FDA VRBPAC Meeting, April 6, 2022 — Meryl Nass, M.D.
Here we are at another FDA [U.S. Food and Drug Administration] vaccine advisory committee meeting. This is CBER’s [Center for Biologics Evaluation and Research] only advisory committee. Since the start of the pandemic, most of the permanent members disappeared and new ones have been appointed as temporary members.
Dr. Arnold Monto is chairing again. He is a temporary member. Today is only a day for discussion of variants, strain selection and boosters. There will be no vote. Dr. Monto emphasizes that the lack of a vote does not minimize the importance of the discussion today.
Dr. Alan Berger is a new member from NIH [National Institutes of Health] who has something to do with human subjects research. The next person was new and I failed to get his name. Amanda Cohn from CDC [Centers for Disease Control and Prevention] is a member. David Kim is an NIH National Vaccine Program administrator. Paul Offit from CHOP [Children’s Hospital of Philadelphia] is well known. Eric Rubin is from the Harvard School of Public Health and NEJM [The New England Journal of Medicine]. Randy someone is a pulmonologist who is the new consumer representative. Jeannette Lee’s area is multicenter clinical trials. Off specialization. Ofer Levy from Harvard’s precision vaccine program is back. Wayne Marasco of Harvard (AIDS specialist), Cody Meissner from Tufts, Michael Nelson from the Army and UVA [University of Virginia] is an immunologist and studied reactions to anthrax vaccines back in the day. Mark Sawyer at UCSD [University of California San Diego], Stan Perlman from U Iowa and the Daszak connection. Last member is Melinda Wharton from the CDC.
Are you surprised at the number of federal employees, two CDC officers, and a 4-person contingent from Boston, where the CDC Director is from?
I missed Dr. Hildreth from Meharry and one person who was mostly muted.
I meant to say that multicenter clinical trials was an odd specialization. Is she an epidemiologist? Wayne Marasco was muted. Paula Annunziato is the non-voting Merck member. Randy Hawkins is the consumer rep?
There will be international guest speakers today. John Beigel will be speaking (more on him later) and someone from BARDA [Biomedical Advanced Research and Development Authority, as well as 2 speakers from the BMGF’s [Bill & Melinda Gates Foundation] own University of Washington. Israel’s Minister of Health, Sharon someone who spoke at an earlier meeting will be here. All have supposedly disclosed their financial relationships.
Dr. Peter Marks tells us that COVID is a big concern as the next cold season approaches. He claims that immunity for those who recovered as well as were vaccinated will have waning immunity. There we need to discuss boosters “if it is thought warranted.” Does FDA think it is warranted? Last week they authorized a 4th or 5th booster but failed to specify or recommend how it might be used. That is because the booster has very brief effect and FDA didn’t want to address that little problem.
Doran Fink leads the next discussion. He says there have been 80 million reported cases and 1 million reported deaths — but this is before CDC removed about 20% of those deaths recently.
CDC estimated at the start of last October that there had been 144 million cases in the U.S.
The Omicron variant affected more Americans than any other, so the vast majority of Americans should have some degree of recovered immunity and about 250 million Americans have been vaccinated.
However, FDA has seen evidence of waning of vaccine-induced immunity. He admits there is waning against severe outcomes as well. About time.
Fink further admits that there has been antigenic escape of current viruses. Current vaccines are not well matched to current viral strains. Nevertheless, booster doses improve immunity. But for how many weeks?
We need to plan for the future. Considerations include vaccine strain composition. Should more boosters be recommended? If so, when and for whom?
We need to make decisions that are sensible, practical and understandable, with all key stakeholders.
It is critical to achieve buy-in and avoid confusion. FDA wants to make the best decisions possible for Public Health.
First presentation is from Health Scobey from CDC, second also from CDC. Third will be Sharon Alroy Preiss the MOH [Ministry of Health] of Israel and a second Israeli on their experience with fourth doses.
After that we hear from Beigel (who helped sink early treatment), Trevor Bedford (another coconspirator of the origin coverup BTW) then Christopher Murray, of the BMGF fully funder IHME [Institute for Health Metrics and Evaluation] at U Washington. Missed someone here. Robert Johnson from BARDA and Jerry Weir will speak. Then there will be an open public hearing with some of our brilliant friends like Peter Doshi, Matthew Crawford and others.
