FDA VRBPAC Meeting, June 28, 2022 — Meryl Nass, M.D.
It is June 28, and I, Meryl Nass, M.D., am back to live-blog the FDA’s “Future Framework” on COVID booster shots for the future.
Why do we need COVID boosters when the Centers for Disease Control and Prevention (CDC) says 95% of U.S. adults are partly to fully immune due to prior infection or vaccination. Since prior vaccination wears off after a few months, that must mean that most of us, even Dr. Fauci, have not been infected and developed fairly strong immunity from infection.
That should have said BEEN infected. CDC said last February that 75% of children were infected and immune. So, why boosters?
The claim is that there will be more waves during the colder weather. How do they know that?
The problem is that the Wuhan original strain vaccines (all current U.S. vaccines) provide very little protection against the current Omicron strains.
Arnold Monto opens the meeting, which will discuss modification of current vaccines.
Dr. Adam Berger and Bernstein are relatively new members.
We go through the list of members. David Kim is with the National Vaccine Program and also attends the ACIP [Advisory Committee on Immunization Practices] meetings. Paul Offit is here, and he has expressed strong feelings about this subject. Adam Pergam works at the Fred Hutchinson center at U Washington, a grateful recipient of BMGF [Bill & Melinda Gates Foundation] cash. Bruce Gellin of the Rockefeller Foundation and directed the National Program office previously replaces Dr. Ovet Fuller. Randy Hawkins is in. Janet Lee is from U Arkansas and works at a Rockefeller program. Ofer Levy from Harvard is back. Wayne Marasco is also from Harvard. James Hildreth is here from Meharry. Cody Meissner is just about to move from Tufts. Michael Nelson is from U Virginia. He says he is an expert in rare adverse events. Stanley Perlman from U Iowa studied coronaviruses for 40 years. Dr. Art Reingold is from Berkeley. Mark Sawyer is from U Cal also. Melinda Wharton is the second member of the VRBPAC who is a CDC officer, along with Amanda Cohn.
Although there is a claim that there is only one conflict of interest in the group of advisers, this is unlikely as many do research on vaccines and receive grants to do so from pharma.
The NVIC [National Vaccine Information Center] submitted my name to FDA about 15 years ago as a candidate for the position of consumer rep on this committee. An FDA employee called me after I submitted my documents to determine whether I had any COIs [certificate of insurance]. I did not. Then FDA never got back to me. When I called to learn the status of my application, I was told they were still deciding. I guess, 15 years later, my complete lack of financial COIs perfects befuddled them. In any event, the FDA staff never would act on my application.
Now we will discuss how the strain composition should be modified for COVID vaccines going forward.
More modeling will be revealed.
Peter Marks is back. We are very lucky to have so many vaccines in the U.S., four at this time.
On June 7, the Novavax was presented, then authorized. He shows a model claiming the vaccines saved millions of lives worldwide. Nonetheless, their effectiveness does appear to wane over time, which became clear a year ago. First in the elderly, then due to new variants. So we initiated booster campaigns, hoping for more immunity in older individuals and needy communities. Marks claims a switch will be made based on immunobridging. This is the opposite of what was said at the April 6 meeting.
At that time it was widely acknowledged that immunobridging (antibody titers) were not a reliable marker of immunity, and therefore actual clinical trials to measure efficacy would have to be done since the U.S. Food, Drug and Cosmetic Act requires an efficacy evaluation to approve a drug or vaccine.
Dr. Marks admits that Americans with and without boosters have waning immunity but the rapid evolution of COVID variants will continue, and as we move inside in winter our risk of a major COVID outbreak increases. We need to be protected from this theoretical risk with theoretically constructed vaccines, it seems the FDA says.
Marks is a consistent exaggerator — now claiming there are 300 deaths/day due to COVID.
FDA wants the best match possible. Maybe we can pull a rabbit out of a hat and prevent symptomatic and asymptomatic infection and transmission since most vaccines work to do so.
It takes months to manufacture and distribute vaccines so a decision needs to be made asap on vaccine composition. Current vaccines provide less robust protection that wanes over time and some vaccines made from Omicron BA-1 have been investigated but BA-4 and 5 are the primary strains now. Based on the questions the group is to discuss, it seems FDA has decided to include some Omicron strain into a new vaccine. No question asks if it is necessary or prudent to continue with COVID vaccines.
