FDA VRBPAC Meeting, June 15, 2023 — Meryl Nass, M.D.

Print

Link copied

It is 8:30 am and the FDA is about to start yet another meeting on COVID vaccines for “periodic” use. Does that mean to mess up women’s periods?

Dr. Monto is back chairing, though we did see the real chair once a couple of months ago. Today the meeting is about choosing strains for a fall COVID vaccination campaign. It seems that no matter how dangerous they are and how poorly they work, the FDA/USG is incorrigible about doling out more vaccinations.

Luckily only 17% of Americans, according to the CDC, have received a bivalent vaccine, which have been the predominant vaccines available over the past 9.5 months.

17% is one in 6 Americans. And only 34% of Americans have accepted a booster of any kind. One in 3 only. Americans figured this scam out earlier than people in most other countries.

Present: Berger, Bernstein, Annunziato, Monto, Chatterjee, Cohn, Kim, Offit, Pergam, Perlman, Rubin, and now temp members: Gellin, Hawkins, Hildreth, Lee, Levy, McInnes, Meissner, Nelson, Reingold, Sawyer, Wharton. 21 voters; Annunziato (works for Pharma) is non-voting.

Peter Marks, director of CBER (vaccines and biologics) speaks briefly, never mentioning that there is controversy about why we should keep vaccinating for what became a mild illness; using vaccines that have mild efficacy for only weeks; soon have negative efficacy, and cause horrendous side effects and deaths–probably contributing to about a 10% increase in all cause mortality in most age groups.

Dr. Kaslow took over Dr. Marion Gruber’s spot as head of OVRR. He tells us FDA plans a simple regimen, and will discuss a protein-based vaccine as well as the only other vaccines available in the US, mRNA vaccines. Dr. Meissner left Tufts and moved to BARDA. BARDA had a workshop on April 27 on protein-based COVID vaccines.

Today is for selecting strains going into next winter; do we need a periodic update; should we change back to a monovalent; so we need more boosters?

The virus evolves rapidly and immunity wanes, thus more boosters expected through period campaigns. They won’t say how often.

The plan is for mfrs to do manufacturing as they do testing to speed up the process, which they call “at risk” cause someone has to pay for the vaccine made if it is not used. Who will pay?

We will hear from the WHO as well as mfrs, CDC and FDA briefers. But who will take these new vaccines? People don’t want them.

The committee will vote on whether to update to a monovalent XBB lineage variant? They they will discuss which XBB to use. This should be decided by FDA not by this group,as FDA has the expertise…presumably FDA is looking for cover by the committee in case they get the strain selection wrong, again.

Gofer Levy asks about the protein vaccines of BARDA. Kaslow says mfrs need strain selection info before they can go ahead…some work needs to be done “at risk”–presumably the USG would pay, which means even if those vaccines don’t work they are likely to be used, once paid for.

Gellin asks for definitions of ‘campaign’ and ‘periodic’–love that guy who likes precision. Kaslow is a champs at waffle.

Bernstein says hybrid immun ity (natural and vaxxed) seems to be preventing deaths and severe disease.Kaslow punts to Kanta Subberao re the strain selection. Hildreth asks are you going to give EUAs or approvals of Marks. The Secretary’s declaration from 564 is still active. EUAs can be issued. They hope to move as many as possible into licensed products, certainly for the adult products. It will help increase confidence. And he hints that covid will be treated like flu wrt vaccination campaigns.

“We have one chance this fall to get vaccines into arms.”–Peter Marks

Next up CDC’s Ruth Link-Gelles, PhD, MPH on effectiveness. Good to see CDC’s claims on VE. Uses the VISION network, based on PCR tests.

It looks like the vaccine works 50% efficacy up to 3-5 months. Note that this is proprietary CDC data, which seems to always back up CDC policies.

IVY Network from 25 hospitals and hospitalizations over the past 8 months. 5 months after bivalent vax could be negative (wide conf interval centering close to zero)

2nd IVY slide shows 2 groups for whom efficacy was negative, one monovalent. Now vision study of pregnant people. After 6 months post vax, no efficacy or neg. During pregnancy women allegedly were protected during their pregnancies.

the Overcoming COVID network looks at 25 pedi hospitals. The confidence intervals are wide, despite many subjects, but seems babies are protected by material vax during pregnancy, for a few months.

Overall, the data confirm rapid waning of efficacy, but are inadequate to compare monovalent vs bivalent, and all omit the presence of natural infection, though it could easily be checked.