It looks like FDA will be recommending strain composition of new COVID vaccines, although I thought this was a CDC function for flu vaccines. Maybe I am incorrect. Whatever gets decided, I suspect that CDC and FDA want some cover from this advisory group in case they get it wrong.
Dr. Hawkins wants a “targeted narrative” to the public. Is this code for increased censorship?
Dr. Hildfeth asked Dr. Marks why he didn’t convene an advisory meeting to make the booster decision last week?
Peter Marks says we thought it was reasonable at the time, and today’s discussion is a larger discussion. In other words, he has no answer to Dr. Hildreth.
Heather Scobie of CDC will discuss strains of COVID. B.A.2 has risen to include over 80% of a COVID strain but there are low case counts and low hospitalizations now. There are 15 RBD mutations that create resistance to monoclonals and convalescent sera.
Over 80% of current U.S. strains that is. She says about 60% of kids have had infection, 22% of elders and 38-48% in other adults.
Based on measures of N antibody 70% of the eligible population has been “fully vaxxed” and 97.5 million have been boosted. The booster percentage is higher than what I saw elsewhere.
Now she acknowledges that 67% of the U.S. monitors cases and vaccination rates at the state level, for CDC.
She omits how the vaccinated are defined, allowing her to say that the unvaxxed have 2.8 times as many cases and many more deaths.
This flies in the face of data from England I discussed the past few days which reveals higher death rates in the doubly vaxxed than the unvaxxed.
COVID-Net involves over 250 hospitals in 99 counties and this appears to be where CDC gets its hospitalization rates in the vaxxed and unvaxxed. HOWEVER, DOES THIS DATASET Accurately collect data on who is vaccinated? One dataset I discussed last night on my blog called most of the vaccinated unvaccinated.
The way this happens is that CDC has other databases with vaccination status of everyone by state. But patients’ clinic electronic medical records and hospital records fail to record all vaccinations because the majority were administered in large stadiums where there was no medical care and they did not get recorded in patients’ medical records.
In addition, you are considered unvaccinated until two weeks after the second dose,
Furthermore, you are not officially considered vaccinated until two weeks after the second dose, so if you get covid before then you are considered unvaccinated. Similarly, hospitals were asked only to report COVID cases if they are positive with a PCR CT under 28. So if you don’t meet that lab criterion, hospitals are not supposed to report your case to CDC.
In other words, changing ways that data are collected and using incomplete databases guarantee that CDC will get incorrect results.
I heard yesterday that researchers at Kaiser had access to the state databases which is the highest quality database of vaccinations. Using this to supplement other data, the researchers Scharff et al found the highest rates of myocarditis post-vaccination in the U.S.: higher than 1 in 2000 18 to 24-year-old males within a few days after the second dose?
Dr. Scobie says they are trying to make all the data available. What a joke that is: see the article by Apoorva Mandavilli in the NY Times at the end of February about how CDC hides most of its data.
Well, the meeting went silent for me. I tried Youtube and it is still silent. I see mouths moving but no sound comes out. Looks like they are having technical difficulties, so there is a break.
Dr. Link-Gelles from CDC is now speaking. At five months kids were at negative efficacy for ? Pfizer vaccine.
The J and J vaccine efficacy in kids was 30%.
mRNA waned faster for Omicron.
VISION Network of ER and urgent visits. After 67 days since the second dose, efficacy is under 20%. She is moving fast and I cannot distinguish between vaccines and ages well.
Now she discusses the data from last week’s NEJM hospitalization paper. She denies waning for a hospitalization effect — probably because the study methods were bogus.
This was explained by Dr. Setty in the Defender. The control group was not appropriate. I suspect she is moving so fast to avoid explaining the methodology of her data
The important this is to go back to the papers (if available) and determine how the subjects and controls were collected. It is simply illogical to think that the vaccine efficacy at preventing cases wanes in a few short weeks, but remains strong at preventing cases. I would like a federal employee to explain the mechanism of how this could possibly occur.
Note that she tends to give very short durations of vaccine effect — such as two months. Do you really care how well the vaccine works at two months? Are you ready to get boosters every two months? Isn’t the real question how it works at 6 or 12 months?
