Here is the live blog of FDA'a VRBPAC meeting regarding authorizing Pfizer COVID vaccine for 5 through 11 year olds

Thanks to another savvy reader who helped me out with successful formating, here is my live blog from October 16, 2021:

 Meryl Nass

Here we are at another FDA Advisory meeting on October 26, designed to see whether, with a minimal amount of information, FDA’s advisers will agree to authorize use of the vaccine, at a 10 mg dose, in children aged 5 through 12

 Meryl Nass

Here is the roster of members, most of whom are temporary members, specially selected for the COVID vaccines. Dr. Monto, in his 80s, has consulted for many pharma companies and is expert at controlling committee deliberations. Drs. Kurilla and Gans often ask good questions. Dr. Meissner also asks good questions, and on more than one occasion Dr. Monto has cut him off. Dr. Offit is a major vaccine promoter. Dr. Pergam works at the U Washington, Bill’s Gates’ subsidiary. So far the roster has not changed from recent prior meetings. Dr. Patrick Moore, U Pittsburgh. Michael Nelson is very bright, used to care for people injured by anthrax and smallpox vaccines. Stan Perlman does not really belong here–he is implicated in the Lancet correspondence that attempted to cover up a lab origin. Amanda Cohn and Melinda Wharton both are medical officers at CDC who work to push vaccines. Both imho have tried to cover up vaccine adverse reactions in the past. They must go along with whatever narrative CDC is pushing at the moment, and I am shocked that they are claimed to have no conflicts of interest.

 Meryl Nass

It is amusing to hear the conflict of interest statement, in which Prabhakara says these special employees of the USG can be given waivers of their COIs. It is difficult for me to understand what she says about the COIs, as she speaks quickly as she goes through it. How many received waivers?

 Meryl Nass

Was she chosen for this role because her accent is difficult to understand?

 Meryl Nass

Dr. Marks, the head of FDA’s Center for Biologics, makes his obligatory presentation. He always tries to make COVID look like a dread disease for kids. He says this is not about mandates, yet he knows that is exactly what is coming if his committee votes yes.

 Meryl Nass

Marks says there have been 8300 pedi covid hospitalizations. He fails to say those have been “with” COVID not “due to” COVID–in 2 hospital studies less than 20% of hospitalized kids had severe COVID–most were hospitalized for other causes.

 Meryl Nass

Doran Fink, MD, PhD tells us we are here to assess the risk vs benefit of the vaccine for the 5-11 age group.

 Meryl Nass

Doran does the “Delta dance” claiming that not only is it more transmissible but it is also more severe. He implies things will get worse this winter. Fink claims this age group has more COVID than other age groups–but the Childrens Health Defense letter to these advisors showed FDA that this group has the lowest death rate of any age cohort, older or younger, according to the CDC. So if they have mre COVID then have more immunity than any other age group, already.

 Meryl Nass

An EUA can only be approved if there is no available, adequate, approved alternative and the risk benefit equation is favorable. He omitted the need to offer informed consent–and the right to refuse, which is also part of the statute.

 Meryl Nass

He admits that the Pfizer trial was unable to show benefit in terms of preventing cases, and there were no severe COVID cases in the approximately 4-5,000 subjects. Does this mean we are debating using a life-threatening vaccine to prevent colds?

 Meryl Nass

The legal answer to the lack of data–FDA’s fallback position–is to get “postmarketing data” i.e., authorize first, collect data later.  

 Meryl Nass

That may sound good, especially for a normal drug that is only sold to small numbers of patients as doctors get familiar with it.

 Meryl Nass

But this “punt” is less than worthless–downright reckless–when you are planning a mass vaccination program in which many millions of people will be receiving the vaccine in just a few weeks or months.

 Meryl Nass

When that happens, collecting postmarketing data simply means that years after nearly everyone has been vaccinated you might find out what the adverse reactions were.

 Meryl Nass

The data obtained will not inform the actual use of the product. So asking for postmarketing studies in this situation is basically a charade of pharmacovigilance. Furthermore, children are supposed to be protected even more than adults because they are unable to provide an informed consent. So, basically FDA is trying to fool us into thinking it is doing its job by requiring postmarketing studies that won’t be reported to FDA until 2024, 2025 and 2027.

 Meryl Nass

I would want to know the adverse reactions and their frequency before vaccinating my children, not several years after.

