CDC ACIP Meeting September 1, 2022 – Dr. Meryl Nass, M.D.
CDC ACIP Meeting for September 1, 2022 – Recommendations to COVID-19 Booster Framework
Good morning on September 1. The meeting starts in half an hour, but I thought I would share with you some of the tricks and confusing verbiage that are likely to be used today, based on what the FDA issued yesterday.
It just took me ten minutes to find a direct link to CDC’s meeting webcast. I had to get it from the Federal Register, which took me to cdc.gov/vaccines/acip/index.html
You could not get there from the ACIP pages directly. I guess they don’t want too many people observing the Kabuki dance today.
Once you get to the URL I provided above, you click on “Webcast link” and that is how you finally arrive at the meeting link, that is, if you don’t want to see me blogging away simultaneously.
First thing you need to know is that the terminology has been changed to confuse the innocent. The new vaccine, which includes 15 mcg of the original Wuhan strain plus 15 mcg of a BA.4/BA.5 strain (2 different mRNAs) for Pfizer, is called the “bivalent vaccine.”
However, last spring FDA and the manufacturers for some reason agreed that original Wuhan plus BA.1 vaccines should be produced. So they were, and they are suddenly being offered in the UK. They went through some minimal human testing. These never-to-be-used-in-the-US vaccines are also being called “bivalent vaccines” and data from these vaccines will be presented today, as if sorta kinda they were the actual vaccines with BA.4-5 spike code.
The vaccines we have been using all along with original Wuhan strain are now to be called “monovalent vaccines.”
FDA is sometimes calling the new vaccines with BA.4-5 ‘updated boosters” as well as bivalent vaccines, just to keep things interesting.
Originally it was said these boosters would be given at least 4 months after an earlier covid shot. That has now been compressed to 2 months.
FDA based its EUA on what it knew about the “other” bivalent vaccine, the old vaccines, and a few studies in mice using the new booster. Feeling secure about the data yet?
The new shots are “expected to provide” increased protection, in case you were wondering.
Here is the scary part: the old boosters for all ages that are eligible for the new boosters are being taken out of service. FDA withdrew their EUAs. Only the new, untested shots are to be used in adults and for Pfizer, kids 12 and up.
What is so special in the new potion that you can no longer receive the old potion? Why the rush, as the Great Reset speeds up with planned shortages of fuel and food. What is so special about this vaccine that you can no longer get the old one? Not that I thought anyone should get the old one, but an immediate withdrawal from the market–when FDA kept those EUAs going even after licensing the vaccines–well, it is just suspicious, that’a all. Watch out.
Melinda Wharton says they plan to cancel the 2 hours tomorrow that was scheduled, so today will be it.
Regarding the public comment, a lottery was held (and my name was not picked). Conflicts of interests are allowed, and conflicted members may present on the vaccines they are studying, but they cannot vote on them.
Roll call: Dr. Jamie Laire, Dr. Wilbur Chen, Dr. Camille Kotton (was supposed to rotate off), Dr. Beth Bell, Ms. McNeilley, Dr. Keipp Talbot (ws supposed to rotate off), Lynn Bahta, Dr. Kathy Paling, Dr. Sybil Cynneas, Dr. Matt Daley (conflicted, but denies it), Dr. Oliver Brooks, Grace Lee, Dr. Sarah Long, Dr. Sanchez is missing. It would be so easy to list all these people or show their faces, but CDC never does that. Instead a generic slide that does not even have today’s date shows up.
Sharon McMullen represents the American College Health Association, who probably knows a lot about how the colleges were induced to impose vaccine mandates on their students. Those colleges demanding current boosters will force students to get the new untested boosters in such a grossly illegal manner. So much for federal laws re experimental drugs and the Nuremberg Code.
CDC has a $100 million dollar media center but we never see the fruits of it at this meeting. Dr. Sanchez showed up.
Dr. Doran Fink is giving a quick update. The reason we are gathered today is yesterday’s EUA for 2 “modified” mRNA vaccines with bivalent strain composition. Pfizer is for 12 and up and Moderna for 18 and up. Each can be used as long as at least 2 months has elapsed since the primary series or last booster was received. Each vaccine contains the ancestral strain vaccine plus a component for omicron BA.4/ BA.5. They will REPLACE the monovalent vaccines, as I noted above, so you cannot even get an older booster if you wanted it as of yesterday.
FDA was so smart to retain the original component (safe and effective) and choosing the current strain as well, BA.5. The EUA is based on clinical trials of similar vaccines. Also based on our extensive experience with the ancestral vaccine. Additionally FDA considered animal studies that provided additional reassurance. We urge everyone to get them. Especially those who have been champing at the bit, or have not gotten a shot lately, we really want you jabbed.