Bruce Gellin wants to know how long it takes to manufacture an mRNA vaccine and learn what they have already made?
Peter Marks loves to answer questions with estimates and says there is a 3-month manufacturing window.
Dr. Marasco says the main question is whether we will dampen a response rather than enhance it with vaccines. Marks waffles. Meissner says if we decide to make a new vaccine, might it not be stored in the NSSDS rather than making a commitment to using it? Marks said we will have to ask the manufacturers. It seems like the FDA expected that if it was made, it would be immediately used. Dr. Lee asks what about the primary series of vaccines? Marks says this will be discussed.
Heather Scobie from CDC shows a variants chart until last January. Why stop six months ago?
Omicron is milder, more transmissible, and is unaffected by most monoclonals.
We know that boosters cause neutralizing antibody titers to rise, but the problem is that this does not necessarily improve actual efficacy.
She claims small molecule inhibitors still retain activity vs Omicron — but not much, sister.
Now we see graphs of Omicron lineages through June. BA-5 is increasing now. BA-1 and 2 are nearly gone now.
BA2.12.1 is the biggest now. Globally reported deaths are at their lowest since February 2020.
86 million U.S. cases were reported. Recent hospitalizations are driven by those over 70. Deaths are way down. There are virtually no current deaths in children.
Only 12% of all deaths have been attributed to Omicron.
69 deaths in kids have been related to MIS-C.
It is claimed that 1 in 4-5 COVID survivors have at least one new symptom, and are at higher risk of pulmonary embolism.
222 million got primary series (71%). 49% got one booster and 17 million Americans got a fourth dose.
17 million is 5% of Americans. CDC links cases, vaccines and death certificates for 70% of the population. Using 30 plus jurisdictions.
She produces the CDC graphs that allege that unvaccinated have many higher case and death rates. These data require certain special adjustments in how cases and deaths are designated.
75% of those with severe COVID have comorbidities with considerable severity.
Cody says there is a lot less MIS-C from Omicron, based on a Danish study. Is that true for the U.S.? She doesn’t know.
Dr. Hawkins says he is seeing cases in the vaxxed. LA County couldn’t get antivirals in May. This might explain why the poor are receiving fewer antivirals.
Heather admits rather poor uptake of second boosters, and it has been six to nine months since the first booster, and so we shouldn’t expect much from them.
Dr. Hawkins says many of his (black, presumably) patients keep refusing the primary vaccines.
Gellin wonders where the recent data are. She shows us some data and there are virtually no deaths in the under 75-year-olds, which was not emphasized earlier. Bruce Gellin wants to know what sublineages are killing people but she waffles and does not answer.
Dr. Link-Gelles will focus on vaccine efficacy, mainly in adults. The Heroes-RECOVER platform uses weekly self-swabs. If you got three doses but it is more than five months after the third dose, efficacy was only 20%.
ICATT partnership tested people in April and May. In 12-15-year-olds, VE is zero at three months after two doses.
In adults, VE drops to 10-30% in adults by four months.
The VISION network is based on EMRs. 60 days after vax in 12-15-year-olds efficacy drops to 20%. And they are getting the adult dose!
Boosters improve efficacy briefly.
The vaccine has higher efficacy for hospitalization. In adults, four months after three dose efficacy is zero.
Why does she look so nervous? Monto asks about the newest variants and she waffles, not answering whether the newer Omicron variants respond differently to vaccination than Omicron-1?
Stanley Perlman asks for data besides observational population data? The next speaker will provide modeling data.
Ganz also asks about the Omicron 4-5 variants. A lot of words said nothing.
She must have been given a list of what NOT to say and so she keeps repeating herself and saying very little.
Dr. Marasco asks about anomalies in her protection data — and now she admits it is probably due to prior immunity!
They have hidden prior infection/immunity in the chart but did check everyone for neutralizing antibodies, which reveal prior infection and thus immunity.
The HEROES study sequences all samples if the CT value allows it.
Dr. Justin Lessler from UNC prevents modeling with help from BMGF’s IHME and others.
They have done 13 projections. Omicron rendered one invalid. 11 were published. The graph makes it appear that their models were reasonable predictors.
He admits they can only predict for a few weeks ahead. Further out, more things change that affect longterm projections.