 Meryl Nass

Pfizer finally reduced the dose for 5-11 year old children to 10 mcg/dose. Other children and adults receive 30 mcg doses. So far I have seen no dose-ranging studies in children that should have been undertaken to determine the optimal dose. They just tried 10, 20 and 30 mcg doses in a 2- dose schedule.

 Meryl Nass

The buffer and electrolytes in the vaccine have changed. They do not explain why. This should have required animal studies.

 Meryl Nass

Oh, this is the excuse for why suddenly vaccine can be given using normal fridges and freezers–some health officer probably decided that parents would not take their kids to big stadiums and if the government wanted maximum numbers vaccinated it would need to be done in their own pediatricians’ offices. So suddenly they knew how to get vaccine to doctors’ offices.

 Meryl Nass

Dr. Naik tells us that FDA is asking the committee one question only: Do the benefits outweigh the risks for this vaccine in 5-11 year olds?

 Meryl Nass

Dr. Meissner is perky–he asks why the change in buffer added so much stability? Everyone looks shocked–Peter Marks says he will use his knowledge of chemistry to try and answer–but no one wants his guess–so it seems this will be postponed until Pfizer can create an answer.

 Meryl Nass

First CDC briefer is here to tell about the severity of the disease. Fiona. Kids are making up a higher % of total cases. This is a good thing! It means they are getting immune, now that they are in school and playing with each other.

 Meryl Nass

The briefer is correct that children have higher seroprevalence that adults. They had 42% seroprevalence in May-June, so by now more than half of 5-11 year olds must be immune–and for them there is zero benefit from vaccination, and heightened risk of vaccination compared to those who never had COVID.

 Meryl Nass

30/100,000 kids is the amount of cumulative hospitalizations that have occurred in this age group–the lowest of all age groups.

 Meryl Nass

Remember most were not actually due to COVID, and only 94 children in this age group have died “with COVID” since onset of the pandemic.

 Meryl Nass

CDC shows a graph that cuts off at week 38 (we are at week 43) to show a recent increase in hospitalizations, which has already dropped significantly–as I showed in the letter to FDA using an updated graph. They caught the wave at its peak, a CDC SOP.

 Meryl Nass

It is pathetic to see how CDC (her name is Fiona) cherrypicks the data so predictably to try and support CDC's narrative. It looks as if COVID in hospitalized children is less severe than flu. I feel sorry for these young doctors who go work at CDC and get trained to do fake science and "public health in reverse." Then again, they could leave and become real doctors.

 Meryl Nass

Yes, children with comorbidities are at much higher risk–this has been well established. No surprise here.

 Meryl Nass

While pedi hospitalizations are being used to emphasize COVID severity in kids, the average length of stay is 2 to 3 days, which does not sound very serious.

 Meryl Nass

Re mortality, her graph correctly shows that 5-11 year olds have the lowest COVID mortality of any age group. 66 deaths in the past year, 94 deaths since pandemic onset–and most were “with” not “from” COVID.

 Meryl Nass

MIS-C is a problem associated with SARS-CoV in kids. There is no evidence that vaccination reduces MIS-C at this time. If CDC wants to claim MIS-C is a reason to vaccinate kids, why didn't it produce the data to show the vaccine protects older kids from MIS-C? 

 Meryl Nass

Fiona cites a national UK survey that says 7-8% of kids had chronic issues 12 weeks after COVID. While this is probably true for this study, the UK’s JCVI vaccine experts reviewed the data from US, UK and Canada and found chronic issues were found in closer to 1% of cases.

 Meryl Nass

The MMWR has devolved into CDC’s in-house propaganda rag. It supports whatever narrative CDC needs to support. Fiona shows us an MMWR paper that said transmission in schools is high. Other studies show the opposite.

 Meryl Nass

But even if transmission is high, if kids only get a cold, and rarely transmit to parents, which has been shown by experts outside CDC,so what? Now they are immune. I have seen research suggesting that teachers pass it to teachers more than students pass it to teachers.

 Meryl Nass

I criticize the MMWR CDC studies because I have personal experience of CDC refusing to share its data source and its algorithm with independent scientists so its findings could be verified–yet this is standard procedure for journal articles.

 Meryl Nass

Question time: Dr. Kurilla asks about MIS-C. Has vaccination prevented it in the 12 and older age groups?

 Meryl Nass

And what about the issue of with vs. from? How are you defining Covid hospitalizations? Fiona has not seen an impact on MISC from older vaccinations.

 Meryl Nass

She thinks the older kids are being hospitalized less.