Dr. Wharton interrupts. We have an opportunity to update and simplify our recommendations for vaccine use. This will be a transition now. I think she is hinting at a lack of human data for future vaccine approvals and EUAs.
Matt Daley: mathematical modeling of the world and vaccines have prevented 13-16 M deaths. Why no real numbers, CDC?
Novavax: only 14, 600 doses have been administered. Americans are smartening up.
He starts with the vaccine that contains BA.1 and has some new words to confuse all: antigenic cartography. There is additional modeling of pandemic outcomes to create any outcomes needed to give the desired outcome. 4 CDC briefers who have proven their unreliability will present, then a break and public comment.
After that, we hear from the Moderna and Pfizer reps, then discussion, then Sarah Oliver , Drs. Hall and Twentyman, then a discussion and vote re rolling out the new vaccines.
I think the reason we don’t see faces is so the presenters can read their scripts without the viewers being aware.
Remember, this meeting needs to be filled with fluff as there are no relevant data. So we are now learning for the Nth time about the spike, the different variants over time, and other irrelevant information.
NAAT refers to nucleaic acid tests (PCRs) but most non-insiders are simply confused by the term NAAT.
Yada yada yada, the older you are the higher your covid risk. None of this is relevant to the new vaccine.
Finally, you can see that COVID deaths are now about as low as they have been since the very start of the pandemic–in other words, everyone’s risk is the LOWEST since the pandemic started, in terms of death.
CDC says 72% of eligible got the initial shots, 49% got one booster. Now CDC presents its fake data claiming worse outcomes in the unvaccinated. This flies in the face of data from every other country.
These data deserve a grand jury to learn how CDC is analyzing its data to come up with these fake, scary numbers.
This was Dr. Scobie presenting. Dr. Paling says hospitalization rates are increasing. So I just checked the CDC-NYT data for today and that is incorrect–they are decreasing. Scobie is discombobulated. Paling wants to say children are at high or growing risk, and is trying to pull a factoid out of Scobie to support this erroneous supposition. Scobie does not bite.
Paling insists “they are increasing for all age groups” but I don’t know what “they” refers to, if you look at the NYT kid hospitalizations are flat, and for all age groups, cases, deaths, hospitalizations and ICU stays are DROPPING.
Daley wants to go back to this issue. The slide of hospitalizations by age does not show a rise in kids, and is also not stratified by vaccine status.
Now, do vaccines prevent long covid? The problem is that there is little long covid with omicron. CDC does not have systematic data on long covid. This probably means they found no benefit of the vaccines in preventing long covid, and maybe the post-vaccine injuries have been lumped into long covid. This is probably why CDC has failed to issue a standard definition of the condition, because it would probably show that similar chronic illness occurs more often in the vaccinated.
Dr. Chen asks about vaccines in pregnancy wrt hospitalizations and deaths.
Dr. Scobie says “we don’t collect any information on pregnancy status” in her group, whatever group that may be. She is a CDC doctor briefing the ACIP and must have been told pregnancy is off limits.
Dr. Chen also wants to know about the monoclonal antibodies in pregnancy. Dr. Fleming-Dutra says pregnancy is important to CDC and they plan to address it at a future ACIP meeting. She will go far at CDC; she is on the ball, jumping in to save the day, and avoid any future discussion today about pregnancy losses after vaccination.
Dr. Lee wants to know whether omicron is really milder or does it seem milder because there is so much population immunity?
She is giving CDC an opportunity to jump in and say “COVID is not really getting milder, be more scared” but they don’t seem to understand the opening she has given them.
I think Scobie said we are confident it is milder. But there is more of it, more cases.
Dr. Chen says the data speaks to the need for boosters. One could also interpret the CDC data showing that the vaccines work for such a short period of time, they are not worth getting.
Now we hear from Natalie Thornburg, PhD. Antigenic Cartography. Her main point is to provide some information that suggests using the BA.1 bivalent vaccine is reasonable to support the new, different bivalent vaccine.
This method uses matrix completion-multiple dimensional scaling algorithm, designed for flu.
See the pretty mice in the diagram.
She says it does not matter that they are using hamster blood compared to human blood. (This is a false claim–the immune response of rodents is frequently different than the response in humans.)
Then you use an algorithm to smooth your data. Is anyone expected to understand this process?
This can be an oversimplification, there may be bias, animal vs human sera may be different, and there is always “map uncertainty” –with all these caveats, CDC must love this modeling method.
