Welcome to the FDA Booster meeting
9/18 Update: Steve Brozak at Forbes has written a review of the meeting here.
Dr. Sara Oliver is at it again. By using the tricks outlined by Dr. Mercola, she was able to lie and claim that unvaccinated people are 22-26 times as likely as fully vaccinated people to be hospitalized. Please review the Mercola article that I blogged a few days ago to learn many ways CDC/FDA manage to designate vaccinated people as unvaccinated.
To demonstrate vaccine effectiveness CDC stopped data collection by July, missing most of this last wave. The vaccine efficacy is just great and remains great. CDC cannot distinguish between effects of delta and waning of immunity, but vaccine efficacy drops (but only 5-10%) after about 6 months.
When asked to confine the data to only the Pfizer vaccine being discussed today, Sara waffles and finally admits Pfizer did not do so well on its own as the 3 vaccines lumped together. Which may be because the Moderna dose is 3.3x as large (100mcg vs 30mcg)
Dr. Kurilla says why did you fail to account for the people with recovered immunity? Sara waffles again, blaming her “platforms.” Kurilla says ok, but what about calculations of immunity, haven’t you done that? Sara will “get back to him” on that.
Sara smiles broadly at the end of questions, pleased that she has managed to dodge every substantive question.
Dr. Jonathan Sterne from UK talks about many of the potential biases in these studies but does not characterize the degree of bias in the studies being looked at today. Arnold Monto shuts him up after 2 questions.
Next we have the Israeli contingent. Dr. Sharon Alroy-Preis says that Israel had several institutions use different methods to assess the boosters. Although Israel has a data sharing agreement with Pfizer, only the final results were shared with Pfizer.
By the end of March nearly everyone who wanted a vaccine got one. Cases dropped and they were able to lift their lockdown without cases. Israel is 3 months ahead of other countries in terms of vaccinating its population. All residents are covered by one of 4 HMOs. All have access to the more accurate PCRs and don’t use the rapid tests. Israel’s data is excellent.
Delta was 98% of cases in June. Now they have more cases of disease than ever before, despite 85% fully vaccinated rate in most at risk population. Severe cases increased more than 10 fold in a month (to 80 cases per million, I think these are daily new cases, at end August), and 60% were fully vaccinated.
Dr. Milo shows that infection rates in all 3 age groups start increasing even after 2-3 months post vaccination, particularly for severe disease in the over 60 age group. He claims that if vaccine efficacy drops from 97% to 85% in a few months, relative risk rises 5x. Aha–this is the metric to be used to boost the boosters: 5x less cases.
Over 80% of the elderly have now received a 3d dose. Overall, more than half of eligible Israelis have now gotten a 3d dose, and the government offered it at 5 months.
I don’t understand why his data claim that on days 1-10 after the third dose you already have 2-5x reduced infection rate compared to those with only 2 doses. I don’t understand it because earlier studies show reduced protection for the first two weeks after the first two doses. There is no logical explanation why a 3d doses would be immediately protective. And in a later slide he shows that cases do not drop until 2 weeks after another dose, both for total and severe cases. Which is contradictory.
I think we can already see where this is going with the FDA.
- The claim will be that the US vaccines still work just great, say 85% efficacy, but with another dose we can get it up to 97%.
- And the next argument is that without a booster, Israel would have exceeded their hospitalization capacity.
What this argument fails to include is the fact that waves go up and then down naturally, they don’t keep going up. And the reason for this is that many people develop natural immunity.
Sharon claims that 7 serious AEs in 2 million recipients below age 65, (including anaphylaxis, myocarditis, Guillain Barre and Bell’s Palsy) were not connected to the vaccine. This simply tells us that whoever is designating causality is not an honest broker. The Israelis claim the booster works against delta, there were no new severe adverse events, and the rates of AEs for boosters are similar to the earlier doses.
Dr. Kurilla asks are you going to have to keep boosting every six months? Sharon says we don’t know where it is going. We will have to see whether there is a waning effect, or not.
Dr. Levy asks about myocarditis in the younger group. Sharon has memorized her talking points, and immediately says that myocarditis is more of a risk from the disease than from the vaccine. No one ever talks about how this would all go away if we treated our cases early with drugs. The participants don’t even mention monoclonals.
Dr. Gans points out we also need to control spread. What about household transmission in Israel, and especially to unvaccinated children in households? Sharon claims the vaccinated, especially those who were not “fresh” vaccinees did infect their households, but paradoxically claims they were not infecting other people.
Dr. Rubin asks who is getting severe disease? Could we focus boosters on them? She simply says age and obesity are the risk factors, but we cannot restrict boosters just to them.
