Coronavirus updates December 2021

[missy]

Waning COVID Vax Immunity; FDA Medical Device Oversight​

— Also this week in TTHealthWatch: surgery for recurrent ovarian cancer​

by Rick Lange, MD, Texas Tech; Elizabeth Tracey, Johns Hopkins Medicine December 4, 2021

Remaining Time -13:36
TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week.
This week's topics include predicting COVID mortality, immunity following COVID vaccination, surgery for recurrent ovarian cancer, and FDA oversight of medical devices.

Program notes:
0:34 Waning immunity from COVID after vaccination
1:34 Who developed breakthrough infections?
2:34 Doesn't address severity of infection
3:37 Some vaccines not directed to the spike protein
3:55 Predictors of COVID death
4:55 Elevated cytokines and tissue injury markers
5:50 Even by day five, vRNA predicts
6:36 Scrutiny of medical devices by FDA
7:36 Approved using 510K
8:36 Device creep
9:26 Recurrent ovarian cancer and second surgeries
10:26 Surgery with platinum-based chemo
11:28 Carefully selected population
12:27 Change in chemotherapy?
13:36 End
Transcript:
Elizabeth Tracey: Is there a benefit to additional surgeries when ovarian cancer recurs?
Rick Lange, MD: Waning COVID vaccination efficacy.
Elizabeth: Can we predict who is going to die from COVID-19 infection?
Rick: And medical device safety.
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: And 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, how about if we turn first to the BMJ since everybody is top-of-mind regarding, "Oh, no, we have this new variant that's emerged," and that everybody is panic-stricken about. What is the elapsed time since vaccination against COVID and subsequent risk of SARS-CoV-2 infection?
Rick: Elizabeth, you set that up very nicely. How did we do this study? We have a lot of data from Israel, which really was among the first countries to initiate both a large-scale vaccination campaign and they did it very early on. By July of 2021, more than 5.2 million Israelis were fully vaccinated with the same vaccine -- they had gotten both doses of the Pfizer mRNA vaccine. Despite that, they noticed that since June of 2021 there has been a resurgence of individuals with COVID infection. So their concerns were whether there would be decreasing levels of immunity as a result of just the time since the vaccines were given.

They looked at those individuals that had developed breakthrough COVID infections. They had been fully vaccinated -- this was 3 weeks after the vaccination which was the earliest time point -- and they chopped it up from 0 to 90 days, from 90 to 120, 120 to 150, and 150 to 180, to determine if the time since vaccine contributed to a breakthrough COVID case.
What they discovered was that was indeed the case. Those that had their vaccination 90 to 120 days had about a 2 or 2½-fold increased risk of developing a breakthrough infection. That carried off for the next 150 to 180 days and even greater than 180 days. It looks like that there is waning efficacy and it begins not at 6 months, but as early as 3 months after vaccination.
Elizabeth: I am wondering if we're going to find out that this is the Achilles' heel of mRNA vaccines eventually.
Rick: The data are pretty clear not only from this study, but from other studies suggesting that there is waning antibody response. Now, what this study doesn't address is the severity of the infection. But I agree with you that currently this does appear to be the Achilles' heel and hence the recommendation is to get a booster for everybody over the age of 18. The Pfizer vaccine is now petitioning the FDA to do it to individuals as low as 16 years of age.

Elizabeth: Well, as Omicron -- I'm sure we are going to detect it here domestically pretty shortly; that's my bet -- in light of that, everyone who isn't boosted really needs to get boosted or what I have called in the past, of course, the third dose. I am even wondering about, well, what about even more than that for those who are willing?
Rick: As we get more variants, I think what we may be doing is having different types of boosters, ones that target these variants. I am sure we are going to be telling our listeners more about this in the weeks to come.
Elizabeth: I do think that also, and I am going to recall for you this pan-sarbecovirus notion that we talked about relative to the antibody production. And my question, which I subsequently investigated, is about vaccines that are targeted against those conserved regions of the spike protein. There is that out there, but it's not as robust as I thought it should be at this point.

Rick: Yeah. But some of these vaccines are not even directed towards the spike protein, so stay tuned.
Elizabeth: Still speaking about SARS-CoV-2, let's turn then to Science Advances. Let me just ask you. It's my recollection that this is the first time we have talked about a paper that's in this journal.
Rick: Right, and we have been doing this for about 18 to 19 years, Elizabeth, and so I'm surprised that Science Advances has escaped our reporting before. But this is an important study.
Elizabeth: This is entitled "Immunovirological profiling validates plasma SARS-CoV-2 RNA as an early predictor of COVID-19 mortality." Clearly, this is something we all want to know clinically. When somebody comes into the hospital and they need to be ventilated, can we determine which of them is most at risk of death?
They did these immunovirological tests on plasma from 279 people. They collected samples at what they call DSO11, so days from symptom onset in a discovery cohort. They performed three different assessments in this: viral RNA that was circulating, low receptor binding domain-specific IGG and antibody-dependent cellular cytotoxicity, and elevated cytokines and tissue injury markers. So a constellation of those.

They developed this 3-variable model of viral RNA that they actually predefined adjustment by age and sex. By doing this, they were able to very reliably identify patients with fatal outcomes. This model remained really robust in independent validation. They are suggesting that these are the kinds of assessments that can be done so that we can say, "This person is really at high risk for mortality."
Rick: Elizabeth, a lot of people have tried to identify who is going to be at risk of death with COVID-19 so we could direct therapies. They looked at just viral RNA, how many RNA particles were actually in the blood, 26 different cytokines and tissue markers, and six different types of immunologic responses. What they found out is really all we need to do is measure viral RNA by Day 11. By the way, when they went back and said, "Gosh, can we predict even earlier?" Even by Day 5, the amount of viral RNA predicted who was likely to die. The downside is this is a fairly small study by most of our standards, but it does need to be validated in a larger cohort.

Elizabeth: I thought they were very intellectually honest in taking a look at remdesivir and other things that might interrupt that whole cascade, and kind of speculating we are not really sure if that's going to make a difference and also that this circulating or this plasma viral RNA does not indicate intact virions or infectability either.
Rick: Right. It could be viral particles that have undergone degradation. But what's clear is the more viral particles, the more tissue injury you have, the higher the immunological response. Instead of measuring those other things, just the viral particle number alone can provide insight.
Elizabeth: Now, let's turn to one that I very specifically wanted you to address.
Rick: All right, Elizabeth, our listeners may not be aware, but I chair one of the FDA panels for circulatory devices. I have had the privilege of serving on this panel for, gosh, probably 10 to 12 years now.

This is a particular article calling for reforms to the medical device safety. When a device is considered to be low-risk, Class I or Class II, it's going to be approved by the FDA with really minimal involvement of committees.
When it may be life-threatening, it's called a Class III device. If it's a new device, we have what's called pre-market approval. They want to look at the device. They want to have randomized control trials showing that it's both effective and it's safe. But once you have that device, when you have other devices like it to speed things up, but to try to make it safe, we have what's called a 510(K) process. If a device looks like another device that's been effective, then it can be approved. It's called predicate device.
There was a device that was approved using the 510(K) to suck clots out of people that were having strokes. This device was based upon another device. Then this device went through 12 different iterations over the course of time. By 2019, this device, called the Penumbra, was recalled after about 200 adverse reports and 19 deaths associated with it. What this reform says is, "Gosh, obviously, in this particular case this 510(K) approval device pathway failed."

Elizabeth: Yeah. Of course, this reveals both of our biases, your bias toward the FDA and the policies that are employed in these device situations and mine against, where I really feel that there is not enough scrutiny. We have other examples of devices -- hip implants that have caused a lot of harm and were also approved under that same aegis. The editorialist, of course, says, "Hmm, maybe it's time for a new paradigm here."
Rick: I think there are some things within the FDA's control and some things that are not. There is what's called device creep. This was a device that was approved years ago and it went through iteration after iteration after iteration. But obviously, over the course of those 12 iterations, the device didn't look anything like the original device, so we need to have some way of dealing with that.

There are some things the FDA can't do, post-marketing surveillance. It doesn't have the teeth to demand that the company do post-marketing studies, and if they don't, to shut the product down. It just doesn't have that regulatory authority to do that.
We have a way of reporting device safety issues, but it's voluntary. There are some regulatory things that need to be done to give the FDA the information they need and the clout -- regulatory authority -- to enact some of these things. I agree with you, there are glaring holes that can be fixed.
Elizabeth: Well, I'm really glad to hear you make that admission and that's, of course, in JAMA Internal Medicine. Let's finally turn to the New England Journal of Medicine, what I served up as, "Is there any benefit to doing second surgeries after women have relapsed and they have already had surgery for ovarian cancer?" We will just remind everybody that ovarian cancer has a dismal prognosis, and that's largely many people feel because it doesn't get diagnosed until it's advanced. A lot of women have what's called cytoreductive surgery to remove as much of the cancer as possible and traditionally then they are not offered surgery again at recurrence.

This study is an iteration of an ongoing bunch of studies that have been examining this a little bit more closely. They had patients who had recurrent ovarian cancer and had a first relapse after a platinum-free interval. That's an interval during which no platinum-based chemotherapy is used of 6 months or more to undergo a secondary cytoreductive surgery and then receive platinum-based chemotherapy, or to receive platinum-based chemotherapy alone. Let me just note that some of these women also received some other agents and we can talk about that a little bit later.
They have developed a metric that's called the AGO score, which is a performance status score of 0 on a 5-point scale, with those higher scores indicating greater disability for entry to the study, ascites of less than 500 ml, and complete resection at the initial surgeries.
They had 407 patients who underwent randomization, about half in each group. Complete resection was achieved in almost 76% of these patients. Those patients who had the second cytoreduction in this carefully selected group of women lived almost 54 months, while those who only got the platinum-based chemotherapy and did not have a second surgery lived for 46 months.

Rick: As you noted, Elizabeth, the prognosis with ovarian cancer is dismal. The key to this particular study is, again, careful selection of women that have recurrent ovarian cancer. Because there was a previous study that's showing that a second surgery doesn't really increase survival. Now, by the way, this survival increase is meaningful -- it's 8 months -- but it's obviously not what we would like and that is a cure.
The other thing that I thought was particularly notable about this study is that it not only looked at survival, but it looked at the quality of life. When these women are carefully selected, they have a good outcome. Seventy-six percent had what was thought to be another complete resection; they don't have perioperative complications, and the quality of their life was no different than those who didn't have surgery. This is a small, incremental, but nevertheless an advance in the treatment of recurrent ovarian cancer.