Garbage In, Garbage Out, but I would make a wild guess that this model predicts that the new bivalent vaccine is going to be perfect for current and even future strains!
I did not give her credit, but the slide she just showed apparently showed that recovered immunity was better than vaccine-induced immunity when dealing with omicron.
BA.1 viruses more different from BA.4-5 than they are different to the Wuhan strain, per Wang 2022. So how can CDC and FDA use data from BA.1 trials to claim that a BA4-5 vaccine is similar?
“All the studies were done with pseudovirus neutralization”–adding yet another uncertainty to the problems with this method of modeling.
Duchin says NEJM yesterday said prior infection with BA.1 or 2 gave the strongest protection against the current BA.4-5 variants circulating.
“Yes, there is cross protection among omicrons” BA.2 has only 3 amino acid changes from BA.4-5.
3 in the spike itself.
We have not yet seen the face of a single person.
Dr. Link-Gelles PhD will present on vaccine effectiveness.
Pharmacy drive-through testing results with loads of adjusting are shown. “Efficacy wanes to zero within a few months.”
This presentation shows horrible efficacy. Grab her slides.
3d system using 162M patient EPIC medical records. Not shared with ACIP previously. This shows terrible efficacy in children after very few weeks.
CDC hopes the 4th dose wanes more slowly, but the cofidence intervals are very wide.
Now I know why they are showing these data: despite the vaccines quickly becoming useless against infection, they appear to provide more protection against hospitalizations.
All the data just presented are from the original vaccines, None from any bivalent vaccines. The 3d and 4th doses increase protection…so are we to keep vaccinating every 2-3 months?
There is no good data re the waning speed after the 4th dose.
Dr. Shimabukuro presents some selected VAERS data, which did not include all vaccinated children. He did not explains how this subset was chosen. Whatever his method, 98% of reports to VAERS in under 5 year olds were supposedly mild.
In 6 month to 2 year olds who were vaccinated, 50-60 % of kids were reported as having a systemic reaction (undefined) to the V-safe system.
His slide 20 reveals that 11% of those over 12 getting a first booster, reporting to VAERS, had a reaction that is designated as serious by the CDC-FDA VAERS staff.
“They are mainly systemic and local reactions.” Yes, Tom, all reactions are one or the other.
Interesting that there is no summation of the results in slide 22, 23 (reports following 2nd booster).
What is the myocarditis background rate? Doesn’t say. Slides 24 and 25 show myocarditis rates and claim that booster rates are a lot less. Yet some other data showed even higher myocarditis rates after a first booster, not of course presented by the CDC which generally only presents its own data.
Moderna has more acute side effects than Pfizer. All data show this. Why does he say “may” be higher when his charts show the rates are definitely higher?
He is reaching to tell us the reported reactions are lower after subsequent boosters. His method fails to take into account that people with significant reactions don’t go back for later doses, so the most susceptible to adverse reactions are knocked out early.
The VSD data are ALWAYS said to reveal no signals for “prespecified outcomes”–finally myocarditis show up as a signal but nothing else. Last summer the claim was made not even myocarditis showed a signal. The method being used to analyze these data is almost certainly unreliable. How are the adjusted rate ratios calculated? They never say.
16-17 year old males and females have more myocarditis after the booster than after dose 2 of the original series.
He says the confidence intervals are wide so the higher numbers are the same as the lower numbers. I do not believe that is the correct interpretation of wide CIs.
Pregnancy and reproductive health: we use 5 systems and have not found anything concerning. We won’t give you any data today but will at some unspecified later date. That concludes my presentation.
They have managed to kill 2 hours without discussing the new boosters at all.
If a myocarditis patient has had covid within the last 60 days they do not meet the case definition and they are DROPPED from inclusion in the number of cases post-vaccination.usion in the
In other words, in either VAERS, VSD or both, CDC has found a way to lower its total post-vax myocarditis cases by simply dropping all those who had a documented case of COVID within sixy days, even though about 90% of cases develop it within 4 days of a vaccination.
Shimabukuro also claims that even people who meet the case definition of serious, well they at CDC didn’t think all those cases were really serious. Whoa! Are they moving myocarditis cases into a “mild disease” category?
Now it is time for a break then the public comment.
Let me take this opportunity to tell you some more of the BS FDA put forth in it press release on authorization yesterday.
It based its decision on the “totality of evidence.” Evidence that included only “non-clinical” data on the new shots, i.e., animal studies. A new phrase was developed to make you think FDA is calling the vaccine safe and effective, though it is not and cannot legally do so. The phrase is “we have worked closely with the mfrs to ensure the development of these updated boosters was done safely and efficiently.”
