FDA VRBPAC Meeting Day 1, June 14, 2022 — Meryl Nass, M.D.
It is time for the final FDA advisory meeting on authorizing childhood COVID vaccines, long after they are needed. We consider the original Wuhan strain vaccine today, which no longer exists in the world.
Dr. Monto is providing a bio today. So are the rest. Dr. Gans, Berger, Henry Bernstein, Archana Chatterjee, Amanda Cohn (CDC), David Kim, Paul Offit, Steve Pergam, Eric Rubin. Many were temp members but now permanent it seems. Here are the temp members: Oveta Fuller, Randy Hawkins, James Hildreth, Jeanette Lee, Ofer Levy, Wayne Marasco, Pamela McInnes, Cody Meissner, Michael Nelson, Art Reingold, Mark Sawyer, Stanley Perlman? (who was announced but is not there), Melinda Wharton (CDC) Oveta Fuller
12 temp members. Why have so many permanent members failed to attend the COVID vaccine meetings? Was this their decision (perhaps avoiding future liability) or was it FDA’s decision (because their votes could not be assured?)
It is of interest that FDA makes a big deal about conflicts of interest. However, it was shown that many advisory committee members get Pharma contracts and funds after they serve on these committees, and presumably, these members know that such benefits are likely to accrue after they leave the committee.
Peter Marks says safety is of paramount importance — well ten, why were such small numbers of subjects enrolled, making sure to miss most of the severe but rarer side effects?
Dr. Agnihothram will discuss the Murderna application. Right now you can get their vaccines for 3 doses in those over 18 years of age. Note that several European countries do not permit Moderna vaccines in those under 30 (and possibly 35 in one country).
It can be used interchangeably with Pfizer vaccines, although a major study in all Nordic countries showed that using a Moderna vaccine after a Pfizer vaccine caused a lot more myocarditis than using a single vaccine for both initial doses.
Data available today are from a blinded follow-up through Jan. 31 in 2500 subjects.
Moderna’s 6-11 year vaccine uses 50 mcg/shot x 2 shots. This is also the dose used in boosters for adults.
The statutory requirements, which I have emphasized are being ignored by FDA, are discussed by Dr. A at 31 minutes into the meeting.
The question. #1 asks whether benefits outweigh risks for the 12-17-year-old group? Question #2 for the committee asks the same question of the committee for 6-11-year-olds.
These questions will be voted on at the end of today.
Dr. Gans asks when the EUAs will move toward approval, and why are the vaccines today not being considered for an approval (full license)? Dr. A says it is because they were not asked by the manufacturer, and not having six months of follow-up. However, this is a BS answer, because the six months of F/U used for the Spikevax approval for adults included several months AFTER the blind was broken and the placebo subjects were vaccinated — so the FDA did not actually have six months of true trial data.
The FDA staffers ignore the statute which says the products should be licensed as soon as possible, especially after one year.
Dr. Dutra shows that federal data suggest most kids are already immune. She reveals that the omicron wave affected the largest number of children, which means that they are still immune to current omicron variants.
Lots of kids were hospitalized during Omicron since this did cause the majority of cases, so FDA tries to twist this into suggesting that kids are at especially high risk of hospitalization–ignoring that only 5-25% of kids currently lack immunity and will only be harmed, without benefit, by vaccinating them now.
She also fails to explain that the youngest children (especially under one year) are always affected disproportionately for any infection, compared to older kids. FDA is really reaching to scare us about the negligible risk to little kids.
Dr. Dutra says there have been lots of “Covid deaths” but if you go to the CDC Covid data tracker these deaths are now specifically titled “Deaths WITH COVID” not deaths due to COVID and not COVID deaths.
2 papers from pediatric hospitals revealed that most hospitalizations with COVID diagnoses were primarily due to other conditions. Deaths occurred mainly in highly compromised kids with other conditions, like cancer, who tested positive for COVID in the hospital.
MISC has not been well defined and seems to resolve for most children, but this is not discussed by Dr. Dutra, who only uses the diagnosis to induce fear of COVID.
Suddenly our federal public health agencies are concerned about school closures, which they instituted. They are concerned about daycare too. They are suddenly worried about minorities, while their policies exacerbated the disparities faced by minorities.
While “most kids hospitalized had no underlying conditions” — this not what the literature shows.