She, like Amanda, is an officer in the Public Health Service. They exemplify how their work is really to confuse and propagandize. The audio has dropped off again.
Dr. Marasco asks about immune correlates in the cases she described, and wonders if in 4-6 months are antibodies too low to protect? These studies did not look at that.
Audio keeps dropping off — I guess FDA/CDC are not comfortable with the presentations.
The VISION has an extremely large catchment area in the millions— so presumably, it has the potential to provide valid data.
The 2 Israelis are presenting together. Dr. Alroy-Preiss has previously presented and tried carefully to give FDA what it wants, even when the Israeli data presented elsewhere are not so positive. It will be interesting to see how she discusses the 4th dose, which has been reported as basically a disaster elsewhere in healthcare workers
A 4th dose was offered to all adults with 50% uptake.
It was offered 4 months after the 3d dose.
The period of analysis was only 7 weeks. About 13% of the subjects got COVID during this brief period.
By week 8 it seems there is no benefit at all from the 4th dose in terms of infection, but it appears there is increasing benefit in terms of severe illness.
How could this be? If you torture the data enough, it will confess to anything.
The definition of severe illness is from NIH and is not a hard endpoint like hospitalization.
Severe illness is O2 under 94% for example, not that bad actually.
Dr. Alroy Preis does not look happy— was she forced into misrepresenting her data?
I did not understand the 4th dose mortality analysis.
Adverse events per million doses within 30 days of vaccination are captured by a passive system and myocarditis only has active surveillance.
Passive reporting of mild and serious reports are relatively small numbers. Twelve serious and 2 anaphylaxis episodes in 750,000 4th doses.
4 pericarditis cases but they are all old, 1 myocarditis, 1 heart attack, 1 stroke
Very few young people, only the chronically ill, were offered a fourth dose.
There were 213 myocarditis cases for all doses in the 30 and under age group in Israel, population 9 million— so probably this represented a population of about 2 million who were vaccinated under 30, maybe less.
In other words, whatever method was used, there were about 1 in 10,000 vaccinees who got myocarditis, or almost 1/5,000 males. The sound has been lost again. There has never been this much audio trouble before, and the weather is good.
Sorry but FDA has still not fixed its audio problems so nothing is happening.
Still no audio and no meeting.
Did FDA not really want to host this meeting?
Trevor Bedford, a Daszak/Fauci co-conspirator on the origin coverup and an NIH grantee from BMGF’s U Washington presents now.
He reveals colored pics of the “clouds” of viral mutation and evolution. You can see that Omicron did not arise from any of the older variants…a telltale sign or lab origin, which he fails to mention.
Omicron has a large number of new mutations, suddenly.
As someone who has demonstrated interest and ability in spinning stories about viral evolution, it is worth watching Trevor to see whether he is creating a new narrative now.
He assumes a rate of 1 in 5 people diagnosed who actually got Omicron. I agree with this estimate, which suggests half the U.S. population got Omicron, whether or not they had symptoms, they have immunity.
He notes that variants can emerge that will defeat vaccine or recovered immunity. Well yes, anything is possible. He admits we don’t actually know much about this.
Now he is making guesses of what might occur. Based on his guesses, he recommends we should be prepared to deal with a wide range of mutations/variants. Duh.
Now for John Beigel. He was involved with vaccine studies at NIAID. Again, we can’t predict the new strains but despite that we have to be ready to respond.
I am hearing a lot about visualizations that seem to add nothing to his discussion. Now he discusses the NIH COVAIL trial which only started recruiting last week. In other words, there is no data and it is mainly looking for antibody levels, not real-world efficacy. So this presentation so far has said nothing. I wonder why he was put in here as a placeholder?
Conclusion: we think there will be continued evolution and we don’t know what it will be. We need to learn how to use available vaccines. What a nothingburger.
Beigel is the guy who nominally changed the endpoints on the Remdesivir trial. So perhaps he is Fauci’s fall guy.
The sound is coming and going, which allowed Beigel to dodge Rubin’s question
Silence envelopes the final question for this section
Monto: “we are going to have to move on.”
Now Bill Gates’ own 2 guys, from the IHME which Bill fully funded, which is located near the BMGF building in Seattle and away from the UW campus.
