FDA VRBPAC Meeting, Day 2, June 15, 2022 — Meryl Nass, M.D.
It is Day 2 as the FDA has saved the worst for last: preschool and baby COVID vaccine authorizations. The stage was set. Moderna received a unanimous vote in favor of its older childhood vaccines, despite the very high amounts of mRNA in them, that went unmentioned.
The members are again presenting their credentials.
I note there are 4 Black members and several Asian members, and many Jewish members. There are 3 members from Harvard. Paula Annunziato and Eric Rubin are late, which is unusual.
Most are pediatricians or infectious diseases or allergy/immunology docs. Three work at NIH or are retired officials there. Two are officials at the CDC. While this may be a diverse group in terms of gender, race, religion probably everyone’s income relies on relies on grants from the federal government, probably mainly from NIH.
FDA has determined that all members are in compliance with federal ethics and COI law, but COI waivers may be granted as needed by FDA. As usual, there is only one waiver issued for Dr. Hildreth. One wonders what constitutes a conflict. Paula Annunziato is the industry rep and may not vote. She rarely speaks and rarely attends the meetings. Hayley Gans should be congratulated for calling in from California, where the meeting began at 5:30 am.
Peter Marks is here to give the committee its charge. The Moderna vaccine is for 6 mos through 5 years (25 mcg/dose) and the Pfizer vaccine is for 6 months through 4 years (3 mcg/dose). Marks brings up a scary chart. He also gets the total number of deaths in this age group wrong. He exaggerates the hospitalizations in kids based on the massive Omicron wave.
I dissected this information two months ago and I guess I will need to pull up my article so you can see how the FDA and CDC lie to exaggerate the risks to small children.
My deep dive into this disinformation is called “How CDC massages its data to terrify parents into vaccinations their preschoolers”.
The Moderna and Pfizer vaccines can be used interchangeably according to the FDA’s first briefer, Dr. A. Note that interchanging the vaccines was NOT discussed yesterday, although it introduces considerably more danger to children re myocarditis. Dr. Naik speaks next.
The proposed Pfizer vaccine includes 2 doses 3 weeks apart and a 3d dose at least 8 weeks after the second dose (when, according to the most powerful NY state data, efficacy has dropped to 12%).
The statutory requirements are read, a daily event, so FDA appears to be following them. Of course, the existence of effective licensed drugs that can be used for prophylaxis, as they are used for prophylaxis against malaria and river blindness, should have mooted all EUAs as well as this meeting. I was of course talking about the licensed, safe and effective hydroxychloroquine and ivermectin.
Now FDA wraps itself in the science flag — but it is the science charade because all contrary scientific evidence has to be ignored.
The statute also requires informed consent and the right to refuse — which FDA also ignores. Finally, unless a drug or vaccine is LICENSED it cannot be termed safe and effective.
Dr. Vinals from Murderna speaks first. They offer a 2 dose, 25 mcg series whose benefits are claimed to outweigh the known and potential risks. No NEW safety signals were identified. (They never are, as the protocol makes sure of that.]
They had a mean enrollment of over 2 months. The briefers are the same as yesterday.
Dr. Anderson squeezed out a pained smile. He consults for over 10 pharma companies. But don’t worry that he is rich as a result.
While he cites CDC data claiming that 63% of kids hospitalized with COVID have no comorbidities, this is BS because most of these numbers were derived from kids hospitalized for something else who tested negative on a swab at the hospital. Other authors note that serious illness is almost exclusively seen in children with comorbidities.
Suddenly the criminal doctors from CDC and Emory shed crocodile tears over the loss of daycare, the loss of education and all the social problems that kids now suffer as a result of lockdowns. What they fail to admit, ever, is that all these problems are the result of the guidances issues by these same criminals at CDC, whose data-free demands that schools, daycares and other institutions close…and they still fail to show these closures helped anyone.
Dr. Das is back. I have a great deal of trouble understanding how, on the one hand, she claims that enrollment in the trial extended over more than 8 months, while the trials were unblinded at about 2 months.
We are again subjected to the immunogenicity (immunobridging) titres as a surrogate for efficacy, even though it has been established by FDA that the surrogate is not reliable.