What a joke in the efficacy chart at 1 hr into the meeting. After pointing out that the confidence intervals are too wide to consider the results reliable, the young lady CDC doc with lots of colors on her lapel tells us one of the studies showed an 83% efficacy at 3 months. Then she moves on, ignoring all the other, lower, efficacy results.
Her next slide, from Pfizer, showed efficacy dropped to zero-zip-nada protection by 3.5 months after 2 doses in children.
The next slide looks at 0-2 months and she admits the efficacy drops almost to zero for the 5-11-year-olds at 59 days!
Note that she is providing CDC data, and omitting the data from outside published studies, which have results that are a lot worse.
It is hard to believe they could be worse, but negative efficacy is worse. Note that most of her data is obtained somewhere in the first two months, which is the brief period when the vaccine seems to provide brief benefit.
Boosters “substantially improve vaccine efficacy” with some evidence of waning. The booster improves this — but they don’t have enough data to tell us whether the “benefit” of boosters prevents hospitalizations or deaths.
Dr. Shimabukuro is up next. He looks more and more unhappy as the vaccine meetings have continued.
He will report on VAERS and he is in charge of the VSD. He first gives the myocarditis numbers through May 26. 635 confirmed reports met the CDC case definition with about 53 million doses given to children. It seems that there were 76 reports per million after dose 2 in 16-17-year-old male or about 1 in 13,000. Quite high for passive reporting, one week after the dose.
Now CDC discusses its survey to make this look like a minor problem — asking patients, patents and HCPs about the condition at least 90 days after the illness onset. Most “seemed to have recovered” and the key findings were that most patients that were reached did not report an impact on their quality of life.
However, earlier meetings revealed that 25-50% of cases still had activity limited at 90 days.
The VSD weekly used “prespecified outcomes” that have previously failed to reveal any signals of safety issues, revealing that the algorithms used are inadequate to find the obvious safety issues found in other studies. This method even missed myocarditis.
Which is pretty amazing. But finally, they have found a myocarditis signal in the 12-17-year-olds, but not others.
OMG, in the 16-17-year-old males, a booster leads to 200 myocarditis cases per million or 1 in 5,000 boys!
In females of the 16-17 group you get a myocarditis case after dose 2 in 1 in 40,000 doses.
So you give myocarditis to 1 in 7,000 males (new chart) 1 hr 21 mins, w/2nd dose, then they don’t get a booster–then you boost the rest and give myocarditis to 1 in 5,000. So now you have given myocarditis to 1 in 3,000 boys if you add them together. And if you add the boys who got myocarditis after dose 1 (about 10%) you have one case in about 2800 boys.
Now we see a slide that finally admits that Moderna causes more myocarditis than Pfizer.
The paper from Nordic countries is titled”SARS-CoV-2 Vaccination and Myocarditis in a Nordic Cohort study” which used national data from 4 countries, revealing not only that Murderna causes more myocarditis, but also that using Murderna after Pfizer roughly doubles the risk that giving Murderna twice would yield–let me repeat. Mixing doses is considerably more dangerous than using a single vaccine for both initial doses.
The three CDC briefers look depressed, wary, nervous as the questions begin, but Monto will protect them with very limited time for questions. Offit and Meissner are wild cards.
Offit says, the variants you showed are largely gone now. Do you have any data on current scariants? Perhaps from other countries? Fleming-Dutra says no, wasting lots of time and running out the clock.
Meissner asks, “If we look at case data from CDC data tracker, 5-17-year-old children have a hospitalization rate of 7 per million, or 350 hospitalizations for the entire cohort of kids, and only 200 that are caused by COVID. And if you remove the kids with comorbidities, you get many fewer hospitalizations from COVID. So how do you balance this very low risk to kids with benefits?
Dr. F-D disputes his claims (she is incorrect based on published non-CDC data, which she totally ignores). She will go far at CDC, because she seems to really believe the CDC narrative.
Dr. McInnes points out that in the recent Feb-March data there seems little benefit from vaccination against omicron.
Dr. F-D spout narrative, but Dr. McInnes asks her to answer the question. So she defers to Dr. Link-Gelles who simply echoes what her predecessor says, which is that when cases are high we see more benefit. (?!?)
Dr. L-G predicts more surges in the future, so that is why we are vaccinating now. She provides no data to support her prediction, nor has CDC or FDA commented on how the increasing degree of immunity in the population impacts on their predictions, especially since half of Americans got Omicron, at least.
Dr. Marasco says the vaccines only protect for 3-6 months, so how do you message that to the population–how will CDC message this?