She looks uncomfortable. Doesn’t want questions. Levy just learned with the pandemic that one size does not fit all. Duh.

He notes she failed to describe her immunocompromised group. He is breaking up a bit. This is a soft ball. She is not giving a clear answer–“we weren’t able to break out specific categories.”

Stan Perlman who is a coronavirus researcher points out the low efficacy vs fact that almost no one gets hospitalized any more. She gives him the broader context and says hybrid immunity is helping . Yeah man!

“Incremental benefit of the bivalent vaccine on top of the immunity from prior infection”–hmmm, is the vaccine giving any immunity now or are they boosting to try and stave off the negative efficacy, while the positive efficacy comes from natural immunity?

CDC does not know if COVID will settle into a seasonal pattern. Most Americans have relatively little vaccine protection left, as they are over a year out from their last dose–so duh what are the vaxxes doing?

Offit says T cells work for covid longer term, as opposed to in flu, so why are you assuming people will need to follow the flu model?

Reingold says something similar. Ruth shows a slide in which the over 65s have nearly identical response to vax as younger groups–by 5 months there was almost no efficacy.

Now CDC’s Natalie Thornburg, PhD will talk about variants and epidemiology of COVID. The XBBs are winning. Omicron strains have ruled since end 2021.

This is a time waster–we have seen similar graphs at earlier meetings

I hate CDC’s modelled data–it is almost always incorrect, we find out later. Why not give up and admit you cannot predict in JUne what will cause problems in December.

The Nowcast dataset and graphs are all based on estimates and models.

Sorry, I am bored. It seems that FDA and CDC will try to extract info on what will happen 6 months from now from datasets that cannot provide the data. Go get a cup of tea while she goes on about this.

Hmmm. only 1.1 million deaths in US associated with COVID–suggesting none over the past year, I think.

Basically no one needs the shots any more but she claims a bivalent booster gives you 6 months of protection, and CDC is always trying to fin populations who can ‘benefit’ from yet another shot.

Thanks Ofer for saying, “All models are wrong but some are useful.”

Dr. Subbarao worked for FAUCI at NIAID and now works for the WHO in Australia on flu vaccines. She is on the TAG-COVAC committee on variants. Last June we saw early omicron variants.

Last June there was major uncertainty about what new vaccines would do.

She says the ancestral strain was retained because people were happy with it, and were uncertain how the omicron vaccine would do.

Population immunity in US now 100% and in Europe 96%. Wondering how this was tested. Now she shows hybrid immunity efficacy. I should have know they would climb on the hybrid bandwagon: that means you already had the disease and you were vaccinated, so you have good immunity. Duh. Plus you like get boosted by repeat exposures to the virus in real life even without shots to boost you.

likely not like

Omicron came off all the older variants, which most scientists think was not a natural event.

“We have limited precision on where these are located but they are antigenically distinct.” Hamster data–is it of any value? Imprinting–will people be able to respond to new antigens when they are already used to old COVID antigens?

Imprinting was seen, but after 2 infections it seemed their immune response broadened. I don’t think we have any understanding of this phenomenon.

Studies vary as to results (neutralizing antibodies) using various variants. The effect of natural immunity appears stronger than from vaccination. Since vaccines reduce your immunity over time (based on infections and not neutralizing antibodies) it seems to me there is no reason to vaccinate. She admits XBB data are very limited. XBB1.5 or 1.16 might be an alternative.

Meryl Nass:: Monto says “it is very difficult to come up with a strain-specific recommendation, giving mfrs a choice.” She says for flu they name strains; she is “not confident about the cadence of the virus’ evolution ” so her committee will review it every 6 months.

Ofer reminds us that there may not be correlates of protection. What about T cells? Neutralizing antibodies are poor against XBB but still good protection exists, so there is something else going on that is not understood. [This is an unusual honesty admitting their methods are limited, which has been said before but usually not be the briefers.]

the WHO wants vax for all, trying to standardize them…not an answer…trying sounds like not gonna happen

kanta says we don’t know where the virus will go.

Moderna’s Dr. Das will tell us about a study they did using Kaiser’s LA population–where an EZ measles vaccines was very dangerous but tested there anyway.

I think she just indicated that the mono vaccine was better than the bivalent but not sure what her percentages mean when comparing vaccines

You can see that the sudden appearance of omicron with 41 mutations from the ancestral strain, in a new pattern, was quite strange.