If dose 3 is given at 8 weeks after dose 2, when is dose 4 given? 8 weeks after dose 3? But efficacy in the NY state database for 5-11 year olds dropped to 50% by one month after vaccination. So should kids get monthly boosters?
We are being asked to believe that the placebo group has the same side effects are the vaccinated cohort. How plausible is that?
I have yet to see an animal study in which the animal was vaccinated with the real COVID vaccines, sacrificed, and their body examined afterward. Why were such studies never presented to any committee?
One child had a seizure after a vaccination. The child was revaccinated anyway. What doctor does that? One of the Moderna payroll.
No MIS-C, myocarditis or deaths. One SAE was considered related to the vaccine. I think it was the seizure —which did not stop the child being revaccinated. So why both identifying these serious adverse events?
bother identifying the SAEs if you do not act appropriately regarding them?
We see the same chart of the COVID waves over time for the 3d time. Now 36.8% efficacy by CDC case definition. 46.4% efficacy using a Moderna case definition. 50.6% using CDC definition for 6-23-month-olds. The lower bound confidence intervals do not meet the FDA requirement.
Now Moderna claims the vaccine efficacy was 44% wrt Omicron — this is doubtful unless it occurred soon after a booster. Data are from Kaiser, and I have not seen them before. Moderna thinks the kids’ efficacy could be extrapolated as being the same. After all, kids are just little adults, aren’t they? (Trick question–the answer is NO)
We can infer efficacy from immunogenicity–except we now know we cannot. Das is a champion actress, whose face reveals nothing of the truth.
Dr. Miller lays crepe regarding the dire risk of COVID to little kids–again, where did she get these numbers, which are way off the bulk of the literature. Now she admits “we did not see cases of severe disease in children prior to the data cutoff”.
Oover 5,000 vaccine recipients with more than 2 months of follow-up plus many placebo subjects, but no severe cases. Yet the benefit is “strongly favorable” because maybe the vaccine prevented some colds. Colds are what all other endemic coronaviruses cause in the US.
They will give some kids a booster, which will be remodeled to respond to Omicron.
It is vital to start protecting children this summer with our marvelous mockup vaccine, which has already minted at least one new billionaire, our CEO Monsieur Bancel.
Dr. Gans asks whether you are looking at how babies may be affected by the presence of maternal antibodies and how they may affect infections in babies? In other words, are you taking natural immunity into account? Dr. Miller says they did not collect that data. Clearly, that lack of collection was premeditated. Miller says they are going to start collecting that data in another study. Dr. Portnoy asks about naturally infected kids? Were they accounted for? She shows a slide that shows higher titers in those who were infected–but the real issue is how it affected efficacy and adverse reactions, which is not revealed.
Other vaccines were not given at the same time as the Moderna vaccines.
While blaming other infections on some of the fevers, Moderna did not test for other infections.
Dr. Miller said “All of us agree that these children will need a third dose at some time.” So parents, don’t think it will be two shots and you are done. She also says “It is critically important to start vaccinating babies”.
It is 1 hr 28 minutes into the meeting. FDA’s Robyn Wisch presents a briefing.
Somehow the study was open-label but later observer blind. Wondering how that works in practice.
The immunobridging study looked for antibodies directed at the ancestral Wuhan strain. Why are we still doing this when it does not exist in nature?
Back to the original prespecified success criteria for immunogenicity. And yes, the pediatric results matched the adult results, so we can call it good, right?
Because we can pretend that the titers mean something when we know they don’t, we can pretend that comparing with adults works, when we know it may not, and we can pretend that efficacy only needs to be provided in “descriptive” fashion.
slide 27 shows efficacy, which fails to reach the prespecified FDA requirements, which she does not mention as she breezes through the slide at 1 hr 41 minutes.
In terms of reactions, of course, the majority of the reactions were mild, which is why we need a discussion of the rare serious events.
But the focus is always on the mild reactions that resolve quickly. Fatigue and irritability/prolonged crying were common.
Fever was more common in vaccinated kids who had already had COVID. She admitted it.
They found no myocarditis in babies up to 24 months–well, how would you find it since they can’t report chest pain or shortness of breath?