Pfizer’s Donna Boyce says the company has distributed 1.7 billion doses. Pfizer submitted its booster data to FDA on Aug. 27, and in only 3 weeks FDA is ready for a decision.
Pfizer claims the issue is NOT delta, but rather waning. Pfizer’s trial for the booster was only conducted in those under age 60 and over 18–in other words, Pfizer omitted the group most likely to have a poor response.
Pfizer asks for approval of a 3d dose in those age 16 to infinity, asking us to take on faith the benefits in the highest and lowest age groups. “The duration of efficacy is currently unknown” but then Pfizer’s Dr. Bill Gruber says efficacy is 83.7% at six months.
Pfizer and Kaiser SoCal (Dr. Nicole Klein) got together and compared recipients after 7 days post dose vs never vaccinated. These data show vaccine efficacy drops to 40-50% at 6 months, but that efficacy against hospitalization doesn’t really drop at all–no doubt because of CDC’s tricks to not identify most hospitalized cases as vaccinated, even when they are.
But we need to keep in mind, says Gruber, that Pfizer prefers the Israeli data presented today to these Kaiser data. (which show the protection is waning as early as 2 months later.) And so we need the booster now, which will “restore” high protection against delta. He extrapolates that efficacy will drop to 60% at 10 months post 2nd vaccination.
Gruber claims efficacy wanes at 6-8 months, though efficacy against hospitalization was NOT SHOWN TO OCCUR. But he warns that we could have an Israel-like effect “soon.” Finally, he shows that vaccinated sera neutralized all 7 variants of current concern. The point is that the delta and other variants do NOT defeat the Pfizer vaccine, despite what you may have heard elsewhere, and despite studies making the same claim.
What this means is that Pfizer is not interested in chasing new variants, and will stake its claim on its original mRNA design, even though the wild type design no longer circulates in the world. My guess is that the reason for this is that FDA approval is much quicker without any change, and most likely it is cheaper to produce the original recipe.
Gruber shows a lot of data on antibody neutralization tests, but if he gave us information on how this test was validated to reflect measured immunity, I missed it. These tests do not necessarily mean much. But if they do reflect immunity, then WHY ARE WE NOT BEING ALLOWED TO USE THIS SAME TEST AND PROVE WE HAVE PRE-EXISTNG IMMUNITY AND DO NOT NEED VACCINATIONS, not even a single dose?
Dr. Gruber went way over his time, and Arnold Monto gave him 3 chances to keep going and wrap up, but he never got to the end. Monto has never given anyone this type of consideration before. Monto is actually a temp member of the VRBPAC, brought in to steer the vaccines to approvals.
Dr. Joohee Lee of FDA comes on, and tells us that Pfizer is not looking for an EUA for the booster dose, but wants it fully licensed. Even though there are only 306 people in the booster trial. All were aged 18-55 and mean age was 41. In other words, all were relatively healthy and cherry picked from the original 44,000 in Pfizer’s Phase 2/3 trial. She presents the immunogenicity data, obtained using a “validated virus microneutralization assay.” And she emphasized the assay was validated–even more reason for the fed agencies to let us use it to demonstrate preexisting immunity. Why aren’t people demanding why the same test Pfizer is allowed to use can’t be used for us?
Somehow Pfizer lost 25% of the 306 subjects. So much for intention to treat analysis–now we are down to 232 subjects. Oops, now we are down to 210 subjects, with no clear explanation of what happened to cause the new loss of 22. And now even more of them are gone and we are under 200 subjects. 35% of the original 306 subjects have been lost–POOF. This is not kosher, but FDA seems to have no problem with it.
Looking at her efficacy analysis, the results are confusing, and she admits it. So let’s move on to the safety data. The obligatory sentence is provided, “The most common adverse effect is injection site pain.” Duh.
She does the same tap dance as in previous meetings, providing systemic reactions for only the first 7 days after the 3d dose. These all go away. None were severe. Which is why we don’t care much about all this data on temporary reactions, which is what gets emphasized.
One month post booster the FDA continues its tap dance by refusing to report diagnoses, instead listing organ systems and symptoms. The heart attack at day 62 was considered unrelated. What were the 3 non-headache neurologic events?
Of interest, appendicitis is now being mentioned as a negative, along with Bell’s Palsy, anaphylaxis and myocarditis. This is a diagnosis that keeps coming up, and which may well be a newly identified vaccine side effect.
Now we have the open session. Finally someone points out that if vaccination induces new variants, it needs to be considered before approving (licensing) boosters. This issue has so far not been mentioned.
