shape
carat
color
clarity

Coronavirus updates December 2021

missy

Super_Ideal_Rock
Premium
Joined
Jun 8, 2008
Messages
56,377
Happy December. New month new Coronavirus update thread.

Reports of mostly mild illness from Covid-19 infections caused by omicron need to be interpreted with caution because they may not reflect the new variant’s severity across a broad range of people. While such anecdotes are encouraging, they may represent only a subset of cases and a fraction of the risk that could emerge if it spreads widely across the globe. As the world awaits more data on the variant and whether it will supplant delta as the dominant strain of the coronavirus, the manufacturers of three vaccines (which are already looking to make boosters for the new variant) have different opinions on what the future holds. Still, more precautions are being contemplated, including tightened travel restrictions for the U.S. Here’s the latest on the pandemic. —David E. Rovella

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


China’s Covid-zero policy may be vindicated as omicron spreads.
Singapore’s long awaited re-opening gets a gut punch from omicron.
 

FDA Panel Narrowly Backs Merck's COVID Pill​

— Questions about efficacy, safety were chief among concerns, regardless of how members voted​

by Molly Walker, Deputy Managing Editor, MedPage

A divided FDA advisory panel voted 13-10 to recommend the oral antiviral molnupiravir for emergency use authorization (EUA) for adults at high risk of progressing to severe COVID-19 on Tuesday.

While votes at the Antimicrobial Drugs Advisory Committee (AMDAC) were largely split, similar questions were raised on both sides of the vote about modest efficacy, especially in light of other available treatments. Very few committee members offered strong "yes" or "no" votes, as most were in the middle. Ultimately, the positive votes felt that despite a number of questions, the benefits of the drug outweighed the risk.


The committee went half an hour over its scheduled time, which AMDAC chair, Lindsey Baden, MD, of Brigham and Women's Hospital in Boston, said was a first in his years of chairing the committee, "which speaks to the complex issues we had to deal with," he added. Indeed, most members when discussing their vote prefaced their comments with how difficult a decision this was for them.

"I agree with all that's been said by the 'yes' and 'no' voters," said Baden, who voted yes. "There are many, many more questions than answers. However ... overall, I trust our practitioners that if we educate them properly, we can deploy this properly."

Of particular concern to the "no" voters was not only that efficacy against hospitalization and death declined from the interim analysis submitted to the FDA (48% relative risk reduction) to the final analysis (30% reduction), but that when examining only the data from the post-interim analysis enrollment, there were fewer placebo patients who were hospitalized or died by day 29 versus patients receiving the intervention (4.7% vs 6.2%, respectively).


Baden said that spoke to the drug having a benefit in the "right population" in the "right time," but others weren't so convinced.

"I was struck by a modest benefit in a highly adherent trial population and then the unclear efficacy in the latter half of the trial when we had increased circulation of the Delta variant," said Daniel Horton, MD, of Rutgers School of Public Health, who voted no. "I think there's the potential for increased pressures for viral evolution in the setting of lower adherence in the real world."

However, the lack of options in the real world is what propelled many members to vote yes.

"There's a potential concern for a lack of availability for an alternative therapy for those at high-risk, perhaps considering the loss of efficacy with monoclonal antibodies with variants," said Michael Green, MD, of University of Pittsburgh School of Medicine, who voted yes.

Interestingly, even those who voted yes argued that it may only be temporary, given other similar drugs in the pipeline that may have better safety and efficacy profiles.

"If another medication becomes available under EUA, this [EUA] should be revisited and have the potential to be withdrawn," said Sascha Dublin, MD, PhD, of Kaiser Permanente Washington Health Research Institute, who voted yes.

Safety was of chief concern among many committee members. While the committee did not vote on the subject, they discussed how the drug should be handled among pregnant women, given that data from preclinical studies appeared to show embryo-fetal toxicity.

The consensus appeared to be that the drug should not be recommended for pregnant women, but that healthcare providers didn't have the right to deny a woman a drug if the benefits would outweigh the risks, based on shared clinical decision-making.

"As a woman of childbearing age, I don't think I'd want to take this drug," said consumer representative Roblena Walker, PhD, of the public health non-profit EMAGAHA, in Georgia, though she did vote yes.


Others suggested a negative pregnancy test prior to administering the drug to a woman of child-bearing age, as well as a pregnancy registry to track potential adverse events. Nearly all agreed that it should not be given to a woman in the first trimester.

For other committee members, potential mutagenicity was an issue, which the committee also discussed, but did not vote on. Baden said that "in the face of efficacy, the real risk is in prolonged replication ... rather than short-term replication." He added that "optimal sequencing and sampling" would be crucial to detect mutations.

However, Peter Weina, MD, of the Defense Health Agency, pointed to a number needed to treat of 34, which "means potentially a large amount of virus is going to be exposed to the drug."

"It plays into the question surrounding mutagenicity of the spike protein, and the potential of creating a new variant," said Weina, who voted no.

James Hildreth, MD, PhD, of Meharry Medical College in Nashville, was unequivocal: "It's an easy vote for me to vote no. Genotoxicity and mutagenicity data raise more questions than answers," he said.

Committee members agreed that the criteria for a "high-risk" individual should adhere closely to how patients were defined in the clinical trial, with definite benefit shown among unvaccinated older adults and those with obesity, although it was possible that those with "suboptimal response to vaccination" would benefit from the drug too. More study was needed, they said.

The FDA does not have to follow the advice of its advisory committees, but it often does.
 
New vaccine on the horizon perhaps?

