Thursday, June 10, 2021

Live Blogging the FDA meeting on pedi Covid vaccine licensure/authorization

UPDATE:  I expanded on the live blog below here, with additional context, and added information on the people at the meeting.  I suggest you read the later version for more detail.

1.  Almost every member of the advisory committee earns money for their work on vaccines.  However only one acknowledged a financial conflict of interest, which was minor. Most of the VRBPAC members at today's meeting are not actually regular members of the VRBPAC committee. It looks as if the Covid vaccine meetings have been stacked with mostly yes-men and women. By my count 10 members are regulars and 12 are temporary members, brought in to help stack the deck.

2.  A Merck employee is a non-voting member today.

3.  Stanley Perlman is a member today.  He signed the Lancet March 7, 2020 Correspondence that was intended to cover up a lab origin and enforce the natural origin theory of Covid!

4.  Eric Rubin, editor-in-chief of the NEJM, is a member today.  He published a fabricated study by the Surgiphere group, the same group that published the fabricated Lancet study that said the chloroquine drugs kill. His journal has been very kind to Covid vaccines.  And today he had the chutzpah to say that we don't even know if the mRNA vaccines cause myocarditis. 

5.  CDC did its own unpublished study to try and jack up the risk for kids of hospitalization for Covid.  They were caught by Dr. Meissner who points out that the current rate is 0.4/million, very low, and the risk of the vaccine needs to be lower than this. Later, Dr Meissner mentioned a 12 year old admitted to his hospital last weekend with myocarditis, 2 days after his second shot.  When Meissner began to beg the others to pay attention to the risks, his mike was cut off.

6.  CDC admits that the data are mixed regarding transmission and cases in kids. Having said that, they present their own (apparently skewed and definitely unpublished) data claiming that children get infected and transmit at the same rate as adults.  They claim that 0-4 year old children have an over 85% rate of symptomatic illness, which is different than what everyone else  has found. 

7.  Seroprevalence for Covid was said to be 27% in children, using antinucleocapsid antibodies (so vaccinees won't test positive), higher than all older age groups. My question:  CDC is presenting serology data but elsewhere claims it is unreliable at the individual level, whereas it can be used at the population level. 

Why can CDC use these data to makes its points but I can't use the same test to travel, cross a border, or attend an event?

8.  Meissner pointed out that the numbers CDC is using re pedi hospitalizations is from April and currently the number is only 1/4 as great.

9.  Dr Stokly at CDC said there is no federal age of consent, and it is determined by the States.  Yet currently municipalities are determining that 12 year olds can give consent in states that do not allow it--but of course this was omitted from her talk. Yet the only way that could happen is for CDC and FDA to give those cities (San Francisco, Seattle and Philadelphia for sure) a green light.

10.  39% of 16-17 year olds have received at least one dose of vaccine, per CDC.

11.  Dr. Steve Anderson claimed there are "no safety signals" currently for the 16 prespecified adverse events, which include myocarditis and thrombosis.  And he had a chart to demonstrate this.  Duh?  What about the fact we know risks are elevated for thrombosis and myocarditis?  Well, they are going to study that in the future.  Wouldn't the absence of a safety signal that has already been found to exist in multiple countries indicate your surveillance system is not working as it should?

12.  Dr. Shimabukuro noted there are 789 VAERS reports of myopericarditis.  475 occured in teens and people in their 20s. Most occur after dose 2.  Over 70% are in males.  The median age after dose 2 is 24.  There are about 8 times as many cases after dose 2 as after dose 1.  I'd call that a pretty clear signal, Dr. Anderson. AND there has not even been time for a second dose in the vast majority of 12-15 year olds, for whom the vaccine was authorized less than 4 weeks ago.

13.  What databases will be used to assess safety in those under 18?  The first answer was just the VSD and BEST, per FDA, while last we heard BEST was still being tested and inoperational.  Later, in response to a question from Chair Arnold Monto (in which I think Monto was trying to clean up a previous answer he knew was incorrect), Anderson said just VAERS and VSD would be used to assess safety in younger children. What happened to all those other databases CDC was going to use?  Disappeared, eh?  

Later, Dr. Kim asked if there were plans to "include millions of other safety surveillance opportunities?" Anderson dodged, saying that "there were other electronic health records systems... we already showed this to your committee..." and then concluded, "we can reshare that slide so you have it."