Elizabeth: I agree. I wanted to note that, of course, some of these women also received, in addition to the paclitaxel and the carboplatin, they received bevacizumab as part of their second-line therapy. They also, some of them, just very few, received what's called a PARP inhibitor. I am wondering about either the addition, or even substitution, of those agents in women who have recurrences. I think we don't know the answers to that.
Rick: Right. There is at least in a subgroup analysis the evidence that the individual that had cytoreductive surgery and received one of those agents actually did worse. These are called post-hoc analyses. That is you look at the whole picture and you try to carve out small little pieces of it to see who drives the best benefit or who may receive harm. In this particular case, the numbers are so small I don't want to draw any conclusions about what the best type of chemotherapy is. But woman should be offered cytoreductive surgery if they have recurrence and they fall into that selective group of individuals.

Elizabeth: I absolutely agree. Finally, I would applaud the authors for saying that the results of this trial cannot be extrapolated to interval debulking after chemotherapy or to treatment of relapse after later lines of treatment. So they definitely identify the limitations of this particular strategy.
Rick: Right.
Elizabeth: On that note, then, that's a look at this week's medical headlines from Texas Tech. I am Elizabeth Tracey.
Rick: And I'm Rick Lange. Y'all listen up and make healthy choices.

 

[TooPatient]

(Short summary is that it ends well, sort of, as she tested negative.)
Family member who works at a school texted me on Saturday that she is sick with severe body aches and a fever of 102. Had gotten tested for covid that morning and waiting on results. Stayed in bedroom away from people until results back.That meant she had exposed my grandparents plus five other family members before she started running a fever.

DH and I visit my grandparents every Sunday. Not this week! Not after that. None of the rest of the family got tested because the school recommends that anyone who is fully vaccinated not bother getting tested unless they start showing symptoms even if they were exposed to a known case. That meant that another family member who works in the schools plus a high school student were exposed (if the test had come back positive) and would be going to school even if the rest came back positive until they showed any symptoms themselves.

Luckily, the test came back negative. Assuming it was accurate, she "just" has some sort of cold/flu. Okay. Running a fever on and off through Sunday. Negative COVID test and no fever by Monday morning so she went to work. This is crazy in my mind! The not bothering to test even with known exposure and returning to work so long as a fever is not currently present just seems like a good way to maximize spread!

 

[tyty333]

Just found out my next door neighbor passed away with covid. He was early sixties I believe (young, too young to go). I do not
know if he was vaxed or not. Hoping I will find out more later. It just happened.

 

[missy]

Just found out my next door neighbor passed away with covid. He was early sixties I believe (young, too young to go). I do not
know if he was vaxed or not. Hoping I will find out more later. It just happened.

I'm so sorry @tyty333

 

[missy]

The latest​

Omicron is slippery. That's the main takeaway from the first in-depth laboratory study of the new coronavirus variant raising alarms around the world. Researchers tested omicron against the Pfizer-BioNTech vaccine and found it eluded disease-fighting antibodies much more easily than other versions of the virus. But there's good news, too. Vaccination still probably provides some meaningful protection, especially after a booster dose, according to the non-peer-reviewed study. The finding was echoed in a separate analysis from Pfizer and BioNTech, which suggested that a booster shot may restore antibodies enough to block the virus.

There are also some early hints that omicron might cause less severe illness, according to Anthony S. Fauci, the nation’s top infectious-disease expert. He cautioned that the data so far were preliminary and anecdotal. “But it appears that with the cases that are seen, we are not seeing a very severe profile of disease,” Fauci said in a White House briefing. "In fact, it might be — and I underscore might be — less severe as shown by the ratio of hospitalizations per number of new cases.”

As we continue the long slog through this pandemic, researchers are warning that the world remains dangerously unprepared for the next one. A report from the the Global Health Security Index found shortcomings in every country could make it harder for them to prevent, detect and respond to future health emergencies. The United States got high marks overall but scored lowest on public confidence in government. As a result, the report said, "people have been unwilling to comply with public health recommendations that would slow the spread of the virus.”

Congressional Republicans are escalating their fight against the Biden administration's vaccine and testing mandates. This week, lawmakers led by Sen. Mike Braun (R-Ind.) are expected to force a vote to revoke the president’s policy, which health officials say is key to controlling the pandemic, The Washington Post's Tony Romm reports. The plan follows the same blueprint Republicans used earlier to attack business restrictions, mask mandates and other public health measures.

Pandemic stress is hitting Gen Z harder than any other age group, a new survey says. Nearly half of Americans ages 13 to 24 say the pandemic has made their schooling and career aspirations worse, according to the poll by the Associated Press-NORC Center for Public Affairs Research. Roughly 45 percent said they had a tougher time maintaining ties with friends, and 40 percent said romantic relationships had become more difficult. Those problems were less prevalent in older adults, the survey found.

Other important news​

A new vaccine from Medicago and GlaxoSmithKline is built from virus-like particles derived from plants. If authorized, it would be the first publicly available vaccine that uses such technology.

A hidden toll from the pandemic: rising blood pressure. American women experienced the highest increases, researchers say.

Boris Johnson’s staff denied there was a Christmas party in the middle of the strict 2020 lockdowns. Then they joked about it on camera.

Lopsided enforcement of pandemic rules has frustrated expats around the world. Some call the restrictions “discriminatory.”

 

[missy]

WHO: Omicron More Transmissible, Not Necessarily Milder​

— When it comes to disease severity, "hope is not a strategy," WHO officials say​

by Molly Walker, Deputy Managing Editor, MedPage Today December 8, 2021

The Omicron variant may be more transmissible, but increased transmissibility does not necessarily mean it will cause less severe disease, the World Health Organization (WHO) said in a briefing on Wednesday.
Omicron has been detected in 57 countries, with more still expected, WHO officials said, with its global spread and large number of mutations causing concern. However, it is too early to draw conclusions, given the lack of data on clinical disease.

Mike Ryan, MD, executive director of WHO's health emergencies program, said that while a virus will adapt to become more transmissible, the idea that a more transmissible virus is a milder virus is "a little bit of an urban legend."
"The outcome of whether a virus is less severe is much more random," he said. "I don't expect in general for viruses to become milder, it can happen randomly, but it's not a process that as a disease becomes more transmissible, it becomes milder."
If mild disease is allowed to go unchecked, it can generate pressure on the healthcare system, he added.
"Hope is not a strategy and we need to be very, very careful" when talking about severity, he said.
However, COVID-19 boosters for all are not the answer either, said Kate O'Brien, MD, WHO's director of the Department of Immunization, Vaccines and Biologicals, adding that the WHO's Strategic Advisory Group of Experts on Immunization (SAGE) recently met to do an "intensive review" on boosters, and that preliminary data indicated the vaccines are "holding up" for the severe end of the disease spectrum, while there have been "further reductions in performance" on the mild end.

"No matter which way you look at it, primary doses always outperform booster doses for those who are at risk," she said. "Primary doses to those who have not been vaccinated have to be the priority."
Soumya Swaminathan, MD, WHO's chief scientist, added that boosters make sense for vulnerable populations, such as those with comorbidities, but "boosters are unfortunately not the solution to this."
WHO officials referenced several early reports on lab data showing a reduction in neutralizing antibodies for the Pfizer vaccine, but pointed out that neutralizing antibodies are only one component of immunity. More clinical data are needed, they said, especially in countries with different populations, such as South Africa, which has a younger population. They also noted early reports on increased risk of reinfection with Omicron, but stressed these were also preliminary.
O'Brien said that while vaccine performance may be affected by the variant, that does not mean vaccines will become "ineffective entirely." She added that herd immunity is more important than ever, noting that people "can't be relying on the concept that other people being vaccinated are going to protect those in the community who choose not to be vaccinated."

By that same token, Ryan said that while preliminary indications are that Omicron is transmitting more efficiently than Delta, that "does not mean the virus is unstoppable," rather that it has become "better adapted to exploiting the connections between us."
That means non-pharmaceutical interventions, such as masking and social distancing, are particularly important, WHO officials said. WHO Director-General Tedros Adhanom Ghebreyesus, MBBS, PhD, called on countries to immediately increase their surveillance, including testing and sequencing capabilities, and to submit more data to the WHO's clinical platform.
"The steps countries take today ... will determine how Omicron unfolds," he said. "Don't wait until hospitals fill up. Act now ... Any complacency will cost lives."
Last Updated December 08, 2021

 

[missy]

Early Lab Data Provide Glimpse Into Omicron's Immune Escape​

— Small South African study shows steep drop in neutralizing antibodies for Pfizer vaccine​

by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today December 8, 2021

Preliminary data from a small study at a prominent South African lab have found a 41-fold reduction in neutralizing antibody titers for the Pfizer vaccine against Omicron.
Alex Sigal, PhD, of the Africa Health Research Institute (AHRI) -- which played a key role in the initial sequencing of Omicron -- and colleagues analyzed 14 plasma samples from 12 individuals fully vaccinated (two doses) with Pfizer.
While the geometric mean titer (GMT) for 50% neutralization was 1,321 against D614G, the wild type strain of the virus, GMT fell to 32 for Omicron, they reported in a medRxiv preprint that has yet to appear there but was posted on AHRI's website.

That's far more extensive than the threefold reduction in neutralizing antibody titers seen with the Beta variant, the researchers reported.
Still, Sigal noted that Omicron escape from neutralization was "incomplete" -- mainly because five patients who were both previously infected and vaccinated still had "relatively high" neutralization titers against Omicron.
Indeed, a graph published with the preprint showed declines for both those who had vaccination alone or vaccination plus previous infection, but those with the latter (also referred to as "hybrid immunity") appeared to maintain superior neutralizing antibody levels.
Experts commenting on Twitter noted this could indicate that booster shots could stand up well to Omicron. Pfizer also announced early Wednesday that its own data showed two doses of its vaccine had a more than 25-fold reduction in neutralizing titers against Omicron, but adding a booster restored those titers to close to what was seen with two doses against the wild-type virus.

"Given 3rd shot often provides 30-40x rise it might not be bad news, meaning not terrible," tweeted Peter Hotez, MD, PhD, of Baylor College of Medicine.
"The hope is that, based on neutralizing data of other variants, 3-dose vaccinated neutralization of Omicron may be reasonable -- MAY," tweeted Shane Crotty, PhD, of the La Jolla Institute for Immunology, cautioning, however, that this remains "speculation for now."
Crotty noted that the paper shows "neutralizing breadth in hybrid immunity is outstanding," adding that a three-dose mRNA vaccine series "partially recapitulates that improvement in breadth."
Sigal tweeted that the results were indeed "better than I expected of Omicron. The fact that it still needs the ACE2 receptor and that escape is incomplete means it's a tractable problem with the tools we got."
Yet others, including virologist Florian Krammer, PhD, of Mount Sinai hospital in New York City, noted that the drop was significant and raised concerns.

