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FDA's advisory cttee meeting Jan 26, 2023 on what the next boosters might be
Looks like they have teed us up for another crapshoot
Below is my commentary for the 8:30 am-3:15 pm segments. I will fill in the rest later. I am usually getting ready for my 19th nervous breakdown at this point. At the end of the day, FDA will not resolve the stroke question. How convenient. Did the person who blew the stroke whistle resign already? Dr. Shimabukuro says “the safety system works” and congratulates his agency for transparency.
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Meryl Nass: Arnold Monto is gone today. Stanley Perlman, who does research on biodefense and coronaviruses and to my knowledge has no experience with vaccine regulation, is back after a long hiatus to take his place.
Meryl Nass: Both Monto and Perlman are temp VRBPAC members. Monto ruled the VRBPAC with an iron fist; let's see if Perlman, from U Iowa, does too
Meryl Nass: Paula Annunziato from Merck is back; Adam Berger from NIH (policy guy), Henry Bernstein a pediatrician from Long Island. Dr. Chatterjee is back; Amanda Cohn the narrative steerer from CDC, where she acquired her vaccine 'expertise'. Hayley Ganz. David Kim from NIH. Paul Offit from CHOP. Steve Pergam, Eric Rubin,
Meryl Nass: Bruce Gellin formerly USG vaccine guy now at Rockefeller; Randy Hawkins' James Hildreth; Jeanette Lee who is at the Rockefeller cancer institute at U Arkansas. Ofer Levy, Harvard pediatrician who is always reliably in favor of whatever vaccine they discus. Pamela McInnes from NIH, Cody Meissner from Tufts, Michael Nelson, Art Reingold at UC Berkeley, Mark Sawyer and finally Melinda Wharton, another CDC champion of the adverse event coverup.
Meryl Nass: Interestingly FDA has convened a very large crew today, with 21 voting members, larger than any VRBPAC I remember.
Meryl Nass: Dr Paydar, FDA compliance officer, is zooming in from home. Will the federal government ever go 'back' to work?
Meryl Nass: Bruce Gellin works directly fro one of the Rockefeller Foundations.
Meryl Nass: Paydar is now providing new language that allows conflicts of interes, as best I understood. One waiver was issued, but other members with conflicts were apparently waved through. This language is new. FDA is trying to CYA regardign conflicted committee members, about 8-10 of whom were specifically listed. FDA is also CYAing regarding its briefers, which I do not recall happening previously.
Meryl Nass: John Beigel of NIH has been used to shoot down COVID treatments will be a briefer. So will Nicola Klein, who can't find a red flag --even if she found herself in the middle of a Russian parade.
Meryl Nass: Peter Marks speaks now. In emails released by Epoch Times yesterday, it was hinted that he may have fired Marion Gruber and Philip Krause as they were standing up against the rapid issuance of the Comirnaty license.
Meryl Nass: Oveta Fuller, who missed a fall meeting, has died. From what? Will we ever know if she was a vaccine fatality?
Meryl Nass: David Kaslow replaced Marion Gruber. He is new head of OVRR.
Meryl Nass: FDA decided to focus on EASE OF USE' today --an attempt to simplify its vaccine schedule, cap colors, and variable doses
Meryl Nass: None of this has to do with either safety and efficacy, which have yet to be mentioned
Meryl Nass: FDA wants VRBPAC to ESTABLISH A PROCESS to select vaccine strains--which is done by CDC for flu shots and is not really within the purview of the VRBPAC. FDA tried to dump this onto VRBPAC last spring, but VRBPAC refused to hold onto this hot potato.
Meryl Nass: Let me remind everyone that the members of the committee are all clinicians and /or medical administrators. None are regulators. They are being asked to weigh in on topics about which they have no expertise. This invariably happens when FDA is stuck with a decision it does not want to be held to, and need cover from its advisors. To be clear, FDA never wants their advice, but it does want their shared responsibility for bad decisions.
Meryl Nass: The big question relates to future strain composistion changes. So far, there is no evidence that the bivalent change improved efficacy or safety. Therefore, let's do it again!
Meryl Nass: Cody Meissner asks whether it is reasonable to choose strains in June. The response is that we will get back to that later. A dodge.