Dr. Jessica Rose did a good presentation on VAERS reports by year.
Dr. Retsef Levi from MIT challenged the happy stats from the Israel Ministry of Health
An ER doc from Louisiana demanded larger trials, explaining that the unvaccinated are very knowledgeable about their risk and vaccine risk, and need better data in order to prove the risk of vaccination is less than the risk of the disease for their demographic.
Steve Kirsch showed information showing higher death rates in the vaccinated. Why were protocol violations 5x higher in the treatment group? Why were Maddie de Garay’s severe adverse events hidden in the Pfizer 12-15 year trial data presented?
David Whitehead points out the data are very weak–very few subjects, and Pfizer/FDA have not investigated the multiple strong vaccine side effect signals. Why have cases spiked in Israel, in lockstep with booster rollout? Why are pregnancy problems not being attended to? Why no carcinogenicity study? He points out the COI of Eric Rubin, editor of the NEJM.
Kermit Kubitz says vaccine hesitancy is not rational.
Peter Doshi asks what problem is being solved by a booster? If this is a pandemic of the unvaccinated, why do we want to give more vaccine to the vaccinated. Yes, a 3d, 4th and 5th dose might nudge up antibodies, but what clinical difference does this make? (I keep getting interrupted by phone calls.) Finally, people who disparage the vaccine are being threatened by their medical boards with investigation, loss of board certification or even loss of license. Most or all of the VRBPAC and many briefers have board certifications and therefore could be subject to sanctions were they to take a negative approach in public to Covid vaccines. This is a conflict of interest. GREAT POINT, Peter.
Michael Carome, MD from Public Citizen likes vaccines but believes they should be equitably distributed.
Kim Witczak, a patient advocate, points out how the goalposts keep changing. How 200 people in a study may lead to mandating a 3d dose for hundreds of millions. mRNA vaccines were not designed to prevent transmission. Why did we ignore treatment to focus only on vaccination? Why do we want everyone to be vaccinated? To obliterate the control group? To mask the effect of variants? Why are we demanding doctors and public figures not tell the truth of their impressions about the vaccine?
Lynda Dee praises the data, the extrapolations, etc. It seems that, as in earlier VRBPAC meetings, if you believe the data presented, you will accept that the vaccines are extremely safe and effective. However, if you review the universe of Covid publications, and/or question the validity of the data presented, you can have a very different impression.
At 1:40, Phil Krause says the Kaiser-Pfizer study was not peer reviewed. The modeling used was complex. The model tells us the efficacy is 58-61%, while the efficacy according to cases is said to be 93.3%. He asked Pfizer why that is? This raises an old issue of how Nicola Klein MD, PhD gets her amazingly good (for the sponsor) results? She earns a lot of money from conducting multiple Pfizer trials using Kaiser HMO subscribers.
Now somehow Pfizer’s audio is awful and we cannot understand the responses. They are taking a break to fix it. Guess the unintelligible strategy didn’t work. Now we are back, and Monto cuts off the discussion.
Dr. Kurilla points out that cellular immune responses are critically important and yet have been ignored. Wouldn’t they be necessary to assess durability of the immune response? Pfizer’s Bill Gruber waffles in his non-answer. The next Pfizer expert is also unintelligible. Will this strategy work or will the committee demand answers? Pfizer’s Jansen asserts it is the antibodies that are most important, without adding any facts to the discussion.
Now Dr. Cody Meissner points out that what Pfizer ought to be doing is to match existing strains, rather than use a vaccine designed for a strain no longer present. Pfizer’s Bill Gruber does the trick of repeating the old slide of neutralizing antibodies against 7 variants, which makes it appear the vaccine works almost the same against all variants. Note these are in vitro data and of questionable relevance. Bill has become unintelligible. Cody retorts that newer variants will most likely come from the delta strain, why not use it? Monto prevents an answer.
Dr. Jansen admits to Dr. Hildreth’s question that they could not come up with a safe level of antibodies, and the necessary immune response is more complicated than antibodies. (It seems she needed to walk back her earlier assertion to retain credibility. This reminds me how she told us about the primate data on transmission at the December 10 VRBPAC meeting. Carefully hedging her words but at the end maintaining accuracy.)
Now CDC’s Dr. Sara Oliver is back chirping. Why does she never have anything of substance to say? Asked why the Israeli data and the CDC data are so different, especially wrt hospitalized breakthrough cases (60% of hospitalized Covid cases are vaxxed in Israel, 2% of them are allegedly vaxxed here, according to the lying CDC where she works). Sarah attributes this to US heterogeneity. Stan Perlman (a Daszak/Wuhan collaborator) blames the High Holy days. However, they just happened, so if they spread disease, there has not been enough time elapsed for people to require hospitalization.