Revisiting the vaccine race​

On Thanksgiving Day in the U.S., while the rest of the world read headlines about a new Covid-19 variant in southern Africa, teams of scientists at BioNTech and Moderna were already hard at work assessing a new threat.
The companies are studying whether the omicron variant, with its large number of mutations on the virus’s spike protein, will be able to evade their vaccines. Just in case it does, they’re also starting to work on a potential new shot.
If an adapted version proves necessary, it will be the second time the two biotechs will have raced to bring a Covid vaccine to the world. On this week’s episode of the Prognosis podcast, we tell the story of the first race — the unprecedented effort to create a successful vaccine against Covid more quickly than any immunization had ever been developed before.
To relive the early stages of the vaccine race is to return to a world in which scientists weren’t sure whether messenger RNA vaccines would work at all against the virus. No medicines on the market had previously used the technology. BioNTech, which worked with Pfizer on its shot, was building off its mRNA for cancer drug development, repurposed for vaccines to prevent infectious diseases.
mail

Sahin and Türeci
Still, there was no internal debate about whether to try to make a Covid vaccine, BioNTech Chief Medical Officer Ozlem Tureci tells us in the podcast. “It was about asking the question, how can we make this happen?” she says. “How could this work?”
“It was clear that it was an obligation to do something,” says her husband, BioNTech Chief Executive Officer Ugur Sahin.
In the end, the pandemic allowed mRNA technology to make its way to patients far faster than what would have previously seemed possible.
Now, with one country after another announcing they’ve found the new variant, researchers at both BioNTech and Moderna are working to figure out whether the vaccines they designed back in early 2020 to respond to the original version of the virus will also protect against omicron. Even before having the answer, researchers have embarked on the first steps to develop a new version of the shot — just in case.
They should know within a couple of weeks whether the vaccines need to be changed. If so, both Moderna and Pfizer-BioNTech have said the next version should be ready by early next year.— Naomi Kresge
 
First Omicron Case Detected in the U.S.
— But Fauci cautions this is an "n of 1" case

by Molly Walker, Deputy Managing Editor, MedPage Today
December 1, 2021


The U.S. confirmed its first case of the Omicron variant (B.1.1.529) on Wednesday, the CDC announced.

The California and San Francisco Departments of Public Health confirmed the case in a recent traveler returning from South Africa, according to a statement. They added that the individual was fully vaccinated and had "mild symptoms that are improving." Close contacts tested negative and the individual has been self-quarantining since the positive test, the agency added.


University of California San Francisco detected the variant through genomic sequencing, which was confirmed at CDC.

At a White House COVID press briefing on Wednesday, NIAID Director Anthony Fauci, MD, President Biden's chief medical advisor, added that University of California San Francisco examined the person, who was in South Africa for a week and returned on November 22. Fauci added that while the person was vaccinated, they were not boosted "to my knowledge."

"This is what we call in medicine an 'n of 1,'" Fauci said, adding that other countries have more cases of Omicron, and scientists are looking closely at these breakouts.

The California and San Francisco Departments of Public Health also issued a joint statement, touting "California's large-scale testing and early detection systems" in detecting the variant. They added that California "will continue to monitor the variant's presence and progress" through whole-genome sequencing surveillance.


The U.S. recently announced a travel ban involving several countries in southern Africa last week, after 77 cases of the Omicron variant were confirmed in South Africa. Other countries in Europe and Asia had already banned travel from South Africa, and the World Health Organization declared Omicron a variant of concern.

Enterprise & Investigative Writer Ryan Basen contributed to this story.
 
The newly detected Omicron COVID-19 variant may be highly infectious and less responsive to available vaccines than other variants, but it is too early to know how it compares to the Delta variant, top infectious disease official Anthony S. Fauci, MD, said Tuesday.

Fauci, speaking at a White House COVID-19 briefing, said there's a "very unusual constellation of changes" across the COVID-19 genome that indicates it is unlike any variant we have seen so far.

"This mutational profile is very different from other variants of interest and concern, and although some mutations are also found in Delta, this is not Delta," Fauci said. "These mutations have been associated with increased transmissibility and immune evasion."


Omicron is the fifth designated COVID-19 variant of concern.


Detected first in South Africa, Omicron has been found in 20 countries so far. There are no known cases yet in the United States, but it has been detected in Canada.

Omicron has more than 30 mutations to the spike protein ― the part of the virus that binds to human cells, Fauci said.

Cross-Protection From Boosters​

Though the mutations suggest there is increased transmission of this variant, he said it is too soon to know how this compares to the Delta variant. And although the vaccines may not be as effective against Omicron, Fauci said there will likely be some protection.


"Remember, as with other variants, although partial immune escape may occur, vaccines ― particularly boosters ― give a level of antibodies that even with variants like Delta give you a degree of cross-protection, particularly against severe disease," he said.

"When we say that although these mutations suggest a diminution of protection and a degree of immune evasion, we still, from experience with Delta, can make a reasonable conclusion that you would not eliminate all protection against this particular variant," Fauci said.

So far, there is no reason to believe Omicron will cause more severe illness than other variants of concern.

"Although some preliminary information from South Africa suggests no unusual symptoms associated with variant, we do not know, and it is too early to tell," Fauci said.


He recommended that people continue to wear masks, wash hands, and avoid crowded indoor venues. Most importantly, he recommended that everyone get their vaccines and boosters.


"One thing has become clear over the last 20 months: We can't predict the future, but we can be prepared for it," CDC Director Rochelle P. Walensky, MD, said at the briefing. "We have far more tools to fight the variant today than we did at this time last year."





I quote from John M. Barry's book "The Great Influenza" (page 371)- "But the 1918 virus, like all influenza viruses, like all viruses that form mutant swarms, mutated rapidly. There is a mathematical concept called "reversion to the mean"; this states simply that an extreme event is likely to be followed by a less extreme event. The 1918 virus stood as an extreme event; any mutations were more likely to make it less lethal than more lethal. The 1918 virus mutated toward its mean, toward the behavior of most influenza viruses. As time went on, it became less lethal".

While we do not know what the mean will be for Covid it appears to be heading in the same direction as other mRNA viruses; it's going to be with us for a long time but hopefully in less lethal forms as time passes.
 