Now the first public speaker starts. Another commercial for boosters. 3 of 4 of us were vaccinated but got covid and my youngest, the only unvaxxed member, was sickest. was the sickest,
Dorit Reiss the vaccine witch and unlicensed law professor speaks. There is pressure to act. Lack of transparency is not good. The vaccines are safe and prevent hospitalizations and deaths. Not sure what her points were.
Ms Nueuenschwander points out that the public comment is being conducted before any data have been presented. Its absurd. You are presenting data from 55 year olds and up yet are proposing authorization for age 12 and up. She stole some of my thunder: FDA says the new vaccine used the same method fo production as older vaccine, therefore they are comparable. This is like saying peanut butter is safe because it uses the same production method as almond butter. Please do you job.
Mrs. Mary Mahoney looks forward to the boosters. Megan Rapp enthusiastically endorses boosters.
More from the press release: We are confident in the evidence supporting these authorizations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization.”
Ho Ho Ho. The standards of the EUA for safety and effectiveness essentially do not exist. The requirement is only that the presumed benefit exceeds the presumed risk. Who came up with that weasel-worded sentence?
Ms. Booth, a pediatrician knows that vaccination is the best way to prevent infectious diseases. And she lives in the county with the first and only monkeypox death. (Why is that relevant?)
Katherine Falk a vaccine advocate. “I commented before.” Then why was she selected for this when I have never been selected? We need clear messaging and carefully managed expectations. I guess that means don’t overpromise. Stop the antivaxxers from using the VAERS website. It could use some refreshing. –Is she a PR professional?
Abraham Allemagne. Professor. The vaccines are very safe. His accent is difficult. He is the last speaker. Why was there only one person who criticized the novel method of vaccine roll out without any human data?
Another break. Here is some of the useful language FDA put forth yesterday: The safety of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older is supported by safety data from a clinical study which evaluated a booster dose of Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1), safety data from clinical trials which evaluated primary and booster vaccination with the monovalent Moderna COVID-19 Vaccine, and post marketing safety data with the monovalent Moderna COVID-19 Vaccine. The safety data accrued with the bivalent vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.”
Here is the URL for FDA’s press release: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use
Dr. Miller from Moderna now presents. Their vaccine will contain 25 mcg of the original Wuhan mRNA and 25 mcg of the new BA.4-5 mmRNA. More than 7,000 adults have gotten one of 4 bivalent vaccines but there will be no data on the new vaccine trial until the end of the year. So expect to use it for 4 months before any trial data is released. Why even do a trial?
It looks like Moderna has vaccinated, in the last 10 days, 512 people. Wonder what country they live in? Were they military service members?
Now she presents the BA.1-Wuhan booster data–a shot that will never be used in the US.
She claims this vaccine causes less side effects than earlier vaccines. Wonder why? The total amount of mRNA for Moderna shots is half in boosters compared to the first 2 shots (50 vs 100 total mcg)
Now I think she is saying that the BA1 bivalent booster is actually better than the Wuhan 1273 vaccine against the Wuhan strain, in terms of neutralizing titers. Hmmm.
Now she mentions that 25% of vaccines developed COVID anyway. Of course the people with prior infection have higher titers, but she claims they still had a 4 fold rise in titers after vaccination, regardless. But does it matter? How likely were the placebo subjects to get COVID after prior vaccination vs after prior infection?
She claims that the old vaccines do provide cross reactivity to BA.4-5, and so she anticipates the newer (untested) vaccines will do even better.
Now slide 19 is hard to believe: higher titers at 6 months than at one month? This can only happen if people got COVID disease between 1 and 6 months.
It looks like they studied at least 40 mice, slide 22 but I couldn’t get a copy and so I am not certain they were using the newly authorized booster in the mice.
Her conclusion is based on other boosters tested. The vaccines sound like manna from heaven. However, if the BA1 bivalent booster is so super, why did FDA order that it not be used, and instead they were to develop a BA.4-5 bivalent booster for which we have no real data?
Dr. Brooks asks a question she cannot answer, and will call a colleague who actually did the studies. They do not show the slide 19 again though I am anxious to see and record it.
Jackie admits that the clinical trial just closed enrollment, which means that FDA is happy with only 512 people in the clinical trial for the new bivalent booster. Dr. Edwards says his mouse test is good but they cannot do it in people.
Median 43 days of followup for the BA.1 bivalent study. I am not impressed. They don’t even have the 60 days FDA required for the earlier EUAs.