 Meryl Nass

Fiona says the hospitalization numbers are based on SARS-CoV-2 tests. She claims 18-19% of hospitalized kids were admitted for other reasons–but in the papers published from 2 pedi hospitals, it is between 50-80 plus%

 Meryl Nass

Dr. Hildreth asks about the proportion of immune children and whether it varies by race? She doesn’t know.

 Meryl Nass

Holly Gans asked about longterm outcomes of MISC and other complications–after 12 weeks, I think. Fiona says we do not have a lot of good data on that now. 

 Meryl Nass

Dr. Perlman repeats Gans’ question: how long do the chronic symptoms last in children? Fiona blathers: some kids have long lasting disease. She prefers to let the cardiologist tell you about the heart issues.

 Meryl Nass

Melinda Wharton, another CDCer, asks about reinfection after an earlier infection. Fiona again says we are seeing more and more, but I don’t have any data on that. Duh.

 Meryl Nass

Dr. Portnoy points out that the rate of hospitalization per case is going to be an overestimate, since most kids are asymptomatic. Fiona blathers without answering. Monto shuts off Dr. Portnoy.

 Meryl Nass

Dr. Moore asks if there are data to suggest the vaccine inhibits transmission? Fiona does not know but will ask her colleagues.

 Meryl Nass

Dr. Sawyer asks about older kids who received vaccine but were already immune–what is their safety profile? Fiona doesn’t know so she defers to Dr. Oster the cardiologist.  I love how CDC never admits to data that don't support their narrative. Or perhaps they make sure not to collect it.

 Meryl Nass

Matthew Oster, a CDC employee and pedi cardiologist is up next. He will speak on myocarditis. He shows a chart of Pfizer and Moderna shots and rates of myocarditis reported to VAERS. The rates are practically the same for the two vaccines–yet 4 Nordic countries stopped the Moderna vaccine in young people or young men because they found more cases in Moderna recipients.

 Meryl Nass

CDC is aware of 877 myocarditis reports, confirmed, under age 30. 95% hospitalized. That tells you these were symptomatic cases that had their doctors concerned.

 Meryl Nass

VSD data for 12-17 year olds of “excess” myocarditis cases per million doses at 54-57. By mixing the genders (males have 4-5x the rate of cases as females) you lower the rate.

 Meryl Nass

One wonders about the reliability of the Vaccine Safety Datalink (VSD) data, since when it was presented in June there was NO SIGNAL for myocarditis–why? Furthermore, this rate is about the VAERS rate, and we know VAERS is highly underreported, so these VSD numbers are very suspicious in terms of catching a high percentage of cases. While it has been previously accepted that the VSD represented active surveillance, it clearly does not, if it equals the passive surveillance VAERS.  Why?  Are there reliable active surveillance data being collected?

 Meryl Nass

Oster’s graph is the same as CHD’s graph that shows an exponential increase in myocarditis in males as they get younger

 Meryl Nass

Oster admits that mortality from viral myocarditis is 4-9% for acute cases in the pre heart transplant era over ? time period.  [A 19 year old female college student did get a heart transplant after vaccination but died a month later anyway. She was not mentioned.]

 Meryl Nass

In MIS-C hospitalizations, 8-9% have myocarditis associated. But this is based on under 400 MIS-C cases

 Meryl Nass

Oster sees almost no myocarditis associated with acute Covid in kids.

 Meryl Nass

It appears that the myocarditis-MIS-C patients improved cardiac function back nearly to baseline in 10 days.  Which is better than the vaccine-induced myocarditis cases.

 Meryl Nass

On autopsy of sudden death in kids, 5-10% are attributed to myocarditis. The AHA and ACA (American Heart and Cardiology Associations) in 2015 recommended that a full cardiac evaluation should precede any return to sports after myocarditis.

 Meryl Nass

Oster shows some features that help predict a good vs poor prognosis

 Meryl Nass

For MIS-C, by 6 months all kids had normal ejection fractions. Usually cardiac MRI findings become normal too after some time. BUT 20-30% of kids or parents reported some quality of life issues afterwards–which were often reported as psychological. But were they purely psychological?

 Meryl Nass

In vax-associated myocarditis, in male teens, 13% had continuing symptoms at one month.

 Meryl Nass

VSD data are shown with very few kids and not extensive workups, so not useful. I find this interesting.  It would seem the HMOs are not doing extensive workups, because they lose money on them, rather than making money from an extensive workup if the patient has fee for service insurance.