Neutralizing antibodies not so good for the current variant compared to last year’s variant (4-5) but does it have actual meaning in terms of protection or side effects? No one has said “side effects” yet.

You inject mice and they develop antibodies. You inject again and they develop 10x more antibodies. This is very predictable but what does it mean?

Why not expose the lab animals to covid and see if they actually get sick?

I keep bringing up the study at Sheba Hospital where HCWs got 4 shots and had very high neutralizing antibodies but got a very high rate of infections within about 3 months. So stop showing me these neutralizing titer cause we all know they don’t mean much–the proof is whether you get sick or not.

I am not writing much cause there is not much new or interesting.

Basically this is all guesswork by the presenters. Which Kena of Pfizer just admitted.

No one has even attempted to explain why people need more of these poison vaccines–there has been NO evidence of serious illness caused by COVID now that a vaccine would ameliorate.

OMG,, more stupid bar graphs showing that giving a booster dose antibodies go up. Duh.

We saw this same worthless info last June and since.

This must be old data with a BA1 boost from early 2022. cc-10 slide. and cc-11. B cell response went up. In a small number of people (how many?) and when?

Pfizer can produce vaccine in 100 days once a strain is chosen. This does not bode well for CEPI, which claims development (choosing a strain) would take 100 days and manufacture only 30 more days.

Pfizer is ready to go by July, August or October to sell the USG liability-free vaccines for the next cold season.

Bruce Gellin asks if Pfizer will sell the same US vax to the rest of the world?

She is in charge of vaccines but says we are having ongoing discussions…she does not admit they will make a subpar cheaper vax for developing nations. Pamela McInnes demands to ask her question while Monto tries to stop her.

McInnes says it looks like we are following the flu model, but should think differently about this. If the periodicity is shorter than it is for flu, we should look at this differently. McInnes is one of the smarter panelists, as is Gellin.

Kena says we cannot predict the winter virus, and that is the bottom line. Pandemic over. No need. Dangerous. And we don’t know how to predict what is coming.

Novavax’s Filip D speaks. 1.5 and 1.16 are essentially comparable wrt the antibody responses elicited. And Novavax would be delighted to produce either.

This is what you need to know about the novavax vaccine. https://merylnass.substack.com/p/novavax-vaccine-contains-1-mg-of?utm_source=%2Fsearch%2FNovavax&utm_medium=reader2

The idea is to demonstrate that current vaccines will not work well against current strains…but I am not sure this was demonstrated clinically. Extrapolation on extrapolation on extrapolation and then you can show anything you want.

The message is we need new vaccines to deal with the mild viruses now circulating. Grrrr.

Whether you use a mouse or a monkey, you see similar boosting data. Great. Show me protection from death or hospitalization, and no one can do that, not sure they are even trying.

All these briefers almost certainly have stock as part of their payment packages, so being convincing actually pads their portfolio.

His last sentence and bottom line: tell us what to make now and we will get it for you in time.

These companies will be happy to produce anything if the USG agrees to buy it. Poison maybe too if there is liability protection.

Which is why the people need to pay directly.

Meryl Nass:: 30 mins for lunch, then the public hearing.

Meryl Nass:: Now let’s see how many people desperate for another new booster the mfrs were able to dig up. Melissa Miller is the first speaker. She is putting out the sensible facts.

She has good data. Even the slides today showed that 50% of recipients had systemic reactions after a second shot.

Excellent recommendations from Melissa

Kermit Kubitz I think has been here before–he is a vax lover; he did not state his conflicts. He likes the Hotez vaccine used in India.

He also said safety testing in people could be done quickly–if necessary. IF necessary? He may work for one of the trade groups like Bio and is KAing at the end.

Mary Elizabeth Christian, MD. Disabled breast surgeon from a hereditary condition. Maybe her parents would have lived if they got a booster. Her infant grandson was low birthweight, premature with his mother vaxxed during pregnancy–yet they vaxxed him as soon as possible as an infant–and her daughter seems to be a doctor too.

They have an autistic child with a mitochondrial disorder. But she wants more vaccines. Well, she did get brainwashed as a doctor. But her vaxxed parents died from covid. She believes her family’s vulnerabilities mean the vax will magically work for them. Sad.

Ms. Paydar finally acknowledges her story, which is very unusual. David Wiseman gives another lovely presentation with great slides.

The vaxes are adulterated — which should result in immediate recall. The RNA and DNA can enter the nucleus and probably genome. Both spike and mRNA are longlasting. Fauci’s Jan article was negative about the possibility of effective COVID vaccines. Chase safety not a new variant.