Now Dr. L-G makes the claim that they see similar waning of natural immunity in the same pattern as the waning of vaccine immunity — which is untrue, no data has been provided to support it, and data dispute it.
Dr. Hildreth asks about the prevalence of immunity in children now. She shows a slide from Feb with 68-77% immunity in different age groups of children. He points out that if so, few kids need vaccines. Dr. F-D is really good at juggling these questions with the “baffle them with BS”. Monto rides in to try and help out, but she is forced to correct him. He still disputes whether CDC’s seroprevalence data are representative of all kids.
Dr. Wong speaks now. It is hard to understand her. She does the same trick she did before: using very old data. Her first slide is from last October. Apparently, she is doing a mea culpa, explaining why FDA missed the myocarditis signal
She mentions the Nordic study but misrepresents the findings. Please go look at Table 3 and the IRR column to see rates up to 20x the comparator, not 2-3 times.
Funnily, she disputes the data just presented by CDC from VAERS (both FDA and CDC study the same data) that showed higher Moderna rates of myocarditis.
Now she is back to last fall’s data. More mea culpa, why we did not take regulatory action about myocarditis last year. Recent evidence supports us. But results are limited by self-reports and a small number. Wait, Dr. Wong–there were 635 confirmed cases by CDC, who did not use self-reports — why are you ignoring this? This is criminal behavior.
Dr. Wong again uses the BEST dataset slide at 1 hr 55 minutes. Previously she never provided any BEST data, only acknowledged the existence of the databases.
Now she does give us data, which provides myocarditis rates–which are remarkably fewer than CDC found using PASSIVE surveillance from VAERS. This is crazy: incidence rates are always lower in passive systems than active surveillance systems, but FDA has managed to turn this on its head.
And so FDA found no problems to change its mind on myocarditis. Duh. Of course, there are potential limitations… large uncertainty due to the rarity … and no difference between risk from Moderna and Pfizer shots.
When Dr. Wong/FDA finds completely different results than CDC and data from national databases in other countries, why didn’t FDA investigate what it was doing wrong? Are the data flawed or is the analytic method flawed? Until the FDA identifies the problem, how can it present these flawed results?
Finally, a signal is found on slide 17, and it is high, in males 12 and up, but I don’t understand why she minimizes it. No one asks a question, as they may be as confused as I am over what she presented at the very end. I will show her slide 17 tonight on my blog for further inspection of its meaning.
Now MURDERNA provides its people and its data. 633 doses given worldwide. First speaker Dr. Vinals notes it got a license in Jan 2022 in the U.S. and 40 countries have used Moderna vaccines in children.
Omicron continues to demonstrate that Moderna provides protection. Duh?
I think she is using CDC data that is inaccurate due to assigning those who get COVID before 14 days after dose 2 as unvaccinated.
She is a good liar, warning about the kids who need ICU care (almost none now). I wonder if the reason so many people with strong accents are used in these presentations is because it is harder to read their faces and body language to detect when they know they are lying. Now the efficacy in kids is 88-100%. How can she keep a straight face?
Dr. Evan Anderson from Emory U speaks next for Moderna. He has loads of conflicts of interest, and 4 kids, so can we get their titers to see if he vaccinated them?
He provides us the “misperceptions” that covid is not severe in children. More than 10M kids already vaxx’d with COVID. Yes, some get hospitalized. Covid is finally catching up to flu in
terms of hospitalizations–but covid is circulating at least half the year, while flu circulates for about 6 weeks in any one area per year.
1/3 of kids hospitalized for covid were otherwise healthy. Average hospitalization duration is 2.6 days for COVID. There are 69 deaths from MIS-C or one in a million.
1.7% of all deaths in children are “with” COVID. Why would this frighten us? He calls it “a leading cause of death that is now vaccine preventable.” That would only be true if the vaccine worked, if we knew how many really died from not with COVID if there was no preexisting immunity in at least 70% of kids.
Now he implies that Moderna shots will improve learning and mental health in kids. Wow!
Why doesn’t he seem happy since he alleges he can improve our quality of life with these wondrous potions?
Now Jaqueline Miller from Moderna speaks. She describes the two studies. Note that Murderna followed FDA’s requirement for 2 months of follow-up. In study 204 Murderna stopped using the 100 mcg high dose in 6-11-year-olds.
Myocarditis emerged as a safety signal during the study. We updated our info and started informing parents. Did parents allow more doses after this?