Christopher Murray is the Director of the Institute. He pioneered the publication of articles with a thousand pages and hundreds of authors, making them essentially immune to peer review.
Now the slides are invisible while the sound works.
Finally, there is a drop of enjoyment as Murray is disconcerted with the AV difficulties.
I am sure these problems would never occur if the BMGF was in charge!
These are the people who gave the US the whacko predictions about COVID and deaths back in 2020, as demonstrated by the COVID Task Force under Trump
Chris Murray, modeler extraordinaire is now modeling immune escape after infection or vaccination.
Now let’s see how good his estimates are…will this be another GIGO talk?
His work is already no good, as he has hospitalizations over time climbing dramatically. Are these cumulative hospitalizations? If so, that is a bad way to demonstrate what is happening
So they model underreporting of deaths — except most people think there is over-reporting of deaths. Then he models infection fatality rate by age. In other words, Bill’s favorite guy, Chris, piles one model on top of another on top of another and then he finally gets something in the end that is a guesstimate of a guesstimate of a guesstimate of an algorithm, plus estimates by analogy …
You get the idea.
This eminence concludes that even Omicron immunity will wane. Also, it is likely that 60% plus of the world will have been infected with Omicron.
The master predicts no waves through July 2022.
Paxlovid won’t affect transmission but will affect deaths, according to Murray. However, if paxlovid works to kill the virus early, it should reduce transmission somewhat also.
His models suggest that 80% of the U.S. is currently immune to Delta and 70% is immune to Omicron right now.
He claims masks and distancing will “dampen” viral transmission and influence the trajectory of his models. Well, that is a good hedge— if his models fail to predict what happens, he can blame masks and distancing.
Sound gone for the first questioner.
Dr. Hank Berman? got his sound. He (Murray?) claims masks had marginal benefit during omicron. There is a time delay so it is hard dto tell who is actually talking.
Cody Meissner got his sound. “Why are we seeing so many variants?” Given its proofreading function in the RNA polymerase, it should have fewer mutations than other RNA viruses. He would have expected an RBD binding mutation (which exist in other coronaviruses) that could put current vaccines out of business.
Murray punts to Bedford, who wasn’t listening. Meissner repeats, asking about mutants that could bypass the ACE-2 receptor. Bedford brushes the question off with a non-answer.
Dr. Kanta Subarrao (prior CDC and NIH) is now at the Peter Doherty Institute in Melbourne, to talk about what WHO thinks about emergency of variants.
There is a technical advisory group to assess methods to assess the impact of variants etc.
After WHO’s experts decided to give over 1000 humans an overdose of hydroxychloroquine in early 2020, one had to ask who are these experts and how are decisions actually made. Do all these committees actually advise WHO or do they provide WHO a veil of expertise to cover decisions made elsewhere?
Dr. Kanta is spending too long describing WHO’s committees and methods.
This perhaps means that in terms of the meat of predicting variants and vaccines, the WHO had nada.
Yes, “This is how we plan to approach this” she says, so in fact, she has absolutely nothing to tell us.
But we are all in it together and the manufacturers are our friends.
Key messages: the current vaccines prevent severe disease and death — I showed this week that is not so.
It seems extraordinary that with all the technical difficulties and people who did not get a chance to speak, Dr. Kanta is give so much time to tell us nothing whatsoever.
I wonder if the approximately 5 second time lag between the video and audio is deliberate so that people can be cut off if they say something that is undesirable
Melinda Wharton, who has covered up vaccine injuries at CDC for decades, chimes in. She asks a simple question: will WHO be recommending a strain change or not, if so, when? Dr. Kanta cannot give a timeline.
Kanta saiys only the Omicron was a significant antigen change…implying that the vaccines were great until Omicron. However, the NY and California state DOH data revealed better efficacy from recovery than vaccinations (by a factor of 3) during the Delta wave. In my book, that is proof that vaccine efficacy was inadequate during Delta. Whether that was due to Delta or due to waning over time I cannot say — but we should not fool ourselves about the benefits of current vaccines since mid-2021.
The current vaccines, Kanta says, provide “some” protection, not robust, against Omicron. But she repeats the meme that they prevent severe illness and death.
We know from the English data I presented over the past few days, published by the UK’s ONS last month, that for those over 70, who comprise the bulk of deaths, the doubly vaccinated were dying at higher rates than the never vaccinated.