But plans need to be made six months ahead.
Notably, his projection graph has no wave after Omicron.
Recent model assumptions were optimistic: 40% drop in protection immediately after infection. This is not congruent with the facts.
Pessimistic assumption was a 60% reduction in immunity immediatey after infection.
At 10:20 am, you can see that the projections were much worse than what happened. And likely they will predict worse COVID cases and other outcomes as time goes forward.
Any model you choose, they have substantial resurgences in the fall. In the beginning, he said the model depends on the assumptions, but he never provided the assumptions by which he generates two future waves.
ALL 4 models show many fewer cases than occurred with the January Omicron wave, over the next six months.
He points out that one group doing the modeling ran multiple projections making small differences in assumptions that led to major differences in the ultimate predictions.
Garbage in garbage out. To sum up, we have no idea what validity these models may have, if any.
Monto asks how Omicron led them to rethink their models?
Lessler says we have done our best to capture that and claims his group did a great job at predicting Omicron’s trajectory once Omicron was discovered in December.
They had underestimated Delta but had an emergency meeting and based on South Africa epi data did a good predictive model for it.
Monto says “We are being asked to have a crystal ball today.”
Ofer Levy ask whther these models use data to constandtly improve themselves?
Lessler says yes, in certain ways. All constantly update. We are not weighting the models when we aggregate based on past performance. Different models peform best at different times. Hmmm. So long as you create loads of models, you will probably always find at least one that provides a reasonable prediction. But how to find that one ahead of time?
Taking a 15 minute break!
The new Moderna president, Stephen Hough is talking. He prevents a bivalent platform and claims the titers are higher than with a single valent.
The new one is measured against response rate (??) and titers. The vaccine has been used in several hundred people and causes roughly as many initial reactions. There are higher titers against Omicron, as expected.
Obviously, if you were already immune your titers were much higher after one of these doses.
Yada Yada, the titers were robust. Since this vaccine has the old strain as well as a new one, it showed it worked to a degree against the old strains that are now of only historical interest.
We need to be concerned that a new vaccine may actually reduce overall immunity, which was strengthened to a great extent for the whole population by Omicron, yielding high rates of robust immunity. Will vaccinating the Omicron-recovered reduce their ability to respond to new versions of coronaviruses?
He claims the new vaccine reduces cases and hospitalizations of delta and Omicron.
Murderna is evaluating boosters at 3 and 6 months. Great. Four vaccinations a year?
Pending authorization, Moderna claims it could have vaccine available at end July early August. This appears to be different than the several months requirement reported earlier.
The Omicron in the vaccine is BA.1 — the earliest Omicron.
Moderna says the antibodies lasted longer with the bivalent vaccine. And rose over time. Which to me suggests the subject probably got boosted by getting Omicron infections in the interim, which he has carefully avoided discussing.
He did not conduct a study in seronegative adults — those never infected.
Ofer Levy asks the obvious question: what about T cells? What about actual efficacy tests, did you prove it prevented actual infections? The answer is no T cell data yet, and no to efficacy testing.
Offit asks about antibodies to current Omicron strains? They don’t have it yet. Offit yet says, “But that is the critical question.”
Now Dr. Swanson from Pfizer presents. She is Dr. Jansen’s replacement. Neutralization data “generally corresponds well” with efficacy. Oh really? Let’s see the data.
“It may be time to consider an update …” She presents a monovalent vaccine with only BA.1 Omicron spike in it. A fourth dose with this new vaccine met serologic criteria (they always do).
New naive individuals were given two doses of the new Omicron vaccines. Serologically it worked against Omicron.
Pfizer also tested a bivalent vaccine with 30 mcg of each Omicron and ancestral doses and 15mcg each. All of the Pfizer vaccines yielded good titers at one-month post second dose. Well, what would you expect?
The 60 mcg vaccines had more side effects.
Pfizer can supply some new vaccine right now.
Pfizer asks to be allowed to switch to a later Omicron version with only preclinical and CMC data.
In other words, they would like to base future vaccine changes on mouse studies, if I understood correctly — I had to move away for a minute.
Levy asks if the mice were challenged and protected? Do you have a correlate of protection? No, the mice have not been challenged with virus to see if the titers are meaningful.
“There is no established correlate of protection,” said Dr. Swanson. So why all the titer data if they have not been shown to correlate to protection.
