg for children 5-11) Lipids (fatty substances) (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) 2[PEG 2000]-N,N-ditetradecylacetamide 1,2-distearoyl-sn-glycero-3-phosphocholine Cholesterol Phosphate buffered saline for people 12 and older (Tris buffer for children 5-11) Potassium chloride Monobasic potassium phosphate Sodium chloride Dibasic sodium phosphate dihydrate Sucrose (sugar)	100 mcg nucleoside-modified mRNA (Booster is a half dose: 50 mcg) Lipids (fatty substances) SM-102 PEG 2000 dimyristoyl glycerol (DMG) Cholesterol 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) Tromethamine Tromethamine hydrochloride Acetic acid Sodium acetate Sucrose (sugar)	5 x 1010 viral DNA particles Polysorbate-80 2-hydroxypropyl-beta-cyclodextrin Citric acid monohydrate Trisodium citrate dihydrate Ethanol Sodium chloride

I got very sick with my second dose ! Was sick for a week and three of those day I ran a fever of 103 with Tylenol and had every symptom you can imagine .

 

[missy]

I got very sick with my second dose ! Was sick for a week and three of those day I ran a fever of 103 with Tylenol and had every symptom you can imagine .

Oh my goodness! I am glad you are better now! Definitely worth getting the vaccines and getting sick because think about how much sicker we could/would get with getting Covid! My theory is the sicker you get with the vaccines that much sicker you would get if you got the virus and weren't vaccinated.

 

[Vanilla Bling]

Oh my goodness! I am glad you are better now! Definitely worth getting the vaccines and getting sick because think about how much sicker we could/would get with getting Covid! My theory is the sicker you get with the vaccines that much sicker you would get if you got the virus and weren't vaccinated.

Exactly !! I would do it again , there’s controversy within my family over the vaccine but I finally said you do you and I’ll do me

 

[missy]

Exactly !! I would do it again , there’s controversy within my family over the vaccine but I finally said you do you and I’ll do me

Smart. Yeah I am lucky that my entire family is on board with getting vaccinated and boosted though my mom threatened she isn't doing this every year. But she will. She definitely will. And thank goodness my DH does what I want him to do. I made him get a fourth vaccine (with our doctor's blessing) because the booster didn't boost his antibodies at all. He was negative for antibodies after the booster. But I digress.

All this to say I am happy my family is pro vaccine. I cannot think of how stressful it would be if I had loved ones who refused to get vaccinated. Nothing is 100 foolproof but IMO it is a fool who refuses the vaccines (without a good reason ie serious contraindication to said vaccine) which are known to translate to much less serious disease than not getting the vaccines.

 

[dk168]

I wish my mum and bro could be vaccinated, however, they can't for health reasons.

DK

 

[missy]

I wish my mum and bro could be vaccinated, however, they can't for health reasons.

DK

And this is precisely why everyone who can get vaccinated should get vaccinated. To protect those more vulnerable than themselves and of course to also protect themselves. But it is selfish if someone who can get vaccinated refuses. Precisely for this reason. I hope your mom and brother remain well @dk168

 

[Vanilla Bling]

Smart. Yeah I am lucky that my entire family is on board with getting vaccinated and boosted though my mom threatened she isn't doing this every year. But she will. She definitely will. And thank goodness my DH does what I want him to do. I made him get a fourth vaccine (with our doctor's blessing) because the booster didn't boost his antibodies at all. He was negative for antibodies after the booster. But I digress.

All this to say I am happy my family is pro vaccine. I cannot think of how stressful it would be if I had loved ones who refused to get vaccinated. Nothing is 100 foolproof but IMO it is a fool who refuses the vaccines (without a good reason ie serious contraindication to said vaccine) which are known to translate to much less serious disease than not getting the vaccines.

That’s strange his booster didn’t do anything at all isn’t it ! I’m glad he was able to get another and it worked , my family that I am around the most are all vaccinated and the others if they want to sit around discussing conspiracy theories have at it but don’t try to involve me because I’m not down with that .