"Little activity was left in vaccinated individuals," he tweeted.
Still, Krammer said that even if protection against infection would be significantly reduced, it would be likely that protection against severe disease "would remain reasonably high in all individuals with baseline immunity," as non-neutralizing antibodies may target more conserved locations on the virus, and T-cell and memory B-cell activity also has a role to play.
The Sigal study used a live virus neutralizing assay (rather than a pseudovirus assay), and Sigal and colleagues started off by confirming that ACE2 was indeed required for Omicron entry into cells.
While six patients had confirmed prior infection with SARS-CoV-2 during the country's first wave in addition to vaccination, the other six patients had no previous record of infection nor any detectable nucleocapsid antibodies. Two of the patients contributed samples from two different time points to get a total of 14 samples.

 

[missy]

From the NEJM

BNT162b2 Vaccine Booster and Mortality Due to Covid-19​

List of authors.

• Ronen Arbel, Ph.D.,
• Ariel Hammerman, Ph.D.,
• Ruslan Sergienko, M.A.,
• Michael Friger, Ph.D.,
• Alon Peretz, M.D.,
• Doron Netzer, M.D.,
• and Shlomit Yaron, M.D.

• • Abstract​

    BACKGROUND​

    The emergence of the B.1.617.2 (delta) variant of severe acute respiratory syndrome coronavirus 2 and the reduced effectiveness over time of the BNT162b2 vaccine (Pfizer–BioNTech) led to a resurgence of coronavirus disease 2019 (Covid-19) cases in populations that had been vaccinated early. On July 30, 2021, the Israeli Ministry of Health approved the use of a third dose of BNT162b2 (booster) to cope with this resurgence. Evidence regarding the effectiveness of the booster in lowering mortality due to Covid-19 is still needed.
    

    METHODS​

    We obtained data for all members of Clalit Health Services who were 50 years of age or older at the start of the study and had received two doses of BNT162b2 at least 5 months earlier. The mortality due to Covid-19 among participants who received the booster during the study period (booster group) was compared with that among participants who did not receive the booster (nonbooster group). A Cox proportional-hazards regression model with time-dependent covariates was used to estimate the association of booster status with death due to Covid-19, with adjustment for sociodemographic factors and coexisting conditions.
    

    RESULTS​

    A total of 843,208 participants met the eligibility criteria, of whom 758,118 (90%) received the booster during the 54-day study period. Death due to Covid-19 occurred in 65 participants in the booster group (0.16 per 100,000 persons per day) and in 137 participants in the nonbooster group (2.98 per 100,000 persons per day). The adjusted hazard ratio for death due to Covid-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% confidence interval, 0.07 to 0.14; P<0.001).
    

    CONCLUSIONS​

    Participants who received a booster at least 5 months after a second dose of BNT162b2 had 90% lower mortality due to Covid-19 than participants who did not receive a booster.

The deployment of the BNT162b2 messenger RNA vaccine (Pfizer–BioNTech) and other vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) resulted in a significant decrease in mortality due to coronavirus disease 2019 (Covid-19).1 Israel deployed the vaccines rapidly, and accordingly, the incidence of Covid-19 dropped from almost 1000 cases per 1 million persons per day in January 2021 to 1 to 2 cases per 1 million persons per day in June 2021.2 However, the emergence of the B.1.617.2 (delta) variant3 and the reduced efficacy of BNT162b2 over time4 led to a resurgence of Covid-19 cases in Israel5 and in other populations that had been vaccinated early, such as the U.S. health care workforce.6 By August 2021, Israel had the highest incidence of Covid-19 worldwide.2 On July 30, 2021, the Israeli Ministry of Health approved the use of a third dose of BNT162b2 (booster). The booster was initially indicated for use in persons 60 years of age or older who had received a second dose at least 5 months earlier. Two weeks later, the age of eligibility was lowered to 50 years. This local regulatory approval was made despite the lack of robust evidence of efficacy and the absence of regulatory approval by the Food and Drug Administration and by the European Medicines Agency.
A global debate regarding the approval of Covid-19 vaccine boosters is ongoing.7 Data regarding the effectiveness of the BNT162b2 booster in lowering mortality due to Covid-19 are still unavailable in all age groups. Therefore, our objective was to assess for any decrease in mortality associated with the use of the BNT162b2 booster.

Methods​

STUDY DESIGN​

The study period started on August 6, 2021, which was 7 days after the approval of the booster for use in persons 60 years of age or older in Israel. The study period ended on September 29, 2021, which was the last date for which data regarding confirmed deaths due to Covid-19 were available on the day the data were extracted (October 3, 2021). The study timeline is depicted in Figure S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org.​

The Clalit Health Services (CHS) Community Helsinki Committee and the CHS Data Utilization Committee approved the study. The study was exempt from the requirement to obtain informed consent.​

STUDY POPULATION​

The study included all CHS members who were 50 years of age or older on the study start date and had received two doses of BNT162b2 at least 5 months earlier. CHS covers approximately 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care. Participants with missing data regarding date of birth or sex were excluded from the study. In addition, participants were excluded if they had been infected with SARS-CoV-2 or had received a booster before August 6, 2021; early administration of the booster was indicated in immunocompromised persons. Finally, participants who received the booster and had a confirmed case of Covid-19 within 3 days before the effective-booster date (defined as 7 days after the booster was administered) were excluded.​

The study population was divided into two groups: those who had received a booster during the study period (booster group) and those who had not received a booster (nonbooster group). Participants were included in the booster group on the effective-booster date to allow time for antibodies to build effectively.4,8 Up to 7 days after receiving the booster, participants were still included in the nonbooster group. A description of the transition of participants from the nonbooster group to the booster group is provided in Figure S2.​

DATA SOURCES AND ORGANIZATION​

We analyzed patient-level data that were extracted from CHS electronic medical records. A specific database was created for this study that integrated patient-level data from two primary sources: the CHS operational database and the CHS Covid-19 database. The CHS operational database includes sociodemographic data and comprehensive clinical information, such as coexisting chronic conditions, community-care visits, hospitalizations, medications, and results of laboratory tests and imaging studies. The CHS Covid-19 database includes information that is collected centrally by the Israeli Ministry of Health and transferred daily to CHS, such as vaccination dates, reverse-transcriptase–quantitative polymerase-chain-reaction (RT-qPCR) test dates and results, and hospitalizations and deaths related to Covid-19.​

The CHS databases were used in the primary studies that evaluated the effectiveness1 and safety9 of the BNT162b2 vaccine in a real-world setting. In addition, the Israeli Ministry of Health Covid-19 database was used as the basis of the initial study that evaluated the effectiveness of the BNT162b2 booster among persons 60 years of age or older.10 A description of the CHS data repositories that were used in this study is provided in the Supplementary Appendix.​

For each participant in the study, the following sociodemographic data were extracted: age, sex, population sector (general Jewish population, Arab population, or ultra-Orthodox Jewish population), and score for socioeconomic status (scores range from 1 [lowest] to 10 [highest]; details are provided in the Supplementary Appendix). The following clinical data were extracted: vaccination dates (first, second, and booster doses), RT-qPCR test dates and results, death due to Covid-19, and any clinical risk factors for death due to Covid-19 that have been identified in the general population,11 such as diabetes mellitus, chronic obstructive pulmonary disease, asthma, chronic kidney failure, hypertension, ischemic heart disease, chronic heart failure, obesity, lung cancer, or a history of cerebrovascular accident, transient ischemic attack, or smoking.​

STUDY OUTCOMES​

The primary outcome was death due to Covid-19. In the primary analysis of the effectiveness of the booster with respect to this outcome, we compared the mortality due to Covid-19 in the booster group with that in the nonbooster group.​

Because the initial approval of the booster by the Food and Drug Administration was for use in persons 65 years of age or older, we performed a subgroup analysis according to age group. We performed an additional subgroup analysis according to sex.​

In a secondary analysis of the effectiveness of the booster in preventing SARS-CoV-2 infection, we compared the frequency of positive RT-qPCR tests in the booster group with that in the nonbooster group.​

STATISTICAL ANALYSIS​

A chi-square test was used to compare categorical variables according to study group. Given that the independent variable (booster status) varied over time, univariate and multivariate survival analyses were performed with time-dependent covariates, in accordance with the study design.12 A Kaplan–Meier analysis with a log-rank test was used for the univariate analysis. Comparison of the survival curves and Schoenfeld’s global test were used to test the proportional-hazards assumption for each dependent variable. Variables that met the testing criteria served as inputs for multivariate regression analysis.​

A Cox proportional-hazards regression model with time-dependent covariates was used to estimate the association of booster status with death due to Covid-19. The regression model was used to estimate the hazard ratio for death due to Covid-19 in the booster group, as compared with the nonbooster group, with the use of sociodemographic and baseline clinical characteristics as independent variables.​

The assumption of a 7-day lag time between the administration of the booster and the effective-booster date, during which participants were included in the nonbooster group, was further tested to verify that this grouping did not create any bias. Validation of the lag time used to ensure booster effectiveness was performed through estimation of the hazard ratio for death due to Covid-19 in participants up to 7 days after the administration of the booster, as compared with the nonbooster group. Use of an alternative 14-day lag time was also tested with the same method.​

R statistical software, version 3.5.0 (R Foundation for Statistical Computing), was used for the univariate and multivariate survival analyses with time-dependent covariates. SPSS software, version 26 (IBM), was used for all other statistical analyses. A P value of less than 0.05 was considered to indicate significance in all analyses.​

Results​

PATIENT POPULATION​

Figure 1.

Assessment for Eligibility.Table 1.

Characteristics of the Participants at Baseline.​

A total of 843,208 participants met the eligibility criteria (Figure 1). The characteristics of the study population are shown in Table 1. The mean age was 68.5 years; 60% of the participants were 65 years of age or older. The most common coexisting conditions were hypertension (46%), obesity (33%), and diabetes (29%). For most sociodemographic and clinical characteristics, the difference between the booster group and the nonbooster group was significant.​

PRIMARY OUTCOME​

Figure 2.

Cumulative Hazard Ratio for Death Due to Covid-19.​

During the study period, death due to Covid-19 occurred in 65 participants in the booster group (0.16 per 100,000 persons per day) and in 137 participants in the nonbooster group (2.98 per 100,000 persons per day). The adjusted hazard ratio for death due to Covid-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% confidence interval [CI], 0.07 to 0.14; P<0.001). Cumulative hazard-ratio curves are shown in Figure 2. At the end of the study period, 758,118 participants (90%) had received the booster.​

Table 2.