Now we have Gregory Glenn from Novavax. He says the company has identified conserved epitopes that remain with all variants, and this allegedly allows his vaccine to be effective against many variants.
The claim is that the vaccine was 100% protection against severe disease and 90% protection against infection. And about 86% protection v. variants.
The vaccines contain a spike trimer. Monoclonal antibodies to their vaccine bind to all the Omicron variants despite being made to the ancestral wuhan strain.
The U Washington IHME? group said their antibodies show good protection. Why would a modelling group be able to say that?
I am so tired of looking at antibody studies. Of course the more doses you give, the higher they go, and of course they go up a month after a booster. this means nothing about protection, nor does it imply anything about how the response will be at a later moment in time.
This vaccine uses an adjuvant termed Matrix-M whose longterm side effects, especially the induction of autoimmune diseases, is unknown.
Novavax also used a BA-1 Omicron vaccine and a bivalent vaccine. They found that the single valent vaccine gives the same serological result as a bivalent vaccine.
In summary, he seems to confuse immunity and efficacy with antibody titers. This is a rookey mistake. His vaccine will be ready in the fourth quarter.
He is an M.D. I wonder how long he has been working on vaccines.
He presented monkey data and called it efficacy, and it was serologic data in monkeys.
He claims they have induced sterilizing immunity with challenge, which, if accurate, suggests his vaccine is superior to all the others, that do not induce sterilizing mucosal immunity. Wondering where the evidence is.
Spike IgG is alleged to be a correlate of protection for the Novavax vaccine. Arnold Monto cuts him off.
Kanta Subbarao will present for the WHO Collaborating Center in Melbourne, Australia Technical Advisory Group on Vaccine Composition.
18 members. Previously issued statements in January and March.
The claim based on multiple studies is that severe disease is protected against but that protection again infection is considerably less.
No surprise that with each exposure to antigen there is a rise in cross-reactive antibodies. You need three doses of Pfizer to get a serologic response to Omicron.
She claims that after Omicron infection there is little antibody response to earlier variants. But whay is that important since we are not going back to those variants?
This involved small numbers of people. Now we have a mouse model. Old vaccine does not respond to Omicron. New vaccine does not respond to older variants. But if you give them multiple doses the titers rise. Duh.
If you give monkeys Moderna x2 then an Omicron boost titers rise as expected.
The graphs are getting smaller. All I can tell is that titers drop a lot at six months. Why does she focus on lower Omicron response to older variants as a reason to not use Omicron monovalent vaccine? Do they need a broad response to old variants? There is limited data on cross-reactivity, antibody and t-cell responses, and they lack data on the current Omicron variants. all the data used by TAG used mRNA vaccines.
WHO is going for the pie-in-the-sky objectives of both preventing severe illness and death, which they claim the ancestral vaccines still do, plus they want broad immunity for the future, and therefore want a bivalent vaccine with the old and new strains in it.
WE saw no efficacy data, only neutralizing titer data from Kanta Subbarao.
Arnold points out she had to make a recommendation based on limited data, asks which she would pick? She makes the obvious statement that she wants to increase the breadth of the immune response and use BA.1 because there is no data on any other Omicron variant.
As well as the ancestral strain, because it has worked so well. Dr. Chaterjee asks about pedi data? Kanta says they saw no pedi data.
“We don’t want the world to lose confidence in vaccines available now.” said Kanta. She does not want a monovalent vaccine and says “it is possible a bivalent vaccine might achieve that.” which sentence contains two separate concerns.
Offit says why did you say MAY at the end? and Kanta says we don’t have much data and the committee came up with it.
What about mixing and matching different vaccines from different companies? I want to point out that in a very important Nordic study if you gave people a Moderna after a Pfizer, the rate of myocarditis rose very high–more than if you gave Moderna twice. I will give you the link later — the data are very profound.
Jerry Weir from FDA is next. He points out what was generally agreed at the April 6, 22 VRBPAC meeting, and what is important here is the need for EFFECTIVENESS data, not just antibody levels.
That was made clear at the meeting since there is no correlate of protection.
He points out that the variants so far have not derived from each other … except that is not true of the Omicron variants which come from Omicron.
We don’t know where they will go from here and we can assume future variants will come from Omicron.”