 

[missy]

NYT January 3, 2022 ​ Good morning. We look back on the pandemic — and ahead to its next phases — with a handful of charts.​ Reason for hope​

As a new year begins, we want to look back on the first two years of the pandemic in the U.S. — and look ahead to what 2022 may bring. Today’s newsletter will do so with the help of a handful of charts.​

Covid-19 is so named because it began spreading in China in late 2019. In the U.S., doctors first detected a case in Washington State in January 2020. Both cases and deaths then surged:​

​ 2021 began with a hopeful turning point: the ramping up of a mass vaccination campaign.​ By February, new cases were plummeting, and by spring, the virus seemed as if it might be in permanent retreat, at least in highly vaccinated countries. On June 2, President Biden gave a speech looking ahead to “a summer of freedom, a summer of joy.”​ ​ Source: Centers for Disease Control and Prevention​ Then came a second, much grimmer turning point: the emergence of the Delta variant, in late spring. It caused many more infections among the vaccinated than earlier variants, but the overwhelming majority of these breakthrough infections were mild.​ As a result, communities with high vaccination rates were mostly protected from the worst outcomes:​ ​ Low: Less than 30 percent of residents fully vaccinated. High: At least 60 percent.Source: New York Times database, Centers for Disease Control and Prevention​ Still, the emergence of Delta meant that 2021 often felt like a frustrating year of pandemic purgatory. In addition to the direct damage from Covid, the disruptions to daily life — intended to slow the spread of the virus — have brought their own costs.​ Children have fallen behind in school, and many are experiencing mental health problems brought on by isolation. Americans’ blood pressure has risen, and drug overdoses have soared.​ ​ Source: Centers for Disease Control and Prevention​ Even people who have avoided the worst of the pandemic’s damage often feel fed up. And now the latest variant, Omicron, has sent cases soaring to their highest level yet, and raised the prospect that 2022 will be another year of pandemic purgatory.​ ​ Source: New York Times database​ The emerging evidence suggests that Omicron really is milder than earlier versions of this coronavirus (either because of intrinsic biological reasons or because of higher levels of population immunity). In South Africa and England, as well as New York, San Francisco and other parts of the U.S., hospitalization numbers are lower than doctors had feared.​ Omicron will still do terrible damage among the unvaccinated in both the U.S. and worldwide. Many hospitals face the risk of being overwhelmed in coming weeks.​ Yet when the current surge begins receding, it will likely have left a couple of silver linings: Omicron is so contagious that it will have infected a meaningful share of the population, increasing the amount of Covid immunity and helping defang the virus. Omicron has also helped focus Americans on the importance of booster shots, further increasing immunity.​ As important, the world has more powerful weapons to fight Covid than it did only a few weeks ago: two new post-infection treatments, one from Merck and a more powerful one from Pfizer, that lower the risk of hospitalization and death. With Pfizer’s treatment, the reduction is by almost 90 percent, according to early research trials.​ All of which suggests that the U.S. could emerge from the Omicron wave significantly closer to the only plausible long-term future for Covid — one in which it becomes an endemic disease and a more normal part of daily life. It will still cause illness and death; a typical flu season kills more than 30,000 Americans, most of them elderly. For the foreseeable future, battling Covid — through vaccination, treatment and research — will remain important.​ But endemic disease does not need to dominate life the way a pandemic does. It does not need to cause the sort of social isolation and public-health problems that Covid has over the past two years. If the U.S. reaches that point in 2022 — as appears likely — the next New Year will feel a lot more satisfying than this one.​ More on the virus:​ Twitter suspended Representative Marjorie Taylor Greene for violating its Covid misinformation policies. Amid a scarcity of at-home Covid tests, some are turning to a company known for selling generic Viagra. Some people are getting unapproved fourth or fifth Covid-19 shots, despite uncertainty about their safety or effectiveness. From medical breakthroughs to personal reinvention, here are hopeful stories of pandemic resilience.

 

[missy]

Podcast transcript

Convalescent Plasma in Early COVID; Chinese Adenovirus Vector Vaccine​

by Rick Lange, MD, Texas Tech; Elizabeth Tracey, Johns Hopkins Medicine January 1, 2022

This week's topics include final results on a Chinese adenovirus vector COVID-19 vaccine, early use of remdesivir (Veklury) in outpatients with COVID-19, use of convalescent plasma in COVID-19, and the impact of boosters on COVID-19 disease.
"
Transcript:

Elizabeth Tracey: Final results on the Chinese adenovirus vector COVID-19 vaccine.