Out of nowhere, Dr. Sanchez or Chen seems surprised that he has not seen any BA.4-5 data, and asks if it isn’t premature [to roll out these vaccines now]? He seems very surprised. Did CDC fail to inform the committee what was going on? Is he especially ignorant? He appears to hve missed the fact that the new plan for vaccines in general is to roll them out without data, which Melinda Wharton hinted at in her introductory remarks.
All these data rely on antibody titers which are entirely unreliable at predicting risk of infection. Plus, trying to say that titers that go up 10-50% are meaningful is another joke.
Dr. Lehre says this is the direction we are going: no human data. Suck it up. I am happy with this.
Dr. Duchin asks how you can relate the mouse to the human. Dr. Miller says the mice have a similar ACE-2 receptor. That begs the question of whether the immune system response is similar for this new vaccine. Dr. Edwards jumps in to help and asserts we have adequate data. “The animal models have translated very well.” He is a dogmatic guy who fails to discuss data.
Dr. Sanchez brings up the forbidden word: pregnancy. Dr. Miller says eventually they will have studied 800 pregnant women. I guess we are supposed to be impressed with the 800 number. Clearly a PR person came up with these nonanswers to sensitive questions in advance. Which likely, as I said earlier, explains why we are not seeing faces–they are riffling through their canned answers.
Dr. Edwards says yes there is placental transfer of antibodies–so he turned the question around into something positive for the fetus. Dr. Sanchez does not let him get away with this pivot, and says what about the spike protein getting to the fetus? Edwards, a slick willy, says yes we have done those studies, but I am not the person who did it, and we can provide that information in future.
Doran Fink jumps in to say yes, we don’t have data on this booster, but we have longer data (on the BA.1 vaccines, he means) and the safety issues do not seem problematic. Reactogenicity is less. However, he then admits they totally lack myocarditis data. Reactogenicity means only short-term, minor side effects and is entirely inadequate to assess for serious adverse events or longer term side effects.
Given the need for timeliness… this unlay FDA’s decision…
Grace Lee just got cut off. It was probably deliberate: she noted that administration errors for the COVID vaccines have been much greater than for any other vaccines, and she wanted improvement of labelling or instructions. This is a direct criticism of CDC’s instructions. She repeated herself when the other members pointed out she had been muted.
Pfizer is now doing their kabuki dance. First we see the “proof” that the original vaccine neutralizes omicron. Now we have mouse data, and the blood of vaxxed mice also neutralized omicron. The BA.1 bvalent vaccine was even better in mice.
These antibody studies have never been considered adequate to show immunity in a human subject. Nor have they allowed anyone to avoid vaccination. So why does CDC accept these titers as evidence of immunity when it comes to authorizing a new vaccine rollout, but not when it comes to demonstrating that a vaccination is unnecessary?
Let me say it now: reactogenicity is not equal to safety. however, the new vaccine does have higher rates of nearly all short-term side effects compared to the original Pfizer vaccine.
cc-15 provides some mouse data. cc-16 looks at neutralizing antibodies 7 days after 3d dose. Humans however are only considered immunized two weeks after a shot, if I understand the boosters correctly. Which suggests mice are not like humans.
No one ever explains why their previous presentations did not predict the real world activity f these vaccines… begging the question of ‘since we shouldn’t hve trusted you before, why should we trust you now?–especially since you don’t even have any human data now?’
A Pfizer employee with a British accent mentioned the difficulty enrolling pregnant women in a trial. What he slid around was the fact that the UK last week withdrew its recommendation for COVID vaccinations in pregnancy.
OMG ACIP Chair Grace Lee did not even know the dose for the vaccine she will be voting on in 2 hours. She points out that the labels provided to the committee do not specify dose! That must mean that FDA and/or the mfr came up with a decision of dose only very recently…which begs the question, what did they fill the vials with that are being rolled out over Labor Day?
I have anxiously been seeking the dose, and only learned it last night when I read through the Fact Sheet issued yesterday.
Dr. Long says thanks for the data… but there aren’t many data upon which to make a decision. You don’t have any human antibody data even over a short period of time?
She wants to decide on whom this vaccine will be used? She must not have heard the USG bought 180 M doses of Pfizer, and most likely some similar amount from Moderna. Which means everyone is expected to get it.
Just looked it up and on Aug 4 Moderna signed a contract for 66 million doses for US.