The covariants.org website lets you see how the variants change over time and vary by country
After nine months there is very little efficacy of two Moderna doses against Omicron but it comes back with a thrid shot (but only measured up to 60 days), which imho is irrelevant.
The data are limited to BA.1 variant only and data are all regarding neutralization and not efficacy in the real world.
So far we have heard absolutely NOTHING about safety of these new vaccines, except for a small amount of reactogenicity data that has nothing to do with myocarditis or any and all serious reactions, which have been entirely ignored although we have been meeting for over 4 hours.
Weir points out that only neutralizing antibody titers are measuresd and how they relate to clinical beneifit is UNKNOWN.
He asks if there is any additional evidence? Vaccine plus infection gives a great response. Might a booster with a similar strain might give similar great response? I want to know that a vaccine adds to immunity in terms of real world efficacy — so far the studies I have seen showed only very marginal difference.
Why would you get 2-3 doses when you only get good titers if you also have a breakthrough infection?
Why not just infect everyone with a mild strain and call it good? This is truly crazy — why do we need the darned vaccine if you have to get a breakthrough case to “make the vaccine work” wink, wink.
Vaccine effectiveness studies will be crucial in determining if the higher titers translate to clinical benefit.
So on April 6 the committee agree that efficacy data were needed —clinical trials were needed — and they were ignored and have been presented with NO clinical trial data that was meaningful.
Next is the lunch break and the public hearing. Then speakers will be brought back to answer questions. Hearing will start in 30 minutes.
The public comments are great. Inalienable Rights Alliance with Eric, a chiropractor, asks great questions. Barucha Weinberger made excellent points about the lack of efficacy for children and tremendous damages. Mike Briskin preceded her and also made fabulous points. The speakers are more knowledgeable about the relevants points than the members and presenters appear to be — since they keep carefully inside the Overton window in which the vaccines never do wrong. Eric points out this is the FDA: Federal Deny Agency. Isn’t there one person at FDA who will deal with the facts? Dr. David Wiseman points out that VRBPAC has been misled. FDA excluded its own experts to hide informatin. Everyone agrees there is no correlate of protection. Wuhan strain immunobridging is irrelevant. FDA junked itw old methodology and guidelines to “may be effective.”
CDC has not conducted safety signal analyses of VAERS, even when analyses have been provided to it. Vital studies were never done. What is the toxicity of multiple doses? Why hasn’t FDA consulted its gene therapy advisors?
Ben Newton asks how to save the most lives. He encourages the new vaccines and the Novavax vaccines — he shows his slides from nine months ago already presented to VRBPAC. What chutzpah. How about presenting recent data?
Dr. Wiseman also asked how would the manufacturing changes be evaluated? This is a critical issue that has not yet been addressed.
I will point out that the 20th Century Cures Act asks that real world data be used to license drugs and vaccines. It did NOT instruct the FDA to license vaccines without any efficacy data and without correlates of protection. The Animal Rule also requires correlates of protection before accepting antibody titers as evidence of efficacy.
Sarah Barry tracks the antivaccine community and cites the digital center for countering hate. She says hundreds of antivaccine candidates are being supported to “use misinformation to weaken the public health infrastructure” — this gal is scary. She is the public outreach person for some pharma astroturf organization named SAFE. She says anti-vaxxers bullied a public health officer in Ohio who resigned. Her organization cannot fight anti-vaxxers effectively unless people understand the problem — contact Sarah at: info@safecommunitiescoalition.org
- Kent Carper is the president of an unnamed commission. He asks FDA to immediately allow distribution of the new vaccines and prioritize immediate vaxes for first responders. The science is clear.
He is from West Virginia. His state learned clear lessons and he wants lots of frequent boosters, more than every six months.
Kailey Soller, I have heard from twice recently, and now I must endure her again. She is a mother and chemist. We must adapt to COVID and get a nimble manufacturing base. All ages must be able to receive the vaccines on the same timeline. We scientists have adopted the flu shot yearly, therefore, adopt a similar mindset as with flu vaccine. FDA MUST adopt this.
FDA should work hand in hand with the manufacturers. We need more than yearly updated vaccines. We know they are safe. We are not changing anything but the sequence, and as a chemist, she seems able to ignore that changing the mRNA totally changes the protein and it will have unpredictable consequences — who knew the original design would cause myocarditis or clots?