There were a lot more respiratory infections in the vaccine recipients, probably due to immunosuppression for 2-3 weeks post-vaccination.
Vaccinees went to the doctor 3x as often as placebo subjects, but that could perhaps be due to a smaller placebo group. In the older kids, there were also more respiratory infections in the vaccinated. Abdominal pain and lymphadenopathy are greater in both age groups and yesterday were also present in vaccinees. These are clearly vaccine-induced side effects. There were no deaths myocarditis, or anaphylaxis in the younger group to age 2.
None of the SAEs were judged related to study vaccines by Moderna and FDA.
FDA plans to base its authorization on immunogenicity, not efficacy. Longer follow-up is needed to assess the rare adverse effects.
Dr. Marasco mentions immune imprinting or original antigenic sin–you are imprinted with the first virus you see — the titers are not good enough. Why are we not being serious about going after the later strains, essentially? Moderna says it is an excellent question that we will deal with over time. But what we are left with is what can be done. We were then shown a slide that claimed to show that after the Moderna vaccination, antibodies against all the variants rose, approximately at the same rate–but because a tiny log scale was used, it was impossible to compare the extent of the rise in antibodies. Plus, no one has presented any evidence for why we ought to accept these particular antibodies that are being measured as valid representations of efficacy.
Dr. Kim actually says the efficacy results out loud. Why so different in the different age groups?
Dr. Wisch admits the confidence interval crosses zero (which means the result may be worthless and it shows no real efficacy. But then she stops suddenly.
Dr. Hildreth shows the titers are the same but the efficacy varies greatly between these age groups–how do you explain this? She waffles regarding the variant, which is not an answer. He asks if an appropriate study was done to back up her claim? She doesn’t know.
Miller tries to save the day. The slide she shows is flashed too fast to understand her point, which she does not explain. Monto says one more question then we go to the break. He always stops the discussion when things start to get hairy.
There is a 13-minute break — longer than the usual 5-10 minutes, a clear clue that Monto knew he had to stop that line of questioning immediately, which could have undermined the entire rationale for the authorization: the reliance on a flawed methodology, immunogenicity by geometric mean titers, aka immunobridging. Lots of big words to obscure that we are looking at antibody levels that have never been validated as accurate surrogates for efficacy. And they were NOT established by FDA in its guidance to industry as sufficient for licensure–but now suddenly they are. WHY? Because this was never about science or public health. It was about giving classified vaccines to the entire population, imposing vaccine passports, and using them to gain broader control of the population.
Dr. Gruber from Pfizer is now speaking. Pfizer evaluated many dose levels in Phase 1, which is what is supposed to happen and is an area where Moderna is at risk — apparently it only tested 2 doses, then split the difference, according to rumor. His slides are hard to read, and too small, was this intended? Even in full screen, because of the manner in which FDA presents 5 boxes in the screen. Pfizer saw AEs that were GI or respiratory, like Moderna. Pfizer also had seizures and a rash occur.
Side effects are claimed similar in the placebo and vaccine groups. Gender, race and ethnicity were balanced between placebo and vaccine groups. Why is FDA showing the slides in this ridiculous manner?
There is always some audiovisual problem at every one of these meetings. Maybe FDA needs to borrow some of the audiovisual staff from CDC, which has spent a small fortune on them.
Blah blah blah, wasting time on minor side effects again. Almost none withdrew, but two did who had rashes. Adverse event rates are being minimized. AEs were reported at lower rates than in older people–duh, maybe that is because they cannot talk yet?
Dr. Gruber claims the vaccine is practically as safe as water, it seems.
He shows that the GMR/GMT titers meet the FDA criteria, in both age groups (under age 2 and over it).
Omicron-specific titers are high, predicting that similar efficacy as in adults could be achieved. Duh, didn’t the efficacy in adults take a major dive to almost zero, or negative?
Now he is back to the 3 dose, which boosts up those titers into a range that makes everyone smile, but tells us nothing about efficacy.
75-82% efficacy after the 3d dose. Wow! But for how many days, Dr. Gruber? The NY data show this only happened for about 2 weeks in the 5-11-year-olds.
Close your eyes to the fact that after dose 2, efficacy stank, ranging from 4 %to 33%.