Moderna worked hard to avoid liability by drawing in others to share responsibility for myocarditis decisions.
Immunobridging was the method by which effectiveness would be determined–even though this surrogate was not proven to be valid. Once FDA understood this, why did they not require the secondary outcome to become the primary outcome endpoint: actually prevention of Covid?
She admitted kids have milder diseases than adults. The studies were done during older scariants.
The trick in all these meetings is to give excess attention to local, brief reactions and almost no serious illnesses, often developing later after vaccination. Another trick is to claim that the placebo group had nearly as many reactions as the vaccinated group.
6% of kids needed a doctor’s visit in both groups. No one was judged to have a reaction that would exempt them from further participation in the study.
43 cases/million doses in males of myocarditis, but she claims the rate is more than 10 times higher from Covid. This has not been found by others and is a crazy comparison.
Has anyone smiled yet during this charade? We are at 2 hrs 48 minutes and I have not seen a smile.
The meeting has now proceeded for 2 hours 50 minutes and I have seen no evidence of enthusiasm. If even one person thought this meeting was going to save the lives of babies and toddlers, don’t you think they would be upbeat, rather than robotic? Wouldn’t they be talking up the amazing lack of serious adverse reactions, and the fact that not a single one was assigned by the investigators (Murderna employed) as due to the vaccine?
Efficacy in the 6-11 year group was challenging due to only 7 cases. The mITT calculation, counting cases 14 days after dose 1, gives Murderna the desired numbers with a narrower confidence interval.
Boy, this is an amazing vaccine, based on immunobridging and the fact there are no adverse events of consequence. Dr. Miller just smiled. She is relieved by how smoothly Dr. Das went through the data.
Efficacy is amazing! We “believe” that protection against severe disease will be similar to adults
Moderna predicts with its model that 1-200 hundred hospitalizations in kids will be prevented per million vaccines. Don’t you love the predictions that come without providing the model used to make the prediction?
We are still studying effectiveness, myocarditis and other adverse events and we are assured that the benefits outweigh the risks. No new safety concerns were identified.
How can they present these fake efficacy numbers when CDC just showed that Pfizer vaccines’ efficacy drops to nearly zero after 2-3 months? Is Moderna that much better? Or is the higher dose (50 mcg/dose versus 10 mcg in 5-11-year-olds) leading to higher efficacy without any increase in adverse events?
Monto points out that the neutralizing titers were against the original Wuhan strain. Dr. Das smiles as she comes back, as she and Dr. Miller have performed flawlessly.
Dr. Gans asks, can we see the data from the millions of doses you have had administered to kids internationally? And what was the immunogenicity of the 50 mcg dose in 12-17-year-olds?
The 100 mcg doses was more immunogenic, confirming or dose selection going forward. We are still setting to meet the FDA immunobridging criteria, but the study is enrolling slowly. It seems Murderna has not looked hard at the international data. There is some from Spain and the UK but more work needs to be done, and we are looking for more collaborators. In other words, dad gum, why do you want us to look at data we did not obtain ourselves and cannot be spun as efficacy over 88%? Do you really think we would collect data that might harm our narrative?
We are again shown the Risk-Benefit model. Useless. Where is the information on duration of effectiveness (if any)? She never answered. Dr. Berger asked about the 70% of black teens who are unvaccinated. Well, Dr. Das noted that diversity is very important at Moderna. They saw no differences wrt immunogenicity by race.
Dr. Zhang is here to present for the FDA discussing the Moderna data and FDA’s benefit-risk assessment.
It seems a new standard has appeared for immunobridging using something called LLOQ –which is a red flag that the vaccine failed to meet standard immunobridging criteria.
It is now hrs 24 minutes into the meeting. Blinded median followup in study P203 was under 2 months–how did FDA accept this when it wanted at least 2 months?
Remember that FDA and these VRBPAC advisors have already acknowledged that these immunogenicity studies are worthless and cannot be used to assess efficacy in boosters. But today they have magically reappeared. Will everyone simply pretend the data are valid for kids, even though kids are the group who should have the most stringent review of efficacy and safety?
She notes that FDA did not confirm the validity of some of the Moderna data she presents. Duh?
More time-wasting with brief reactogenicity data used in place of meaningful safety data.
Dr. Zhang confirms that adverse reactions are considerably higher in those recipients who have already had SARS-CoV-2.
They found no anaphylaxis nor myocarditis in any recipients.
There is no real efficacy data from 6-11-year-olds (in other words, they can’t show it prevents cases).