15 minute break. Here is what TIME magazine wrote about rolling out boosters without human data, quoting Paul Offit: That has vaccine experts divided. Dr. Paul Offit, a member of the advisory committee, says this strategy makes him “uncomfortable” for several reasons. He notes that the data presented from Pfizer-BioNTech and Moderna in June involving their BA.1 booster shot, which focused on the levels of virus-fighting antibodies the vaccine generated, were underwhelming. “They showed that the neutralizing antibody titers were between 1.5- and two-fold greater against Omicron than levels induced by a booster of the ancestral vaccine,” he says. “I’d like to see clear evidence of dramatic increase in neutralizing antibodies, more dramatic than what we saw against BA.1, before launching a new product. We’re owed at least that.”
Let me point out, though probably everyone already knows this, that the decision of this committee today will, if positive, prop open the regulatory apparatus so that anything goes. Anything at all can be injected into you on the basis of a data-free promise. Remember also that the briefers, the CDC officials and the members of the committee come into this process sharing a common trance: that the COVID vaccines used so far are safe and effective.
Sara Oliver is here to do the part of these meetings I abhor: the part where CDC staff perform a dance called “Evidence to Recommendation Framework.” Here people pretend that they can quantify benefits and risks in 5 domains, and they always conclude the benefits far outweigh the risks of whatever rollout vaccine is being pushed. This gives everyone–the CDC, the HHS and the members of the committee–cover to vote in favor of whatever is being asked of them.
Apparently there is a federal law requiring this type of evaluation. So does ethical public health practice. But when CDC performs this assessment, it uses fake data. Not just cherrypicked, which is also done, but also faked.
Sara always acts out magnificent concern for the underserved vulnerable populations and today she is all about equity. In other words, CDC doesn’t think black folk have been sufficiently damaged by the COVID vaccines, and wants them to share the pain equally with other groups.
She presents the “evidence” which is derived from the BA.1-Wuhan bivalent booster. And it’s antibody responses. Yada yada yada. Redness was the most common local reaction. Why say this? To make it appear they are paying attention to side effects, when they never tell you the side effects that are serious and probably vaccine-induced. Instead, today we heard twice about a broken bone after getting the shot. Duh.
NO severe adverse events were “assessed” as related to vaccination. Who does the assessing? Pfizer’s paid employee.
The reactogenicity data for bivalent doses were similar to the ancestral vaccine, she says. Thanks, Sara. They both caused redness and pain. How informative. What she failed to say is that the bivalent vaccine caused MORE local reactions of almost all kinds.
Since we tolerate a rate of myocarditis of 1 in 5,000 in the 18-24 year olds in Canada, then of course we should tolerate a lower rate for boosters. WHAT? We should not tolerate either myocarditis rate for a vaccine that has negative efficacy after several months and may cause a wide range of unacknowledged side effects due to damage from spike protein to the lining of blood vessels.
Note that known toxicity of spike protein has not been mentioned once by a single person at this meeting today.
Now we get to the part I hate most. The scenario modeling hub which is “ensembled by the hub.”
They make all sorts of bogus assumptions and pretend to take risks into account–but they value things incorrectly so the result is always that the vaccine is the best thing ever.
For example, in those who already had covid, the bivalent vaccine works fabulously! Slide 55
BA.1 and BA.4/5 are different by at least 10 mutations. The Qataaar data slide, after 55 but unnumbered, seems to show that efficacy of the vaccine was very low unless you also had had COVID. But the graph went by quickly.
Then she showed a slide based on 4 or 5 individuals getting 3 different vaccines. Ridiculous.
And another quick slide with very few people studied. Now we go to the equity question. All racial/ethnic groups supposedly had similar antibody levels and similar side effects, but there were very small numbers of subjects so the data need to be taken with a grain of salt.
So here is what we know, she says: high degree of safety. Very rare myocarditis cases, but we know they have a high degree of safety. Initially they protected against infection and transmission. (I thik this is incorrect.) They expand the immune response after infection. (Based on what exactly?) “It is important to acknowledge what we don’t know; the rate of myocarditis. Unlikely to have an impact. We don’t know effectiveness.
In summary, the balance of benefits and risk: increase the immune response (this may be the opposite of what happens). Hospitalizations and deaths are averted. (Also not true) and the benefits and harms are best assessed when the clinical trial subjects represent the US overall demographics. Undesirable effects are small.
Moving to VALUES: 70% of a survey said they wanted a new booster. however, the number who already took a 4th booster is I think 30% or less.
According to the NYT/CDC today, only 33% of eligible Americans took even a third dose. I think something like 10-15% got a fourth.
But these numbers are not mentioned by Sara or anyone else. How many people would want to be the guinea pig for this one?
Now to the Acceptability Domain. Over 606 million doses administered in the US. She claims that 40-50% of people got a booster, whereas the NYT/CDC say 33%. See what i mean about the fake data?