 Meryl Nass

CDC is investigating the longterm effects of myocarditis. It is surveying VAERS reporters and healthcare providers. A total of 26 cardiologists have responded from over 100 surveyed. Maybe CDC needs to work harder at collecting these data?  It started late and is going slowly.

 Meryl Nass

So far, the longterm data are sparse but collecting it is ongoing.

 Meryl Nass

Dr. Pergam asks how pericarditis comes into this. In my read of the literature, pericarditis occurs later and may not be part of the myocarditis syndrome, which usually shows up within 4 days of a shot.

 Meryl Nass

Dr. Oster included myo plus peri together, but his data omitted pericarditis cases that occur without myocarditis.

 Meryl Nass

Dr. Meissner asks about late MRI-gadolinium scan data. Late phase uptake in adults suggests ongoing cardiac problems. What does it show in children?

 Meryl Nass

Dr. Oster says this is controversial among cardiologists. When all you have is a little signal on MRI with everything else appearing normal–we don’t know what to make of it.

 Meryl Nass

Kids tend to bounce back “a bit better”. We have been pleasantly surprised to see how well the MIS-C cases do over time.

 Meryl Nass

Dr. Rubin asks about biopsy/pathology results in kids to understand the myocarditis in kids compared to adults.

 Meryl Nass

Only 1-2 of our 900 cases has had a biopsy (which makes sense as an endomyocardial biopsy is dangerous and usually unnecessary--you know what caused the myocarditis:  the shot).

 Meryl Nass

Dr. Kurilla asks if those having myocarditis after Dose 1 are more likely to have had a Covid case, especially a recent Covid case?  I have to say, Kurilla was hot, asking very on-point questions.

 Meryl Nass

This is what was seen in a military series of myocarditis cases published by Margaret Ryan et al.–all 4 cases after Dose 1 were recovered after having had COVID. However Dr. Oster does not know. More rigorous studies are being planned.  Meryl Nass

Dontcha love it? We are planning to study it–while nearly 200 million Americans and billions more have already been vaccinated?

 Meryl Nass

Oster is looking very nervous as Dr. Gans questions him, wondering why?

 Meryl Nass

She asks about the myocarditis from MIS-C vs post-vax myocarditis: how do they differ?

 Meryl Nass

18 of 24 kids w/ myocarditis in the 12-15 group had prior Covid.  BINGO! This is strong evidence that vaccinating the recovered kids is associated with INCREASED risk for zero benefits, compared to the COVID-naive.

 Meryl Nass

Dr. Nelson points out that all the data presented have been passively collected, do you have better data? BINGO!

 Meryl Nass

Blacks and Hispanic have higher rates of MIS-C; Blacks have more even when controlling for their increased Covid cases. VAERS overreporting is not a concern “because 90% of cases reported have been adjudicated”--the real problem is underreporting and the failure to derive a rate of underreporting.

 Meryl Nass :

 Meryl Nass

Oster does admit they are missing mild cases. And so far he has not mentioned any data collection that is trying to identify this actively–prospectively. And he agrees we still do not know longterm outcomes of cases.

 Meryl Nass

12 minute break

 Meryl Nass

Now Pfizer’s honcho Bill Gruber who promises to be brief and to the point. There is a favorable reactogenicity trial and robust immune responses. Reactogenicity means short-term adverse effects. By using that term, Bill has signalled that he is not going to be revealing imporatnt safety information regarding side effects that do not resolve.

 Meryl Nass

He says there is more MIS-C that we heard earlier. I guess this is what Pfizer wants to hang its hat on–except there is no evidence vaccination prevents MIS-C.

 Meryl Nass

But MIS-C can affect healthy children. He think vaccination helps bring herd immunity–except we know herd immunity is a myth, not a possibility–per UK’s chief vaccinologist.

 Meryl Nass

Let me be clear: reactogenicity is NOT safety, it is immediate, short term reactions that almost invariably resolve quickly. Pfizer has tried to conflate reactogenicity with safety surveillance–they are not the same

 Meryl Nass

Proving efficacy was possible in this particular trial, he says. Yet the initial trial subjects were insufficient, so FDA said enroll more, and Pfizer added 2379 more–who were followed for a grand total of 17 days on average.

 Meryl Nass

The first 2200 were followed for a mean of 2-3 months.

 Meryl Nass

Local reactions are as in other groups w/70-80% having local reactions. Fatigue and headache occurred in 40 and 28% respectively, with the smaller dose.

 Meryl Nass

These systemic reactions are only collected for 7 days after a shot.

