FDA VRBPAC Meeting, October 26, 2021 — Meryl Nass, M.D.

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Dr. Jessica Rose reports over 19 times the rate of baseline myocarditis after vaccination – 80% of cases are in males and 80% after dose 2. Deaths in 23 children under 2 years old were reported to VAERS. How were they vaccinated? Were they in trials?

Dr. Guetzkow is next. He points out that protocol violations resulting in dropping subjects from the trial occurred many more times in those who got vaccine, rather than placebo, and the chance this happened by chance is 1 in 10,000. How can we expect children to shoulder the risk to reproductive organs? Where are the data from Pfizer’s study of troponin elevation? Your approval today means mandates tomorrow. I implore you hold the line. You won’t be able to say you didn’t know.

Shoshana Fishbein is from an organization called Families Fighting Flu, who is speaking to make sure all children have access to safe and effective vaccines.

Tinnitus was reported in many thousands of Covid vaccine recipients, including one former member of VRBPAC

The next person is making the same point I did – that the study showing the vaccine works against Delta was only done in 34 kids using a nonvalidated assay. The survival rate in children is 99.98. Bell’s Palsy was added to the AEs in Canada. What fertility risks are there? She found a study FDA requested of Pfizer that will not be reported on until 2027!
Please do not assume that this vaccine is safe in our children until all data have been evaluated.

Amy Alvo is a mom who vaccinated her teenaged daughter on March 31. The next day she fainted and had a seizure. No one could answer any questions. The hospital sent back their copay. Abbie’s right arm shakes, and a medical exemption was requested twice and denied twice. The family was told she could try a different brand of covid vaccine for her next shot!

Ms. Macauley, an attorney and parent, who supports authorization. It is so interesting how people who desire the vaccine do not understand either its limitations or risks. They miss the issue of not preventing cases and transmission

Those in favor present no data. Those opposed have charts, tables and look like extras from Alice’s Restaurany. Kim Witczak, a former consumer rep. begs that the members read all the comments (there were over 90,000 yesterday am). “Let’s be honest, an authorization will almost certainly result in mandates*. Expanded access would allow every parent to make the best decision for their children. She says it could be used off label in kids–but I doubt any doctors would do that because of the potential liability of using these vaccines, which they know can cause harm, in children, without a specific indication for that age group.

Luke Yamagushi points out that some of the most vaccinated nations are seeing the highest number of
new cases.

He notes, as CHD did, that Covid hospitalization rates include many who were hospitalized for something else. He also notes that there is more risk from vaccination to the recovered than to the covid-naive. If around half of our kids are already recovered, we don’t know what their risks will be, and FDA’s analysis omitted this risk.

Dr. Dressen repeats that there is insufficient data from inadequate trials. He invited Pfizer to carry out an adequate trial.

Most importantly, his wife was in a covid trial last November who had a severe reaction after dose 1-this led to her being dropped from the trial. So were hundreds of others-so their injuries would not have to be reported.

Until the full scope of injuries that are happening to adults are addressed, the VRBPAC has no business approving this vaccine for innocent children.

Linda Medonca, president of the national association of school nurses is next. She wants to urge everyone to be vaccinated. She, like several others, have been led to believe that vaccinating everyone will put an end to the pandemic. They missed the fact that this infection will become endemic, that herd immunity cannot be achieved. that a leaky vaccine can’t achieve what she expects. It is strange that so many people think vaccines work perfectly. when they know that all drugs don’t.

Kermit Kubitz, a polio survivor, repeats the “146 deaths” that some have stated. Yet the CDC data show the number of deaths in the 5-11 group CDC claims is 94.

He thinks vaccination will prevent mutations. while in fact it may encourage mutations that break through vaccine protection.

Kristi Dobbs speaks next. She received one dose of Pfizer in January, anaphylaxis and high BP, followed by fatigue, lymphadenopathy. Then sharp pains, tremors and paresthesias, tinnitus, brain fog, sleep disorder, autonomic neuropathies. She has seen over 20 doctors including at NIH Her injury was reported to top public health officials, and have others’ injuries. But the information has been suppressed. There is no recovery plan or financial support. She met Maddie deGaray who has gotten no help. “We were wrongly coerced into taking these vaccines by politicians.”

Dorit Reiss has popped up. She wants us to continue risks and benefits in context. Some states do not allow masks in school, despite high community transmission rates. The parents need choice. She warns the VRBPAC to ignore disinformation and misinformation.

She seems to be telling the VRBPAC to ignore the 90,000 plus comments to the FDA on this subject. How undemocratic!

Brooklyn Aaron is an ethics student. She is at high risk. She says we have to reduce risks for immune compromised

Paul Offic points out that many kids have recovered immunity-was that included in your models, Dr. Hong Yang? We considered everyone susceptible, she said. She notes that if 45% have immunity, her models change. She then assumes recovered immunity is equal to vaccine induced immunity, which we know is incorrect. She then says we don’t have the data. Monto looks unhappy at this line of questioning

Dr. Sawyer also challenges the model, pointing out the hospitalizations were 80% not actually for Cavid. How was this considered in your mode?