Don Ford is without conflicts. WHO and EU recommend a monovalent vaccine. [Why? Probably because the bivalent did not work so well so we are back to a mono.]. He likes novavax, not mRNA. It is good to make his points, but the only reason he can support Novavax is because there is not so much literature about it since so little has been used.

Novavax costs 10-100 times as much perdose as the mRNA vaccines currently.

Despite denying conflicts, he clearly has access to proprietary data and is in the field.

Kevin McKernan is here and explains that the expression vectors for the vaccines are still in the vials (12 checked) in high concentrations. E coli plasmids remain in vials that were not used in the original batches and clinical trials. Pfizer vaccines have an SV40 promoter

EMA has a DNA/RNA limit which is greatly exceeded. The vaccine is giving you material that may result in positive PCR tests. It can induce clotting. Primer sequences are public and his work can be duplicated by others. Excellent presentation.

Joaquin Beltran is a moderna investor and he is here to push novavax. Thair Phillips says it is not gone and we must maintain our readiness. Is he from the army?

Amy Harth was terrified that she could not get yet another bivalent booster. She thinks they are “generally safe” and she needs to work and maintaining that status is tenuous. I feel sorry for so many PhDs who worship medical journals and have never envisioned corruption. She got COVID with complications.

Katherine Matthias DO and a vaccine advocate. Hard to listen to her repeat CDC lies about safety.

Karyne Jones whose org receives funding to do vaccine education for the black population. Equity important.

Burton Eller from the Grange and rural America. Not sure of his point.

Robin Strongin is so grateful and thankful but cannot allow society to become complacent. Where do they find these doubletalkers who never get to the point… oh now she explains–she wants to reduce the spread (to herself) and get everyone vaxxed. Why has no one told her that Rochelle and Tony admitted the vaccines do not prevent spread in August of 2021?

Let’s hope she does not continue to inform and guide consumers. Elle Pierce is next, and she wants more novavax now for little kids NOW.

Jerry Weir recaps all the arbitrary decisions that have been made over the past 2.5 years. This is the most boring meeting I have ever attended, and that is saying something!

He is trying to justify why they made a bad decision last year (although no one has really showed useful data about effectiveness of the bivalent vaccines today.

An updated strain “may be beneficial.”

Nice that he wrote what FDA is doing: garbage. Finding viruses and doing just antibody studies. Which were proved to not be correlative of protection. Don’t you feel sad about how far this agency has fallen in only 30 years since PDUFA was passed? That is the bill that allowed FDA to charge mfrs “user fees” for FDA to assess their products

He claims the neutralizing antibodies are correlative but they often have not been–Sheba Hospital, my friend! and others. That is why the members ask for B cell and T ce;ll data.

He has a monotone as well…and now we have to hear about more mice. Can I go home yet?

Global coordination of the covid vaccine strain composition: global public health regulators meet throughout the year to align their recommendations.

XBB is an adequate candidate from 3 other international groups, they want a monovalent vaccine. Updating the vaccine “will be a continuous process…and we have to be prepared…there are many challenges and uncertainties that remain.”

Need to improve durability and protection. Need to correlate the neutralizing titer to clinical outcome–hey he is repeating what I said.

Ofer asked for correlates of protection, since Weir did doubletalk on that issue.

yada yada yada time wasting blather…”today at this meeting we are using neutralizing antibody” for strain selection… we are not there yet–with solid data. Wish we had T cell data, we encourage mfrs to do them…BUT FDA COULD DEMAND THE MFRS DO THEM.

Gellin asks how about testing to optimizing the dose and reducing reactogenicity (side effects)? Weir (the regulator) says he does not know how much the mfrs would be willing to spend on that. But FDA is the boss! I think everyone is afraid to test to reduce side effects because they will find some.. Likely bad ones, especially if they continue to look for them after the first few days post-vax. And why optimize dose? IIf we cared about health and human benefits, we would immediately recall all the vaccine with plasmid DNA in it–but we ignore it.

The PREP Act is what Weir and everyone else today is depending on to protecting them from liability when this vaccine things finally blows.

Offit says will dosing data be available before you start jabbing kids with these proposed new vaccines? Weir says ooooooh, not sure about that…….

Peter Marks says there is no new safety data since the last meeting. Hmmpf!

McInnes is also unhappy about dose response curves that are missing.

10 minute break.