 Meryl Nass

His list of adverse events confuses the listener because the reactions are not specified but rather lumped by organ system, which makes it impossible to know severity, duration, etc.

 Meryl Nass

All serious adverse events “were considered” unrelated to the vaccine. Considered by whom?

 Meryl Nass

They had no myocarditis, bell’s palsy, anaphylaxis or appendicitis in the trial–which simply tells you the trial is too small.

 Meryl Nass

The observed AE profile did not suggest any safety concerns–according to Pfizer.

 Meryl Nass

Because there were so few cases of Covid in both the vaccine and placebo groups, “immunobridging” is being used instead to suggest efficacy. However, no specific antibody level has been shown to be protective against Covid, so this surrogate marker may not be valid.

 Meryl Nass

Only 34 subjects’ blood was tested to see efficacy against the Delta variant, and the antibodies worked well. Why were only 34 subjects chosen for this important assay, which is intended to show the vaccine works against Delta–which is controversial. Bill has not submitted these data to FDA yet. Wonder why?

 Meryl Nass

Efficacy was supposed to be durable for up to 4 months–although they didn’t really measure efficacy, which regards real cases of disease. Instead they did immunobridging studies and neutralization assays.

 Meryl Nass

Bill tells us about the 5 trials that Pfizer has agreed to perform for up to 5 years. Great. Once everyone is vaccinated we will find out what the adverse reactions are.

 Meryl Nass

fIt is claimed that myocarditis in the 12-15 group is lower than in the older kids and young adults. This is not what was shown earlier today by Dr. Oster.

 Meryl Nass

cc-33 is the slide of risk-benefit. It seems that the risks and benefits, even according to Pfizer, seem to balance. I will need to recalculate the numbers, but what jumps out at me is the low estimate of myocarditis cases, which are based on passive not active surveillance.

 Meryl Nass

Even so, Dr. Gruber only suggests that vaccination will prevent 1 child death in this age group per million vaccinees. But what if 1 million vaccinees equates to 150 cases of myocarditis?  Or 75?  Some of them will die and some will have a partial disability. The risk outweighs the benefit.

 Meryl Nass

Dr. Gruber talks about the buffer, saying it improves shelf life. Nick Warne from Pfizer comes in to discuss the buffer change–it gives them 10 weeks of refrigerator temp stability. This gives ease of use for medical providers. He claims they are pharmaceutically comparable and the LNP is unchanged. Nobody provided a shred of data or even handwaving to suggest that this change in the product was tested for safety/efficacy in humans

 Meryl Nass

Monto asks about what they know about giving this lower dose 10 mcg to the 12-15 year olds? Gruber says (duh) the higher dose gives higher titers. He says “we have some possibility of looking at that in the future….as we move out of the pandemic.” In other words, we got the higher dose approved, why would we want to spend money to see if a lower dose is just as good or less dangerous?

 Meryl Nass

WOW! Bill Gruber was asked directly, and just answered, that his trial used the other PBS buffer. So Pfizer is giving the vaccine to kids but its final formulation is different than what was used in the trial, and all they can say is they expect the same result. How is FDA letting that skate through? Especially in the 5-11 age group?

 Meryl Nass

Dr. Levy asks for the evidence that the vaccine inhibits viral transmission. Dr. Gruber says we did not look, but there is a great deal of real world evidence that the vaccine prevents transmission in adults. But he fails to cite any specific evidence and I am not sure there is any.

 Meryl Nass

Dr. Moore wants real data on whether the vaccine prevents transmission. Gruber looks chagrined, as Moore tells him exactly what blood samples he already has, that could be used to establish an answer.

 Meryl Nass

Dr. Gruber gave a waffling response, failed to say he would do the suggested study.

 Meryl Nass

Dr. Kurilla notes that at least 50% of cases in these kids are asymptomatic–and by ignoring their recovered immunity you overestimate vaccine efficacy. He further asks whether any data suggest the vaccine will work longer in kids than adults and prevent serious disease?

 Meryl Nass

Dr. Gruber points out that the trial was so brief they don’t have data but will check this at the 6 month mark.

 Meryl Nass

He is encouraged that the immediate immunity is high. Kurilla asks if the lower dose produces the same memory response? Bill does not know. Just amazing what FDA is letting Pfizer get away with.