Rick Lange, MD: Dose administration with remdesivir in outpatients prevent progression of severe COVID?

Elizabeth: What about convalescent plasma again for COVID-19 disease?

Rick: Does vaccine booster prevent mortality due to COVID?

Elizabeth: That's what we're talking about this week on TT HealthWatch, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I'm Elizabeth Tracey, a Baltimore-based medical journalist.

Rick: I'm Rick Lange, president of Texas Tech University Health Sciences Center in El Paso, where I'm also dean of the Paul L. Foster School of Medicine.



Elizabeth: Rick, I am chagrined to admit that this week we are doing all COVID material to round out 2021. Which of these four articles would you like to start with?

Rick: Let's start with the vaccine booster. How's that?

Elizabeth: Okay.

Rick: Israel deployed vaccines very rapidly in the early part of 2021. They dropped their cases from 1,000 per million persons to 1 to 2 cases per million. That was by June of 2021. However, when the Delta variant arrived shortly afterwards, there was a resurgence of COVID-19 cases in Israel. In August of 2021, Israel had the highest incidence of COVID-19 worldwide. On July 30th of this past year, the Israeli Minister of Health approved the use of a third dose of the Pfizer booster.

This study assessed whether that booster actually reduced mortality. They have attained data for all members of the health services who were 50 years of age or older and had received two doses of Pfizer at least 5 months earlier. Then they looked at the mortality of those individuals who received the booster versus those that did not. They have over 843,000 participants.



Now, about 90% of those went on to get a booster, about 10% didn't. The participants who received the booster at least 5 months after the second dose had a 90% lower mortality due to COVID-19 than the participants who did not receive a booster. That's pretty convincing evidence.

Elizabeth: It is indeed. This is in the New England Journal of Medicine and Israel right now, of course, is in the process of even giving a fourth dose to a lot of their population. One of the questions I have is, just in this interval, what exactly was the rate of infection among the people who had received the booster?

Rick: If we're looking at just numbers of infection, the incidence was about 30 per million in those who didn't receive the booster as opposed to 1.6 per million in those who did receive the booster.

Elizabeth: Clearly, the other piece of data that's missing here, and one that I'm not sure we're ever going to get, is just testing everybody and seeing what's the rate of asymptomatic viral shedding among those who are completely vaccinated.



Rick: If you're asymptomatic and you're a spreader, it's not much of an issue if everybody around you is vaccinated. The issue, however, becomes much more germane when people are unvaccinated or, as we just discussed, if there is waning immunity and they haven't received a booster.

Elizabeth: Let's turn now to the Lancet. Since we are talking about vaccines, then let's look at this final efficacy analysis, their interim safety analysis and immunogenicity of a single dose of a recombinant adenovirus type-5 vector in adults. This is that vaccine that's been out there for a long time.

This was a really big study, double-blind, conducted in adults 18 years and older at study centers in Argentina, Chile, Mexico, Pakistan, and Russia. Clearly, they randomized these folks to either receive the vaccine or not.

They had 21,250 participants, 45 days median duration of follow-up, and they basically showed a 57.5% efficacy against symptomatic, PCR-confirmed COVID-19 infection. They saw sort of the relatively low level of side effects as a result of having had the vaccination. They point out that the benefit to this vaccine, even though it's not as good as some of the others in protecting against disease, is that this is a refrigerator-stable, single-dose vaccine that's efficacious against symptomatic disease.



Rick: There have been over 7 billion doses of COVID-19 vaccine that have already been administered. While the developed countries have vaccine coverage that range from 60% to 80%, there is less vaccine availability in lower-income and middle-income countries and the vaccine coverage is only 5% to 30%. Hence, the need to try to get as many vaccines out there that are affordable.

Now, as you mentioned, this can be refrigerated, but it doesn't appear to be as efficacious certainly as the mRNA vaccines, and it may not be as efficacious as other adenovirus vaccines. Now, most of the other vaccines are two-dose. In fact, this particular one that we're talking about now is being studied in a two-dose regimen as well. What was particularly concerning to me is there was marked lack of efficacy in people over the age of 60. That is at 28 days and further after vaccine there is only about 17% effective in preventing these infections. More importantly, in women, it was much less effective than in men.