We also know from the California DOH data released in January that there were more hospitalizations in the double vaccinated than in the never vaccinated. That was not true for those who got a 3d booster. So, while getting vaccinated every few months may help prevent deaths and hospitalizations for now, those original two doses do not provide you protection against these outcomes.
Robert Johnson from BARDA reveals how the USG spends about 1.5 billion yearly to try and get manufacturers up and running to be ready to provide product when it is needed.
Sorry, 2 paragraphs ago I should have said the double vaccinated had more hospitalizations than the never vaccinated, but recovered.
This is another talk that is entirely unnecessary. Presumably, this meeting is occurring to FDA can say it happened, since none of its experts is expert in manufacturing and none of their advice is relevant to what is being discussed.
Now both Johnson and Ganz are talking at the same time but we only hear Ganz.
What about a COVID plus flu shot? They think it will be easy to manufacture.
Dr. Rubin asks about the platforms being used for mRNA: how fast can new vaccines be made?
The delay has increased. Is it 10 seconds now? Dr. Rubin tried to respond to the non-answer, but he was muted.
The censorship just seems to be getting more and more obvious.
Now is the best part of the meeting — the outside speakers
Josh Guetzkow of Israel asks why so many don’t go back for the next shot. I have noted that about 14% of those who got a first shot did not go back to complete the initial series. Why?
Josh shows the MOH database minimizes adverse reactions by several orders of magnitude.
He mentions the Sheba hospital study in healthcare workers, in which 6.5% of subjects getting a 4th shot had a serious adverse event.
The effect of repeated doses is unknown. Approving boosters when the efficacy is very low and questions about safety and efficacy have not been answered is unacceptable.
Jessica Rose showed high rates of disability after 3d and 4th doses. She then emphasized the issue of conflicts of interest in voting members of the VRBPAC.
David Whiteman always gives one punch after the other— he goes so quickly I cannot keep up. Every point is spot on.
22 slides in 2 minutes: He started at 1: 50 pm. Watch it and slow it down to get all his points, as it is impossible to grasp all of them in real-time.
Next is Maria who barely survived after COVID. Her life will never be the same, and she feels vaccines are the answer. Unfortunately, she did not receive early treatment and was sent home from the hospital before later being admitted. It is too bad she does not realize she was failed by the medical system when she became ill.
Peter Doshi is next. He discusses the Pfizer trial/Ventavia whistleblower, who revealed serious deficiencies in the conduct of the trial, which managed about 1000 subjects. The trial was unblinded for staff and this is expected to affect the outcome. Yet FDA accepted all the data generated by the Ventavia sites, despite knowing the problems and failing to do a site visit or further investigation.
Moderna only inspected 1 (1%) of its trial sites. The public paid for hte products and the studies and has a right to data transparency. FDA has an obligation to act on the information provided.
Brianne Dressen is a subject who was injured by her 1st dose fo the Astra-Zeneca vaccine, as a trial participant.
She was NOT followed by A-Z despite claims to the contrary in the trial protocol. The NEJM would not publish a letter she wrote about her experience. She knows others who had similar experiences, some of whom committed suicide. She still has no access to treatment for her vaccine injuries.
The members of VRBPAC could demand the data on the vaccine adverse events. They could recommend that studies start. FDA could assure safety and efficacy, which it has not done. FDA’s silence is deafening.
Alexis Robinson is another vaccine victim who presented next. She has a list of about 20 different problems and symptoms. She is in constant pain. Her symptoms were never disclosed as potential reactions to the experimental vaccine she received.
When will the injuries be acknowledged and treated? When will they be believed? Why won’t doctors report us to the healthcare system?
We need research into vaccine injuries; instead, we are continuously silenced.
Sarah Gleason, a 42-year-old massage therapist who closed her business until she could be vaccinated. After the two Moderna doses she became ill the same day. She too has more than 20 different problems. There is no transparency of the data. But her doctor can only provide “bandaids.” She can’t work or socialize. She has no income. Why isn’t the healthcare system curious about our injuries?