 Meryl Nass

Dr. Hildreth notes that myocarditis cases in one scenario (a series of assumptions made to address risk-benefit in this meeting, which involved so much modelling their applicability is questionable) exceeded covid hospitalizations

 Meryl Nass

Dr. Leslie Ball, very longterm FDA employee, is presenting, not one of the new kids on the block–I wonder if this is because she is savvier and can answer questions better

 Meryl Nass

She is now speaking about the EUA and the Comirnaty versions, which is tricky for them to explain. This may be why she was brought in.

 Meryl Nass

I was wrong–there was a dose-finding study with 10, 20 and 30 mcg doses in Phase 1.

 Meryl Nass

US, Finland, Poland and Spain is where the study was conducted.

 Meryl Nass

3100 kids got vaccine in the early and late cohorts. She says there was “continuous surveillance” for adverse events, which is not what I have heard from trialists.

 Meryl Nass

Dr. Ball says the first cohort includes sFETY DATA THAT INCLUDES SAEs (serious adverse events) , AESI(adverse events of special interest)s as well as reactogenicity. 

 Meryl Nass

Pfizer (again) does not use all subject in its “safety study” so although over 3K kids got the vaccine, only 750 were used in the “safety analysis”--no wonder they did not find myocarditis cases, because Pfizer pretends this is a 5,000 child trial...but only subsets are studied.  Why even vaccinate the others?

 Meryl Nass

9% had already had Covid. 12% were obese and 8% had asthma in the safety subset.

 Meryl Nass

Only 264 children had their blood checked for immunobridging of the >3,000 total

 Meryl Nass

So why enroll so many kids if you only use less than 10% for the pivotal serosurvey?

 Meryl Nass

Cases of Covid were defined by one symptom (could be sore throat) and a positive PCR. I did not see the cycle threshold listed.

 Meryl Nass

There were 3 cases of Covid in the larger vaccine group and 16 cases in the smaller placebo group. All Covid cases occurred in the US apart from one case in Spain. They did not seek info on transmission or asymptomatic cases.Then why did FDA allow them to truncate the trial duration and submit data now, instead of gathering real efficacy data?  Why submit just 17 days of data on the second cohort?

 Meryl Nass

Solicited local and systemic reactions resolved within 1-2 days after onset (since these brief reactions were the only side effects they were asking about)

 Meryl Nass

Only one child was removed from the trial for fever with preexisting benign cyclic neutropenia.

 Meryl Nass

Henoch-Schonlein purpura was diagnosed 21 days after first dose. No lab tests were done!

 Meryl Nass

Serious ARs occurred in 1-2/1000 subjects. They claim an insect sting was a serious AE. Is this masking something else?

 Meryl Nass

And Dr. Ball also promised the future safety studies that Pfizer will perform. Now her mike is cut off.

 Meryl Nass

We are back. She points out that the studies in the 5-11 are essentially the same as the 12-15 group–in other words, equally brief and unsatisfying, with inadequate safety data and efficacy data, with no strong support for why this type of immunobridging analysis is sufficient.

 Meryl Nass

All serious adverse events were considered unrelated to vaccination.

 Meryl Nass

Dr. Wong is going to present BEST data, which includes a variety of different databases of insurance claims, which cover 25-30% of Americans.

 Meryl Nass

It also includes EHR data from 8 pediatric hospitals. 1.2 million 12-17 y/o recipients should be captured by these databases.

 Meryl Nass

Her slide 9 includes safety endpoints of special interest. But the problem is that not a single one of these diagnoses, including myocarditis, shows up as a safety signal in this extensive database. Yet we know from VAERS that many of them occur at high rates, such as pulmonary embolism and myocarditis. Something is wrong when such a big data set misses what we know is there.

 Meryl Nass

Dr. Wong is about the 3d person to thank her colleagues for working nights and weekends to get this presentation ready.

 Meryl Nass

They produced their presentations 17 days after Pfizer provided FDA its submission. What was the rush? Was FDA trying to get in front of the growing realization of all the serious side effects?Dr. Hong-Yang presents the benefit risk assessment.

 Meryl Nass

Now we are told the incorrect assumptions that went into the risk benefit equation. FDA chose the week of Sept 11, when cases were probably double what they are now–at a peak.

 Meryl Nass

Hospitalizations were calculated for the Aug-Sept period when kids had a peak of hospitalizations, though most were "with" covid.

 Meryl Nass

Myocarditis rate was calculated from the VSD–which, if you recall, in June failed to showed a myocarditis safety signal. In other words, the VSD clearly underestimates myocarditis risk post-vaccination.