Dr. Gans asked, "when we add in all the safety surveillance systems what % of kids will be accounted for?"  Anderson was gobsmacked by this simple question whose answer he must know.  Yet he very slowly answered, "I'll ask my staff."

Then Gans asked, "why not be proactive? All the autoimmune side effects are not on the solicited list of adverse events.  Can we add them?" At this point Anderson started stuttering. He eventually said "we are considering doing something similar." BTW, I have found the "we are considering" answer to be standard bureaucrateez when the real answer is "Hell no, do you want us to incriminate ourselves by showing there are more problems than we are willing to acknowledge?"

And then the expected happened:  Monto tried to end the discussion. Shimabukuru tried to make it okay, jumping in to say he would be happy to work with his FDA colleagues on this.  That gave Dr. Meissner the opportunity to ask him the rates of thrombosis with thrombocytopenia in young women, and myocarditis in kids.  Then it was Shimabukuru's turn to stutter.  Finally he said it is too early to say.  This appeared to be another example of not wanting to incriminate himself with a lie, while he doesn't want to tell what he knows.  The reason is that having this number would permit the committee to perform a risk-benefit comparison (Covid hospitalization rate vs vaccine myocarditis rate) which would probably sink both an EUA and licensure in children.

Meissner didn't stop. "Shouldn't this risk be included in the Informed Consent?" he asked. Shimabukuru said his slides had the info (but the info would not pass his lips). He then asserted that CDC is committed to transparency and transparency in communication. I think this meant, "Hell no, we are not adding this to any patient information sheet."  

14.  The VSD database at this point only includes 121 adolescents who received a second dose.  Guess that is the excuse why the myocarditis carnage couldn't be identified by FDA and CDC before this meeting. Is that why the meeting was held now, before additional databases with tens of millions of enrollees were added to BEST data in mid June?  Because then it would be harder to claim they didn't know about the serious adverse events?

15.  It was claimed "the data" only show 1/60,000 doses develops myocarditis.  But the Israeli data in young men showed 1/6,000 doses, according to (I think) Dr. Meissner.  Dr. Dror Mevorach, who did the study for Israel, says the rate of myocarditis in young men is 5-25 times the baseline rate. Some say the rate is 1/2,500.

16.  Dr. Anderson or Dr. Shimabukuru said "at least 81% of myocarditis cases made a full recovery."  But they only have followup on less than half the cases.  No one told us how many had died. 

17. After presentations on the data requirements for an EUA and licensure in different age groups, which were set to rely on "immunobridging" even though the antibody test used apparently fails to provide a direct extrapolation to immunity, Monto declared, "We're not going to have the time to answer everyone's questions."

18.  Kurilla asked whether the vaccines, made from a strain collected 18 months ago that is no longer in circulation, is the right one given current variants. Monto cut that right off, saying "We're not talking about variants, because it's a global issue." Which made no sense, but got the group away from any consideration of variants. This was important, because further discussion would probably reveal the fact that current vaccines have poor efficacy for some variants, and should perhaps be replaced with better targeted vaccines.  In fact, wasn't the ability to easily and cheaply switch mRNA midstream to target new variants the rationale to use mRNA vaccines in the first place?

19.  Dr. Nelson pointed out that since the trial populations were very small, would FDA correspondingly pay attention to smaller safety signals than usual? By vaccine or by class?  I thought it was a great question. [Michael Nelson used to care for anthrax vaccine-injured soldiers at Walter Reed and I have previously been impressed with his clinical work.] Doran Fink played it safe by providing a meaningless response, saying FDA would "follow the data."

 20.  The meeting is nearly over, and not a single person has mentioned that the spike protein itself might have toxicity.  

21.  Nor has anyone pointed out that the animal studies (required before FDA gives permission for human studies) were not done.  We do not know the pharmacokinetics in a human or animal body of the spike protein, the S1 protein, the mRNA, other proteins that may be produced, and the multiple components of the lipid nanoparticle. Pfizer injected 2 of the 4 lipids into rodents and called it good. Furthermore, I have seen no evidence regarding the duration during which the spike protein is produced, and what happens to cells that produce it. A study out of Harvard showed it can be produced for at least two weeks.

22.  No one mentions what might be causing menstrual abnormalities.  No one has discussed blood clots outside the very limited perspective of adult women age 30-50.