Association of Confounding Variables with Death Due to Covid-19.​

The results of the Cox proportional-hazards regression model with time-dependent covariates are shown in Table 2. The model included only variables that met the criteria for the proportional-hazards assumption on the basis of the results of Schoenfeld’s global test (Table S1). Therefore, population sector, asthma, and hypertension were not incorporated into the model. In the Cox regression model, age, male sex, chronic kidney failure, lung cancer, and history of cerebrovascular accident were confounding variables that had a significant association with death due to Covid-19. Socioeconomic status, diabetes, chronic obstructive pulmonary disease, ischemic heart disease, chronic heart failure, obesity, history of transient ischemic attack, and history of smoking did not have a significant association with death due to Covid-19.​

VALIDATION OF THE 7-DAY LAG TIME TO ENSURE BOOSTER EFFECTIVENESS​

The hazard ratio for death due to Covid-19 in participants up to 7 days after the administration of the booster, as compared with the nonbooster group, was 0.95 (95% CI, 0.86 to 1.05; P=0.32). However, the hazard ratio for death due to Covid-19 in participants up to 14 days after the administration of the booster, as compared with the nonbooster group, was 0.67 (95% CI, 0.60 to 0.74; P<0.001). Therefore, our assumption of a 7-day lag time between the administration of the booster and booster effectiveness was confirmed. Details of the results of these analyses are provided in Tables S2 and S3.​

SUBGROUP ANALYSIS​

Among participants 65 years of age or older, death from Covid-19 occurred in 60 of 470,808 participants in the booster group and in 123 of 35,208 participants in the nonbooster group (adjusted hazard ratio, 0.09; 95% CI, 0.07 to 0.13; P<0.001) (Table S4). Among participants younger than 65 years of age, death from Covid-19 occurred in 5 of 287,310 participants in the booster group and in 14 of 49,882 participants in the nonbooster group (adjusted hazard ratio, 0.13; 95% CI, 0.04 to 0.40; P<0.001) (Table S5).​

Among female participants, death from Covid-19 occurred in 54 of 400,300 participants in the booster group and in 13 of 47,972 participants in the nonbooster group (adjusted hazard ratio, 0.06; 95% CI, 0.03 to 0.11; P<0.001) (Table S6). Among male participants, death from Covid-19 occurred in 83 of 357,818 participants in the booster group and in 52 of 37,118 participants in the nonbooster group (adjusted hazard ratio, 0.12; 95% CI, 0.08 to 0.18; P<0.001) (Table S7).​

SECONDARY OUTCOME​

During the study period, confirmed SARS-CoV-2 infection was observed in 2888 participants in the booster group and in 11,108 participants in the nonbooster group. The adjusted hazard ratio for SARS-CoV-2 infection in the booster group, as compared with the nonbooster group, was 0.17 (95% CI, 0.16 to 0.18; P<0.001) (Table S.​

Discussion​

Our study showed that among participants who were 50 years of age or older and had received a second dose of the BNT162b2 vaccine at least 5 months earlier, those who received a booster had 90% lower mortality due to Covid-19 than those who did not receive a booster.​

Israeli authorities approved the administration of a booster on July 30, 2021. In Israel, the decision to receive the booster is based entirely on personal preference. Delays in getting a booster may be related to logistic issues, including the ability to make an appointment at a convenient time and at a clinic close to home or at work. Delays in, or avoidance of, getting a booster may also be related to personal safety concerns. However, we found that by the end of our study period, most (90%) of the eligible persons 50 years of age or older had received the booster.​

The waning vaccine effect that was observed in Israel and in other populations that had been vaccinated early5,6,13,14 may occur in upcoming months in many other populations, in concordance with the timing of the first two doses of BNT162b2 in the mass vaccination campaign. Nevertheless, regulatory approval or recommendation of the booster, especially for participants younger than 65 years of age, is still under debate in many countries. The evidence generated in this study, which shows significant lifesaving potential from providing the booster, may help to resolve this issue.​

The 90% lower mortality due to Covid-19 with the use of the booster is somewhat less substantial than the effect observed in a preliminary study based on data from the Israeli Ministry of Health,15which showed approximately 93% lower mortality due to Covid-19 with the booster. The difference could reflect the different study designs; the use of a 12-day lag time to ensure booster effectiveness in the Ministry of Health study, as compared with a 7-day lag time in our study; the 32-day follow-up period in the Ministry of Health study, which was considerably shorter than the 54-day follow-up period in our study; and our use of the CHS operational database to adjust for coexisting conditions.​

The primary limitation of our study is the relatively short study period (54 days). However, during this time, the incidence of Covid-19 in Israel was one of the highest in the world.2 Moreover, the social-distancing restrictions imposed on the public in Israel were limited. Therefore, exposure to SARS-CoV-2 was substantial, and accordingly, the number of deaths due to Covid-19 was sufficient to show a significant association between the use of the booster and lower mortality due to Covid-19.​

Confounding sociodemographic and clinical characteristics may have led to bias in the analysis of effectiveness. We attempted to overcome such bias by adjusting for the variables known to affect mortality due to Covid-19. However, for some sources of bias, measurement or correction may not have been performed adequately.​

Older participants (≥60 years of age) started to receive the booster earlier than younger participants (<60 years of age) and had higher mortality. This might have introduced bias in the estimation of survival, resulting in higher mortality in the booster group than would be expected in the overall study population. In addition, data from older participants were censored earlier in the survival analysis, as the participants were transitioned to the booster group. This may be a potential source of bias due to informative censoring. However, the inclusion of age as a covariate in the Cox regression model minimized such bias.​

The main population sectors in Israel — the general Jewish population, Arab population, and ultra-Orthodox Jewish population — have different health-related behavioral patterns. Our analysis was adjusted for these subpopulations, but the adjustment did not significantly affect the study outcomes. This observation may be explained by the fact that all participants included in our study had chosen to receive the first two doses early in the vaccination campaign, and therefore, it is possible that they had similar health care–seeking behavior.​

The incidence of Covid-19 and thus exposure to SARS-CoV-2 changed during the study period. However, we assume that after adjustment for all covariates, including socioeconomic status, these changes had a similar effect in the booster group and the nonbooster group.​

Another major limitation of this study is the lack of data regarding serious adverse events. Future studies will be needed to assess the safety of the administration of the booster.​

Finally, our findings are limited to the BNT162b2 vaccine. Other vaccines have shown different patterns of waning immunity over time.16 Ongoing research comparing the vaccines (e.g., a planned U.K. study17) may provide insight on this issue.​

Despite these limitations, our study may provide meaningful answers to crucial questions regarding vaccination policy that remain partially unanswered by clinical trials.18 Although this study is observational in nature, we believe that the significant findings and the observed potential for saving many lives could assist decision makers in assessing the benefit of providing the booster to broad populations, especially persons 50 years of age or older.​

Our study showed that participants who received a booster at least 5 months after a second dose of BNT162b2 had 90% lower mortality due to Covid-19 in the short term than participants who did not receive a booster. However, studies with longer-term follow-up periods to assess the effectiveness and safety of the booster are still warranted.​

 

[missy]

An attempt at being faultless​

The emergence of omicron has turbocharged Hong Kong’s already extreme travel quarantine system. In the last week or so, the Asian financial city has moved over 30 countries to its high-risk category, mandating that residents returning from those places serve 21 days in hotel isolation after crossing the border. The knee-jerk reaction — by now a hallmark of Hong Kong’s virus strategy — was underscored by government officials moving Cook Islands, a tiny tropical island nation that recorded its first Covid case of any variant this week, to the high-risk category. A day later, Cook Islands was moved back to the medium-risk category after Hong Kong found out that its single case wasn’t of the omicron variant. The confusion and chaos were characteristic of a quarantine policy that even mainland China’s own scientists say is an overreaction. A traveler exits the arrival hall of the Hong Kong Port Passenger Clearance Building of the Hong Kong-Zhuhai-Macau Bridge. Photographer: Chan Long Hei/Bloomberg To those in Western countries and even other former Covid-zero Asian places like Singapore, Hong Kong’s 21-day quarantine sounds unimaginable, and in many ways it is. Less than 2% of people tested positive after 14 days in a study of Guangdong travelers, and the vast majority of those positive tests were picking up remnants of past infection — so the 21-day policy isn’t rooted in scientific understanding of how the virus spreads. Why, then, does Hong Kong continue to want its residents — especially many among its expatriate population who moved to the city for its connectedness — to not travel except at extreme financial and mental health cost? The answer can only lie in its desire to be as faultless as possible in its Covid-zero strategy so that Beijing might be moved to reopen the mainland border, Hong Kong’s economic lifeline. Officials have hinted that China may finally agree to do so before the end of the year. With Hong Kong having bartered away its openness and reputation as an Asian hub for the world, it remains to be seen if the city secures the tradeoff it apparently seeks. —Rachel Chang

 

[dk168]

Willing to travel a 37 miles or so round trip to another town to have my booster on 17 November before Omicron hit the news was probably one of the best decisions I had made in recent months.

>>> feeling grateful!

DK

 

[missy]

Covid 19 Treatment Options:

COVID-19 treatment options for mild to moderate symptoms include over-the-counter drugs for self-care at home. Severe symptoms of COVID-19 may require hospitalization. In the hospital, you may receive antivirals, drugs that reduce inflammation, and other supportive treatments, including oxygen. For people with risk factors for developing severe symptoms, monoclonal antibodies, as well as investigational drugs can help reduce the likelihood of severe disease and the need for hospitalization.
The more you know about COVID-19 treatment options, the better able you are to make an informed decision about your care if you contract the infection or become sick.

COVID-19 Treatment At Home​

Infection with SARS-CoV-2, the virus that causes COVID-19 does not usually cause symptoms. When symptoms occur, they develop 2 to 14 days after contracting the virus. Mild and moderate COVID-19 symptoms can include cough, fever, shortness of breath, muscle aches, stuffy or running nose, headache, sore throat, and loss of sense of smell and taste. Over-the-counter medicines can provide some relief for most of these symptoms.
OTC drugs and self-care at home include:

• Cough suppressants
• Decongestants for mucus buildup
• Fever reduces and pain relievers, such as acetaminophen (Tylenol) and ibuprofen (Advil, Motrin). Early studies suggested ibuprofen may worsen COVID-19, but follow-up studies do not show a correlation.
• Rest and fluids

COVID-19 symptoms last 1 to 3 weeks, but timing varies considerably between people and COVID-19 can worsen quickly.
Even if you or the person you are caring for has a mild form of COVID-19, you should monitor body temperature, skin color, and breathing throughout the day, and contact a medical professional for guidance if symptoms become more intense or severe.

Serious symptoms that might indicate severe COVID-19​

Severe COVID-19 is a medical emergency. It can occur in some people approximately one week after initial symptoms. Seek immediate medical care for (call 911) for signs and symptoms that can include:

• Difficulty breathing or struggling to breathe
• Change in level of consciousness, such as difficulty waking
• Chest pain or pressure
• Skin and mucous membranes that are paler than normal. This is cyanosis due to a lack of oxygen. People with light skin may appear very pale or pale blue. In people with dark skin, cyanosis is easier to see in the normally pink mucous membranes, such as the lips, gums and eyes.