Meryl Nass: My sound keeps going on and off.
Meryl Nass: Reingold wants to know based on time to manufacture what a best date is to make future booster decisions. No comment.
Meryl Nass: Dr. Scooby-Do is back from CDC, where a new crop of ignorant but pliable young women are being groomed for mid-range administrative positions.
Meryl Nass: She is already out of date wrt the range of variants currently circulating. She waffles over the fact that NO monoclonals now work and ALL have been taken off the market, due to mutations in the virus that resist them.
Meryl Nass: Why do these young women stay at CDC, where they can pretend they are military officers while they are trained to create fake science to fool the public, when they were trained to care for patients?
Meryl Nass: She shows a series of slides that show COVID severity is low compared to historical rates. Hopitalizations in kids under 6 months are high because they have not had time to gain earlier exposures, which convey partial immunity.
Meryl Nass: Deaths are about as low as they have ever been, this month. Death rate in those over 74 are 1000 times higher than in the 5-11 age group
Meryl Nass: 73% of Americans got the first shots and 16% have gone for the bivalent booster (1 in 6). Americans behaved logically: the kids with low risk are in the lowest rate vaccination group.
Meryl Nass: Don't you hate it when they call vaccinations 'opportunities'? This is not the first time--that word must be handed off to these young ladies-in-waiting who are still in the process of demonstrating they have sold their souls and have no compunctions about sharing the truth with the public
Meryl Nass: Now she shows that the unvaxxed are at extremely high risk of hospitalization and death from COVID. The only problem with these graphs is that that conflict with data from the states and every other country.
Meryl Nass: I don't know what CDC uses for a method, but I suspect it has to do with requiring a positive PCR test with cycle threshold 28 and below, PLUS hospitalization--CDC switched to this to discuss breakthrough cases on May 1, 2021 and it is a great way to keep the number of breakthrough cases a small fraction of what they really are--so in comparison the unvaxxed numbers seem much higher.
Meryl Nass: Scooby-Do looks about as happy as the astronauts did when they had to give a press conference after returning from the moon.
Meryl Nass: Note the faces of the CDC women carefully. They hint of abuse. They are very careful with their answers and they fear getting anything wrong.
Meryl Nass: Perlman is also looking very intent, very careful. Will he shut off discussions as readily as Arnold Monto did?
Meryl Nass: My sound has gone on and off about ten times. Luckily I am using two computers and so I can swap out the sound. Is it happening to anyone else?
Meryl Nass: Dr. Gellin, who historically is more honest, asks how long protection lasts.
Meryl Nass: She weaves around, finally admitting that the vaccine only prevents infection for 3 months. Longer for severe illness. Link-Gelles will elaborate
Meryl Nass: Meissner points out that the Massachusetts data show there are relatively few serious cases now. How do we determine who is actually hospitalized for covid symptoms? CDC's rates seem 3x higher than those for Massachusetts.
Meryl Nass: Scoobey-Do says they used an algorithm that "divides people out" and estimates how many are there with vs for covid. Of course. CDC estimates everything--whoa be it for them to provide raw data that we peons could analyze independently.
Meryl Nass: Watch the body language as she waffles through this. Note that the young women makes themselves appear as homely as possible.
Meryl Nass: McInnes is one of the smart members. Scooby dodges the answer regarding true seroprevalence. McInnes pushes her. Scooby calls for an intervention and Dr.Jones gives us out of date numbers that are unhelpful
Meryl Nass: And his numbers are also unbelievable, suggesting far too few had been infected one year ago. McInnes looks as disgusted as I am.
Meryl Nass: Now he says that number hasn't changed much in the last yeaer. Yet virtually everyone I know got a case of covid in the past year.
Meryl Nass: Perlman "moves us on" as he does a Monto imitation.
Meryl Nass: Link-Gelles is another gal being groomed for greater things: She is an enthusiastic public health officer --why don't we admit that CDC invented the trend of women doctors wearing drag (military officer gear)
Meryl Nass: The shots work for 2 months in little kids. Are you impressed? She carefully never looks beyond 3 months and even then the efficacy is not impressive.
Meryl Nass: She present drugstore data published in the MMWR yesterday. These data were very questionable, relying on self-reports of symptoms, lack of stratification, and --of cours--only went as far as 3 months after a bivalent booster.