Dr. Offit says the word periodic worries me. And what do we mean by waning infection. The word campaign implies a yearly campaign. There is plenty of info about T cells by various people that clearly show the relationship between helper and killer T cells and covid. Omicron stopped the epidemic of severe illness and death. T cells may prevent severe infection and may last for years. CDC can help us with the information sought. This is not flu!! We missed twice on H3N2 in the last ten years but we are confusing people about this virus.

Yes–because they act as if brain dead, plodding forward with another vaccine without evidence of need, efficacy or safety. Even Rubin is complaining. But he says we need a new one, the bivalent was not that goo. Dr. Lee points out that most of the data is from people with many earlier doses. Are we going to be recommending initial series in babies?

And the answer from Dr. Weir was yes, we are ‘simplifying’ and everyone will get the same formulation. In other words, we will experiment on six month olds equally as we will experiment on adults.

Now we dither about the poor wording of the question to be answered, which is whether a periodic update for this year’s fall dose should be a monovalent XBB–which has been the only option, the only data provided all day long. So why pretend there is a question. That was the only option–that or nothing. I might prefer nothing, given the poor data quality.

And the dangers of the vaccine. peter Marks reveals his ignorance once again–he does not understand his committee.

He wants to give the mfrs the final formulation for this fall asap and people should stop with the nitpicking already. Bernstein bravely says he disagrees with Peter Marks.

Gellin says the words are confusing and needs to be reconsidered. There used to be a risk communication committee at FDA to send better messages and the right expectations.

But they are paused because if they told the truth it would be all harm no benefit.

Finally many of those who usually go along to get along seem pissed off. Peter Marks says we need a better vaccine but we go to war with the army we have…remember he said earlier that he was just kicking the can down the road when he ordered the third dose…

These people never ever ever say they made a mistake. Monovalent. Bivalent. Monovalent. Never once did anyone explain why these decisions were made. Because they were a crap shoot and maybe DOD was making the decisions. Tune in to Sasha Latypova on CHD-TV Roundtable Friday (tomorrow) June 16 at 10 am ET and maybe she can tell us who is in the driver’s seat.

Peter Marks was asked to provide a favorable benefit risk. He says in the older age group it does provide some benefit, right (?). Ishe hinting we will stop using them on children? Doubtful that these criminals will do anything good for humanity.

Peter Marks usually stays away from these meetings and does not get into rough and tumble, but he must have seen this as a possible loss and wanted to show his weight.

Dr. Kim imho is about the smartest and most practical doc here, and he works for the govt; he points out that uptake of the vaccine is poor and they should inject a spoonful of realism to the recommendation: you can make all the recommendations you want but if people don’t get it, why are we ignoring that. Perlman points out that not everyone should get the vaccine. Messaging is important. High transmission means less boosting by shots is needed cause we get boosted by exposure.

Peter Marks gave in on a minor point and agrees to change the question with a tiny tweak–to remove periodic from the question.

Paydar wants to read her statement. Then the vote.I predict that despite the many outstanding questions, we will get 21 agreeing unanimously, now that they have had a chance to let off steam.

This is like the game of Jeopardy. As if this is a real vote and it was a real question and the regulators and their advisors are really regulating.

Instead today was all about having screwed up with the bivalent recommendation, and the one before, and this whole damn vaccine–so the FDA needed cover from its advisory committee so if/when this recommendation blows up, the blame will be shared with the committee and will not lie at Peter Marks’ feet.

And now for the envelope… 21 voted yes. Am I good or what? Is this a great country or what? (From the movie Graveyard Shift)

What we can all be sure of that no one on this committee actually cares about the health of children.

Arnold, I do not want to hear them bare their chests and say why they voted the way they did: we know why. A. No courage. B. They were chosen for agreeability. C. Pharma grants or speaking engagements in future. D. They are federal employees (Cohn, Wharton, Kim) and have no choice.

Now they are supposed to discuss which specific XBB to choose, but they don’t have much evidence to go on and they are not the experts in this area anyway. If Weir says it is not an easy choice, why even bother discussing–FDA WILL make this decision.

Thank you, Arnold–who just said what if we think we don’t have enough information to make this decision?

I think I am going to sign off. The rest will simply be more blather, and Peter Marks just hinted that the XBB1.5 is already being manufactured, so they will likely go with that one.

Next Wednesday to Friday is another ACIP meeting. We can suffer together then. Fortify yourself in the meantime, and remember, there really are a lot of good people out there. They just don’t wind up pimping for the FDA.–Meryl