COVID-19 antiviral drugs​

Antivirals are available for some viral infections, such as shingles, HIV and influenza. These drugs inhibit how the virus multiplies or infects cells.
The Food and Drug Administration (FDA) approved the antiviral drug, Veklury (remdesivir) for the treatment of COVID-19. Veklury is not specific for SARS-CoV-2, but it has been shown to reduce recovery time for patients hospitalized with COVID-19.
Who it’s for: Hospitalized patients 12 years of age and older and weighing at least 40 kilograms [kg]. Veklury also has a EUA (Emergency Use Authorization) for hospitalized pediatric patients weighing less than 40 kg.
A healthcare professional administers Veklury by intravenous (IV) infusion.

Oxygen support​

People hospitalized for COVID-19 often have reduced lung function. This can drastically reduce the amount of oxygen the body gets causing low blood oxygen. Supplemental oxygen can increase oxygen saturation, reduce the risk of respiratory distress, and increase recovery in some cases. Patients receive oxygen with a face mask or nose (nasal cannula).
For acute respiratory distress, patients receive high-flow or positive pressure oxygen. Mechanical ventilation through intubation may be necessary when high-flow or positive pressure ventilation is not sufficient.
Some people need supplemental oxygen after discharge from a hospital stay or from the hospital’s emergency department. This requires a doctor’s prescription and management.

Dexamethasone and other glucocorticoids​

Under certain circumstances, doctors prescribe dexamethasone and other glucocorticoids for COVID-19 in a healthcare setting. These drugs reduce inflammation by suppressing parts of the immune system.
Who it’s for: Hospitalized patients with severe COVID-19 who require supplemental oxygen, high-flow or positive pressure oxygen, or mechanical ventilation.
The COVID-19 Treatment Guidelines Panel (“the Panel”), composed of a variety of medical professionals, does not recommend these drugs for patients in stable condition.
The Panel also recommends a course of dexamethasone for people with COVID-19 who need supplemental oxygen but cannot be admitted to the hospital, such as when healthcare resources are limited.

Inflammatory pathway inhibitors​

Body-wide, or systemic inflammation can reach very high levels in people with severe COVID-19. To help reduce inflammation, doctors administer drugs that inhibit specific inflammatory proteins and pathways. Immunomodulator is another name for these types of drugs. Medications include:

• Baricitinib
• Sarilumab
• Tocilizumab
• Tofacitinib

Who it’s for: Hospitalized patients receiving high-flow oxygen or requiring a ventilator to breathe. The Panel recommends specific drug regimens and doses in specific circumstances, sometimes as part of a clinical trial.

Convalescent plasma​

People who have recovered (convalesced) from COVID-19 have produced abundant antibodies to SARS-CoV-2 that protect against reinfection. When administered to people with COVID-19, plasma from recovered donors has the potential to help the person’s immune system to fight the virus. Low-titer plasma has a low concentration and high-titer plasma has a high concentration of antibodies against SARS-CoV-2.
Early on in the pandemic, some health centers began infusing low- and high-titer convalescent plasma into patients with COVID-19. It improved the course of disease in some people. The FDA issued an EUA for high-titer convalescent plasma for the treatment of hospitalized patients and impaired immunity.
Who it’s for: Hospitalized patients with impaired immunity may receive convalescent plasma. However, the COVID-19 Treatment Guidelines Panel states, “There is insufficient evidence...to recommend for or against the use of high-titer convalescent plasma for the treatment of COVID-19.” Nonhospitalized people with COVID-19 may receive high-titer plasma as part of a clinical trial.

COVID-19 monoclonal antibodies​

A monoclonal antibody is a laboratory-made biological drug, or “biologic” that can be very effective at inhibiting the progression of certain diseases, such as cancerand a variety of inflammatory conditions.
With COVID-19, monoclonal antibodies that target the virus can help prevent the infection from progressing into severe disease. The three types of COVID-19 monoclonal antibodies are:

• Bamlanivimab plus etesevimab
• Casirivimab plus imdevimab
• Sotrovimab

Who it’s for: People who have been exposed to the COVID-19 virus and who have a high likelihood of developing severe COVID-19 should they contract the viral infection. COVID-19 monoclonal antibody treatment is known as post-exposure prophylaxis.
Risk factors for severe COVID-19 include having a chronic medical condition, being 65 years of age or older, being disabled, or being from a marginalized community, among other factors.
Healthcare professionals administer COVID-19 monoclonal antibodies by infusion at a hospital or other medical facility.
Demand for COVID-19 monoclonal antibody therapy is increasing, which may affect availability. Healthcare centers prioritize people most at risk. Talk with your doctor to determine if you are eligible for this treatment.

Oral antiviral medications for people at high risk of severe COVID-19​

Drug companies are in the process of testing oral medications that can reduce the risk of severe disease in people with mild or moderate COVID-19. These antivirals are different from Veklury because they target pathways or proteins specific to SARS-CoV-2.
Pfizer is collaborating with Roche on a COVID-19 pill known as Paxlovid. The FDA is reviewing clinical trial data on the drug, which showed an 89% reduction in the risk of hospitalization or death due to COVID-19.
Merck is working on molnupiravir, a pill that reduces the risk of hospitalization by about 30%. (Early results showed a 50% risk reduction.)
Roche and Atea Pharmaceuticals are working on an oral antiviral drug as well. The drug is in clinical trials and early results are promising.
Who it’s for: People with SARS-CoV-2 infection who have a high likelihood of progressing to severe COVID-19. These drugs are still in clinical trials and do not have emergency use authorization or approval from the FDA.
Talk with your healthcare provider if you need more information about COVID-19 treatment options.

 

[missy]

Willing to travel a 37 miles or so round trip to another town to have my booster on 17 November before Omicron hit the news was probably one of the best decisions I had made in recent months.

>>> feeling grateful!

DK

Glad you got the booster @dk168

 

[missy]

What is next with omicron?​

A little more than two weeks since omicron’s discovery a lot has been learned about the latest coronavirus variant. And a lot remains to be discovered. Early data from South Africa, the epicenter so far, shows that the virus appears to spread far faster than earlier strains, but also doesn’t appear to be causing severe disease. With omicron cases doubling every few days in the U.K., policymakers and investors are grasping at any clues; the spread in Britain could be a harbinger of things to come across Europe and the U.S. But the world is still somewhat in the dark as nothing is definitive yet. We still don’t know how it developed, whether it will cause more severe disease in countries with older populations than South Africa and whether it can out-compete delta in places where that version is dominant now. It’s not clear yet if 2022 will succeed where 2021 has been defeated: suppress the spread of the virus enough to stop the rolling infection waves and finally end social restrictions. A Covid-19 rapid PCR test site sign at Cape Town International Airport. Photographer: Dwayne Senior/Bloomberg So where to from here? That depends who you listen to. Richard Friedland, the chief executive officer of South Africa’s biggest private hospital group, Netcare Ltd., is relatively optimistic. “I actually think there is a silver lining here,’’ he says. That is, the virus may be attenuating itself where it’s highly contagious, but doesn’t cause severe disease. “It’s early days, but I’m less panicked. It feels different to me on the ground.” The World Health Organization is remaining cautious for now given so many unknowns, and the concern that any variant is a risk. “If they’re allowed to spread unchecked, even though they’re not individually more virulent or more lethal, they generate more cases, put pressure on the health system and more people die,” says Mike Ryan, executive director of the WHO emergencies program. “We should hope for the best outcome, but in this particular case, hope is not a strategy. We need to be very careful on making any final determinations on severity.”—Antony Sguazzin

 

[missy]

Early U.K. Data: Two Vax Doses Don't Cut It Against Omicron​

— But booster bumps effectiveness to more than 70%, technical briefing finds​

by Amanda D'Ambrosio, Enterprise & Investigative Writer, MedPage Today December 13, 2021

Two doses of a COVID-19 vaccine were significantly less protective against Omicron compared with Delta, but a booster shot restored immunity back to high levels, according to real-world data from the U.K.
A two-dose series with the Pfizer/BioNTech vaccine provided just under 40% protection against symptomatic infection with the Omicron variant about 25 weeks after the second dose compared with around 60% protection against Delta, a technical briefing released by the U.K. Health Security Agency found.

"These early estimates suggest that vaccine effectiveness against symptomatic disease with the Omicron variant is significantly lower than compared to the Delta variant," the agency noted in the report. However, "moderate to high" vaccine effectiveness was observed in the early period after a booster shot, they added.
A Pfizer/BioNTech booster increased vaccine effectiveness to 76%, the agency found. Among people who received the AstraZeneca series for their initial immunization (which offered almost no protection against Omicron), vaccine effectiveness jumped to 71% after a Pfizer/BioNTech booster.
The U.K.'s research compared vaccine effectiveness against Omicron versus Delta, and included 581 people who were infected with the new strain and more than 56,000 infected with Delta from the end of November to December 6.
In a separate analysis, the U.K. data showed that the rate of reinfection with Omicron was also much higher than reinfection with Delta. Of 329 individuals infected with Omicron, 7% had a previous infection, compared with 0.4% of the approximately 85,000 people infected with Delta.

After adjusting for age, public health region, and collection pillar, the risk ratio of reinfection for Omicron was 5.2 (95% CI 3.4-7.6).
The report also found a 20- to 40-fold reduction in neutralizing antibody activity compared with the viruses used to develop the vaccines. However, a booster dose significantly improved neutralizing antibodies, regardless of which vaccine was given in the initial immunization.
Katelyn Jetelina, PhD, an epidemiologist at the University of Texas Health Science Center at Houston, said that the data on vaccine effectiveness and reinfection ratesfound in this study confirm what researchers have already discovered in lab research -- vaccines offer significantly less protection against Omicron, and reinfection rates are expected to be high.
Jetelina noted that it was reassuring to see that "we can curb infection still with a booster, which is really quite phenomenal." But she also cautioned that cases are likely to increase.

"I think all this data is showing us that we're going to have a lot of infections with Omicron," Jetelina told MedPage Today. Although a high rate of infection does not necessarily equate to severe illness at the individual level, Jetelina said that she is concerned about population-level outcomes resulting from a flood of new cases.
"That's where I get a bit more nervous," she said. "Because a very transmissible variant will be sweeping across the United States, and even if the rate of severe disease is low, if you're talking about 330 million people, those numbers start adding up real quickly."
The U.K. Health Security Agency noted that these results should be interpreted with caution, due to the low number of Omicron cases included in their analysis. Additionally, more data are needed before scientists can determine how well vaccines will work against severe illness, hospitalization, and death from the Omicron strain.

"It will be a few weeks before effectiveness against severe disease with Omicron can be estimated," the agency stated. "However, based on this experience, this is likely to be substantially higher than the estimates against symptomatic disease."
The U.K. reported that cases from Omicron are doubling in the country every 2 to 3 days, and it reported the country's first death from the new strain.
Given the potential for an influx of Omicron cases here in the U.S., remaining vigilant in practicing public health interventions will be critical, said Jetelina.
"I think we still really need to curb transmission with masks, ventilation, and testing," she added. It is also extremely important that the "unvaccinated get vaccinated."