Karen Discoll is the next speaker. 62-year-old RN. After the second Pfizer her life changed. She too has a list of about 20 symptoms including serious brain fog, hyperacusis, vibrations, postural orthostatic tachycardia, breathlessness. She cannot work. Her doctors provided no answers. Specialized tests show continuing platelet activation and endothelial dysfunction. We need scientists here to try and find solutions to help us.
Amy Fischer age 58 is another person with a serious vaccine injury with autonomic dysfunction, mast cell dysfunction and chronic fatigue syndrome. Weeks later she was overwhelmed with intense fatigue then pains in her legs. There was no long COVID. She is incapacitated with mild exertion, pain in all limbs, buzzing in ears, and has not worked in a year. Would steroids and IVIG have helped? Why didn’t her doctors know? She is still not reported to VAERS by anyone. How can FDA be talking about more doses and newer cOVID vaccines while we, the vaccine injured, have been ignored?
Rita Das is a Moderna employee and ID doctor. Why is she speaking as a member of the public?
She is one more person who (again) claims the Moderna shot prevents severe Omicron disease. She supports a second booster. Bivalent vaccines are already in clinical trials as modified boosters, with an Omicron antigen. Moderna is committed to producing vaccines for emerging variants of concern.
Mathew Crawford says there is no transparent data showing vaccine efficacy. Why were so many people in the treatment arm excluded from the analysis? The trials never met basis evidence standards.
The study methodology could make a saline solution appear to have 72% efficacy. He points out a variety of methods by which bias has been introduced into the vaccine studies. Absurd results reveal the bias. Data in some studies were manipulated prior to publication. He points out other data that suggest vaccination is associated with significantly increased deaths.
Kim Witczak asks why are we meeting to discuss boosters today when FDA authorized boosters last week with no meeting and no vote. What happened to the open transparent process we were promised?
By March 2021 Pfizer was studying boosters. Before Delta. Always another dose to end the pandemic. And now Peter Marks hinted we will likely need a 5th shot in the fall. Despite the historic high number of VAERS reports of injuries and deaths.
The European Medicines Association is concerned about problems from too many boosters, while we try to justify ongoing boosters. The use of the EUA is poised to cement a regulatory precedent that will destroy the public’s confidence in FDA regulation for years to come.
Rebecca Rotem. Her son had two Pfizer doses and a proven case of COVID, but now he is being required to get a booster— at age 12. Please explain this to me.
Andre Cherry is a 22-year-old seriously injured by his COVID vaccines. He can barely leave his home and is in a wheelchair. FDA won’t let people make free decisions when it hides the facts. We demand our god-given right of justice and equality.
Tanya Grisham was a healthy person until her Pfizer vaccine. Brain fog, paresthesias, hair loss, inability to stand, hyperacusis, and her 21-year-old son had to come home to help her. Finally, she got confirmation of her vaccine injuries from 3 doctors. She begs FDA to acknowledge the vaccine injured exist and need treatment. Just last month 3 members of the vaccine injured community committed suicide. We should not be abandoned in our time of need.
Jasmine Walker got one dose of Pfizer and developed an autoimmune disease with neurological issues, brain fog, tremors, skin lesions, single mom of 2 special needs children. No assistance from govt or health system. We are being swept under the rug and unheard. Please help us. Please don’t ruin the lives of our children. We did our part to keep everyone safe. We need FDA and the medical community to take us seriously. The danger is known. This could have been avoided.
Matthew Matlock. Combat vet and father of two girls, just finished a half ironman. Changed after second Pfizer vaccine. Ignored and gaslighted. Finally found physicians to acknowledge his cardiac issues, reactivation of Epstein Barr, purple extremities, a mast cell disorder, etc. Why were we affected? Apheresis, antiplatelet and antithrombotic seem to help. Please look into this. Stop shielding information to the public. This is not informed consent, it is deception. It is borderline criminal behavior.
Daniela Clark is another vaccine victim with similar symptoms: hyperacusis, tinnitus, tremors, brain fog, insomnia, extremity pains and paresthesias. Vomiting and 20 lb weight loss. Burning neuropathy. The reports of symptoms are so similar … and remind me of those severely injured after anthrax vaccine.
Pam Warren got two Moderna shots, and worked at the Red Cross running apheresis machines. The vaccine injured were forced to start taking care of each other and doing their own research. This is not our burden — this is the FDA’s job.