Gruber’s confidence intervals stink, with lower bounds that are negative in 2 of 3 groups.
No myocarditis in children less than 5 years, but they will keep looking for cases as part of routine pharmacovigilance. He fails to mention that FDA required BioNTech to study myocarditis in children through 2027.
He claims there is a highly favorable benefit-risk profile.
Now I get it. FDA and the sponsors (Moderna and Pfizer) decided that the way they would push the vaccines through these meetings would be to ignore all the requirements FDA had previously established, and minimize the issue of whether the data provided show more benefit than risk.
The lower bound of confidence intervals, and the efficacy after 2 doses, fail to meet the established FDA criteria that was presented numerous times and are provided in the letter by RFK Jr. to FDA sent last week.
Gruber just admitted that the 80% efficacy “is early” — how early Dr. Gruber? 2 weeks? And didn’t FDA require a 2 month check on efficacy and safety? Why did you omit the time period at which you claimed to establish 80% efficacy, which we all know is ridiculous?
Dr. Gans asks about the dose (only 3 mcg)? Dr. Gruber says they would see more fevers with higher doses — Pfizer thinks this is the right dose. He fails to discuss the big question, which is why does Moderna use 25 mcg? Why do the side effects appear to be comparable? And efficacy? So why? Does the Moderna mRNA break down more?
Dr. Portnoy asks what is the difference between Pfizer and Moderna mRNA? Dr. Gruber says “obviously we don’t have a complete understanding of how the vaccine produces an immune response.” 3 hrs 10 mins into the meeting. Portnoy asks if you ever measured the protein that got made? Gruber says it is a broad question, “somewhat academic” and he is obviously nervous about this issue. Dr.Janssen pipes up: the 2 mRNAs are very different, have different formulations. She says they have optimized it and it produces lots of protein. She has already tendered her resignation to Pfizer, and she no longer cares about stroking the committee, it seems.
Amanda Cohn waded into a swamp asking about the efficacy after 8 weeks, and Gruber knows he can’t talk about this because the data are terrible. So he doesn’t. Amanda probably does not realize all the implications of her question. Gruber says they have a reasonable expectation of efficacy. He waffles around it making sure to cite no data.
Now FDA is back with Dr. Wollersheim to give us the FDA assessment.
I used a photo of a high-jumper to illustrate what FDA and these sponsors wanted to achieve: a brief moment in time during which they could generate data that would get them over an arbitrary FDA standard. They only needed to achieve the standard once — it might be two weeks or two months after a vaccination — while it did not matter how far below they were compared to the requirement before or after that moment in time.
4500 participants in the first study, 3,000 vaccinated. Children came from the US, Finland, Poland or Spain. A third dose was given 8 weeks after dose 2. Unblinding is occurring at 6 months, which is better than what was done earlier.
Immunogenicity was evaluated after ONE MONTH. i.e., 4 weeks — that brief moment in time when they may meet the requirement.
Immunobridign (comparing the numbers with adult numbers) is known to be useless at predicting efficacy, but that does not stop the charade for FDA.
81% of the subjects were Americans. 4-6% had comorbidities.
The immunobridging study easily met the FDA criteria for matching to adult titers, since all it takes is measuring the response at the right moment. I like to quote the Israeli study from Sheba hospital, where medical staff got a fourth dose, had very high titers (they rose by a factor of ten) but efficacy was about 30% for Pfizer and 12% for Moderna around 2 months after receiving the booster–proving that the 10x or 1000% antibody rise was of virtually no benefit at preventing infection.
Dr. Susan, did you ever hear about the Sheba hospital study?
Median follow-up for efficacy was 5 weeks for one group and 6 weeks for the other group. I missed the next bit of information. But efficacy in the 6-23 month group was derived from 1 case in the vaccine group and 2 cases in the placebo group — which is uninterpretable.
Her slide 32 seems to indicate there is no difference between the placebo and vaccine group wrt efficacy. And Susan makes clear that there is virtually no benefit from the first two shots.
One child was hospitalized at 99 days after dose 2 (in other words, the most serious case occurred in a doubly vaccinated child).