23.  Amanda Cohn, MD from CDC is a member of VRBPAC.  She was one of three CDC physicians who lied to Congressman Tom Massie regarding CDC's recommendation to vaccinate people who have recovered from the disease. Another person who lied was deputy director Schuchat, who has since been fired by Director Walensky.  Of course, Walensky has recently been lying about the number of teens hospitalized due to Covid. Hard to find an honest doc at CDC it seems. Walensky promised she would always tell us the truth in a prominent NY Times Opinion piece in January. Sad.

Thinking about the dishonest CDC physicians and committee member conflicts of interest, I forgot to mention that Dr. Melinda Wharton is also a temporary member of today's committee.  She is probably the top person at CDC whose job is to coverup vaccine safety problems.  For example, here is a 2004 Congressional testimony she gave, in which she cites the "Denmark data" CDC cooked up with a Denmark contractor.  Their collusion is described in a book by James Grundvig.  The "Denmark data" was faked by Poul Thorsen in order to claim that thimerosal in vaccines was not dangerous.  Psychiatrist Thorsen, who is now a fugitive wanted by DHHS, has been accused of multiple crimes, including forgery, stealing $900,000 from CDC and stealing from his university in Denmark.  Naturally, DHHS forgot to add his scientific misconduct. Yet CDC still cites his "study" as the basis for denying thimerosal injuries. UPDATE:  Actually, I just looked this up again; I had made this claim in a 2019 testimony and checked the link then, when CDC was still citing Thorsen.  Today I see CDC has removed the Thorsen-named publications from this graphic. But they include the tainted Danish research.  And include this paper about it, whose last author is Thorsen's then-lover and CDC employee, Diane Simpson.

24.  Phyllis Arthur, from the industry association BIO, was given 10 minutes to provide the "industry perspective." Why was she there?  Why was Merck there? She made the disease in kids out to be pretty bad.  She claimed kids were needed for herd immunity, which was disputed in the WaPO and relies on the. claim that children readily spread Covid, which is at least debatable. Finally, she wanted to know whether FDA would help industry market Covid vaccines to the world, or in her words, "assure global alignment for pediatric Covid vaccine programs."

25.  Peter Doshi provided a public comment which was, as usual, astute. I especially liked his reminder that a median 2 months of follow-up being used to issue an EUA was not likely to detect long-term adverse effects of vaccination.  It took 9 months to identify narcolepsy as a side effect of Pandemrix vaccine, and 4 months for Israel to identify myocarditis as a side effect of the Pfizer vaccine. Finally, he pointed out that if FDA does not have a high bar for EUAs/licenses, the point of regulation is lost.

26.  Several members asked about studies testing different doses, or a single shot in children, but not a single presenter from CDC or FDA would talk about lower doses. Very curious. Surely the FDA does not plan to give children, who respond with higher antibody levels to the vaccines, adult doses, despite their smaller size and weight than adults.  Why did FDA refuse to discuss this?

27.  Gans asked, is anyone looking at risk factors for myocarditis (or other adverse events)? CDC's Shimabukuru stuttered and blathered.  FDA's Anderson pointed out that he has not identified a signal yet.  (In other words, how could he be expected to look into risk factors for side effects when his fabulous surveillance systems have not found any side effects yet!). Then he backed up just a bit, adding, "but your question is a valid one."  Yup, it may be valid, but the FDA isn't going near it.

28.  Dr. Offit pointed out that we vaccinate for polio, but we have not had a case of polio in the US since the 1970s, so why not keep vaccinating for Covid even after it's gone?  Offit is wrong about polio.  We had only vaccine-induced polio cases between 1979 and 1999, at which point oral polio vaccines were taken off the market and replaced with safer, but less effective killed polio vaccines.

29.  FDA's Doran Fink pushed back against longer-term followup of trial subjects, and larger trials.  Instead, he claimed, what we need is post-marketing surveillance.

30.  The statistician Dodd, a new member, pointed out that it was meaningless to talk about how large the pedi trials whould be when you cannot make that calculation until you know what you are trying to look for.  I imagine the docs who had been throwing out numbers felt sheepish, since she is of course correct.  That ended discussion of trial size.