Dr. Jerry Weir is the next speaker. He is an FDA researcher. His is the final prepared presentation
So now I will tell you the bottom line of this meeting: FDA has no idea what it wants nor what it will do regarding planning for new versions of boosters. None of its speakers is willing to venture a guess as to what will be needed. Of course, all are scared that they will recommend some variant that will have disappeared before the vaccine rollout.
So this is why wwe are still using the old Wuhan strain vaccines: no one has the guts to select a new strain.
And there has been virtually no intellectual discussion regarding the data already available to make such a selection. In other words, this meeting, apart from the fabulous public presentations, is a lot of verbiage, signifying absolutely nothing.
Nothing.
Weir says vaccines for flu are 60% effective when they match circulating strains. That might be true, but overall efficacy for many years, averaged, is more like 40%
So if none of these national experts and Israelis can do anything to suggest the next version of the vaccine, maybe we don’t need a new vaccine. Hello? Did that ever occur to any of these experts? If Bill Gates’ people, the CDC, the FDA, and the Israeli MOH have no advice for us, doesn’t that say something? Doesn’t that shout something?
Furthermore, I don’t think any of them want their fingerprints on a new version of the vaccine, since they may be dragged into a courtroom and they don’t want themselves to be culpable, given what they know. They are probably already wondering how FDA allowed so many of the vaccine injured to tell their stories today — they will not be able to protest they never heard about such problems.
It is bizarre to hear that FDA seems to have done nothing in terms of going forward regarding newer COVID vaccines — as if today is the first time they thought of it. Is this because they are slow-rolling the idea?
I think the FDA is scared to death of the corner it has been backed into with these vaccines. It can continue with current vaccines (it is good at institutional inertia) but is leaden in terms of having taken even a single step forward in planning for newer vaccines.
I wonder if Robert Califf is simply trying to avoid the COVID vaccine mud puddle? The FDA has unbelievably left it to the VRBPAC to design its program. I have never seen anything like this before. And the sound just went off too.
Peter Marks just entered and said there is a compressed time frame to make a decision on new COVID vaccines. Monto says you can’t get clinical trial data until a variant emerges … Peter Marks says let’s think about a May-June timeline.
Has any of these people ever heard of ivermectin or hydroxychloroquine?
Why don’t they simply admit the vaccine experiment failed and move on to early treatment…especially since the drugs IVM and HCQ can also be taken weekly for prevention in those at high risk of a bad outcome?
Meissner admits we do not have correlates of immunity. Exactly. Antibody tests do not reveal vaccine effectiveness. Dr. Weir agrees that, unlike for flu, you cannot rely on antibody levels to assess COVID vaccine efficacy?
Doran Fink does not know what the effectiveness threshold should be for new vaccines. Hmm, seems he forgot what he laid out in December 2020: 50%.
He says that FDA will rely on CDC data for effectiveness. Uh oh. We know how CDC spins its data. FDA has access to massive datasets, such as the medicare, medicaid and VA databases — it ought to do its own study of effectiveness since it can easily do so.
Hayley Gans points out that “this is an unsettled environment” and there is no reason to think other models like flu are applicable. What the committee needs to hear so we can make recommendations and vote, is we have to have explicit information on correlates of protection that are valid. Thank you Hayley for calling a spade a spade. The VRBPAC seems to be getting dumped on without updated data to make decisions that cannot be made using science. We also don’t know what is already in the pipeline.
Monto agrees that the committee has insufficient information to give comments on ANY of the questions posed. He had hoped to get clinical trial data, but none has been presented.
Even Monto is annoyed by this FDA circus today!
Eric Rubin agrees with Hayley Gans. He also notes that FDA relying on U.S. data is too late when talking about new variants — need to look at the whole world. Weir responds with a bland nothing.
Paul Offit points out this is a mucosal illness. When do we lose protection against serious illness? Will we need a primary series instead of just a booster? Dr. Weir says that is possible and protection against serious illness won’t hold up forever. (Yes, it has not held up.)
Monto asks Peter Marks what he needs today because his committee is not prepared to take on the discussions FDA tried to dump on them. Marks says perhaps just put up the questions for discussion and see if anyone wants to say anything.