 Meryl Nass

The myocarditis risk was estimated as the 12-17 y/ risk, which may be higher or lower than the actual risk, which is unknown–but extrapolating from the exponential curve we saw earlier, we would expect the risk in 5-11 year olds to be greater than in the 12-17 group.

 Meryl Nass

Another things she has not mentioned is that the risk is much higher in boys, and so the genders should be separated because the risk benefit equation might be positive for girls and negative for boys.

 Meryl Nass

The chief assumptions- that efficacy is 70% vs cases and 80% at preventing hospitalizations, is simply a guess with no data presented to support it. Remember, there were no hospitalizations in the trial.

 Meryl Nass

Her slide #8 shows postulated benefits vs risks for 3 child age groups. And if you accept all Pfizer-FDA’s assumptions, the benefit does exceed the risk. Even for males, and obviously for females. However, the assumptions have not been justified

 Meryl Nass

Some things were ignored: preventing asymptomatic or mildly symptomatic cases is actually a negative, not a benefit, because these kids would derive much stronger and long-lasting immunity than they receive from the vaccine.

 Meryl Nass

Preventing hospitalizations assumes that every “with” hospitalizations was actually a “due to” hospitalization. This could multiply the hospitalization benefit by about 400%, based on the 2 pedi hospital studies cited in CHD’s letter to FDA.

 Meryl Nass

In terms of preventing deaths, there have only been 94 “with” deaths in the 5-11 age group since the pandemic’s start. CDC’s own charts call these deaths “with” Covid and “involving” Covid. If deaths parallel hospitalizations, and only about 20% are actually due to Covid, then less than 20 children aged 5-11 have died from Covid in this age cohort since January 2020. FDA’s assumption misses this .

 Meryl Nass

Slide 21 admits that there are a lot of guesses built into FDA’s models–and so while the scenarios claim benefit exceeds risk–which is REQUIRED by the statute in order to issue an Emergency Use Authorization–FDA HAS to present a positive risk benefit analysis. Had it been negative, FDA would have already told Pfizer to take a hike and never convened this meeting.

 Meryl Nass

Dr. Monto says we are too late for questions. We can do some questions later.

 Meryl Nass

28 minute break till 1 pm

 Meryl Nass

Now the open public hearing is starting. FDA is making a big deal of requesting financial COI information from each speaker. Funny how they have not actually done this with the voting members, as pointed out in CHD’s letter to FDA.

 Meryl Nass

Dr. David Berger, a holistic pediatrician is first. His point is calling for civility and respect for all viewpoints on vaccination.

 Meryl Nass

Steve Kirsch presents some info on a series of teenagers who died shortly after vaccination. Why is CDC unable to determine causality after 17,000 deaths reported to VAERS when in Europe they could do so with around 100 deaths. What are the stopping criteria for these vaccinations? Why are autopsies not being done in those who die post vaccination?

 Meryl Nass

The Kostoff paper found 5 deaths per life saved in kids from vaccine; why was it retracted against the opinion of its editors? There are too many unanswered questions for VRBPAC members to vote in favor of 5-11 vaccinations.

 Meryl Nass

Andrea Kline-Tilford, pres of the National association of pedi nurse practitioners is next. She emphasizes the serious mental health issues in kids which have increased dramatically during the pandemic. Her organization, NAPNAP supports widespread equitable rollout of vaccine to every eligible child. Even in schools (where informed consent sometimes gets lost)

 Meryl Nass

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?

 Meryl Nass

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.

 Meryl Nass

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.

 Meryl Nass

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

 Meryl Nass

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.

 Meryl Nass

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!

 Meryl Nass

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 its not preventing cases and transmission

 Meryl Nass

Those in favor present no data. Those opposed have charts, tables and look like extras from Alice’s Restaurant.  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.

 Meryl Nass

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

 Meryl Nass

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.

 Meryl Nass

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

 Meryl Nass

Most importantly, his wife was in a covid trial last November and 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. This is never discussed by the panelists:  the ways Pfizer conceals bad news from its reports and presentations,

 Meryl Nass

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

 Meryl Nass

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.

 Meryl Nass

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.

 Meryl Nass

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

 Meryl Nass

Kristi Dobbs speaks next. She received one dose of Pfizer in January, immediately suffered 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, as 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 wrongfully coerced into taking these vaccines by politiicians.”

 Meryl Nass

Dorit Reiss has popped up. She wants us to consider 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. This becomes the new justification for authorization, since the data fail to support overall benefit in my estimation.  So the justification becomes to help those very few high risk kids who really need the vaccine.