New analyses were done expanding the person-months and by doing so Moderna somehow got efficacy numbers up to 80%.
It seems the vaccine clearly causes lymphadenopathy and abdominal pain. Note that Maddie DeGaray’s paresis and need for a feeding tube were reported as abdominal pain.
FDA and Moderna will take a collaborative approach to assessing adverse events.
Duration of protection is unknown. Based on the totality of evidence, do the benefits exceed the risks? It is of interest that we have already established that at least 70% of kids are already immune, that adverse events in these 70+% are higher than in the nonimmune, and that protection is likely to be very fleeting–so where is the quantitative risk-benefit assessment, which is surely negative?
Why not offer vaccines only to non-immune kids, which would be the scientific approach were these people to be actual scientists?
Dr. Marasco points out the limited duration of effect–immunobridging is not sufficient.
They lost the placebo group when they unblinded the group, so they cannot assess efficacy, according to Dr. Zhang. Excellent acknowledgment. Loss of the placebo group also means you cannot assess safety. So why do FDA and sponsors claim they are still following the subjects? Because all they are doing is performing a charade of regulatory analysis.
Doran Fink jumps in and promises that someday FDA will look at real efficacy data. Trust us.
Monto says that for omicron you need 3 doses but we are being asked to authorize 2 doses. Will there be another process for the 3d dose? Yes, says Doran Fink, we will get there as soon as we can expediently make the booster dose available.
Lunch now for 30 minutes, then the one-hour public comment period will begin before more of this playacting commences.
Ashley Serrano, Ph.D. psychologist provides a Moderna commercial. While she claims that the 40 countries that have used Moderna vaccines in kids have highly monitored them, when Moderna was asked about what this international real-world data showed, they didn’t know.
She also wants mandates and shows us a photo which is presumably Ashley herself with a 9-month pregnant belly, for some reason. Who wrote her speech?
The second speaker is another young woman who also reports no COIs and similarly gives a very professional talk repeating all the good news about Moderna vaccines.
Now she speaks as if her daughter had repeated episodes of hypoxia, but it is unclear why.
Brucha Weisberger reminds the participants that God is listening to everything to everything said today. Is the vaccine necessary, does it work and is it safe? The fear is being hyped up. 100% of covid deaths were in kids with preexisting conditions. Fraudulent efficacy claims are based on immunobridging, not actual efficacy. Safety? Pfizer’s own briefing document acknowledged that more myocarditis would be caused than lives saved. You know they are not safe and effective. Maybe you members are here on earth now to vote against the shot.
Dr.Jane Newburger of Boston Children’s represents the American College of Cardiology. She balances MIS-C myocarditis against the risk from the vaccine. She claims the vaccine prevents MIS-C. But I don’t believe there is reliable evidence that vaccination prevents this syndrome. (I could have missed recent data.)
Tamara Thomson is the next speaker, a young attorney and mother. She wants to protect the youngest kids with both vaccines. It seems that this mother, like an earlier mother, barely allow their kids out due to fear of Covid. She claims the risk is great right now. The vaccines are safe. She is mom #3 who seems to know all about immunobridging as if coached.
Aime Baker is mom #4 who has her kid home while working because “daycare is not safe.”
All these moms are well informed about the Moderna claims of efficacy but are totally ignorant regarding the real-world data re the Pfizer vaccine–12% efficacy at 8 weeks and negative after that. She mentions that her mental health has suffered. I think we can assume that we have had 4 moms who are in a state of chronic anxiety, who mistakenly believe that injecting their toddlers with a poison will relieve their anxiety and allow their lives to get back to normal. I feel very sorry for them.
Carolina Bourque describes a typical severe reaction to the vaccine and how it ruined her life, with no answers from many doctors.
Robyn Handsman describes her reaction, sadly also typical, with spiking BPs, kidney damage, elevated blood sugars and new onset food allergies — which I used to see from anthrax vaccine too. There is complete immunity for injuries.
I meant the manufacturers and government have complete immunity.
Richard Erickson developed multiple symptoms shortly after his second Moderna shot. He got a booster 8 months later and then got seriously ill. Again, the symptoms sound like severe anthrax vaccine reactions. Extensive workup at Mayo Clinic was unrevealing as to
effective treatment. The ill need resources to understand the illnesses and develop effective treatments.
He still supports the vaccine mandate!!! Now, just in case you did not think anyone was brainwashed/hypnotized/ mind controlled–well this productive man’s life has been ruined, he had a positive challenge-rechallenge, and he wants everyone else to be forced to take the same risk.