Last week, just days before scientists discovered the Omicron variant, South Africa’s government asked Johnson & Johnson and Pfizer not to make some planned deliveries of their Covid-19 vaccines. The country already had more doses in storage than it could use — about 16 million, in a country of 60 million people — and officials were worried that further supplies would spoil before they could be used.​
How could that be?​
The main answer should be familiar to Americans: vaccine skepticism. “There is a fair amount of apathy and hesitancy,” Dr. Shabir Madhi, a vaccination expert in South Africa, told Reuters. For similar reasons, Namibia, Zimbabwe, Mozambique and Malawi have asked donors to pause vaccine deliveries, my colleague Declan Walsh has reported.​
(This article on vaccine skepticism in Africa, by Lynsey Chutel and Max Fisher, has more detail.)​
The sources of the skepticism are different in the U.S. and in Africa. In much of Africa, they are related to decades of exploitation and poverty. In the U.S., the biggest cause is political polarization: More than 35 percent of Republican voters are unvaccinated, compared with fewer than 10 percent of Democrats.​
But both forms of skepticism stem from distrust — of experts, institutions and government leaders. And that distrust has become a major reason that the world is struggling to defeat Covid. The more people remain unvaccinated, the more the Covid virus spreads and the more people die. Less vaccination also increases the chances that dangerous variants will emerge.​
“I think that Covid is not real — they are playing with us, politicians and everyone,” Tidibatso Rakabe, a 20-year-old resident of a township near Pretoria, told The Times. She does not plan to be vaccinated.​
After scientists in South Africa announced the discovery of Omicron, some commentators in the U.S. jumped to the conclusion that unequal vaccine distribution between rich and poor countries was the cause. But that’s not quite right, as the stories of Africa’s unused vaccines make clear. (Plus, Omicron may not have originated in Africa.)​

The airport drop​

Unequal vaccine access was a major issue earlier this year. High-income countries were faster to order vaccines and could afford more of them initially. They also had the infrastructure to produce and distribute the shots. India and South Africa are among the few lower-income countries that manufacture Covid vaccines.​
As a result, even residents of many low-income countries who were eager to receive vaccines often had to wait weeks or months to do so.​
Today, though, a simple lack of access is less of a problem in many places. The U.S. and other rich countries are distributing hundreds of millions of doses for free, and pharmaceutical companies are selling others at a discounted price, often less than $10 a dose. In many poor countries, vaccinating the entire adult population would cost significantly less than 1 percent of annual G.D.P.​
It still is not close to happening, however. Worldwide, about 56 percent of people have received at least one vaccine dose. Every continent is above 50 percent except for Africa — which is at about 10 percent. In South Africa, the share is 29 percent.​
mail
One problem is a lack of public health infrastructure in poorer countries, especially in rural areas, as Lynsey and Max note in their article. There often are not places to store the vaccines or people to administer to them. Governments have also failed to explain the vaccines’ importance to their citizens.​
“Almost no investment in vaccine education or promotion has gone into low-income countries,” Dr. Saad Omer, a Yale University epidemiologist, said. “Why do we expect that all we will have to do is drop vaccines at an airport, do the photo op, and people will come running to the airport and grab the vaccine?”​

A legacy of mistreatment​

The lack of vaccine education plays into an underlying mistrust of many medical treatments, especially those that come from other countries. That mistrust has its roots in a history of horrific experiments under colonialism.​
In present-day Namibia during the early 1900s, German officials sterilized some local residents, injected others with arsenic and deliberately infected people with smallpox, typhus and tuberculosis (as this Times essay by Kavena Hambira and Miriam Gleckman-Krut explains).​
Such direct harm became less common in the second half of the 20th century, but mistreatment was still common. Drug companies sometimes conducted research trials without people’s consent. Only a decade ago, Pfizer made financial payments to the parents of dead children in Nigeria after a research trial went wrong.​
Arguably the biggest source of modern distrust in southern Africa is H.I.V. After inventing lifesaving treatments, Western pharmaceutical companies initially kept their prices too high for many Africans to afford, and governments did not fix the situation for years. In South Africa, Zimbabwe and some other countries, life expectancy fell by more than a decade from 1990 to 2005 — a decline with little modern equivalent.​
Given this history, it’s not exactly surprising that many Africans are skeptical of the Covid vaccines, even though all available evidence suggests they safe and effective. Online misinformation exacerbates the problem, as it does in the U.S.​
In a survey of 15 African countries done late last year, 49 percent of respondents said they believed rumors that Covid was planned by a foreign actor and 45 percent said they believed Africans were being used as guinea pigs in vaccine research trials. Those misperceptions are costing people their lives.​
 
Thank you for keeping us updated, @missy . I'd read some of the information you posted. But your post is so much more informative. Thank you for taking the time to post and keep us well informed.
 
Thank you @missy ! I am close to my personal stress breaking point for different reasons and appreciate all the effort you put into this, so I can just get my information from someone I trust!!

If I may ask, have you happened to come across more studies re the vaccination for young children?

My 5 y/o is only eligible on France if she's in the "at risk" category. Which she is because of her Asthma.

Nevertheless her regular pediatrician and her pedio - pneumo-allergologist have advised against a C19 vaccination in her case. They won't be prescribing it even if specifically wanted it. I'm a bit puzzled. They have strongly recommended the flu vaccine, though (received the doc today, taking her in ASAP).
 
Thank you @missy ! I am close to my personal stress breaking point for different reasons and appreciate all the effort you put into this, so I can just get my information from someone I trust!!

If I may ask, have you happened to come across more studies re the vaccination for young children?

My 5 y/o is only eligible on France if she's in the "at risk" category. Which she is because of her Asthma.

Nevertheless her regular pediatrician and her pedio - pneumo-allergologist have advised against a C19 vaccination in her case. They won't be prescribing it even if specifically wanted it. I'm a bit puzzled. They have strongly recommended the flu vaccine, though (received the doc today, taking her in ASAP).

Hi @kipari, I am sorry you’re dealing with so much and it is a complex issue yes or no.

I’d want to know *why* they are advising against it in your daughter’s case. I would hesitate to go against their advice as they know her medical history and have been her physicians for some time.

Having said that, in the past year alone we’ve had bad advice from our own “trusted” physicians. Resulting in misdiagnoses. Luckily I was on top of it and diagnosed Greg myself and brought him to two top specialists for second and third opinions. We caught his thyroid cancer in time and also got the diseased parathyroid out. The reason I go into this is because we can’t always trust what our physicians say.

I’m on the road at the moment heading to a doctor appointment. When I get home I’ll research this topic and get back to you.

In the meantime FYI.









 
Hi @kipari, I am sorry you’re dealing with so much and it is a complex issue yes or no.