Now we have Amanda Cohn jumping in to try and resurrect the narrative. Why are two CDC staffers members of the VRBPAC? Major COI. Amanda wants to raise the issue of sick young people but Sharon Alroy-Preis didn’t bite.
Now the audio is spotty again. Sara Oliver says ‘stay tuned’ in regard to Holly Gans’ question. Mark Sawyer asks how big the safety cohort was for other vaccine boosters, such as meningococcus ACY and W35? Doran Fink says FDA does not have one standard. For the JE vaccine they used 300 people–of course, almost no one receives it; it is a travel vaccine, not a vaccine being mandated for hundreds of millions. The DTP booster had about 1,000 people in the clinical trial. Dr. Portnoy is also having audio issues, as is Sharon. She does admit that 1% of those getting the booster saw a doctor for the adverse effects.
Dr. Levy wants to know whether myocarditis rates vary for the 3d dose–especially since it occurs about 4x more frequently after the second dose than the first. The rate was 1 in 6,000 between 16 and 20 earlier (2nd dose). The results for the third dose look good, but actually too early to tell.
Now Monto lets Pfizer have the last word, as they have fixed their audio. The ProPublica “Dollars for Docs” website tells us that in 2018 (the most recent year provided) Monto received $25,000 from drug companies, including $3,500 from Pfizer. Not bad for a guy in his 80s.
Now to the Question. It has been phrased as whether the Comirnaty vaccine should be approved (licensed, which implies mandated) for a 3d dose based on the small Pfizer clinical trial. But Peter Marks jumps in to say NO, you can use any data you want in your vote.
Dr. Hildreth says we needed an understanding of whether high neutralizing antibody titres might worsen myocarditis risk, and echoes concern about why the mRNA code was not adapted to reflect newer variants. Dr. Gans points out the lack of safety data that was provided. Notes missed opportunities–why weren’t the 3d dose subjects checked for humoral and cell-mediated immunity before and after the 3d dose? Why hasn’t Pfizer looked at alternative schedules (and I think she means alternative doses here, too). Paul Offit says memory B and T cells are induced by the first 2 doses. OMG he actually points out that the risk might outweigh the benefit in the young people. He will only support a booster in older age groups. Arnold is getting nervous.
Dr. Kurilla wonders what FDA has to say about 4th doses etc. He also wonders how Pfizer can say on the one hand that their 2 doses provide strong T and B cell immunity, but after 6 months things wane significantly? How can both be true?
Marion Gruber PhD says Pfizer only asked for approval of a 3d dose.
Cody Meissner says we still dont know the proper interval between doses, nor do we know the proper dose. Some data suggest a lower dose might be effective. Why hasn’t Pfizer checked before and after troponin levels? We need reassurance on myocarditis.
Dr. Fink says according to VAERS reports 1/15,000 16-17 year old males are reporting myocarditis. He has other data suggesting 1/5,000 doses cause myocarditis in this age group. OMG, he suggests they should study to find out the rate of subclinical cases!!! That is exactly what needs to be done.
This means the FDA has finally gotten cold feet re pushing this vaccine on children. Recall the 2 military studies that showed 1 in 30 who got one dose of smallpox vaccine developed subclinical myocarditis.
Eric Rubin says we don’t know enough about risk. It is probably okay in people over 60, based on Israel. Eric Rubin claims that transmission is driven by the unvaxxed in the US, and therefore it will continue to occur. (He omits the issue of ever increasing natural immunity.)
It is funny that by accepting the fake CDC number (only 2% of hospitalized Covid patients are vaccinated) the committee and most of the FDA staff seem to be against a booster dose now. Biden may not get his Sept 20 third doses after all. I predict CDC will now be tasked with showing that suddenly we are drowning in breakthrough, vaccine failure cases… and then boosters will be granted.
3:15 and gotta run to work—
It is 4:40pm and the NY Post reports the committee did vote against the license for a 3d booster dose. For now. Wonder if they were pissed they had not been asked their opinion about licensing it in the first place?
The panel noted research published in the New England Journal of Medicine in July showing that people who have received both doses of Pfizer’s COVID-19 vaccine are still 88 percent protected against getting sick from the Delta variant.
I also wonder if some of this hinged on the fact there is an insufficient amount of the licensed vials to begin boosters right now for the public. Tripped up by their happy talk about how effective these frankenshots are? Scared about what would be happening to children? Who knows.