Caroline Bishop is mom #5 who is scared to death. She believes in the masks. She has no idea what an 8-week duration of efficacy means. She begs for safe and effective vaccines. She does not know they are neither.
Kailey Soller is mom#6 who begs for vaccines for the preschoolers. She is a scientist herself. She could talk forever about the benefits of these vaccines. Really? What kind of scientist might she be? What does she know that FDA and Moderna missed?
Jennifer Dougherty is chronically anxious and isolated mom #7. Same story.
Someone just sent me CDC’s journal Emerging Infectious Diseases, July 2022 issue. Authors from the University of Colorado describe two fully vaccinated adolescents who had breakthrough cases (vaccine failures) of COVID, followed by MIS-C. I wonder if it will turn out that MISC occurs more often in the vaccinated kids?
Dr. Harvey Klein is a retired orthopedic surgeon who again invokes God, the lack of efficacy and lack of safety of the vaccines, warning of hell for those who push these vaccines on innocent children.
Donna Truebig is an anxious grandma who again describes how the family has changed their way of life to protect a toddler and an immune-compromised member.
Elle Pierce is an RN who wants the Moderna vaccine. The wait for the vaccines has been protracted and excruciating. It is incomprehensible that this could be done to us. Why is it that all these ladies who quote the risks of covid with alacrity have zero sense that the vaccines could cause the slightest harm? “These mRNA vaccines are incredible.”
Kate Schenck is mom #8 begging for the vaccine. Despite requests by FDA to specify COIs before they speak, almost no one has done so.
Dr. Donald Middleton just proved me wrong — he is paid by Moderna for his advisory board work. He says he is speaking for himself. Hello? He admits it is “likely to produce at least temporary protection.” How is that for 3 caveats in a single sentence?
Let me explain negative efficacy — it means that being vaccinated makes you more likely to get the disease. In the UK, being vaccinated also means that after about 6-8 months you are more likely to die from COVID. This is based on official UK government data from the office of national statistics, which I have linked to on my blog and substack.
If you vaccinate your child, you are likely setting them up for both negative efficacy and limiting the breadth of the immune response they will mouth to the infection.
Michael Baker wants to protect his toddler. Justine Luzzi describes her serious vaccine reaction.
Sorry, mount to an actual infection. If your child gets a bad reaction, there will be no treatment available, and it is unlikely anyone will pay you any benefits: the federal program (CICP) (the only possible way to be compensated for an injury or death) has not paid out for a single COVID injury.
Now we go back to the FDA’s sessions. Peter Marks jumps in and repeats that FDA does not agree, necessarily, with the speakers. CDC speakers are now available to respond to questions.
Pamela McInnes is very deeply offended by the comment that FDA could be called the Joseph Mengele Institute and demands an apology.
Dr. Reingold asks about prevention of infection and transmission–what are the data?
Also, might the risk of myocarditis be related to changing seroprevalence?
Dr. Link-Gellessays the 3d dose give “some protection against infection for a couple of months, and therefore of transmission.”
Dr. Tom Shimabukuro admits prior infection increases the risk of vaccine adverse reactions, but they lack evidence that the increased reactions are serious. He did not say it does not cause more serious reactions; instead that they don’t have data.
He could not comment on the myocarditis question. The next member asks whether there is data on longer-term COVIS sequellae. Dr. Dutra says she is not the expert. Will Dr. Link-Gelles weigh in? Dr.L-G says there is some effectiveness, 78% in one study, but the studies of this are very varied and there is no standardized case definition … therefore there is no evidence it prevents MIS-C, long covid, etc.
Dr. Sawyer asks about hospitalization with vs due to COVID — were the data collected during omicron? He expects the hospitalizations due to COVID would be reduced from Omicron. The data quoted earlier were collected during all waves, and she says 86-87% of hospitalizations were due to, not with covid. This is BS data from CDC that is totally at odds with what others have published.
Dr. Fuller asks what CDC is doing to look at vaccine side effects? Is CDC looking at the people who got sick after vaccination?
Dr. TS refuses to answer the question asked, and reverts back to his databases, which provide no evidence regarding the syndromes of illness that patients are reporting post-vaccination. I told you Fleming-Dutra is a consummate liar. She sounds very sincere. She should go far at CDC.