I’d want to know *why* they are advising against it in your daughter’s case. I would hesitate to go against their advice as they know her medical history and have been her physicians for some time.

Having said that, in the past year alone we’ve had bad advice from our own “trusted” physicians. Resulting in misdiagnoses. Luckily I was on top of it and diagnosed Greg myself and brought him to two top specialists for second and third opinions. We caught his thyroid cancer in time and also got the diseased parathyroid out. The reason I go into this is because we can’t always trust what our physicians say.

I’m on the road at the moment heading to a doctor appointment. When I get home I’ll research this topic and get back to you.

In the meantime FYI.










Thank you so much for your support, @missy !

They both said that her multiple allergies vs the risk of a C19 infection even taking her Asthma into account and the specifics of her Asthma ( not severe asthma in high frequency, but life threatening episodes rather seldom) make them say no to the vaccination.
I asked both of them: if this was your child, what would you do? Both said without hesitation: I wouldn't do it.


Absolutely great job by you regarding Greg's diagnosis!!! You really rock!!

Good luck with your appointment!!
 
Here we go again, sort of, however, I strongly believe it will not be as bad as same time last year, as I have confident in the booster programme!

I shall monitor the situation closely, and shall cancel some of the events I have planned for if I don't feel comfortable about them.

What gets me is that, allegedly, people don't breath in pubs and restaurants, or cinemas and theatres; yet they do in shops and public transport! :roll2:

DK :roll2:
 
Just got my booster yesterday. I was hoping for not too much reaction but last night I was in bed with 2 heavy blankets and my fleece
bathrobe. I live in FL so this isn't normal. I had full-body shivers and could not keep my teeth from chattering. Got up and took an
Aleve today and felt much better around 2pm but now at 5:15pm I'm ready to go back to bed. I'm sure I'll be feeling much better
tomorrow. Why does everything take so much effort when you don't feel good?
 
Omicron is also now in New York, Colorado and Minnesota.
 
Seems like just as COVID cases go down, a new variant appears. What I'm afraid of is we're only a few variants away from a virus that is more serious and evades vaccines...


"Remember back in season one of Covid, when we thought maybe we’d be in this for just five seasons like Breaking Bad, and now it’s like, surprise y’all, this is Grey’s Anatomy."
 
I'm waiting for my self purchased rapid test to do its thing right now. We had two student cases in my school that we were just alerted to today. I taught both students this week. Both were maskless (one is very young, one was in crisis). My own Harry got his second dose in the Moderna trial today, Ben gets his second Pfizer tomorrow. This is quite the emotional roller coaster that I do not enjoy one bit.
 
Here we go again, sort of, however, I strongly believe it will not be as bad as same time last year, as I have confident in the booster programme!

I shall monitor the situation closely, and shall cancel some of the events I have planned for if I don't feel comfortable about them.

What gets me is that, allegedly, people don't breath in pubs and restaurants, or cinemas and theatres; yet they do in shops and public transport! :roll2:

DK :roll2:

The difference for me is that people don't NEED to go to pubs and restaurants, that's a choice and a risk that they assume. Most people do need to shop for things and take transit, they should be safe when doing so.
 
one hospital is at historical high covid cases and the other 2 are getting there in my area.
We have one hospital system that gets a lot more patients because the other 2 after using millions in public funds to build new buildings kicked out nearly all the medicaid patients over loading the one hospital system.
 
Thank you so much for your support, @missy !

They both said that her multiple allergies vs the risk of a C19 infection even taking her Asthma into account and the specifics of her Asthma ( not severe asthma in high frequency, but life threatening episodes rather seldom) make them say no to the vaccination.
I asked both of them: if this was your child, what would you do? Both said without hesitation: I wouldn't do it.


Absolutely great job by you regarding Greg's diagnosis!!! You really rock!!

Good luck with your appointment!!

@kipari unfortunately there is no 100% yes or no answer here. If this were my daughter I would err on the side of being super conservative and not give her the vaccine. Because, her doctors, more than one, feel the risk outweighs the benefits.

Instead I would continue having her wear masks, (try to) physically distance as best as possible and just play the waiting game. This pandemic inevitably will end. The virus, most likely will continue mutating but getting weaker and weaker where it shouldn't cause death eventually. Like the Spanish flu of 1918. Which evolved into the flu we see today. The fact that not just one of her doctors but more than one, said they wouldn't give it to their child under these circumstances would give me pause.

I am really sorry because I wanted to be able to say for her to get the vaccine. I know it is a huge worry for you and the family. It's just we don't have enough info for young children and given her special circumstances I would be hesitant. Having said that I do think it would be safe but I just don't know for sure (no one does) and wouldn't take the risk since her doctors feel strongly she shouldn't be vaccinated. Now as time goes on their advice might change. This is truly a one day at a time issue and new evidence is coming to light on an almost daily basis.

Wish I could've given you cheerier news. Sending bucketloads of good wishes and good health vibes to you, your DD and your entire family. I know you have all been through the proverbial wringer as of late and I am keeping you in my thoughts. And thank you for your kind words. XO.
 
@kipari unfortunately there is no 100% yes or no answer here. If this were my daughter I would err on the side of being super conservative and not give her the vaccine. Because, her doctors, more than one, feel the risk outweighs the benefits.

Instead I would continue having her wear masks, (try to) physically distance as best as possible and just play the waiting game. This pandemic inevitably will end. The virus, most likely will continue mutating but getting weaker and weaker where it shouldn't cause death eventually. Like the Spanish flu of 1918. Which evolved into the flu we see today. The fact that not just one of her doctors but more than one, said they wouldn't give it to their child under these circumstances would give me pause.

I am really sorry because I wanted to be able to say for her to get the vaccine. I know it is a huge worry for you and the family. It's just we don't have enough info for young children and given her special circumstances I would be hesitant. Having said that I do think it would be safe but I just don't know for sure (no one does) and wouldn't take the risk since her doctors feel strongly she shouldn't be vaccinated. Now as time goes on their advice might change. This is truly a one day at a time issue and new evidence is coming to light on an almost daily basis.

Wish I could've given you cheerier news. Sending bucketloads of good wishes and good health vibes to you, your DD and your entire family. I know you have all been through the proverbial wringer as of late and I am keeping you in my thoughts. And thank you for your kind words. XO.