Here is the NYT URL so you can look it up yourself. https://www.nytimes.com/interactive/2021/us/covid-cases.html
Here is what NY Times says about where it gets the % booster vaxxes: Sources: Centers for Disease Control and Prevention, state governments, U.S. Census Bureau. The C.D.C. reported on Nov. 30 that booster doses are sometimes misclassified as first doses, which may overestimate first dose coverage among adults.
She claims 210 million people are currently eligible for a booster.
She claims the USHG purchased 171 million doses and there might be shortages…a finite supply. I love how Sara’s voice goes up and down to give emphasis to her narrative.
She shows another slide that suggests about 50% of eligibles got a booster. Back to reemphasizing the finite supply. Slide 107 cites an unpublished blog and preprint. And it is not CDC-authored. But for somereason she has not explained, it is being used to estimate cost-effectiveness.
With no explanation, the unpublished paper estimated that QALYs and $ would be saved by a vaccination program.
QALY stands for something like “good quality of life: years gained.”
Now she claims the vaccine program would save billions in direct medical costs. We have not heard anything about the direct medical costs incurred by vaccine-induced illnesses. Now she has “finsihed the data”–did I hear any relevant or validated data? Don’t think so.
Sara says we have extensive safety data on themRNA platform and 1400 people who got a different bivalent vaccine, and there were no safety concerns in the 1400. We are satisfied about safety, but we do not know the degree of incremental benefit the vaccines will provide. Note that there is no consideration of the possibility there may be no incremental benefit and instead negative efficacy?
Sara then mentions some of the models the work group looked at with different assumptions. This is the part that is fake quantitative– note the graphs with huge uncertainty (gray) areas. But in fact the truth may be way outside even the gray area.
Round 14 model was for a yearly booster. Round 15 model looked at projections for a Sept vs November booster rollout.
“Hopefully that is clarifying.” Yes, clear as mud. Thank goodness the first questioner (Bahta?) asks are you predicting a new big wave in Jan? Yes, says Justin, we would predict immune escape __i.e., no benefit from vaccine due to a new variant. Which has been selected for by vaccination.
That is only on the right side of slide 52. The 2 left graph do not predict any immune escape.
Did they assume early waning? she asks. What if there is a January wave and the vaccine immunity has already waned after a September rolloout?
Justin, the math guy, explains that different models made different assumptions about waning. Duh. He describes his models. But we don’t actually care about his models as all are theoretical. He then says the loss of efficacy was compensated for by the benefits of prevented cases early in the fall. However, there are few cases now (relatively) and definitely few deaths and ICU cases, so their understanding of their own model seems lacking.
Dr. Sanchez is pissed off. We are still having a lot of Covid despite vaccinations. He is struggling over this booster “that has not been studied in humans” we are going to make a recommendation for the mass of Americans? The BA.1 is not the vaccine we are going to be recommending.”
Dr. Twentyman is brought in to change the subject. CDC is “no longer looking at total number of doses. A bivalent booster should not be denied based on total doses a patient has received.”
Even if you had 3-5 doses, as long as 2 months have gone by, you are urged to get this new booster. Assuming this group of sleepy ACIP members goes along with the CDC recommendation…and some of them were on the Task Force and have already been screened as yes voters.
Now we have a commercial for Evusheld monoclonal antibodies as a preexposure prophylaxis treatment for the immunocompromised., OR those unable to be vaccinated.
It got an EUA last December and the dose changed upwards in February 2022.
Last December was when the earlier monoclonals were found to have lost efficacy, and so FDA was in a rush to get something out fast, and Evusheld squeezed through. It is “predicted to work” against BA.4/5. Most Americans have not received it, and only 5% of the immunocompromized have received it. It is free (as are all EUA products since they cannot be sold by law).
The total volume of Evusheld is 6 ml i.m. This is 20 times the volume of the Pfizer vaccine. It probably costs the federal government a lot. 6 ml could contain a lot of junk, potentially, since there is no liability for this product.
Now we are hearing that the new bivalent vaccines can be given together with a seasonal flu shot. This may mean the dual mRNA flu-COVID vaccines will not be rolled out this season.
“No specific safety concerns were identified.”
CDC will provide education to reduce administration errors. So I guess Grace was actually supposed to make her comment about administration errors, because they are spending an awful lot of time talking about label and cap colors.
Tom Shimabukuro just said that people who get vaccinated soon after a case of covid have increased reactogenicity, fever, fatigue, muscle aches–but he says “there is a lack of evidence that it places you at increased risk of myocarditis.”
The current speaker just admitted that CDC is distributing hundreds of thousands of vaccine doses TODAY–before they had an approval.