FDA asked VRBPAC to assign the role of VRBPAC in coordinating strain composition decisions. This is a huge punt by FDA — it has never been the role of VRBPAC to coordinate strain composition for any vaccine. FDA must be scared s*****ss to make this decision and are flailing desperately to find another entity to blame for the decision.
You have to remember that all the people at this meeting are trained at bureaucratic infighting and avoiding responsibility.
No one has mentioned the issue of ADE. No one has admitted there probably already is negative efficacy in some groups, and that further narrowing the immune response could be a disaster over the long and short term.
Mark Sawyer says boosters every 4 months is not sustainable— thank god someone just said that finally.
Another bizarre aspect of this discussion is that it is not FDA, but CDC that determines the flu strains every year. So how did this decision wind up in the FDA?
Since there is no laboratory correlate of protection, some of the scientists have said that clinical data will be absolutely necessary. But Dr. Rubin said we don’t have time for that, we need immunogenicity— in other words, despite the fact that we cannot correlate antibody levels with immunity, we will need to use them as a surrogate of immunity anyway.
This may be a clue why the quality of articles in the NEJM have dropped precipitously — because the editor doesn’t actually believe in science but rather in pretend science.
Note also that after 20 people gave extremely compelling evidence about problems with the vaccines, with the scientific studies, what actual data reveal, and how the vaccines cause reproducible, severe and long-term side effects— no one at the meeting has said one word about any of this.
Mark Sawyer begs for them to use science, actual clinical outcomes instead of guesses. Peter Marks loves the discussion. He has heard about some of the challenges. As if he was not aware of the challenges. He very much understands they have no correlate of protection — and FDA is the arbiter of this. (The lack of correlates held up new anthrax vaccines for a very long time.). This seems to be one of the few black lines at the FDA — correlates of protection must be valid in order to adopt them in lieu of real-world evidence.
Monto says the fourth dose was based on trying to avoid severe outcomes, rather than transmission.
Jerry Weir wonders if the committee will come back soon when there are some data available. And I pray they don’t because I am not sure I can sit through another day like this.
Monto said it: what would you say about a booster dose if it only works for 8 weeks? Cohn of CDC keeps waffling, so he asks if she favors boosters every 8 weeks. She is forced to admit it is not a long-term strategy. But then she brings in the high-risk people and we have to do something about them — it is not clear what she implies, whether frequent boosters, drugs, monoclonals, etc. She wants to commit to assigning an efficacy number. But that is FDA’s job. All of this is FDA’s job, though CDC would normally pick the variants to use in a new vaccine.
Peter Marks admits his recent booster decision was a “stopgap measure” but moving forward he dances around the fact that most Americans have NOT had a third dose (and presumably do NOT want one. Then he talks about pie-in-the-sky new versions of vaccines…but admits we can’t get there so we have to work with what we have now.)
I always find Dr. Kim refreshing as he does not waffle around the topics like his colleagues do. He suggests that 2 subcommittees be established to continue the dialogue and review information as it becomes available, as the committee cannot answer these questions on an ad hoc basis.
2 members say we are in uncharted territory. Dr. Fuller says neither the public nor “we” understand how complicated this is.
She points out that the fed agencies (actually FDA) are supposed to issue this guidance for industry so they know what to make.
She repeats the claim that the vaccines prevent hospitalizations and deaths. She does mention adverse effects of the vaccine — she seems to be the first person on the committee to acknowledge this.
She reminds the committee we are 2 years into this … it took a very long time to create a plan for dealing with flu. Why expect to be ready to respond to COVID so fast. No one has the answers. The public needs to know we don’t know.
Dr. Kim is not giving up. He points out how other fed committees operate to accomplish business and interact with each other. “There is a forum through which this dialogue takes place among federal agencies, and VRBPAC could bring this issue up to these other groups to exchange information.”
Dr. Monto asks can we go now? Dr. Marks says he wants some final words. He wants to apologize for the technical difficulties. The dialogue is so helpful to us. How we consider boosters going forward is a very high priority and is committed to assuring that our decisions “continue” to be done in a transparent manner. Note: there was no transparency of FDA’s 4th dose last week, and FDA went against its advisory committee last year regarding the 3d dose as well.
That’s all folks!
The post FDA VRBPAC Meeting, April 6, 2022 — Meryl Nass, M.D. appeared first on Children's Health Defense.
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