Thank you for your well thought out advice, @missy! It means a lot to me. Lots of love right back at you!

((Hugs))
 

Why Top Virologist Is Concerned About Omicron​

— Trevor Bedford, PhD, says the new variant "feels like January 2020 all over again"​

by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today December 1, 2021


A photo of Trevor Bedford, PhD

For virologist Trevor Bedford, PhD, the past week has felt like January 2020 all over again.
In those earliest days of the pandemic, as early modeling data on the transmissibility of the novel coronavirus started to roll in, "it was pretty clear what would happen," he said.
"It was fairly easy to realize with those numbers that we were actually now on planet B, though so much of the world still thought we were on planet A," added Bedford, who was one of the first experts to raise alarms about community spread in the U.S. "When we got to March 2020, it became very obvious that we were on planet B now."

Bedford spoke during a virtual panel hosted by his employer, Fred Hutch, a cancer research center in Seattle. He and other researchers were interviewed by Fred Hutch president and director Thomas Lynch Jr., MD, as well as comedian Trevor Noah, host of "The Daily Show." Bedford made those previous remarks to Noah.
Bedford also told Noah that researchers back in January 2020 weren't willing to make calls despite the evidence mounting before them.
"This phrase that I hate is, 'There is no evidence that...'" Bedford said. "'There's no evidence that the Alpha variant is more severe,' or 'There's no evidence that masks work.' When, really, it's that you don't have firm, hard evidence where you can say, 'Yes, this is definitely the case.'"
"But you should, with the mix of evidence that you have, be able to say, 'Yes, we suspect that masks do work,' or 'We suspect that the Alpha variant is more severe,'" he noted.

"People aren't willing to walk out on a limb enough [when it comes to] what they actually think," he added.
Bedford also described to Noah what it was like to be at the forefront of getting coronavirus testing up and running in the U.S., noting that in February 2020, his lab had samples that indicated community spread but "we were being told not to test them."
"We did anyway and discovered community transmission," he continued. "By genome sequencing of the virus, we were able to tell there were about 1,000 infections at that point rather than just one."
So why is Bedford concerned about Omicron? He told Lynch that the number of mutations in the spike protein is "kind of wild."
Other variants including Alpha, Beta, Gamma, and Delta have had "maybe eight or 10 mutations in the spike protein, and that's largely what's given them their advantageous phenotype. Omicron comes ... perhaps from an immunocompromised individual, with 30 mutations in the spike protein."

"As soon as people were able to see that genome, it looked striking, it looked worrisome," he noted.
The rapid spread in South Africa's Gauteng province is also a red flag, as it's rapidly replacing Delta, he said.
"If you look at case counts over time, you get maybe three times the current rate of spread of Delta," he explained. "Delta [spread] was two times compared to previous variants."
Taken together, the changes in the genome and the rapid rise in cases "had people very concerned for good reason."
It will take about 2 weeks to get clearer information on Omicron's immune evasion via neutralization assays, though it "already seems like it will be different," he said.
Bedford explained that the Beta and Mu variants, for instance, brought an eight- to 10-fold drop in antibody titers in neutralizing assays testing vaccinated immunity -- but fortunately, that hasn't had a large impact on vaccine efficacy.

"What we're waiting for is to see what Omicron comes in at," he said. "Is it 20-fold? Is it 30-fold? We know 20-fold is very different from 50-fold. There's a very wide range of numbers that you could imagine for this drop."
There's also the possibility that booster or third doses of the mRNA vaccines offer decent protection against Omicron, he noted.
"We know from three doses you get a nice broadening of immune response, so it might be less of a drop with the three doses, but we don't know yet," he said. "We could get lucky and three doses will still protect against infection quite well. Or we might need to try to very quickly have an Omicron-specific booster and move that through the regulatory process."
It's also possible, he added, that three doses won't confer protection against infection, but will prevent severe disease.

Monoclonal antibody therapies, on the other hand, are likely to be affected, said Rachel Bender Ignacio, MD, MPH, a Fred Hutch expert who was also on the panel. That's because they target regions where Omicron has known mutations, she explained, and previous variants have caused similar problems for these therapies.
But direct-acting antivirals like Merck's molnupiravir or Pfizer's ritonavir likely won't be affected, Bender Ignacio continued. Both of these target viral replication.
"Omicron has a lot of mutations in the spike protein, but we really don't think that those mutations will have an effect on the way that the virus reproduces itself once it's inside the cell," she said.
That's a sign of hope, as Bedford made a strong call that there will never be a "post-COVID" world.
"People need to realize that it's going to be around forever," he said. "Every year, just like we have flu season, there will be COVID season. It's going to be a thing that we have to deal with every year."
"We'll be working on better vaccines, on better ventilation, and on antivirals," he promised.
 

Will Kids Need Boosters?​

— Pfizer says it's not currently conducting trials of a booster dose in kids​

by Sophie Putka, Enterprise & Investigative Writer, MedPage Today December 1, 2021


A rubber gloved hand holds a syringe with an out of focus child covering her face in the background.

It's been 6 months since the FDA authorized Pfizer's COVID-19 vaccine for kids ages 12 to 15, prompting some parents to ask whether their children will need boosters, especially in the face of the Omicron variant and waning efficacy in adults.
Pfizer has requested authorization of boosters for kids ages 16 and 17 -- but the company told MedPage Today it's not currently conducting a clinical trial of boosters in younger children.

When asked if there were any plans to ask for authorization of a booster for those children, Pfizer spokesperson Jerica Pitts told MedPage Today in an email, "We have not finalized any plans for a booster study in this age group and happy to keep you updated on that front."
Pfizer didn't respond to follow-up questions about clinical trials of boosters for children; nor did Moderna return a request for comment on kids' boosters (though their vaccine isn't yet authorized in kids under 18).
Infectious disease and pediatric experts have noted that there isn't yet a rush to boost young kids. The American Academy of Pediatrics, for instance, said it has no position on booster shots for children at this time.
According to CDC data, those under 18 have had the lowest rate of breakthrough cases, and adults over 65 have had the highest breakthrough death rates. The rate of hospitalization for vaccinated children ages 12 to 17 was 0.3 per 100,000 at the end of September compared with 3.8 per 100,000 for adults.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, told CNN that young people are simply better equipped to fight disease, and their immunity via the vaccine may last longer.
"It may be that they will go a much longer period of time before they start to wane," he said. "They have a very robust immune system. So I would not be surprised that they will have a protection that will go way out beyond that 6 months."
Paul Offit, MD, of Children's Hospital of Philadelphia, agreed, though he believes most people don't need boosters, with the exception of older adults, the immunocompromised, and people in long-term care facilities.
If the goal of a vaccine is to prevent serious illness, he said, then two doses are still doing just that.
Children hospitalized with COVID at Offit's facility have been, for the most part, unvaccinated, he said.