Next is Ashley Serrano who I think we have also heard before. She and her 3-year-old were so happy she got vaccinated last week with Moderna and she had no AEs. Now she can go into peoples’ houses. I guess she is unaware of the NY data that shows after 1 month, the 5-11-year-olds only had 50% efficacy against cases, and by two months efficacy had dropped to 12%. So how long is she going to be able to visit friends’ houses? But Mom wants those boosters soon. Luckily she did a COVID test on her kid (already) which was negative. I guess that means the vaccine works, huh?
Jessica Nehring thanks everyone for the joy she felt when her son finally got his first shot last week. She wants to be able to go inside without being scared about contracting long COVID. She wants to stop stuffing down her anxiety. Her hope is the bivalent vaccines will prevent long COVID — but since they failed to present any clinical data, there is no reason to think they will do so. She wants new boosters “at least once a year.”
I have to say that I have never attended a meeting like this one with less meaningful data presented. This meeting is a joke. Now we have Catherine Diehl who has a Ph.D. in medical ethics. She wants to streamline the regulatory process. Accelerate the flu process further. She is a great example of what the degree in medical ethics stands for: wrapping yourself in the ethics flag to make all kinds of unjustified claims — usually while an academic in a pharma-sponsored chair.
She is bitching about what Cody Meissner said at the last meeting, who pointed out the minute risk of a COVID death to children. She claims he “pandered” to anti-vaxxers. Kate Schenk is next with three kids who got vaxxed last week. No AEs. Her 7 month old is crawling faster than ever. Thank God. She is so relieved her daughter will be protected when she starts school, but actually she won’t, because Omicron. Duh. So why are you happy about vaccinating your babes with a vaccine that does not work against Omicron? What is wrong with these mothers? They know, but they don’t know. They are logical then illogical. This one wants “equal protection going forward.”
Aime Baker says the committee has reviewed the relevant data — boy is she wrong. Her two kids got their first shots last week. It was hard to get, we had to crowdsource information from social media. Some members of this committee she claims incorrectly have impeded vaccinations for children. Wow. Who paid her to demand improved rollout! She disses those who did not order vaccines for the youngest children, those medical providers who presumably are tired of damaging their patients. Corey C. is aligned with Aime.
This person also bitches about how long the vaccines were delayed. Pharma must have orchestrated these young women to beat on the FDA over this. She performed a survey of 200 parents, she claimed, and they almost all wanted Moderna. It took too long for parents to get an appointment, or to find Moderna in particular.
She says, “we have been an afterthought” and she wants Omicron vaccines for all ages asap.
Katarina Lindley, another repeater, but she is concerned about the safety. To assume newer vaccines are safe is reckless and counter to good regulation. Safety signals are evident but ignored.
Valerie borek, JD from Stand for Health Freedom points out that Informed Consent is critical and has been denied illegally by FDA regarding EUA. She quoted Dr. Rubin and Dr. Weir and Meissner to make excellent points, including that the shots drive variants. Known potential risks have been ignored, though required by statute for EUAs. Everything was rushed and there is no long-term safety data. VRBPAC and ACIP members ask for more data on safety. Americans need the missing data to make an informed choice. FDA’s authorization without safety and efficacy data is illegal. Yup. She is correct.
Dr. Hershie Klein says letting the manufacturers to do the studies is the fox guarding the henhouse. Dr. Weir says the sars-cov-2 is unpredictable. But now you are prepared to throw caution out the window. It seems like you are contemplating disbanding the FDA since the mRNA can be changed without any data or regulation.
Now we are back to the regular meeting. Ten-minute break till 2:45.
Dr. Scobie confirms that there is much less MIS-C after Omicron compared to earlier variants. Overall there is not a lot of disparity in terms of deaths by race and ethnicity. But it seems whites may be higher.
The belief is that the old vaccines protect against serious illness. No one has asked about the quality of the data that claims this — we just saw one slide with a list of studies that were too small to read. Offit wants a higher standard of evidence. Good for him.