No new or unexpected adverse events were identified in both age groups. No anaphylaxis. The serious adverse events are not precisely described and the numbers of them in vaccine and placebo groups are different–but there were 3.1% SAEs in the vaccine group, which need to be looked at individually and compared with the 2.3% claimed to occur in the placebo group. This is a high SAE % in a pediatric trial. Reports of AEs are voluntary she says, except for a few. VOLUNTARY??? This is a clinical trial. All AEs are supposed to be reported.
Susan relates the surveillance studies in progress or to be conducted –what she fails to say is that they won’t be completed for up to 5 years, long after the current vaccines are no longer being used, allowing FDA and the sponsor to dodge the serious safety issues in the short term when the vaccines will be given to millions of the youngest Americans.
Amanda wants to know about reactions after the 3d dose? How are you relating the 3-dose immunogenicity study to adults in whom 2 doses were given?
She says there was no significant changes in antibody level based on when they were measured. We have not seen these data so we are supposed to take her word on this, and I am not sure she is correct nor what it means, when what we really care about is cases and hospitalizations prevents.
prevented. Doran Fink is asked to step in. He says we have “very preliminary” efficacy results after dose 3, limited by follow-up time. In other words, we cannot guarantee dose 3 shows efficacy. HMMM! It “needs further data to inform.” Then why is he having this meeting today?
“In terms of what the efficacy is after the third dose… is going to require some more digging.” Did Dr. Fink just say that they are not going to authorize this?
Susan says “We don’t have a correlate of protection” admitting (perhaps because Fink gave her the go-ahead) that the data are meaningless.
The titers are much lower for Omicron than for the earlier scariants.
Monto–will he put the kibosh on the discussion now? Paul Offit chimes in. Why does Moderna seem to protect after 2 doses but not Pfizer? Susan says she can’t make the comparison, thx for the question. What this really means is that the data do not make any sense when looked at together. And yes, Monto called a break till about 1 pm, then the public hearing.
The first person is vaccine injured and discussed her problems getting help.
Ashley Serrano is back, repeating what she said yesterday, in another commercial. Why was she given 2 spots but I was refused a spot? I have never been given a place in a public meeting, despite at least 4 separate requests. Ashly even shows the photo of her pregnant belly again. Why?
I don’t think I can bear to report on the many misinformed parents who are speaking today. I will say that I was gratified by one of the committee members who listened to the comments yesterday and was also upset by how poorly informed these parents are. We could blame the parents, but that would be wrong. They have been exposed to deliberate messaging misinformation for the past 2 years, and it is no wonder they think the vaccine will be a magic bullet. I apologize for any insensitive remarks I made yesterday. These parents are scared out of their minds. No wonder they cannot assess the data logically.
Congressman Louie Gohmert is a hero! He is hot! Why has FDA not answered the letter he and 18 members sent? What about ADE?
Can the FDA affirm there is no risk of ADE for vaccinated children? How many lives will be saved, and how are they being balanced against the deaths listed in VAERS? Will the vaccine cause increased risks? Why was the efficacy bar lowered for the youngest children? Especially since 70% of them are already seropositive…esp. in light of the liability shield. All the risks are to the children, and the benefits all go to Pharma. We have got to care more about the children!
Dr. Heshie Klein reads from the RFK letter to FDA. I wish everyone would read it–it shows why authorizing these vaccines is completely insane.
Here is the letter, which every politician and everyone interested in this subject should read
Kailey Soller spoke yesterday and she is back again today. How did this happen? Why are these people speaking twice on the side of authorization?
Tamara Thomson is back and reading her same spiel again: #3 at least of the pro-vaccine moms who want the “life-saving” vaccines.
Sam Dodson ripped the FDA and members a new …
Donna Truebig is #4 person to repeat their spiel from yesterday. Who at FDA made the decision to waste everyone’s time with these repeaters, all of whom demand that babies be immediately vaccinated. None have suggested that the same tests that Pfizer and Moderna used to identify prior infection be made available to the public, so they can see if little Johnny is already immune. That is what is really needed–prior immunity is stronger and much more long-lasting (against Omicron anyway) than vaccine-induced benefits, and there is no risk to getting a titer test, unlike the risk from vaccination.