That younger people are at greater risk of myocarditis as a side effect of the mRNA vaccines shouldn't be ignored when considering third doses, Offit said.
"It's a very, very rare risk, but it's a real risk, and it's not a trivial problem. Which is fine, as long as the benefits clearly and definitively outweigh the risks," he said, noting that he'd like to see evidence of better protection against serious illness with the booster in kids before they are widely recommended.
Offit and other experts have said that vaccinating the unvaccinated -- adults and children alike -- is more urgent at this time.
Allison Agwu, MD, ScM, of Johns Hopkins University School of Medicine in Baltimore, told MedPage Today that the priority should be to "assure that we are still doing our best to mitigate spread (no matter how sick we are of COVID) and that the millions of individuals who have yet to be vaccinated, get vaccinated."

Indeed, CDC Director Rochelle Walensky, MD, MPH, has strongly encouraged everyone ages 18 and up to get booster shots, especially with the emergence of the Omicron variant.
But Offit countered that "we will do far better taking these third doses for people who are already, for the most part, protected against serious ailments and sending them to the developing world."
About 69% of the U.S. population has received at least one dose of a vaccine compared with only 6% of countries classified as "low income." Countries in West and Central Africa, as well as Yemen, Syria, and Papua New Guinea, have some of the lowest rates of vaccination.
 

A Goldilocks Model for Yearly Covid Vaccinations​

The best way to administer doses may be to immunize some of the people all of the time.
By
Lionel Laurent

December 3, 2021

Two doses? Three? More? The euphoria that greeted safe and effective Covid-19 vaccines a year ago has turned to confusion and debate in the face of resurgent cases and an ugly new variant. The rich world is doubling down on booster doses, ignoring warnings from the World Health Organization that this will worsen supply shortages in the developing world.

The firms that brought us the mRNA marvels — Moderna Inc. and Pfizer Inc. — aren’t sure of much, except for one thing: It doesn’t look like the need for shots will stop anytime soon. Moderna Chief Executive Officer Stephane Bancel warned vaccines might need retooling next year against the omicron variant, while CEO Albert Bourla of Pfizer has mooted a course of jabs every year to maintain a “very high level of protection” over time.



The idea of an annual Covid vaccine sounds in theory quite similar to influenza shots, which are upgraded every year to cope with new strains. But in reality, even countries with deep pockets are struggling with bottlenecks as what began as one nationwide rollout becomes several.
In France, where 19 million people are now eligible to get a booster, only about 290,000 slots were available over the next two weeks from primary-care app Doctolib on Tuesday, according to media. In the U.K., where the minimum gap for a booster is to be halved to three months, doctors reportedly say they’re “overwhelmed” and operating at full capacity. This is not a desirable outcome.

A Steady Vaccination State​

Annual Covid-19 shots might be best rolled out at a continuous Goldilocks rate

Source: Bloomberg, BIOCOMSC/BarcelonaTech

One potential answer, according to a team of researchers at BarcelonaTech, would involve building a new planning framework for Covid vaccinations: Administering doses at a rate quick enough to build protection, but not so quick it requires a new nationwide rollout every few months. A Goldilocks approach, in other words, that would work as a continuous cycle — immunizing some of the people, all of the time.

https://www.bloomberg.com/opinion?re_source=postr_index

The model imagines various outcomes based on a potential drop in protection over time after a third dose. In this model country — call it Jabland — a rollout that vaccinates 1% of the population every week brings a low level of protection over a long period of time, while a 4% rate would be better but might require more doses given the pace at which a larger cohort loses protection.
The Goldilocks rate the researchers propose is 2%, which would mean covering around 80% of Jabland’s population in 40 weeks. If pasted onto the real-life region of Catalonia, this would be equivalent to vaccinating 150,000 to 200,000 people per week, or 10,000 per day. With the region boasting around 400 primary care centers distributing 30 shots per day each, it looks wholly feasible.
Scale it up to a country-sized population, and it’s clear that France and the U.K. could manage about 1.3-1.4 million doses per week. The U.K. is alreadyat over 2 million.
But this would require a permanent war footing, requiring more investment in primary care.


There are other big caveats, given our world is a non-Goldilocks one. For countries with less success in encouraging uptake, even a rate of 2% looks like a stretch. Romania and Bulgaria, among the least vaccinated countries in Europe, have failed to hit this level for most of the year. Demand is a problem in countries with high vaccine hesitancy, and compulsion is a policy that’s yet to be really tested.

Supply is the other big issue in the developing world. In South Africa, where omicron now looks to be the dominant variant, the country is nowhere near a weekly rate of 2%.


And there’s also the risk that future variants, whether omicron or others, will escape the best-laid vaccination plans of public-health officials.

Still, if annual shots do end up the norm, the Goldilocks model has advantages. It would be easier to explain and operate than the current oscillation between crisis and complacency. There might be less confusion — and cynicism and fatigue — if talk of booster shots, third doses and tweaked vaccines were replaced with a once-a-year mindset.

This kind of fairy tale thinking might end up humbled by the reality of Covid, of course. But policymakers should start work on all possible pandemic endings — even happy ones.
 