Elizabeth: They determined the vaccine efficacy in men at almost 66%, while [in] the women it was only 40% at 28 days post-vaccination.

Rick: These are concerning numbers. Now, this was one of the very first vaccines to be developed. At the time, when they started this phase III clinical trials, none of the other vaccines had been through phase III trials. Since then, we have had phase III trials for the Moderna vaccine, the Pfizer, the AstraZeneca, the J&J adenovirus vaccines, the Sputnik, Novavax purified protein vaccine, Sinovac inactivated whole virus vaccine, and Sinopharm-inactivated vaccine. We now have many other vaccines on the market that weren't available when this was first being tested.

Elizabeth: Right. It is important to note, however, that in this study there were no COVID-19 related deaths in vaccine recipients even with that single dose of this vaccine.

Rick: Right. It's received full authorization in China and EUA [emergency use] authorization in 10 other countries. You're right. It may not prevent symptomatic infection as well as it prevents mortality associated with COVID infection.



Elizabeth: Let's turn back to the New England Journal of Medicine, looking at remdesivir.

Rick: This is an anti-viral drug that's been on the market for a while. It's use has been limited to individuals with moderate to severe disease that are in the hospital. It requires IV infusion over a number of days, as opposed to antibodies, which are directed towards specific COVID variants.

This acts at the RNA polymerase, which is pretty much conserved across all the COVID infections. Its effects really haven't been diminished by the emergence of these variants. The question is if we gave it early on to outpatients, could we prevent progression to severe COVID-19 infection?

They took 562 patients. These are individuals that had symptoms within the previous 7 days and who had at least one risk factor for disease progression, such as age over 60, obesity. They received either placebo or they received IV remdesivir over the course of 3 days.



The average age was 50. About 42% were Hispanic or Latinx. Two-thirds had diabetes. Over half had obesity, and half had hypertension. In those that received remdesivir, it reduced the risk of hospitalizations or death 87% compared to those that received placebo.

Elizabeth: This is really persuasive, isn't it? This is something that, in discussing with people right now who have COVID-19 with colleagues in the MICU, I have asked if you had someone who was infected with COVID right now, what would you do to stave off more serious infection? This sure seems like a pretty practical thing to do.

Rick: Well, it does. We know that monoclonal antibodies can do that and now it appears that remdesivir can do the same thing. But it does have some advantages over the monoclonal antibodies. First of all, in some places the antibodies are limited availability. Secondly, they come in as a liquid, they have to be refrigerated, and you have to observe people afterwards to make sure they don't have a reaction.



The remdesivir is a powder. You mix it up. You give it to somebody. You don't even have to sit and watch because they really don't have any reactions afterwards. In places where monoclonal antibodies aren't effective because of a variant or they are not available, remdesivir may be an acceptable alternative.

Elizabeth: I'm wondering if we know anything about, let's say, that you do choose a monoclonal antibody, you infuse that, can you then -- if it doesn't appear to be having the impact you want -- go ahead and use remdesivir?

Rick: That's an interesting question, because the authors of this talk about combination therapies that may include both a direct-acting viral agent at an early stage and then giving antibodies, particularly to those that are immunosuppressed. We haven't done those studies yet, but it certainly may be effective.

Elizabeth: Clearly, all of this is getting even more complicated with Paxlovid [nirmatrelvir/ritonavir] and molnupiravir.



Rick: Yes. By the way, I didn't mention, Elizabeth, is they are testing an oral pro-drug of remdesivir. We may not have to give it intravenously in the future. We may be able to give oral doses and get the same effect.

Elizabeth: Even more impressive. Let's turn now to medRxiv, this ongoing, speaking of treatments, issue of convalescent plasma in treating people with early COVID-19 disease. There is so much controversy relative to does this actually work.

This is a widely distributed study where they looked for participants with symptom onset within 8 days of their infection and they were transfused within the subsequent day. They had a total of 1,225 participants randomized and 1,181 transfused. They administered high-titer SARS-CoV-2 convalescent plasma. And in this population they were able to reduce outpatient hospitalizations by more than 50% by employing this strategy.