Dr. Bernstein asks whether there are data for males on myocarditis when the period between doses is lengthened? These data were presented by the Canadians at an earlier meeting. The claim was that widening the interval between the first 2 doses reduced myocarditis–but FDA/CDC etc. seem to have decided against the longer interval after all. Note that no one has mentioned the Nordic study regarding the mixing of brands. Amanda Cohn jumped in to respond, even though she is a member not a briefer. She says CDC “allows” an 8-week pause between doses. Thanks, CDC.
Dr. Chatterjee wants another comparison of myocarditis after vax vs after covid. Someone asks for CDC’s Matthew Oster, who cites the MMWR, then fails to make a substantive comment.
Cody Meissner points out a paper showing that vaccination did not prevent long covid. He is concerned that the public has so much misinformation, based on the public comments. He notes that 75-95% of adults are immune…implies that this should be included in the myocarditis risk.
Dr. CM does not know the risk of myocarditis after infection, so how can you compare the risk after infection to the risk after vaccination?
Dr. TS cites a Harvard-CDC study (Picorna?) and risk was greater after disease–but now that most are immune the equation has changed.
Dr. Gans asks about lowering the dose for the second shot to reduce myocarditis. Dr. Das says we don’t have such data. Dr. Gans says what about moving forward? Dr. Das says our booster is a half dose (so we are kinda doing it, throw us a bone).
Dr. Gans says the 2nd dose is the problem–she missed the slide that showed the booster had an even higher rate of myocarditis. Dr. Offit says it is clear that a booster at 4-6 months improves efficacy, but we are being asked to approve 2 doses–will 3 dose data be ready in a few months?
Arnold says there is a misunderstanding about the 3d dose. Dr. Das says boosters are necessary for variants. She claims incidence rates were low for delta and breakthroughs were significant only for omicron. I don’t think all the data agree with that claim. Furthermore, I wrote an article 2 months ago showing how data were being spun incorrectly by CDC to make the omicron wave appear to be dangerous to kids, when it really wasn’t, as part of their messaging to get these vaccines authorized.
Peter Marks jumps in. He has the worst taste in art, btw. Says nothing. Dr. Fink rides in to save the day. He too says little, except to repeat that FDA will expediently approve a Moderna booster as soon as they get the data from Moderna.
I think the members are as bored as I am; they are not recalling earlier remarks and repeating things. Dr. Levy asks about abdominal pain: please tell us more and give us a theory for why it occurs. Is there a correlate of protection for omicron or not?
Dr. Das waffles on the abdominal pain. FDA has little to add. There is no correlate of protection work done with omicron. We haven’t identified a threshold… higher levels seem to correlate with protection. Dr. Levey says what about durability?
He says VRBPAC is asked to keep meeting with no resolution about the actual correlates of protection, can the feds do some work on this?
Moderna’s data, with no controls, shows vaccine efficacy lasted 5 months then suddenly waned.
Dr. Das is pretty good at handling the softballs and medium balls. Dr. Rubin pipes in, asking how this vaccine compares ot other childhood vaccines. He was the member who said we won’t know how safe the vaccine is until we give it to kids.
No one can really answer, so Doran comes back, saying “we expect a very favorable benefit to risk balance… and the covid vaccines do have a very favorable benefit to risk profile.”.
He acknowledges the risk of anaphylaxis and myocarditis–still ignoring the syndromes reported by so many people in the public comments from many of these meetings. “We consider the benefit-risk balance to be favorable.”
Dr. Nelson, one of the smartest people on the panel, asks about the effect of vaccines on current variants. And what about people who became immune from infection during the study? Dr. Das shows a slide showing that yes, those who were already seropositive have higher titers after vaccination. No surprise. But the question was whether prior infection might influence the assessment of efficacy, and I don’t think she answered it. Dr. Nelson also asked about myocarditis in the 18-25 age group, and she waffles (as this is the age group with the highest risk of myocarditis)
Dr. Less points out the dreadful efficacy data wth huge confidence intervals, and wonder if we will ever know true efficacy? Dr. Zhang admits that yes, we won’t have efficacy data if we authorize this. Dr. Das says that the MITT population had 25 cases … rah-rah. Dr. Das waffles about the fact Moderna will do “post-marketing efficacy work” with Kaiser in the future.
Dr. Hildreth forgets he has a meeting on June 28 to discuss the question he raised, which is how an omicron-based booster, a new molecular entity, will be authorized or approved by FDA. Peter Marks says studies have started…we will have data from different manufacturers so we hope that on the 28th we will be able to make some comments about how comfortable we are about changing a variant strain.