 Meryl Nass

She seems to be telling the VRBPAC to ignore the 90,000 plus comments to the FDA on this subject. How undemocratic! She is a lawyer.  The law requires these committees to receive public comments. 

 Meryl Nass

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

 Meryl Nass

Paul Offit points out that many kids have recovered immunity–was that included in your models, Dr. Hong Yang? We considered everyone susceptible, she said.This means we can immediately reduce the proposed benefit by 50%.  It also means her models are rudimentary.  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.

 Meryl Nass

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

 Meryl Nass

Dr. Forshee (apparently a supervisor trying to save FDA's butt) jumps in and says we don’t have the details, we relied on CDC data, what does CDC have to say about whether it considered this? Don't you just love it?  FDA creates models, plugs in CDC data, but does not know how those data were derived. They call it science.  I call it the blind leading the blind, after each has affixed their blinders voluntarily so they can come up with a preposterously positive risk-benefit equation.  I wonder how many models they went through before coming up with an algorithm that gave them what they wanted? 

 Meryl Nass

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

 Meryl Nass

Paul Offit is a bellwether.

 Meryl Nass

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.

 Meryl Nass

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.

 Meryl Nass

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

 Meryl Nass

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

 Meryl Nass

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

 Meryl Nass

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

 Meryl Nass

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.

 Meryl Nass

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.

 Meryl Nass

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.

 Meryl Nass

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

 Meryl Nass

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

 Meryl Nass

Dr. Kurilla asks for the time frame 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 wonder if they put these models together yesterday.  They are laughable.

 Meryl Nass

I think that comment just did in the authorization.

 Meryl Nass

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

 Meryl Nass

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.)

 Meryl Nass

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

 Meryl Nass

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

 Meryl Nass

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 NEJM 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 reprint sales.

 Meryl Nass

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

 Meryl Nass

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

 Meryl Nass

Gruber cannot tell us about the mRNA in humans. He says he  can tell about the animal studies–then goes silent. Duh?  Did he get a message from Pfizer to keep quiet?

 Meryl Nass

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.

 Meryl Nass

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

 Meryl Nass

Doran Fink says it is CDC data–not ours–go ask them. (In other words, we are FDA, we take what is given us and we don't ask for more (data).  Amanda Cohn tries to answer but is disconnected.

 Meryl Nass

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.

 Meryl Nass

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.

 Meryl Nass

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. (Now Pfizer is questioning the specificity of troponin for identifying myocarditis?  This is a delaying action.)

 Meryl Nass

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

 Meryl Nass

Dr. Gans asks about vaccine 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.

 Meryl Nass

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.

 Meryl Nass

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, failing to test more doses, trying one dose instead of two, and varying the time between doses. 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.?

 Meryl Nass

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 the logical tests until you reach babies? Probably because babies respond less well compared to older children, and will help justify giving more not less.

 Meryl Nass

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 am an incorrigible optimist.

 Meryl Nass

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

 Meryl Nass

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

 Meryl Nass

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.

 Meryl Nass

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

 Meryl Nass

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

 Meryl Nass

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?

 Meryl Nass

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.

 Meryl Nass

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

 Meryl Nass

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?

 Meryl Nass

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 THIS WAS THE QUESTION FOR TODAY. AM I WRONG?”

 Meryl Nass

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.

 Meryl Nass

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.

 Meryl Nass

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.

 Meryl Nass

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. .

 Meryl Nass

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

 Meryl Nass

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.

 Meryl Nass

Dr. Perlman says he is voting Yes. Of course he is. He covered up for lab origin of SARS-2; why wouldn't he ignore vaccine injuries and naturally do his masters' bidding?

 Meryl Nass

He does not seem to have understood the presentations today.

 Meryl Nass

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)

 Meryl Nass

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 rate will be different than in adults. We should expect breakthrough cases, need for boosters, etc.

 Meryl Nass

Dr. Nelson 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 risk-informed public is the way ahead. Depriving access to the high risk is a problem.

 Meryl Nass

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.

 Meryl Nass

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.

 Meryl Nass

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

 Meryl Nass

Amanda claims no deaths from myocarditis (obvious lie, they are documented) and complete recoveries–well, 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.

 Meryl Nass

Dr. Rubin says ACIP should ask for discretion in how the vaccine is used. This is called kicking the can down the road.

 Meryl Nass

Another VRBPAC meeting, and the bandwagon effect was in clear view today. Good afternoon. Signing out.