Bruce Gellin says if they change the production how will it would have on global production? Not sure what relevance this has when Moderna just admitted throwing away 80 million doses. And the probable real reason to change the vaccine is to get people to start accepting it again in the U.S. Apparently, in some other developed countries people are willing to go for more boosters, but Americans have said NO to boosters three and four (3rd and 4th shots). Marasco says maybe we don’t need to change the strain composition, as the Novavax data looked good for Omicron. Monto says, aren’t we just talking about mRNA vaccines? Weir says FDA has not reviewed the Novavax data!
Cody Meissner says “We haven’t discussed safety” and what will it do to issues such as myocarditis? Monto and Weir are concerned with this line of questioning.
Monto wants to remind the committee of Dr. Subbarao’s discussion and increasing the “breadth” of immunity. No one has mentioned the Nordic study that showed mixing caused a considerable amount more myocarditis. That study is by Karlstad et al. and is titled “SARS-CoV-2 vaccination and myocarditis in a Nordic Cohort Study of 23 million residents” published online in JAMA Cardiology April 30. Monto changed the subject but now Dr. Hildreth echoes the safety argument, and says the Novavax data are impressive, and FDA might get more takers of a protein vaccine than an mRNA, so more forward with novavax. Holly Gans wants a more durable response, the composition should be changed, the later B4 or B5 will probably give the broadest coverage. (But there is no B4 or B5 that has been presented today.)
Steve Pergam has a bizarre painting behind him that looks like an oriental man wearing what looks like a funnel as a mask. WTF? Monto and Pergam think there is not enough time for this meeting. Monto says we should focus on mon vs bivalent boosters.
This reminds me of the April 6 meeting, in which there is no data to answer the questions asked and the members have no idea where to go with it. Hank Bernstein asks why relevant data like T cell immunity have not been collected. Dr. Weir says it is hard to generate good data. Well then, come back when you have the good data and then ask to get a vaccine approval. Duh.
Peter Marks did not hear when they said they would have vaccine available — he thought it took three months — but they promised to have it sooner, which is probably indicating they have already started.
Moderna’s Hough says they will 100s of millions of doses in July and August and they have already been making it. To change to a BA4-5 it would take three months if they needed no clinical data — could have large amounts in October and November, which assumes a rapid FDA concurrence.
Kathrin Jansen is back! She is wearing silk. She retires very soon. Apparently, Pfizer is ready to roll out lots of BA-4 by October. Novavax has also been manufacturing “at-risk” and has BA.1 and BA.5 in the works. They can supply it by fourth quarter but made a strong case for their prototype vaccine as sufficient, without going to an Omicron additional antigen. They need to know what clinical data will be required if any.
Levy asks what is going to happen at FDA regarding correlates of protection — when will we have data we can rely on? It needs federal leadership, and the sponsors should be required to gather this information. Why no correlate, no T cell data, inadequate preclinical data.
Peter Marks jumps in as this meeting is not going well. He stutters. T cell immunity is very important, we have not ignored it, we are pursuing it — it will be increasingly important as we lack a naive population. We can extend the meeting another half hour. Monto laughs. (He is probably thinking, how can I pull this together with 30 more minutes?). Monto says there are 10 hands raised. I can’t speed this up. I am not sure we can address the BA.1 vs BA.4 or 5 today. We can’t force the agenda. Dr. Sawyer says we are all troubled by the erosion of immune protection.
Eventually, we will have vaccines that do not protect against severe disease. We will be behind the 8 ball if we wait longer — we have enough data to move forward with the strain change. A BA.1 is sufficient and I am willing to extrapolate data for all ages based on what we have heard.
He is trying to herd the team back to the usual unanimous yes vote. Adam Berger says it mutates much faster than flu … WHO seems to make sense … concerned about the meaningfulness of the titer data, however, I support the idea of a strain change, but not sure it is needed now. We don’t know what we will have later in the year. Not sure we have evidence to support a change. Novavax showed a strain change may not be necessary. Maybe the question we vote on needs to be narrowed.
Monto asks Marks to comment on the waning of severe disease protection. Marks begins by saying we must be accurate. Hmmm. We know that efficacy is waning. Half the U.S. has not gotten a single booster. Their immunity has waned. After three doses esp those over 60 protection wanes which translates to increased risk of death that is ameliorated by a fourth booster (dose). But we can’t keep giving boosters. The thought is to try to match the furthest evolved strain. Four to five are the strains for which current vaccines have the least effectiveness. The goal for today is to try to come up with the right composition for deployment this fall. Not for right now, since we are at a plateau of cases (and the lowest level of deaths since the start of the pandemic — Nass).