Dr. McInnes points out that an EUA does not mean a vaccine is safe and effective, but rather that the benefits outweigh the risks. If so, and the manufacturer does not have to demonstrate safety and effectiveness, why is there no table from the manufacturer? Dr. Das says we have the data and she shows an old slide that does not answer the question, but Dr. McInnes is not satisfied with the waffle.
Dr. McInnes is losing patience. When I tried to add up the numbers I found there were many dropouts, but they were not acknowledged by Moderna…so IMHO the numbers were contradictory. Moderna promises to compile them now during a ten-minute break.
The I in the last paragraph was Meryl Nass, not Dr. McInnes. I found trying to resolve these numbers incredibly frustrating, so I stopped.
Dr. McInnes repeats her question. Given that she needs to do a risk-benefit assessment, hasn’t the manufacturer already done a quantitative assessment, as required by the statute?
How many subjects were included in the safety and efficacy assessments? Moderna provides her the numbers.
Dr. Meissner asks Moderna how its vaccine will improve the 30% uptake in the 5-11 year age group currently seen. Dr. Das said we can’t speculate, but we are doing outreach. I don’t think he asked about marketing, but rather whether Moderna claimed to be superior to Pfizer.
Monto says Moderna does not claim that 2 doses are better than 3 doses. Amanda Cohn, who forgets she is allegedly a member of the committee and not a CDC nudger, tries to put lipstick on the vaccine pig. Don’t worry about the 100 mcg dose! Don’t worry about myocarditis! Not having boosters available now is not a problem! Just get the shots. Ignore the science!
Rubin and Monto say the vaccine passes.
Dr. Gans says we need another brand and we feel comfortable with the safety data.
And we hope the booster will be available soon. Dr. Sawyer hopes someone will gather data on myocarditis and a wider interval between doses. So he has decided to vote yes.
Of course, Melinda Wharton votes yes —she is a CDC staffer.
Let me briefly recap: The risk from COVID was exaggerated. The risk of myocarditis was grossly minimized. Other risks were never really described, apart from myocarditis.
Dr. Offit points out that the real issue is whether the vaccine will stop omicron now? It seems with a 3d dose only.
He does sometimes tell the truth.
Dr. Reingold votes yes, and is mad that as a Jew he was likened to Mengele. He brings up polio as another disease where most are asymptomatic. Just because we don’t know long-term effects on fertility etc., well it is an unanswerable question.
Dr. Marasco suggests someone should be collecting tissue to understand more about myocarditis and risk factors. He fails to understand that the feds don’t want to identify those at high risk of AEs–they have adamantly refused to fund such studies for any vaccine. Because the policy is to vax all no matter what. That is why CDC keeps eliminating more and more contraindications to vaccinations.
Dr. Chatterjee mentions encouraging boosters. Amanda drools at this. “If you haven’t gotten a dose in the last 5 months, you need a dose.” “The people we need to target are those who have not gotten the primary series yet.” Dr. Hildreth says these were the best briefing documents. But we need to make the public aware that the risk of covid is relatively small. For families that want to get vaccinated, good, but it should be optional…70% are already infected. Dr. Levy says we should consider the vulnerable population. He positions himself as an ethicist, but I am not sure what he is trying to say–oh, he is talking about messaging! Yay for diversity and inclusion.
Someone acknowledges that in 3-5 months your immunity is going to wane … but he is still in favor.
Peter Marks says he wants to reassure the members that “we had a diverse trial population.” Dr. Offit repeats that Omicron crossed a line and the vaccine didn’t work … but a 3d dose DID work — you need a 3 dose primary series.
Dr. Hawkins would have liked to see more black people in the trial. Dr. Kim says the data do meet the requirements established by FDA. Let’s reduce hesitancy.
Dr. McInnes asks how patients will have a choice when most clinics will only stock one vaccine? Good point. Most clinics offer the cheapest one. That was Pfizer at the onset.
now to the vote. I predict it will be unanimous in favor.
I guessed right. 22 members voted in favor: Unanimous. I know these people. They are bandwagon jumpers. And they fail to question the false assumptions in what they are being given.
I forgot –they need to vote for 2 age groups, so now we will see the vote for 6-11-year-olds. I predict a unanimous yes again.
I nailed it again. Not sure I can stand the last 30 minutes where they all say why they voted yes.
Signing off till tomorrow. Stay strong!
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