Dr. Forshee jumps in and says we don’t have the details, we relied an CDC data, what does CDC have to say about whether it considered this?

I am starting to think the committee will vote against the authorization

Paul Offit is a bellwether.

Dr. Fiona Havers says CDC does review the hospitalizations-but it seems this is an ad hoc procedure, not a formal procedure as was performed in the published papers from pediatric hospitals. And her procedure only excluded 19-20% instead of 45-84% when separating the with covid from the due to covid hospitalizations.

Dr. Meissner notes that the assumptions that are made determine the reliability of the model. You said you took data from the week ending Sept. 11, which was the peak of the 4th wave, with 1/100,000 hospitalizations, which is now 0.4/100,000. You have taken the worst case scenario, which is not reflective of what we are seeing at the present time.

Dr. Hong Yang says she does have a more representative scenario, scenario 3. AS they continue to debate this, Monto cuts them off.

Dr. Fuller asks if these scenarios have been used before? How long has the BEST system been used?

Dr. Yang says no, we don’t do the scenario modelling for each vaccine, only for difficult decisions.

Dr. Lee notes that the pandemic goes in waves. which is missed by the scenarios.

I cannot understand Dr. Yang’s answer, she has a thick Chinese accent. Amanda Cohn asks about myocarditis rates in her scenario, noting that the kids are getting a lower dose, so should have less myocarditis

Bottom line, Hong Yang’s scenarios are all based on modelling, using numbers that are guesses, and have not been verified. Amanda tried to encourage Yang by suggesting other countries’ data-but Yang says we don’t know how to evaluate the other countries’ data. FDA’s Forshee says yes, we are likely to be using overestimates but there is little population data for this age group.

Which is simply further evidence that guesses upon guesses need to be perceived as guesses. Models can show anything you want, as those from Gates’ ICME and Neil Ferguson have shown.

Dr. Portnoy asks if we know how good the recovered immunity is? Does it change the response to the vaccine? Affect adverse effects?

Dr. Forshee says CDC showed blah blah blah – he does not answer the question.

Dr. Kurilla asks for the timeframe for the scenarios? Six months. Did FDA include waning of immunity over six months? Nope, the model assumed the efficacy was high throughout the six months.

I think that comment just did in the authorization.

Horg says in most scenarios they assumed 70% immunity against cases and 80% protection against hospitalizations constant over six months.

Dr. Hildreth says it seems the model may not be representative. Dr. Forshee jumps in and tries to salvage the sinking ship. We tried to make conservative assumptions, he said. (Not really, it seems.)

His comments fall to resurrect his models. They are dead in the water.

Let’s see what Dr. Perlaman has to say. Lost audio. Dr. Rubin? His audio cut off too.

He comes back. Can we identify a high risk child population for which it would be important to make vaccine available, disregarding the population data? He too is baling water furiously. Of course, at a recent meeting, this NEM editor in chief said we didn’t even know if the vaccine caused myocarditis! He is a pharma shill without question. His journal gets most of its revenue from pharma ads and reporting sales.

Fiona says about 30% of hospitalized kids had no underlying medical conditions.

Perman asks about the kinetics of degradation of the mANA in children. And T cells and antibodies. Or. Gruber says there is no antibody data yet, it is too soon.

Gruber cannot tell us about the mRNA in humans. He can tell about the animal studies-then goes silent. Duh?

Dr. Nelson asks the smart questions about how the immunocompromised kids respond to the vaccine in terms of antibody duration…Bill Gruber says Pfizer has started a study in aged 2-18 years, no data yet.

CDC gave FDA numbers of many thousands of teens who were vaccinated-Dr. Gans asks what about safety and efficacy data from them?

Doran Fink says it is FDA data -not ours–ask them. Amanda Cohn tries to answer but is disconnected.

Excuse me, he said it was CDC data. Dr. Cohn comes back. Yes we have data on those under 12 year olds, but it may be misclassified.we don’t seem to know much about these data but we will look into it this week.

Dr. Sawyer says the immunobridging was whittled down to 264- presumably whittled as a result of finding preexisting antibodies. You could then study this group to learn about vaccinating, the already immune. Gruber answers about antibody levels, but not about safety and efficacy in this group.

Dr. Meissner asks about troponin and BNP levels?
Dr. Gruber says we did not obtain blood in the first few days after vaccination when myocarditis occurs. But once we determine the specificity of troponin, we will then do a study.

It seems like there is a lot of wiggling going on.

Dr. Gans asks about escape by variants, but Gruber says they have not tested for that in children. She asks about the persistence of immunity to Delta. No good answer.

Dr. Nelson asks more about whether lower doses were tested? Gruber repeats what was shown earlier, which shows 10 mcg, was the lowest dose tested.

He claims they optimized the immune response and minimized adverse reactions. Elsewhere Gruber claimed they had reached the “sweet spot” in dosing. Basically this is just an excuse for sloppiness. Dr. Kurilla points out that a 3 week period between doses is not ideal, since the durability of immunity is brief, didn’t you test other intervals, a single dose, etc.?