At least 75% of little Johnny will be immune, and then these crazed parents and grandparents who desperately want these shots injected into their precious offspring might be able to finally relax.
Has no one ever told them that efficacy is not 100%?
I think I will have to go get an ice cream sundae when this is over. The current mom is crazed over the lack of the mask mandate. Hasn’t she seen how they use the masks? She thinks the protection from the shots for hospitalization, serious illness and death is excellent. I guess she didn’t hear that there were no deaths and almost no hospitalizations in the trial — so there is no evidence the vaccines help with any of these. In fact, the only hospitalized child in a Pfizer trial presented today was vaccinated, and hospitalized 3 months later. Maybe a booster would have helped. Maybe. None of the placebo kids were hospitalized. Why are these moms deaf to the information presented?
Asked about efficacy in the high-risk, obese kids Moderna cannot respond, but they will have data in the future from SoCal — presumably, they made a deal with Kaiser that includes 100s of thousands of subjects.
The response is titers, not efficacy. And the sample size is small.
Dr. Gans says the titers are not immune correlates of protection for viruses. So she put it out in the open that the standard FDA is using is known to be fatally flawed.
Dr. Reingold asks about safety in those already infected. Moderna shows a slide indicating only slight increase in AEs, especially systemic reactions after the second dose.
Dr. Nelson points out that the titers are 2x higher in black babies, is this real and what does it mean?
She says that this was a function of the tiny cohort for immunogenicity: 20 kids per cohort.
Dr. Portnoy demands vaccine for the desperate, while Dr. Meissner tries to put the quantitative risks/benefits into perspective–the chance of dying is about the same as the chance of being hit by lightning.
It is starting to sound like another unanimous vote in favor. The members are salving their consciences by asking for future studies and better messaging to parents. Why aren’t they asking why the parents have the totally wrong idea about the risks of the disease and the benefits of the shots.
Dr. Sawyer notes that some parents are going way beyond the recommendations in terms of isolating their kids, and vaccination is important to alleviate their anxiety.
Hmm. Wouldn’t telling them the truth help rather than giving them a vaccine for which they have no clear understanding of the risks and benefits?
They lost a temp member since yesterday. Wonder why? Now they vote. I go for unanimous positive for each manufacturer.
So what happened is that without admitting it, FDA jettisoned its standards for issuing an EUA. Those standards were published at the end of the letter RFK Jr. Sent to FDA last week. Neither vaccine meets those standards. So the standards were silently changed, and none of the members ever mentioned it either.
Yes, unanimous for Moderna vaccine in babies 6 months to 6 years old.
Dr. Hildreth says “we gotta be honest about the real risk of COVID.” That is at least something, an acknowledgment that none of the parents begging for the vaccines have a clue what the information presented was.
It is risky to listen to all the members explaining their vote: it leads to suicidal feelings. Can they really be that ignorant? Have they sold their souls to the devil? Are they unaware of all the deaths in young people that have skyrocketed? Maybe the censorship has been so good that they are truly ignorant.
Charles Piller at SCIENCE magazine (the AAAS) revealed that FDA advisory committee members are likely to get “after-the-fact” compensation from pHarmacidal companies after they leave their posts as advisors. Here is the important article from 2018.
I hate to say it, but the amount of double talk and saying things between the lines by these advisors suggests to me that the prospect of such compensation probably helps them to tone down the level of discussion.
I don’t think there is any reason to keep blogging. We know that FDA broke all its own rules that it established for COVID vaccine EUAs. We know they were not called out on this by anyone. We know the supine advisors challenged none of the pap they were fed today and yesterday.
We know that everyone is doing this “for the children.” Now there is a break and then they discuss the Pfizer vaccine for the youngest kids.
Is there any debate that all the presenters, staffers and members are committed to seeing, hearing and speaking no evil of these products? I am going to end this.
Everyone involved colluded in suppressing the relevant information, which is laid out in the CHD letter and in many other studies. The criminals who just invoked Science as their God are knaves and fools. But we didn’t expect much else.
What I will say, is that it took FDA from Feb. 10 until the end of May to figure out how it would hide the evidence and pull this off. It is up to us now to turn this around. Signing off.
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