Marks says BA.1 vaccine does not do a good job neutralizing the BA 4-5 variants. Weir is asked to jump in as Marks may have put his foot in it. Monto inserts the need to make a decision today.
Weir says look at everything. BA.2 is closer to the current variants than BA.1. Monto tries to shut him up but he wants to finish.
Dr. Perlman wants a later variant, not BA.1. BA.4-5 picked up some of the older mutations. He wants a bivalent vaccine. But worldwide will this fly? Will it be accessible in the rest of the world? Will this affect getting vaccines out to the rest of the world? Dr. Reingold is worried about the profusion of different vaccines for providers. Confusion. Storage.
Dr. Lee — but Cohn starts talking instead. She wants a bivalent vaccine since the prototype vaccine is so good. Four to five seems the right way to go.
Dr. Lee supports strain change but data are all in adults. She missed the data on even more waning in children. How could she miss the NY state DOH data that was reported in the NYT and preprint on Feb. 28 and was published about six weeks ago.
Chatterjee says we are seeing severe disease in vaccinated people. So change strain. A bivalent with 4-5 would be good if we dont need it right away. Where is the pedi data? Saying there is none is inadequate. She will not extrapolate adult data to children and pedi studies need to be done now.
Dr. Bernstein says do we need to change now? The strain change should be data-driven but today’s data are very limited, especially for 4-5. And they have not proven to be effective against severe disease. We don’t know if there is improved efficacy. In sum, the data are limited. Monto looks unhappy. Bernstein reminded people of the last meeting in April when they all demanded real data.
Marks tries to change the subject, invoking a potential emergency need. The totalitarian method: invoke a possible future emergency. He tried to herd everyone away from data concerns.
Monto is unhappy. Marks says the manufacturers have made BA.1. If we need to deal with something “right now” we could deploy the BA.1 vaccines. We should assume we would need to deploy in October-November.
Monto shocks me by saying something sensible: why give the ancestral strain since it will never come back?
Nelson likes the bivalent vaccine. He thinks we don’t know what is happening at the cellular level.
The members realize time is apace, and so now they are telling us how they will vote to move things along. Sounds like they have decided to avoid the questions of how many boosters are too many, the lack of data, the issue of imprinting (as raised by Dr. Meissner now).
Meissner says the bad word again: myocarditis. He does not say that boosters are causing increased rates (which has been seen in at least one study I read).
Meissner says when we don’t know what side effects will ensue, let us confine the new vaccine to adults first.
Peter Marks makes me want to scream — he feels very comfortable regarding safety using the BEST system — what a fraud he is, they hide all that data. He is an apologist “I think we will have good safety systems in place because we already have them here …”
Gans sings a peaen to our safety data. What? Bruce Gellin says the vaccines are marvelous but we need better and he wants to know the plans to get ahead of the virus.
Berger wants to see some CMC data, we really need some clinical data to support a change. Sawyer says clearly the majority says four to five is the way to go. He says we won’t hear about myocarditis in the clinical trial, and will only learn about it when we roll out the vaccines in bulk — echoing what Dr. Rubin said last October. Amanda Cohn says there is no myocarditis in kids according to “our data” which I assume means the CDC data, which no one trusts at this point.
Amanda wants to separate out the younger kids as at no increased risk for myocarditis — but we have seen to data supporting her claim.
NO data. Offit asks is Omicron what we need? What if he told you the boost in titer was not clinically significant with current strains? Offit drops another truth bomb. He is not comfortable and why ask patients to take a risk when we don’t have enough info?
Monto says we must vote now, comfortable or not.
The question for a vote is whether to add an (unspecified) Omicron component to COVID boosters in the U.S.?
I said add, but the question does not address whether the Omicron component would be monovalent or bivalent or something else.
Two No’s, 19 yeses, no abstentions. Bernstein and Offit voted no.
Good evening. This committee never disappoints. They always choose the worst option. The best option was to abstain on the basis of lack of information imho, or a no.
They are so lacking in backbone and memory — since in April this committee demanded clinical trial data before they would advise on a new booster. And here it is June, and they genuflect to Pharma and FDA. When Paul Offit is the most honest member of this bunch, all you can say is that we live in interesting times.
See you later!
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