For body and mind​

A new generation of Covid-19 treatments will soon be available, and they matter more than many people realize.​
They have the potential to substantially reduce hospitalization and death. And they are likely to be effective against the Omicron variant, many scientists believe, even if Omicron makes the Covid vaccines weaker at preventing infections. As Dr. Monica Gandhi of the University of California, San Francisco, told me, the treatments are “a huge deal.”
In the simplest terms, they can help turn Covid into a more ordinary respiratory disease, similar to the common cold or flu, rather than one that’s killing about 1,000 Americans a day and dominating daily life for millions.​
Two treatments are on the way — one from Pfizer and one from Merck — and they will have both medical and psychological benefits. Not only can they reduce serious Covid illness, but they can also reduce Covid fears and help society move back to normalcy, lessening the pandemic’s huge social and economic side effects.​
(If you haven’t read my colleague Campbell Robertson’s story about the continuing crisis in schools — including mental health problems among children and exhaustion among teachers, nurses and janitors — it’s sobering.)​
Both Pfizer’s and Merck’s treatments are pill regimens that people take for five days after a positive Covid test. The pills prevent the virus from replicating inside the body and are broadly similar to treatments that revolutionized H.I.V. care in the 1990s.​
Pfizer’s version, which is likely to become widely available early next year, appears to be the more effective: It reduced the risk of hospitalization or death by 85 percent in a research trial. Merck’s version, which should be available sooner, reduced risk by 30 percent.​
An F.D.A. panel of experts this week voted narrowly — 13 to 10 — to recommend the approval of the Merck treatment. The agency has not yet said when its experts might vote on Pfizer.​
“These will be game-changing for our ability to control Covid worldwide in 2022,” Gandhi said.​

Pandemic side effects​

In truth, the virus has already been largely defanged for most Americans, and it would be surprising if Omicron changed that. The death rate for vaccinated adults under 50 is virtually zero, according to data from Minnesota and King County, Wash. (which publish detailed statistics); the hospitalization rate is similar to that of a typical flu. For children, vaccinated and not, the risks are even smaller.​
But I know that many Americans remain terrified of Covid. After nearly two years of pandemic living, returning to normal can be hard, especially with the genuine uncertainty about Omicron. Once the treatments are widely available, they can offer reassurance, as a last line of defense against severe Covid.​
Of course, the medical benefits will be even bigger than the psychological benefits for people who remain vulnerable to Covid.​
Deaths are predominantly occurring among the unvaccinated, although vaccinated Americans older than 65 — especially those with existing medical problems — are also at some risk. So are a small percentage of younger Americans, like those who have had an organ transplant or are receiving some cancer treatments. (Find the death rate for any county.)​
One major advantage of the pills is that people can take them at home. Current Covid treatments, like monoclonal antibodies, are typically administered in a hospital.​
Another advantage is that they do not attack the part of the virus that changes most with each new variant: the spike protein. That’s why scientists expect the treatments will work even as the virus evolves.​
mail
Pfizer’s pill in production in Germany.Pfizer, via Agence France-Presse — Getty Images​

30 pills, 5 days​

Pfizer has projected that it will produce enough doses to treat 20 million people in the first half of next year and another 60 million in the second half. The Biden administration has agreed to buy 10 million of the treatments, known as Paxlovid, at a cost of about $530 each. Americans will probably not have to pay much, if anything, out of pocket.​
As a rough sense of scale, 10 million treatments would have covered every American 65 and above who tested positive for Covid in the past year — with millions of doses left over.​
Merck projects that it will produce more than 10 million courses of its drug, called molnupiravir, by the end of this year, and at least 20 million more in 2022. The federal government has agreed to buy 3.1 million of those courses for around $700 each. A Merck spokesperson said that the government would provide the drug to patients for free.​
Both treatments will present logistical challenges. People will likely need to prove that they have tested positive for Covid and then receive a doctor’s prescription. At least for the next several months, only vulnerable people — those who are older or have medical conditions — may be eligible. And the treatments involve a detailed schedule of pill-taking: three pills, twice a day, for five days, in Pfizer’s case, and two additional pills per day in Merck’s case.​
Ideally, the treatment should begin within five days of the first Covid symptoms.​
For people who can get access to the pills and take them as prescribed, they may make all the difference. In Pfizer’s research trial, the treatment reduced the risk of hospitalization by about 90 percent among people who started it within three days of having symptoms. There were zero deaths among the patients who received it.​
“These treatments are not going to single-handedly end the pandemic, nor are they going to be anywhere near as impactful as vaccines,” Rebecca Robbins, who covers pharmaceuticals for The Times, told me. “But if they can reach people fast enough, and that’s a big if, they have very real potential to save lives and ease the burden on hospitals.”​
More on the virus:​
 
Many virologists and epidemiologists do not consider Dr. Monica Gandhi to be a trustworthy or reliable source. Search for her name on Twitter for critiques of her work.
 
Many virologists and epidemiologists do not consider Dr. Monica Gandhi to be a trustworthy or reliable source. Search for her name on Twitter for critiques of her work.

I have shared many specialists and scientists thoughts and advice and opinions on this topic. I feel it important to obtain an expansive view and explore all points of view as we are all still learning. Thanks for chiming in and please continue sharing info here too. All points of view are welcome. That is how we learn.
 
The world still doesn't know for sure if omicron is more transmissible than delta (though there’s some preliminary evidence), let alone if it causes more serious disease, but drugmakers continue to sound the alarm that vaccines will need to be tweaked (which means they would be making, and selling, more boosters). But nations will face an omicron wave with a new weapon: treatments that could help make infections less deadly. As of Friday, at least six U.S. states have confirmed omicron cases, with Nebraska reporting six cases. South Africa, where the variant was first detected, reported the daily number has virtually quadrupled in four days. Here’s the latest on the pandemic.