And the fed agencies have dug themselves nto a hole, because FDA withdrew the EUA for the boosters that have been used for the past year. So they HAVE to roll out the new boosters, they have no choice. They cannot use the old ones.
Another issue that got briefly touched on, is that some other countries like the UK and Canada are using a different vaccine, the BA.1 bivalent. why did they behave differently?
Ms. Bahta was not aware the old EUA was withdrawn yesterday, enquired about the old vaccine, and Dr. Hall answered her without explaining that the EUA was withdrawn so if they don’t vote yes there will be no available booster for Americans over 12 !!!
Are the members getting restless? They are asking questions about intervals between shots, and between shots and Evusheld, indicating some degree of discomfort with the proceedings today. Maybe they are waking up to the fact that it makes no sense that the vaccine works wonderfully but the CDC is recommending a booster 2 months after the last dose. So Sara the chirpy lady whose job it is to shepherd this recommendation through the committee, is trying her best to suggest, nah, it isn’t really 2 months, that is just the legal minimum.
Now someone is saying more boosters may be needed (of course) down the road…
Dr. Sanchez asks about iv admin for Evusheld? Apparently it was tested iv but was not authorized for that use–so go look it up! says the Astra-Zeneca rep, it was published.
Now Dr. Sanchez appears to be backtracking in favor of this untested vaccine. Which he has done before.
Now there is a question about people receiving monkeypox and covid vaccines, both of which can cause myocarditis.
The answer is , read the text.
In other words, only the members who a briefing book can learn how CDC plans to deal with the dual myocarditis risk from both vaccines.
Sara/CDC have created a new term: hybrid immunity, which is having gotten covid and having gotten vaccinated. It appears that this is how CDC will deal with natural immunity: it is an adjunct to vaccine immunity! This is ridiculous but par for CDC’s course.
They get away with it by claiming that natural immunity is only 50% effective. While that may be true for early infections pre-omicron, ist is unlikely tobe true if you have had an omicron, similar variant.
merylnass:Weird question: omits the fact that the older vaccines can no longer be used since the EUA is gone, unless the feds decide to give themselves liability and offer the licensed Comirnaty and Spikevax vaccines. Pretty unlikely.
This is the question the ACIP is supposed to vote on: “should updated bivalent vaccines be recommended for personals already recommended to receive a COVID-19 vaccine booster dose?”
Persons not personals.
Dr. Brooks is nervous about no human data. Dr. Long is happy with no data.
Reluctantly, of course.
FDA’s Doran Fink MD phD is trying to explain how FDA chose this version of the vaccine, waffling around…he claims one reason was advice from the VRBPAC. However, I listened to all the VRBPAC meetings and they did not provide any formal guidance regarding which strains to FDA, nor did FDA seek that guidance, leaving the issue open in their question, which was “Should we include an omicron variant in the next booster?”
The next day the White House ordered the BA.4/5 boosters, so I think the decision of what vaccine to use was not actually made at the FDA.
And it might have been made BECAUSE there would be no human testing. Doran got caught: one member asked if the VBPAC voted on this, and he had to admit they had not been asked.
And now they are being asked, did you consider, given the risk-benefit, only recommending the vaccine for those over 50? Daley says we considered it, but decided to make an overall recommendation.
Someone piped up and said had we done so it would have been too complicated.
Now it is acknowledged, finally, that the EUAs were rescinded yesterday for the old vaccines. Sara uses her voice to soothe the listeners.
Sara just said “It is a PREP Act liability if” they change the recommendation to be different from the FDA’s EUA language. Melinda Wharton, who is Sara’s superior, comes in to try and end this discussion abot 2 months before a new booster–people are really unhappy about giving vaccines too soon. They have not read the Dorabwila JAMA paper about how fast the vaccine efficacy wanes for kids (12% efficacy at 8 weeks for 5-11 year old).
Dr. Lee is trying to corral them regarding her motion to just vote, darn it. now the ex officios are coming out of the woodwork to herd the members back to the CDC’s desires.
Talbot wants to wait and see which way the wind blows. So far all vote yes.
Talbot gives a yes, there was one no, and I missed who that was for vote #1. Now there is vote #2. This one is just for the Moderna vaccine. Sanchez voted no, everyone else yes. Now Dr. Long (having voted yes) backpedals a little so she won’t feel guilty when this mess reveals itself.
Good for Dr. Sanchez. He has stuck with his position.
I hate it when they all try to justify their votes after. Who cares?
It is always a sad, deflating ending to a sad, deflating day. But if you expect the worst, you won’t be disappointed.
BYE!
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