• Amanda D'Ambrosio is a reporter on MedPage Today’s enterprise & investigative team. She covers obstetrics-gynecology and other clinical news, and writes features about the U.S. healthcare system.

 

[Karl_K]

Had to go to the hospital today for an ultrasound.
Covid cases and deaths are at the highest level ever there.
All delta by what the news is saying.
We know family members of a few of them, one who they turned off life support just a few hours ago.
This sucks.

 

[missy]

COVID Vaccine 'Passports' Work to Boost Uptake​

— Six-country study shows benefits, particularly for young adults​

by Crystal Phend, Contributing Editor, MedPage Today December 14, 2021

Countries that required certification of COVID-19 vaccination, a recent negative test, or prior infection for travel or entry to public places generally saw faster uptake of the shots, a study showed.
Vaccinations increased in the 20 days before implementation of the policies and for the first 40 days afterward, reported Melinda Mills, PhD, and Tobias Rüttenauer, PhD, both of the University of Oxford in England, in the Lancet Public Health.

"As mass vaccination programs continue to play a central role in protecting public health in this pandemic, increasing vaccine uptake is crucial both to protect the individuals immunized and break chains of infection in the community," Mills said in a Lancet press release. "Our study is an important first empirical assessment of whether COVID-19 certification can form part of this strategy."
The impact varied across the six countries studied. It ranged from an additional 127,823 vaccine doses per million people in France and 243,151 per million in Israel to 64,952 per million in Switzerland. In France alone, that meant an extra 8.6 million doses around the introduction of the so-called passports for entry to restaurants, hair salons, hospitals, large public events, and other venues.
"The effect was related to the average pre-intervention levels of vaccine uptake and reasons for introducing certification, with countries that had lower-than-average levels of uptake showing more pronounced effects (France and Israel), particularly in some age groups," the researchers noted.

Local circumstances also appeared to play a role, like low vaccine availability at the time of Denmark's policy and a federal election that used Germany's certification as a political pincushion.
However, age was a consistent factor, especially in those younger than 20, but also those ages 20 to 49, when the certification covered not just nightclubs and large events, but also the hospitality sector, small events, and leisure activities.
"Given higher vaccine complacency and hesitancy in certain groups, such as younger people (<30 years), this intervention could be an additional policy lever to increase vaccine uptake and population-level immunity," Mills and Rüttenauer suggested.
The study also attempted to determine the impact of vaccine passports on actual case load. While "logically," there would be a reduction from anything that increases vaccination, the researchers said, available data didn't provide a clear picture.
"For some countries (France, Germany, Italy, and Switzerland), we found a reduction in cases after the intervention, whereas for others (Israel and Denmark) we found a continued increase above the rate in control countries," they wrote. "The context of the pandemic trajectory when implementing the measure was important because many countries introduced certification during a period of increasing cases."

The study examined data from Denmark, France, Germany, Israel, Italy, and Switzerland on the number of vaccine doses and infections up until Nov. 8, 2021, after these countries introduced COVID-19 certification at some point from April 21 to Sept. 23, 2021.
Limitations included the range of reasons why and when each country introduced its policy, as well as the varying restrictions between these policies.
Mills and Rüttenauer acknowledged the downside of mandatory vaccine passports, such as risk of exacerbating inequalities for ethnic and socioeconomic groups that already have poorer vaccine uptake and lower trust in authorities.
Certification appears to help but likely should be paired with other strategies, such as geographically targeted vaccine drives and peer-to-peer or community dialogue for vaccine-hesitant groups, the researchers suggested.
"COVID-19 certification is only part of a constellation of multiple policy levers that could be used to counter vaccine complacency and hesitancy and increase uptake," they concluded.

 

[missy]

Long COVID Guidance Focuses on Breathing Discomfort, Cognitive Symptoms​

— Physiatry society builds on previous guidance on fatigue​

by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today December 14, 2021

A physiatry society published two more clinical guidance statements in its series on long COVID, this time focusing on breathing discomfort and cognitive symptoms.
The American Academy of Physical Medicine and Rehabilitation previously published guidance on fatigue. These latest consensus statements on post-acute sequelae of SARS-CoV-2 infection (PASC) were also published in its journal, PM&R.
The guidance statements originate from the PASC Collaborative, a network of 34 centers that focus on treating long COVID, which includes more than 50 experts spanning various disciplines, such as physical medicine and rehabilitation, primary care, pulmonology, cardiology, and critical care medicine.

Benjamin Abramoff, MD, of the University of Pennsylvania and a co-chair of the PASC Collaborative, said physical medicine and rehabilitation specialists are an ideal specialty to create such guidance since they "have a lot of experience taking care of complex patients with multi-organ-system issues."
"We're used to working with larger teams to treat these complex issues," Abramoff told MedPage Today. "PASC patients have a lot of different system involvement and you need a multidisciplinary team to optimize outcomes."
He acknowledged that PASC can manifest as a wide-ranging constellation of symptoms, and there will be overlap between the guidance statements.
"It's really difficult to silo fatigue, cognitive dysfunction, breathing issues, and so on," he said. "Even though we talk about them in separate guidance statements, we refer to the others. Sometimes treating fatigue, for example, can help with some cognitive dysfunction."
He said the guidance statements are aimed at primary care physicians and other specialists who are interested in developing centers specialized in treating PASC. Both statements offer expert consensus on how to identify and diagnose these ailments, and make treatment recommendations.

Overall, about 10% to 30% of the general post-COVID population have some form of long COVID, Abramoff added.
Breathing Discomfort Guidance
Respiratory symptoms are among the most common symptoms reported by patients with long COVID. These symptoms include shortness of breath, impaired exercise tolerance, cough, and chest pain, the guidance noted.
Generally, the severity of ongoing lung disease appears to be associated with the severity of the initial episode, according to the guidance. Patients who had mild COVID are less likely to have pulmonary function test (PFT) abnormalities or imaging abnormalities. Yet shortness of breath and breathing discomfort "remain common aspects of PASC among patients with mild acute COVID-19 and warrant close evaluation," the guidance stated.
The guidance recommends taking pulse oximetry at rest and during ambulation. Patients with more severe impairment who have abnormal PFTs or new oxygen desaturation with exertion should be referred to a pulmonologist.

"Does the initial workup demonstrate evidence of PFT abnormalities, or objective evidence of pulmonary dysfunction? That could be considered a red flag for an additional workup or referral to a pulmonologist," Abramoff said.
The guidance also discusses options for rehabilitation and cases in which formal respiratory or pulmonary rehabilitation would be warranted.
"For those who don't necessarily have objective findings or for those who are more subjective in their breathing issues," he noted, "we have some resources in terms of breathing exercises that patients can do in their own homes and some self-guided programs that can help."
Cognitive Symptoms Guidance
Common neurological and neuropsychiatric symptoms associated with long COVID include fatigue, myalgia, headaches, sleep disturbance, anxiety, depression, dizziness, anosmia, dysgeusia, and "brain fog," according to the guidance. Primary cognitive symptoms include deficits in reasoning, problem solving, spatial planning, working memory, difficulty with word retrieval, and poor attention.

There's no evidence that SARS-CoV-2 infects the central nervous system (CNS), but proposed mechanisms of CNS-related pathology include increased inflammation as a result of the activation of CNS immune mediators; excessive glutamate/NMDA excitotoxicity and neurotransmitter depletion; or an unmasking of previous subclinical neurologic and neuropsychiatric impairments.
Subjective measures such as patient self-reported decreases in cognitive symptoms can be supplemented with commonly used neurocognitive assessments, including the Mini-Mental Status Exam, Montreal Cognitive Assessment, Saint Louis University Mental Status Exam, Mini-Cog, and the Short Test of Mental Status, according to the guidance.
"We don't prescribe one specific cognitive tool or test to use," Abramoff said. "We give options for a few different ones that can be considered."
"The other strong consideration is that it's important to rule out other things that can contribute to cognitive dysfunction, whether that's impaired sleep, anxiety, depression, or pain. All of these things, if left untreated, can cause people to have worsening cognitive function," he added.
Recommended therapies -- following an individualized treatment plan -- include cognitive rehabilitation; sleep interventions to improve cognitive symptoms; watching for the potential impact of medications on cognitive function (including anticholinergics, antidepressants, antipsychotics, benzodiazepines, and skeletal muscle relaxants); and behavioral health interventions if needed.

 

[rainbowstarry]

Thank you @missy for these threads

 

[missy]

After a brief lull in activity, weekly COVID-19 cases in children returned to the upward trend that began in early November, based on data from the American Academy of Pediatrics and the Children's Hospital Association.

Vaccinations in children, however, continued to do the opposite by falling for the fourth consecutive week, with the largest decline for the week of Dec. 7-13 coming from those most recently eligible, according to the Centers for Disease Control and Prevention.



New COVID-19 cases were up by 23.5% for the week of Dec. 3-9, after a 2-week period that saw a drop and then just a slight increase, the AAP and CHA said in their latest weekly COVID report. There were 164,000 new cases from Dec. 3 to Dec. 9 in 46 states (Alabama, Nebraska, and Texas stopped reporting over the summer of 2021 and New York has never reported by age), the District of Columbia, New York City, Puerto Rico, and Guam.

The increase occurred across all four regions of the country, but the largest share came in the Midwest, with over 65,000 new cases, followed by the West (just over 35,000), the Northeast (just under 35,000), and the South (close to 28,000), the AAP/CHA data show.

The 7.2 million cumulative cases in children as of Dec. 9 represent 17.2% of all cases reported in the United States since the start of the pandemic, with available state reports showing that proportion ranges from 12.3% in Florida to 26.1% in Vermont. Alaska has the highest incidence of COVID at 19,000 cases per 100,000 children, and Hawaii has the lowest (5,300 per 100,000) among the states currently reporting, the AAP and CHA said.

State reporting on vaccinations shows that 37% of children aged 5-11 years in Massachusetts have received at least one dose, the highest of any state, while West Virginia is lowest at just 4%. The highest vaccination rate for children aged 12-17 goes to Massachusetts at 84%, with Wyoming lowest at 37%, the AAP said in a separate report.

Nationally, new vaccinations fell by a third during the week of Dec. 7-13, compared with the previous week, with the largest decline (34.7%) coming from the 5- to 11-year-olds, who still represented the majority (almost 84%) of the 430,000 new child vaccinations received, according to the CDC's COVID Data Tracker. Corresponding declines for the last week were 27.5% for 12- to 15-year-olds and 22.7% for those aged 16-17.

Altogether, 21.2 million children aged 5-17 had received at least one dose and 16.0 million were fully vaccinated as of Dec. 13. By age group, 19.2% of children aged 5-11 years have gotten at least one dose and 9.6% are fully vaccinated, compared with 62.1% and 52.3%, respectively, among children aged 12-17, the CDC said.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.

Thank you @missy for these threads

Thank you @rainbowstarry
I am so sad DF is not here anymore e to challenge me about Covid and vaccinations.