31.  Things ended quickly after that, since FDA/Dr. Monto had determined the meeting would cease at 3:30. A few intelligent comments were made, ignored, then Peter Marks, head of FDA's Center for Biologics hopped on to emphasize how terrible the disease was in children. He lied about the death rate, choosing to use the invalid statistic (which even CDC disputes) of only those who had a valid positive test, which is a bit more than 1 million Covid cases in the 11-17 age range.  (However, CDC estimates that over 1/3 of the country has had Covid.  Extrapolating that to the 11-17 age group yields over 9 million cases in that age group.) By choosing a false metric, Dr. Marks' mendacity enabled him to claim the death rate was very high in teenagers, which is simply not true.

Here are the real CDC numbers.  Between Jan 1 and March 31, 2021, 204 children aged 12 through 17 were hospitalized for Covid.  One hundred forty-four of them had pre-existing conditions.  None died.  Their average length of stay was 2.4 days. 

So, of 24 million children in that age group, 60 healthy children had brief hospitalizations for Covid and no deaths during our highest Covid incidence period.  

Now here are the total number of US Covid hospitalizations on the dates January 1, March 31 and June 9, 2021.  These come from the NY Times.

Jan 1, 2021            130,000

March 31, 2021       43,000

June 9, 2021            20,000

What this tells you is that during the highest months of Covid cases and hospitalizations (which is the time period CDC chose for its analysis), only 20 otherwise healthy children needed a brief hospitalization for Covid per month, in the entire country.  There was not a single death.  And now we are at roughly a quarter of those rates. Another way of looking at this is that during those entire 3 months, every US state and territory had about one--ONE--healthy kid require hospitalization for a couple of days for Covid. That should cast Peters Marks' and Rochelle Walensky's claims of dire Covid risk for teenagers in the fairy tale category.  And it should make clear that Walensky and Marks are the wicked witch and wicked wizard, who would willingly injure children for a few pieces of silver and a government job on their resumes.

For this minuscule risk the US government wants all our children vaccinated, despite heart inflammation that seems to occur at 5-25 times the expected rate after mRNA vaccinations, and may well leave your child with permanent heart damage.  Why is there a complete lack of information on the longterm side effects that may ensue? Because FDA regulators didn't ask the manufacturers to look.

This is not medicine, this is medical fascism.

32. Five months ago, at the December 10 meeting of the VRBPAC, we were given an estimate of total US Covid cases at the time, which was over 50 million.  Or about 3 or 4 times the rate of positive tests and diagnoses then.

However, today there were no estimates given by the presenters.  The number of cumulative US Covid cases, according to today's federally employed physicians, had dropped from over 50 to around 33 million cases.  I guess they think it is a better number to help push vaccinations, rather than admitting that perhaps 3 or 4 times that many are already immune. This went on while the CDC website on June 11 estimates there have been 114.6 million US cases of Covid.

Now, what was the purpose of today's meeting?  I suspect it was to get a few "experts" from outside the FDA on record as being in favor of quick licensure. Here is my prediction, for which I have no inside info:  FDA will license the Covid vaccines for children and adults on the same day in early August, in order to cover everyone's mandates for colleges and schools.  Unless there is an uproar regarding side effects, the vaccines are likely to be placed on the childhood schedule, which is required in order for the manufacturer to skirt liability for injuries once the vaccines are out of EUA status.

Today, the third member of a sister FDA drug advisory committee quit.  It turns out that every member of that committee had voted against approving a $50,000/year drug for Alzheimer's, and then the FDA went ahead and licensed it anyway. One of those who quit called the advisory committee process a "sham process."

Aaron Kesselheim, a well known Harvard professor of drug regulation, was the third to publicly leave the committee.  As the WSJ reported

 “Th[e] pivotal question was not discussed at the advisory committee meeting, and its premise was specifically excluded from discussion,” he wrote in his letter of resignation to FDA Acting Commissioner Janet Woodcock.

Calling the agency’s decision a “debacle,” Dr. Kesselheim said the move “will undermine the care of these patients, public trust in the FDA, the pursuit of useful therapeutic innovation and the affordability of the healthcare system.”

The iron hands of controllers Janet Woodcock and Marion Gruber have to go. FDA's brazen disregard of the truth, the data and the science may soon have Americans asking why we spend $3.2 billion a year to fund FDA. 