Gruber says they will definitely do that in babies under one year of life. I doubt he will make many friends with that remark-waiting to do logical tests until you reach babies?

Monto shuts off questions and turns to the committee discussion before they vote. The question asks whether the benefits exceed the risks. I think this presentation has not shown it does. I think this vote can go either way, but I think the majority will vote no. Let’s see if I’m an incorrigible optimist.

I am finding it hard to grasp the meaning behind every comment now. Dr. Rubin and Dr. Hildrech both think some children do need the vaccine but it is not for everyone.

Dr. Sawyer suggests the models are not worth much. High risk children need the vaccine. Sounds like he will vote yes.

Dr. Portnoy says he has received 4,000 emails asking him to vote no, but also parents want the vaccines. He is voting YES. I guess I am an incorrigible optimist after all.

Dr. Less seems to think the vaccines will help avoid school closures even though the virus isn’t going away.

Dr. Gans also thinks vaccinating little kids will help “open things up.”

Dr. Pergam thinks the immunocompromised parents need the vaccine. Dr. Kurilla (he is so sensible) resents the fact the decision has to be all yes or all no. Why not allow it for the high risk but not the healthy kid?

He points out that the virus isn’t going away. transmission isn’t prevented, there are so many kids already immune-2 doses for everyone under EUA is not giving parents and providers the options to choose what is best for their children.

Dr. Kurilla points out that new variants are coming, and it will be harder and harder to get effective boosting

Dr. Marks told the committee not to talk about mandates and not to consider different groups-but of course these are important issues. Why not consider rephrasing the question?

Arnold Monto wants to put the kibosh on that and asks Peter Marks to come in to squash it. Marks said vote on the question as it stands, then potentially we might do another vote. Monto wants something stronger and says, “it was my impression THOS WAS THE QUESTION FOR TODAY. AM I WRONG?”

Dr. Meissner says the vaccine is likely effective. The parents are eager to get it because they are so scared. But we saw that most kids hospitalized (68% have comorbidities) and then if you take 45% of the 32% who have immunity you are getting to a very small number of kids who will benefit. This vaccine is probably not going to prevent infection. It is going to prevent severe disease. To mandate this vaccine for children in order to go to school would be an error. We are in a very difficult decision making process.

Amanda Cohn is certain the benefits outweigh the risks. Children are dying. She claims “far fewer hospitalizations and ICU admission occur from flu but we vaccinate for flu. Flu shots are not as dangerous, though.

Dr. Fuller asks how we will know if the vaccine turns out to be more dangerous than we now know? Dr. Marks did handwaving about the wonderful safety systems that FDA and CDC have. Of course, we know these systems have missed almost every adverse events reported in huge numbers to VAERS, and no attempt has been made to explain why.

Dr. Fuller, surprisingly, recognized his non-answer for what it was, and repeated her question. Dr. Marks repeats himself claiming his safety systems are really good.
Dr. Forshee then tries to give some details about VAERS, VSD but these are rudimentary explanations. Dr. Fuller does not look convinced…

Amanda (who is the executive secretary of ACIP, which ought to have disqualified her from being on the committee) tries to look really understanding as she accused parents of blaming vaccines for adverse consequences because they desperately need to blame something

She keeps talking, in an attempt to tell the VRBPAC that they don’t have to worry about who gets the vaccines: ACIP will do that

Dr. Periman says he is voting Yes.

He does not seem to have understand the presentations today.

Dr, Moore says the myocarditis risk is theoretical and no one has died from it. WRONG. CHD sent one VAERS report of a 15 year old who was vaccinated and died from myocarditis. Myocarditis is not a theoretical risk. It is a well-established risk. The only question is how often it occurs. It probably occurs somewhere between 1 in 30 vaccinees to 1 in 3,000 vaccinees (including subclinical cases).

Dr. Kurilla tries to explain to the other members that all the recovered kids have no benefit at all from the vaccine. Why is vaccinating kids with a vaccine calibrated to a strain 2 years old and no longer around is not ideal. There is no reason to expect the antibody decay fate will be different than in adults. We should expect breakthrough cases, need for boosters, etc.

Dr. Neison does not like the question either. There shouldn’t be a mandate for all in this age group. We shouldn’t underestimate the intelligence of the public. Providing choice to a fully riski-informed public is the way ahead. Depriving access to the high risk is a problem.

And now THE VOTE. Do the benefits of the Pfizer vaccine outweigh its risks for use in children 5-11 years of age? There are 18 voting members.

Everyone voted YES except Dr. Kurilla who abstained. Meissner now provides a mea culpa. He says we do not know a lot about the vaccine. Some kids may well gain benefit but some kids will develop myocarditis. We have to very carefully monitor the safety profile of this vaccine going forward. He would like the ACIP to recommend it for the high risk groups.

Drug treatment of Covid was never once mentioned during this meeting.

Amanda claims no deaths from myocarditis and complete recoveries-most recover. Some do not not. Most live. Some do not. If you have a sudden death you won’t know what caused it without an autopsy.

Dr. Rubin says ACIP should ask for discretion in how the vaccine is used.