All right. Well, what's all the controversy around it? That you got to harvest plasma from people who are convalescent from COVID-19 disease. That that's pretty variable what that titer is. In this case, they made sure that they had sufficient titer. They do point out that you can actually use one person's donation if it has high enough titers of antibodies in up to three different people. They validate it with an independent laboratory to make sure that there is enough antibody in there.



The other thing that they point out is that we do have these other plethora of treatments that we have already discussed. Again, if we look at more low-resource settings, this may turn out to be a pretty practical strategy in those places, so it shouldn't just be thrown out.

Rick: Elizabeth, as you mentioned, there are controversies. There are previous studies that show that harvesting these antibodies really wasn't effective. But as you mentioned, one of the issues was that sometimes they weren't using a high enough titer or level of antibodies. This particular study limited to only individuals with high levels. The other is if you give it too late in the disease process, it may not be as effective. So this is a pretty convincing study.

One of the advantages of this over the monoclonal antibodies is this evolves as the variants evolve. People that develop antibodies have obviously been infected. They develop antibodies to the particular variant they were infected with. It is thought that some of the monoclonal antibodies aren't effective against the Omicron variant. But if you harvest antibody for someone who has been infected with the Omicron, then they certainly will have antibodies that attack it.



Elizabeth: Exactly. In one of my previous interviews with one of the authors of this study, he told me that one thing they had discerned was that the convalescent plasma that's administered locally turns out to be way more effective, and so that local harvesting is a pretty important point.

Rick: And obviously for the reasons we mentioned. Anyway, it's fairly inexpensive to do and it can be done in resource-limited countries. As we mentioned, it's probably more effective than monoclonal antibodies, especially when there are variants around.

Elizabeth: I guess what I am tempted to do then is to sum up our studies for this week and for 2021 on a hopeful note that most of the data that we have reported today is good news with regard to getting a handle on COVID-19 in spite of it being Omicron largely.

Rick: Elizabeth, I hope we have no listeners that are unvaccinated, but I can't stress the importance of vaccination in preventing hospitalizations, death, and long-COVID symptoms as well. Anybody that hasn't been convinced that vaccination is important, I hope that they wouldn't close out 2021 with stressing how incredibly important it is.

Elizabeth: A success story. On that note, that's a look at this week's medical headlines from Texas Tech. I'm Elizabeth Tracey.

Rick: I'm Rick Lange. Y'all listen up and make healthy choices. Happy New Year!

"

 

[missy]

That’s strange his booster didn’t do anything at all isn’t it ! I’m glad he was able to get another and it worked , my family that I am around the most are all vaccinated and the others if they want to sit around discussing conspiracy theories have at it but don’t try to involve me because I’m not down with that .

Thanks @Vanilla Bling. We don't know if it worked yet. But we did the best we could do and now we hold tight.
Not testing his antibodies probably til February when we see our doctor again.

 

[dk168]

As seen in the Times newspaper today:







DK

 

[missy]

FDA Lowers Age Range for Pfizer Booster Shot​

— Agency also shortens interval between primary series and boosters for ages 12 and up​

by Molly Walker, Deputy Managing Editor, MedPage Today January 3, 2022

Adolescents ages 12-15 can now get a booster dose of Pfizer/BioNTech's COVID-19 vaccine (Comirnaty) under emergency use authorization (EUA), the FDA said on Monday.
The agency also changed the interval for boosters shots of Pfizer's vaccine in all individuals 12 and up to at least 5 months after the second dose (was previously 6 months), and allowed a third dose for certain immunocompromised children ages 5-11 at least 28 days after their two-dose primary series.

This comes about a month after the agency authorized a single-dose booster for teens ages 16 and 17.
"Based on the FDA's assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research in a statement.
FDA cited real-world Israeli data from 6,300 individuals ages 12-15 who received a booster dose at least 5 months after their primary series, and no new safety concerns from a population of 4.1 million individuals in Israel ages 16 and up who have received booster doses.
Once again, the agency did not convene the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to support this decision.