 

[missy]

An opinion piece.​

​

Waves, Variants, Vaccines: What More to Expect From COVID-19​

Salvador Macip, MD, PhD
December 15, 2021






The COVID-19 pandemic has entered a new phase, which for many is particularly confusing. After the improvements seen at the end of summer, a new wave is surfing the planet and a potentially dangerous variant has emerged in South Africa, which has the experts worried. Weren't vaccines supposed to solve everything? Why are we still feeling like we keep going back to square one?
Vaccines work, and they work beautifully. They have reduced mortality around 10-fold and brought hospital admissions to very low levels. However, they can't do what they were not designed to: eliminate transmission. A fully vaccinated adult has around 50% less chance of getting infected or transmitting the virus. Although these numbers are great, they are not zero. This means that if we throw all caution to the wind after being immunized, cases will rise again. Which is exactly what's happening.
This is the main reason behind what Europe is calling "the sixth wave," an uncontrollable rise in new cases that started after the summer, after the vaccination rates crossed the 70% threshold, particularly in Western Europe. Although the percentage of mortality is nothing close to what we saw in prevaccine waves, the trend is still worrying.
A high number of infections will inevitably lead to more severe cases, which could have been avoided if the wave had been nipped in the bud. But this requires remembering that the pandemic is still very much alive and we still have to continue doing what we know works: testing, handwashing, ventilation, masks. Many people seem to have forgotten that.

In the face of this new wave, there are different strategies to follow. The most logical one is to increase vaccination efforts, particularly in places like the US, where less than 60% of the population has received a full course. Reaching those that so far have refused to get a jab is not easy. Many are unlikely to change their minds, whatever we do. But others are still on the fence, and these should become the urgent target of all campaigns.

One way to promote vaccination is to limit the activities of those that are not fully immunized. This is the job of the COVID pass, aggressively implemented in some countries in Europe (even forbidding access to work or to leave your house if you don't have one), and more timidly in others (just to access recreational activities).
Meanwhile, other paths are being pursued in parallel. We are still not sure how effective boosters or child vaccinations will be, but they are likely to contribute somewhat to reducing the spread of the virus. That's why they are also at the top of the list of things to try before moving to the next level — going back to restrictions. Some countries can't afford the luxury of waiting for more people to get vaccinated and have already had to implement curfews and even lockdowns, which should always be the last resort, given the strong impact they have. We have to be aware that these strategies work, and we may still have to resort to them at some point while the pandemic is still active. One step forward, one step back. That's how it goes.

Apart from this, we have to start thinking once and for all about how to respond to the pandemic in a global way. As we discussed before, there is no point in vaccinating everyone in the richest countries if a full continent is still struggling to cross the 10% immunization rate. We know that this increases the chances of new, more aggressive versions of the virus appearing. The Omicron variant, spreading now across the globe, has just confirmed this. We still don't know how bad it's going to be (more infectious, certainly, but maybe not more deaths, and hopefully still sensitive to the antibodies we have); we'll have to wait and see. In any case, this will still happen in places where the virus can circulate freely, and we'd better reduce our chances of a truly aggressive variant coming up in the future by vaccinating those that need it the most first.


With cases in the States and Europe steeply rising again, even before we see whether Omicron is going to change the rulebook, the best we can do is to insist that, although we are much better than we were last year, this is far from over.

We have to remain vigilant. Get a jab if you haven't received one. Get another one if it's offered to you (or to your children). And don't forget that this is not enough and we still need the rest of tools we have to protect us, common sense being chief among them. While we do this, let's remind our leaders that we are all in it together and we have to help the countries that are still struggling if we want to improve everyone's chances of coming out of this alive. The pandemic is far from over, and no one will be safe from it until we all are.

 

[missy]

Mayo, Others Post Pleas to Take COVID Seriously: 'We're Overwhelmed'​

Marcia Frellick

December 15, 2021

Leaders at Mayo Clinic in Rochester, Minnesota, and Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, are among the most recent voices pleading for COVID-19 vaccinations as available beds dwindle amid the current surge.

"We are overwhelmed," said a tweet from Mayo Clinic's Pulmonary and Critical Care Medicine team. The plea was signed by CEOs from nine other hospital systems in Minnesota as well.



"We're heartbroken. We're overwhelmed. The situation is critical," the tweet read. "Please get vaccinated, wear a mask, wash your hands and get tested for COVID if you feel sick." Mayo also took out an ad with that message in the Star Tribune, the advisory board reports in its daily briefing.


The publication reported that a spokesperson for the Mayo Clinic said its Rochester campus "has been treating approximately 100 patients with Covid-19 on a daily basis, some of the highest levels of Covid-19 patients we have seen in Rochester throughout the pandemic."

Michael S. Calderwood, MD, MPH, an infectious diseases physician, epidemiologist, and the chief quality officer at Dartmouth-Hitchcock, wrote in a commentary in the New Hampshire Bulletin: "We're now in the biggest surge of cases since the pandemic broke out nearly two years ago. Currently in the state, we're averaging 80 times more cases per day than where we were this past summer (and around 1.5 times more cases than our prior peak last winter, when vaccines were only just becoming available)."

He noted the state's positivity rate is back where it was in April 2020, and in some areas of the state the rate is as high as 25%.


"I wish I could say things are getting better, but they're not. The current modeling suggests that things will get worse over the next couple of weeks," Calderwood writes.

As of Tuesday, 78% of the available intensive care unit beds in the nation were in use, 20% of them used for COVID-19 patients, according to the US Department of Health and Human Services.

Others straining under the new cases include hospitals in New York, where providers are seeing an "alarming jump" in COVID cases and hospitalizations, Gov. Kathy Hochul said today, according to a report by news site PIX11.

"We anticipated a spike after Thanksgiving and it has arrived," Hochul said. "This is an alarming jump statewide."


The governor said the average number of cases per 100,000 people in New York has surged by 58% since Thanksgiving. The average number of hospitalizations per 100,000 people in the state jumped 70% in that time.


The story is the same in other countries as well. The Associated Press reportstoday that "[t]he omicron variant is spreading so rapidly it has the potential to overwhelm Britain's hospitals."

All Hands on Deck​

"Our hospital workers are doing all they can in this pandemic," Dartmouth's Calderwood writes. "It's time for everyone else to do all they can, too."


He and other healthcare leaders make the same urgent plea for five simple steps: "Get vaccinated. Get boosted. Wear a mask. Keep your distance. And wash your hands."

 

[MRBXXXFVVS1]

I'm feeling anxious because my siblings are going home to my parents house for Christmas. Everyone is boosted, but my siblings participate in high risk activities (large, indoor, unmasked holiday party maybe with hundreds of guests) and are flying. With Omnicorn, I'm anxious they could give it to my parents whom I don't think will do well if they got COVID. Of course there's no telling my siblings to not go home for the holidays (I texted asking them to be careful and take precautions) and my parents won't deny spending the holidays with them. I of course continue my isolation and will not be joining. But I am anxious for my parents. I'm even nervous about going to doctor appointments myself.

#1 gift this holiday season? Omnicorn.

 

[missy]

I'm feeling anxious because my siblings are going home to my parents house for Christmas. Everyone is boosted, but my siblings participate in high risk activities (large, indoor, unmasked holiday party maybe with hundreds of guests) and are flying. With Omnicorn, I'm anxious they could give it to my parents whom I don't think will do well if they got COVID. Of course there's no telling my siblings to not go home for the holidays (I texted asking them to be careful and take precautions) and my parents won't deny spending the holidays with them. I of course continue my isolation and will not be joining. But I am anxious for my parents. I'm even nervous about going to doctor appointments myself.

#1 gift this holiday season? Omnicorn.

I hear you. I feel similarly. My nieces are in school and while fully vaxxed and wearing masks in school and anywhere else that is not home when indoors they managed to catch colds in October. And then spent Thanksgiving at my parents. Unmasked inside. So yeah it's a concern for sure.

My dad is 87 and my mom is immune compromised. Everyone is fully vaccinated and boosted but still. Nothing is perfect. But I will remind you we can only control our behavior and not others. We can share how we feel with them and do what we need to do but that is all we can do.

And ditto going to doctor appointments which we have far too many of but they are all necessary. We do the best we can do and that is all we can do.

If it makes you feel any better Omicron looks to be less dangerous than Delta but Delta is still in full force here. Sigh.

You and I have much in common. We didnt spend Thanksgiving with my family. We spent it just the two of us.
We can only control what we do and not what others do. You gave it your best shot and they know how you feel.
Hopefully everyone will remain safe and well.

We will be spending a quiet Christmas holiday by ourselves.

Scale back Christmas plans, England’s chief medical officer warns public

England's chief medical officer warned people not to mix with others unless they have to in the run-up to Christmas after Britain recorded its most daily coronavirus cases since the start of the pandemic.

www.reuters.com

"
LONDON, Dec 15 (Reuters) - England's chief medical officer warned people not to mix with others unless they have to in the run-up to Christmas after Britain recorded its most daily coronavirus cases since the start of the pandemic.

With a new highly transmissible Omicron variant of the virus surging across Britain, a further 78,610 COVID-19 infections were reported on Wednesday, about 10,000 more than the previous high reported in January.


Chief Medical Officer Chris Whitty said that Britain is being hit by "two epidemics on top of each other" as he urged the public to scale back their Christmas plans.

"People should be prioritising those things, and only those things, that really matter to them," he told a news conference. "Don't mix with people you don't have to."


Whitty warned that the number of daily cases would continue to break records in the next few weeks and a big rise in hospitalisations is "a nailed-on prospect".

Prime Minister Boris Johnson agreed with a "general instinct to be more cautious" but ruled out further government restrictions for now.


"We're not cancelling events, we're not closing hospitality, we're not cancelling people's parties or their ability to mix," he said.

More than 11 million people have now tested positive for the disease in the United Kingdom, which has a total population of around 67 million.

While the number of daily cases is at a record, deaths are running at a much lower level than earlier in the pandemic. The government hope that a rapid booster rollout will help keep levels of severe disease low even as cases rise.

Jenny Harries, chief executive of the UK Health Security Agency, earlier called the Omicron variant "probably the most significant threat" since the start of the pandemic.

"The numbers that we see on data over the next few days will be quite staggering compared to the rate of growth that we've seen in cases for previous variants," she told a parliamentary committee.

Harries said that Omicron had the potential to put the national health service "in serious peril" because of the speed at which infections were increasing.

Amanda Pritchard, head of the National Health Service in England, told lawmakers that the health service was now gearing up for a wave of hospitalisations "as big or even bigger than the previous wave this time last year".

She said that the record tally "should worry all of us".

The new variant of the virus has a doubling time under two days in most regions in Britain, with its growth rate was being notable in London and Manchester in particular.

More than 10,000 cases of Omicron have been recorded, with at least 10 people hospitalised. One person has died after contracting the variant, which is set to become the dominant strain in London.