Health authorities around the world spent the week probing the omicron variant in an urgent effort to understand its potential threats. The picture is far from clear, but new information has come to light in the past couple of days. Here's the latest:

  • Omicron appears three times more likely to reinfect people who previously had covid-19 than other variants such as delta, according to a non-peer-reviewed study from scientists in South Africa, where the variant was first identified. The findings indicate that omicron has a “substantial ability to evade immunity from prior infection," the researchers said. Reinfection may also partially explain how the variant has spread. The study was not able to measure how well vaccines protect against omicron.
  • New daily coronavirus cases have almost tripled in South Africa in three days, from about 4,400 on Tuesday to more than 11,500 on Thursday. It's too early to say for sure whether omicron is driving the surge, but experts worry the variant is starting to overtake delta.
  • At least 10 cases of covid-19 linked to omicron have been detected in the United States. Health authorities have spotted omicron infections in New York, California, Nebraska and several other states. More are sure to follow soon. Officials say many of the known patients had recently traveled to Africa. But an unvaccinated omicron patient in Hawaii is said not to have traveled recently, indicating possible community spread.
With U.S. cases rising sharply, President Biden unveiled an array of measures aimed at blunting a winter infection wave and addressing whatever challenges omicron might bring. Plans include a revamped vaccine and booster campaign, stricter testing for international travelers, and an expansion of free at-home tests. Health experts voiced satisfaction with some aspects of the plan but said the administration must invest more in testing. The United States still lags behind Europe in making at-home tests free and easily accessible.

Omicron might not be widespread yet, but it's already taking a psychological toll. The flood of news has left people anxious and exhausted, knowing that a swift victory in the pandemic is out of reach. As the public health crisis enters its third year, experts say it might improve our mental health to adjust our expectations, acknowledge that the virus will be with us for a while longer, and behave accordingly.

It's also important not to lose sight of the more immediate threat. Communities from coast to coast remain in the grip of the highly transmissible delta variant, which still accounts for the vast majority of the nation's caseload. Even if omicron turns out to be a flash in the pan, delta is likely to fuel a cold weather surge over the coming weeks, with cases trending back up above 100,000 new reported infections a day. “We are not even handling delta well, no matter what happens to omicron,” Eric Topol, director of the Scripps Research Translational Institute, told The Washington Post.

Amid the uncertainty, health officials sought to reassure the public Friday, saying the country is in a far better position now than last winter to handle the pandemic.

“Not only do we now have knowledge and experience from addressing other variants, such as delta, we also have far more tools with proven prevention methods and more treatment options to fight the virus than we had at this time last year," said Rochelle Walensky, director of the Centers for Disease Control and Prevention.

Other important news​

The U.S. economic recovery continues to be lopsided. A disappointing 210,000 jobs were added in November, even as unemployment hit a new pandemic low.

BioNTech's chief executive said the company's vaccine could be tweaked “relatively quickly” to fight omicron. But more research is needed.

The military's vaccine deadline has passed. Some 19,000 active-duty Marines and Navy sailors haven't gotten their shots.

An array of vaccine combinations are safe and effective as boosters, with those based on mRNA technology appearing to work best, according to a new study.

A top Australian official blamed white supremacists in the United States for targeting Aboriginal people with vaccine misinformation.
 

Mexico’s stockpile of unused vaccines​

Mexico has a stockpile of unused Covid-19 vaccines that’s doubled in the past six weeks to over 40 million. The country’s vaccination rate lags behind most regional peers.
Speculation about the stockpile abounds. Some conspiracy theorists think the doses were stolen, others that they’ve gone to waste. One expert, a mathematician at UNAM University who has closely followed vaccine distribution, thinks the whole thing is an accounting error.
“It’s most likely they made a mistake counting how many came in, how many they applied, and the numbers just don’t match,” Arturo Erdely said in October, when the stockpile was at 16.5 million.
The administration has denied reports of lost or spoiled doses but has offered no real explanation of why the stockpile keeps growing. The country’s slow vaccination rate, one of the likely reasons for the buildup, is mostly due to poor logistics that are made worse outside of big cities like the capital.
mail

Mexico was the first Latin American nation to administer a vaccine against Covid last December and has received by far the most donations from the U.S. Yet it has fallen far behind regional peers in the race to protect its people from the virus. Mexico has fully vaccinated about 51% of its population.
In contrast, Chile has covered 84% and Brazil 71%. Even Ecuador, which had barely 3% of its population vaccinated in May, is now way ahead at around 65%. Some countries in the region have also started offering boosters and vaccinating the young.
President Andres Manuel Lopez Obrador has said his priority is getting vaccines to adults in far-flung villages, and only recently broadened the campaign to teenagers 15 and older after parents all over the country filed injunctions in state courts to get their children vaccinated. He said Mexico will soon open up boosters to teachers and the elderly.—Andrea Navarro

Track the virus​

Omicron Variant Risks Recovery Momentum

Covid-19’s omicron variant is throwing up a new risk to global trade just as factories and some exporters show signs of stabilizing. Shipments from trade powerhouse South Korea in November jumped more than expected, putting the country on course for an annual record, stoking optimism that some global activity has been able to power through the damage of the previous so-called variant of concern, delta. Read more in the Bloomberg Trade Tracker.
 
@missy Curious to know when you will feel comfortable "returning to normal life?" My thought is when cases are very, very low (like in May/June) I will start to live everyone else's 2020 - taking small risks like meeting friends outside, outdoor dining, going out with my mask, etc.
 
@missy Curious to know when you will feel comfortable "returning to normal life?" My thought is when cases are very, very low (like in May/June) I will start to live everyone else's 2020 - taking small risks like meeting friends outside, outdoor dining, going out with my mask, etc.

Hi @MRBXXXFVVS1, I can’t say right now. I keep watching the progress and will not know til I know lol. But right now given the trajectory I’d say not anytime soon.

Honestly it’s not that important to me to eat out and socialize indoors. I will one day resume but not until I am confident we are as safe as we can be. I take risks for important things (like medical visits we must go to and surgeries my DH had to have) but to me these are not critical things I need to do (now or anytime soon) to risk our health.
 

THE HAGUE, Netherlands (AP) — Princess Beatrix, the 83-year-old former Dutch queen, has tested positive for the coronavirus, the royal house announced Saturday.

In a statement, the royal house said Beatrix got tested after feeling “mild cold symptoms.” It said she is in isolation at home and abiding by rules for people who have tested positive. The princess lives in a castle in the central Netherlands.

Beatrix was queen of the Netherlands for 33 years until abdicating in 2013, when her eldest son, Willem-Alexander, became king.

Last week she visited the Caribbean island of Curacao, which is part of the Kingdom of the Netherlands. At the time, she told reporters she had had her COVID-19 booster shot.
 
GET 3 FREE HCA RESULTS JOIN THE FORUM. ASK FOR HELP
Top