The agency added that the "known and potential benefits" of a booster dose at 5 months "outweigh the known and potential risks."
FDA also authorized a third dose of Pfizer's vaccine for children ages 5-11 who underwent solid organ transplant or have another immunocompromising condition and who "may not respond adequately to the two-dose primary vaccination series." Third doses are not authorized for all other children in this age group, the agency noted.
CDC's Advisory Committee on Immunization Practices (ACIP), which was not convened when the EUA was expanded to 16- and 17-year-olds, is expected to convene later this week to discuss booster recommendations for this population, according to media reports.

 

[missy]

Omicron Does Not Evade T Cells

By Reuters Staff


(Reuters) - A key part of the immune system's second-line defense - its T cells - are highly effective at recognizing and attacking the Omicron variant, a new study shows.
Omicron's mutations help it escape from antibodies, but researchers have speculated that other components of the immune response would still target Omicron.
In test tube experiments, researchers in South Africa exposed copies of the virus to T cells from volunteers who had received vaccines from Johnson & Johnson or Pfizer/BioNTech or who had not been vaccinated but had developed their own T cells after infection with an earlier version of the coronavirus.
"Despite Omicron's extensive mutations and reduced susceptibility to neutralizing antibodies, the majority of T cell response, induced by vaccination or natural infection, cross-recognizes the variant," the researchers reported on medRxiv ahead of peer review.
"Well-preserved T cell immunity to Omicron is likely to contribute to protection from severe COVID-19," which supports what South African doctors had initially suspected when most patients with Omicron infections did not become seriously ill, they said.
SOURCE: https://bit.ly/3z7o7CY medRxiv,

 

[missy]

The Food and Drug Administration on Monday authorized booster shots of the Pfizer-BioNTech vaccine for 12- to 15-year-olds, as well as third shots for kids as young as five who are immunocompromised. The agency also said anyone eligible for a booster shot can get one five months after their last vaccine dose instead of six months. The moves are awaiting a sign-off from the Centers for Disease Control and Prevention, which is expected to green-light them later this week. It's welcome news for many parents as schools reopen amid soaring infections from the omicron variant. While some school districts have reverted to remote learning, many are pressing ahead with in-person classes.

After an alarming spike in omicron infections that began in late November, new cases have plummeted in South Africa over the past week and a half. Hospitalizations are down, too, and officials said the increase in fatalities has remained low compared with South Africa's three previous surges. All told, the first country to detect the new variant appears to have made it to the other side of its omicron wave relatively swiftly — an outcome other countries will keep a keen eye on as they battle their own rising caseloads.

Among South Africa's health-care workers, boosters of the Johnson & Johnson vaccine appeared to slash hospitalizations by 85 percent, according to a new, not-yet-peer-reviewed study. Researchers looked at hospital admissions from mid-November to mid-December, tracking roughly 69,000 health-care workers who got a second Johnson & Johnson dose.

How long will the omicron wave last in the United States? It's hard to say. Long- and medium-term pandemic forecasts have repeatedly turned out wrong, prompting some modelers to limit their predictions to one week ahead. Experts watching the variant's spread expect the wave here to be very tall and, like South Africa's, relatively quick — “measured in weeks rather than months,” as my colleague Joel Achenbach reports.Researchers from Columbia University estimate infections could peak the week of Jan. 9, with about 2.5 million confirmed infections in that seven-day period, possibly more. Hospitalizations could still rise after infections start to taper, threatening to overwhelm hospitals in hard-hit places.

The new variant could prove especially devastating in the Southeast, where vaccination rates are lower and fewer people heed public health recommendations. Florida, Georgia, Louisiana and Mississippi are already experiencing some of the country's sharpest increases in hospitalizations since Christmas. Experts are watching to see whether outbreaks there will end up deadlier than in the North.

The CDC's decision to cut the recommended isolation period for covid-19 from 10 days to five days drew a flurry of criticism from public health experts who said it was too permissive. Acknowledging the backlash, Anthony S. Fauci, the White House pandemic response chief, said health officials may soon add a testing requirement to the isolation guidance. The move comes as other countries are shortening their isolation and quarantine policies out of concern that omicron could sideline large portions of the essential workforce with mild or asymptomatic infections.

Other important news​

The Biden administration defended its vaccine mandate to the Supreme Court, arguing that the justices shouldn't block a program that will save thousands of lives.