More than 146,000 people have died from COVID-19 in the United Kingdom."

 

[missy]

Expecting a surge​ ​

Get ready for the Omicron surge, and take it seriously. But remember that the vaccines appear to provide strong protection against what matters most: severe Covid illnesses.​

That’s my reading of experts’ reactions to the latest developments on the Omicron variant. Today, I will walk through them.​

Highly contagious​ ​

The news over the past few days — both scientific studies and real-world data — has added to the evidence that Omicron is more contagious than any previous version of the Covid-19 virus.​

In South Africa, where Omicron was first identified, the recent rise has been steeper than during any previous surge. “When Omicron enters a community, the increase in case numbers looks like a vertical line,” Dr. Paul Sax of Brigham and Women’s Hospital in Boston said.​

Chart shows 7-day daily average.Source: Johns Hopkins University​

In Britain, new cases also hit a record yesterday. In the U.S., Omicron has not yet spread as widely, but scientists believe it’s only a matter of time.​

One reason that Omicron seems to spread so quickly is that it causes more cases among the vaccinated than earlier variants, although they are likely to be mild. “There will be a lot of breakthrough cases,” Dr. Jennifer Lighter, an epidemiologist at N.Y.U. Langone Health, told me.​

Dr. Muge Cevik, an infectious-disease expert at the University of St. Andrews in Scotland, noted on Twitter that much about Omicron remains uncertain, but its infectiousness seems clear:​

The only thing I am sure of is that Omicron will spread so quickly through the population, making it likely impossible to contain even with the most stringent measures and giving us very little time over the next few weeks. So get your vaccines and boosters!​

I know that some readers will find this news extremely alarming. And it is alarming in several respects: Unvaccinated adults are at even greater risk than they were a few weeks ago, and about 15 percent of American adults remain unvaccinated. (The global share of unvaccinated adults is probably not much higher; many of the world’s unvaccinated people are children, and serious Covid illness remains extremely rare in children.)​

The large number of unvaccinated adults means that Omicron may lead to spikes in Covid hospitalizations and deaths, which in turn could overwhelm some hospitals. This prospect is why Cevik emphasized the importance of the next few weeks. Persuading more vaccine skeptics in both the U.S. and other countries to get shots — before the Omicron surge has fully arrived — can save a lot of lives.​

“I have been telling my unvaccinated patients that it is extremely urgent for them to start a vaccine series as soon as possible,” Dr. Aaron Richterman of the University of Pennsylvania said.​

The power of vaccines​ ​

The most encouraging news about Omicron is that it does not appear to cause more severe illness than earlier versions of the virus.​

Some evidence even suggests Omicron is less severe. A new study from Hong Kong, for example, found that Omicron replicated itself less efficiently than Delta inside the lungs, which could make it less likely to cause acute symptoms. But many scientists say it is too soon to be confident.​

Either way, the crucial question for most people is not whether Omicron is less severe than earlier versions of the virus; the question is whether Omicron is more severe. So far, the answer is no.​

If that continues to be true, it will mean that Omicron — like earlier variants — presents only a very small risk of serious illness to most vaccinated people. It is the kind of risk that people accept every day without reordering their lives, not so different from the chances of hospitalization or death from the flu or a car crash.​

Unfortunately, there are some vaccinated people for whom any Covid case remains a threat. Those whose health is already vulnerable — like the elderly, people undergoing cancer treatments, people who have received organ transplants and some other groups — can become extremely ill from a Covid case that is mild in a technical sense. Their bodies are weak enough that any infection can cause major problems. It’s the same reason that the seasonal flu kills tens of thousands of Americans annually.​

These are the people, in addition to the unvaccinated, who need the most attention now that Omicron has arrived.​

Next steps​ ​

What can be done? A few things, experts say:​

Anybody eligible for booster shots — Americans 16 and older who received their second vaccine dose at least six months ago — should get one. Boosters appear to make a major difference against Omicron, as Dr. Anthony Fauci and experts at the World Health Organization emphasized yesterday. Even if your health is not vulnerable, a booster can reduce the chances you contract Covid and pass it on to somebody who is vulnerable. Likewise, vaccinating children can protect their grandparents. Rapid tests — more widely available than a few months ago — can help, too. If you’re socializing with somebody who is medically vulnerable, try to take a test beforehand. And the Biden administration can do more to cut the tests’ costs, many experts say.

We will learn more about Omicron in coming weeks, and the facts could still become either more worrisome or less so. For now, the variant seems to represent a step toward the future of Covid. It will not disappear, but there are many ways to lessen its toll — and live as normal a life as possible.​

As Dr. Monica Gandhi and Dr. Leslie Bienen, two public health experts, wrote in a recent Times Opinion article, “America is in the slow process of accepting that Covid-19 will become endemic — meaning it will always be present in the population at varying levels.”​

 

[missy]

Covid deaths in the United States surpass 800,000.​

By Julie Bosman, Amy Harmon, Albert Sun, Chloe Reynolds and Sarah Cahalan

• Dec. 15, 2021

Coronavirus deaths in the United States surpassed 800,000 on Wednesday, according to a New York Times database, as the pandemic neared the end of a second year and as known virus cases in this country rose above 50 million.
The new death toll — the highest known number of any country — comes a year after vaccines against the coronavirus began rolling out in the United States. It also comes at a tenuous moment in the pandemic: Cases are rising once again, hospitals in some parts of the country are stretched to their limits with Covid patients and the threat and uncertainties of a new variant loom.
More than 1,200 people in the United States are dying from Covid-19 each day.
The last 100,000 deaths occurred in less than 11 weeks as the pace of death has picked up, moving faster than at any time other than last winter’s surge. The current uptick is being driven by the Delta variant. It is not yet known how the Omicron variant, which continues to emerge in more states, might affect those trends in the coming weeks and months.
Naoko Muramatsu, a professor at the University of Illinois at Chicago’s School of Public Health, said that from the beginning of the pandemic in 2020, older people have suffered disproportionately.



“Early on, Covid was considered to be an older people’s problem,” she said. Nearly two years later, those difficulties have persisted, whether in the form of a high death rate or isolation, which in many cases already existed but expanded significantly as the months wore on. Older people steered clear of crowded public gatherings and younger relatives stayed away, fearful of exposing those more vulnerable to the virus.
Some 75 percent of the 800,000 Covid-19 deaths have involved people 65 or older. One in 100 older Americans has died. Countless others have found themselves isolated.



“Covid really made something visible that was already going on for older adults,” she said. “Older people were so vulnerable.”
After the first known coronavirus death in the United States in February 2020, the virus’s death toll in this country reached 100,000 people in only three months. The pace of deaths slowed throughout summer 2020, then quickened throughout the fall and winter, and then slowed again this spring and summer.
Throughout the summer, most people dying from the virus were concentrated in the South. But the most recent 100,000 deaths — beginning in early October — have spread out across the nation, in a broad belt across the middle of the country from Pennsylvania to Texas, the Mountain West and Michigan.

​

The benchmark of 800,000 deaths in the United States occurred despite the wide availability of vaccines for most of 2021.

The Coronavirus Pandemic: Key Things to Know​

U.S. surpasses 800,000 deaths. Covid deaths in the United States surpassed 800,000 — the highest known number of any country. About 75 percent of the 800,000 deaths have involved people 65 or older. One in 100 older Americans has died from the virus.
The Omicron variant. The new Covid variant has been detected in dozens of countries. While Omicron is perhaps less severe than other forms of the virus, it also seems to dull the power of the Pfizer vaccine, though the company said its boosters are effective. Dr. Anthony Fauci said Moderna and Pfizer boosters are likely to offer substantial protection.
Warnings of a new wave. The C.D.C said that Omicron’s rapid spread in the U.S. may portend a significant surge in infections as soon as January. In Europe, Britain is speeding up its booster program to counter a “tidal wave of Omicron,” while Denmark and Norway predicted the new variant will be dominant in a matter of days.
Pfizer’s Covid pill. A study of Pfizer’s oral Covid treatment confirmed that it helps stave off severe disease, even from the Omicron variant, the company announced. Pfizer said the treatment reduced the risk of hospitalization and death by 89 percent if given within three days of the onset of symptoms.

• 
  
• 
  
• 
  

Older people have been vaccinated at a much higher rate than younger age groups and yet the brutal effects of the virus on them has persisted. The share of younger people among all virus deaths in the United States increased this year, but, in the last two months, the portion of older people has risen once again, according to data from the Centers for Disease Control and Prevention.
By now, Covid-19 has become the third leading cause of death among Americans 65 and older, after heart disease and cancer. It is responsible for about 13 percent of all deaths in that age group since the beginning of 2020, more than diabetes, accidents, Alzheimer’s disease or dementia.

Coronavirus​

• A C.D.C. panel will discuss a blood clot risk linked to J.&J.’s vaccine.
• Studies indicate Moderna and Pfizer boosters are likely to offer substantial protection from Omicron.
• Britain breaks a daily record for new cases, amid worry about the possible impact of explosive growth.
• Overall health spending in the U.S. reached record levels in 2020.
• New York University is the latest college to cancel events over a coronavirus surge.
• The C.D.C.’s first coronavirus tests were contaminated and poorly designed, the agency says.
• Omicron could be dominant in Europe by mid-January, officials say.

 

[missy]

The results from initial studies of the omicron variant of the coronavirus are starting to roll in almost daily, and early suspicions are gaining more support. The mutation is much better at infecting—70 times faster than delta and the original strain. But the severity of illness is likely to be much lower, according to a study from the University of Hong Kong, echoing earlier observations from doctors in South Africa where the variant was first observed. The supercharged speed of omicron’s spread in the human bronchus was found 24 hours following infection, according to the university. However, the study found it replicated in lung tissue much less efficiently than earlier mutations, which may signal “lower severity of disease.” Here’s the latest on the pandemic. —David E. Rovella

 

[Gloria27]

The devil is in the details:

It's not 70 times more infectious than Delta from human to human, it multiples in the human bronchus 70 times faster than Delta, but infects lung tissue less.

Apparently it's 4.2 times more infectious than Delta.

 

[rainbowstarry]

Thank you @rainbowstarry

I am so sad DF is not here anymore e to challenge me about Covid and vaccinations.

I hope and pray that his passing was not related to his vaccination status. His passing is very sad. Thanks for keeping us all informed

 

[tyty333]

800,000...I remember feeling sad when it hit 40,000 thinking "that's enough deaths. You can stop now." If only.

 

[Calliecake]

I felt exactly like you did @tyty333. Day after day I felt saddened and stunned watching the number of people lost to this virus rise.

It’s scary now because so many of the hospitals are already full. I wonder just how much more our healthcare professionals can handle.
My stepdad was in the hospital two times this past month. Both times there were no beds available. The nurse said this was the case for many area hospitals.

i heard on the news earlier that France is back to closing schools.