This meeting brought some prescient lyrics to mind.  Poor Doran Fink, FDA's chief vaccine flunky.  He's got an MD and a PhD and his dishonorable vocation is to keep a lid on the truth. Same goes for Peter Marks.  Poor Drs. Shimabukuru and Steve Anderson.   How much are they paid for their malfeasance? Have they no shame?

Twenty years of schoolin' and they put you on the day shift...

Johnny's in the basement 

Mixing up the medicine 

I'm on the pavement 

Thinking about the government...

You don't need a weather man 
To know which way the wind blows

Nope.  All you need are a few hours at an FDA meeting.

* On June 12, I expanded this live blog with additional background and links here.


Anonymous said...

Thank you for providing your insights for people like me with zero medical background. The hearing was very much over my head.

The only part that I could understand was that experts are convinced that although counterintuitive, the most scientific way to evaluate safety and efficacy of vaccine on children is to appply the data that was already collected for older age groups. Also, lack of data collection need not be a concern because other vaccines were approved using assumptions instead of data.

—diane s.

Anonymous said...

I am no scientist or doctor but from what you describe it’s hard to believe that these people can be so reckless with our children’s health. Since it’s obvious thus far this virus doesn’t affect young children why expose them to the risks we already know about in older children and adults and the longer term ones we don’t yet know about.

Anonymous said...

Most of the ten or so public comments told them to STOP this travesty; and one accused this of being an operation without quite being so direct.

Those on panel admitted they have not done any "deep dive" into VAERS data, since they see no "signals" to prompt any alarm to do so. And that they have no intention of doing so at this time.

And they admitted they are not even all that familiar with the adverse events, and so how can they be on this panel without being up to speed on the adverse event data?

Brian said...

June 9, 2021 Why We Petitioned the FDA to Refrain from Fully Approving Any COVID-19 Vaccine this Year By Prof. Linda Wastila, Dr. Peter Doshi, Hamid Merchant, and Kim Witczak

We are part of a group of clinicians, scientists, and patient advocates who have lodged a formal “Citizen Petition” with the United States Food and Drug Administration (FDA), asking the agency to delay any consideration of a “full approval” of a covid-19 vaccine.

Anonymous said...

What about kids who play competitive high-end sports? What will be the risk of heart problems post myocarditis, recovered fully or not?

Anonymous said...

Someone please correct me if I'm wrong...but don't most pandemics naturally fizzle out after 2 years? We're at the 1.5 year mark so far.

Dr Chris King said...

This is a great example of CYA medicine in action. (CYA: cover yer arse!)

It leaves the patient's buttocks exposed, pants around the ankles. If we let it.

Let's follow Nancy's advice and JUST SAY NO!

Anonymous said...

Dr. Nass, thank you for summary; and forecast of August approval.

The vaccine danger to children v. actual risk from disease it seem to me means filing request for preliminary injunction in federal court, since nothing is going to stop this train either.

Force a trial on this. Keep injunction on approvals until trial is over. Trial could take years. This medical issue should take years to resolve itself doing research to make determinations based on science.

At this point this may be only way to force government and manufacturers of the drugs to release the information needed to make a rational decision.

Absent this, I have my own prediction: attorney generals in a number of states convening grand juries to prosecute drug makers, MDs and public officials lying and gas lighting public. Prosecute them as criminals.

Then we'll really see who actually loves our children in this country.

Nina McDonald said...

Dr Meryl--have you listened to this interview?

Anonymous said...

Pithy, right-on comments throughout. Invaluable! A sham and travesty and the recent resignations support your analyses.

Anonymous said...

Today, I watched Dr. Pierre Kory on the Bret Weinstein (Darkhorse podcast) - where Dr. Kory elaborated on how widespread prophalactic use of Ivemectin could quickly bring Covid cases to an end. And Bret made the point that from an evolutionary biology perspective the quicker the pandemic ends the less chance that the virus will evolve / mutate to become a yearly problem like such as seasonal influenza.
I was not, not, not at all a Trump fan. However, Trump did have a big mouth and I would like to believe that Trump would be using his time at the microphone to publicly champion Ivermectin, Hydroxychloroquine, Fluvoxamine and other off label drugs to the benefit of the American people and the world. President Biden that is what we need from you at this moment.

Thomas said...

Shocking. Just shocking. Thanks for covering this scandalous procedure.