Israel is expanding its booster campaign: Anyone 60 and over can now get a fourth vaccine shot.

Washington, D.C., avoided big coronavirus waves for most of the pandemic. Now it's one of the country's worst hotspots.

The United Arab Emirates is requiring coronavirus booster shots for citizens seeking to travel abroad.

 

[wildcat03]

So, the potential differences in collection for "lateral flow" (antigen) tests has been a hot topic on one of my physician pages this week. As you might imagine, LOTS of physicians testing positive after Christmas break whether from social, family, childcare, or work contacts. Obviously antigen tests are scarce, so very few head to head comparisons but one of my friends did one. On her nose swab (which she said was VERY thorough, she self-administered) she was barely barely positive (said she might have called it negative if it weren't for years of honing her practice on pregnancy tests). On her nose and throat swab, collected as per the UK instructions, the positive was clear as day.

Here are the instructions: https://assets.publishing.service.g...19-self-test-throat-and-nose-instructions.pdf

 

[missy]

Speaking of antigen tests...
Two new antigen tests reviewed.

"
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.

At-Home antigen tests:
These provide results within 15 or, sometimes, 20 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 first test result is 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 since this variant has mutations that predominantly affect the spike protein rather than the nucleocapsid protein, which is the target of most antigen tests authorized in the U.S. However, the FDA indicated on 12/28/21 that the ability of some antigen tests to detect Omicron may be lower than for previous variants. A week earlier, the FDA had indicated that tests by the NIH, using heat-treated virus samples, showed the Abbott BinaxNOW and Quidel QuickVue tests able to detect the Omicron variant as effectively as other variants, but this information has been removed and replaced by a statement that testing with live Omicron virus suggests that some antigen tests may have reduced sensitivity. The FDA has not yet published further details, but also on 12/28/21, Abbott announced that BinaxNOW detected the Omicron variant in all tests performed by the company at equivalent sensitivity as other variants based on live virus tests, and Quidel announced that the QuickVue antigen tests are able to detect the Omicron variant with similar performance as with other variants based on live virus tests conducted by the NIH. Information about how well other brands of antigen tests detect the Omicron variant have not been published.

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, there are several good home antigen tests (Quidel QuickVue, Roche At-Home Test, BinaxNow Self Test, and Flowflex) 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, CLINITEST, BD Veritor, On/Go, AccessBio CareStart, and InteliSwab). Note that all antigen tests should be used within the first six days of symptoms (and tend to be most accurate within 2 to 4 days of symptoms), and all those listed below focus on the nucleocapsid antigen, so should be able to detect the Omicron variant -- although not necessarily quite as well as the Delta variant.

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). Roche COVID-19 At-Home Test is nearly as accurate at Quickvue. 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 than 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. CLINITEST and BD Veritor pick up fewer positives than Flowflex and iHealth, but are very good at detecting negatives. BD Veritor is also slightly more costly and requires an app (which does not work on all phones) to interpret the results. 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. 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, our Top Pick, 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.
  
• Roche COVID-19 At-Home Test (manufactured in Korea by SD Biosensor) is an antigen test available over-the-counter that provides results within 20 minutes (about 5 minutes longer than other antigen tests) 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 95.3% of positive samples and 100% of negative samples collected from people within seven days of symptom onset (FDA 2021). Each test cassette has a unique QR code that, according to Roche, will allow "individuals and health care professionals to remotely and securely store, display, and share results" through a system called NAVIFY Pass — although the test is not overseen by a third-party and this "pass" does not seem to qualify for use in airline travel. According to Roche, the test is expected to be available across the U.S. sometime in January.
  
• Abbott BinaxNOW COVID-19 Antigen Tests:
  
  -- BinaxNOW COVID-19 Self Test (includes 2 tests for serial testing) is an antigen test 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 samplesand 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.
  
• CLINITEST Rapid COVID-19 Antigen Self-Test (from Siemens) 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 86.5% of positive samples and 99.3% of negative samples collected from people within seven days of symptom onset (FDA 2021). Interestingly, this test is the first to include in its FDA filings the results of testing by the NIH, which showed that it detects the Omicron variant, but not quite as well as it detects the Delta variant. CLINITEST does not yet appear to be available for purchase in the U.S.
  
• 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.]

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