Meryl Nass: Now we see one of CDC's many data collection systems. WHY does CDC use these limited data collections when it has access to much more comprehensive datasets. She does not tell us how long after a shot these data were accrued.
Meryl Nass: I call BS for not proving adequate info to assess the numbers she presented.
Meryl Nass: Dr.Shimabukuro is a super coverup kid. He's been doing this a long time. He is not happy but he is very accustoed to what he is doing.
Meryl Nass: Now Dr. Klein, perhaps the most evil one of all. She is the head of vaccines for Kaiser Permanente, who gets paid to experiment on Kaiser enrollees with whatever experimental vaccines she can get paid for--like Heplisav when it was thought to cause heart attacks. She is responsible for young kiddie COVID experiments.
Meryl Nass: Her VSD analyses are bereft of intelligence--she can never find a red flag. Is it her personal analysis or the CDC's algorithms that are at fault? Even though she doesn't look that old, she was covering up Anthrax injuries one-two decades ago
Meryl Nass: The method she claims to use is comparing adverse events in the first 3 weeks compared to the second 3 weeks after vaccination. For illness like autoimmune diseases that have a slow onset of symptoms,, there may be similar rates of AEs during both periods. If so, Nicola will find NO RED FLAG!!
Meryl Nass: I assume she has become very wealthy as a result of performing these bogus analyses for CDC for many eyars and getting vaccine mfrs to pay her and Kaiser to turn Kaiser patients into guinea pigs. And she does not even need an informed consent if the vaccine is licensed--as happened with Heplisav.
Meryl Nass: Now she describes 7 hoops she jumps through to get the right answer. Why then does she almost always get the wrong answers?
Meryl Nass: Dr. Katie Sharff, a Kaiser infectious diseases doctor, took aim at this BS and hit the target, explaining all the things Nicola did wrong so she would be sure to miss most myocarditis cases
Meryl Nass: If you ever get the chance to be in a room with Nicola, chant Katie Sharff, Katie Sharff and with luck, Nicola will scream "I'm melting" before she disappears into the crpet.
Meryl Nass: Strokes: the total number of strokes is the area under the curve--and the first 3 weeks shows considerably more strokes than in the second 3 weeks.
Meryl Nass: Why is she telling us only about one hospital's results? The VSD has 12 million people from many hospitals. It seems she is giving us silly data to hide the facts. Nicola is the BEST at presenting irrelevant data to hide trends.
Meryl Nass: Just give me the raw VSD data on strokes and I can analyse it myself, please. Her slide 19 finally shows that in the early period people had about 60% more strokes.
Meryl Nass: She flipped the script--the later people are lucky to have fewer strokes than expected???Her slide 21 shows double the strokes in patients who got both a hi test flu shot plus a bivalent booster. How do she and the USG paper over this?
Meryl Nass: Now she uses the same trick she used on myocarditis. Creates an expectation of a stroke rate (which is probably a fiddled statistic) to beat down the difference. BUT she still has double the rate during the first 3 week period compared to the second. She can create fog but the numbers do not go away.
Meryl Nass: Now she blames the adjuvanted flu vaccine. That is a reasonable hypothesis--adding MF59 toa flu shot, for which there is no eveidene of benefit, is a crime that is performed only on those over age 65. Is this part of why we have seen a 3 year decrease in life expectancy ver the last 3 years.
Meryl Nass: Now she claims, with no data, that there has not been a concomitant rise in heart attacks in lockstep with strokes. Where are the data, Nicola?
Meryl Nass: Now Dr Shimabukuro promises to do a good job moving forward of evaluating the VSD data.
Meryl Nass: Stanley asks them to explain ischemic strokes to the public so it understands.
Meryl Nass: MF59 is a squalene-containing adjuvant designed to boost the immune response. It may cause serious adverse events but we don't really know because CDC is careful not to look. It is only given to the elderly in the US but is included in one flu shot for 6-24 month old bbabies in Canada. Avoid it like the plague.
Meryl Nass: CDC and FDA have been experimenting with more potent flu shots over the past decade and adding MF59 to some of them has been one of the experiments.
Meryl Nass: Here is the first Katie Sharff takedown of Nicola's methodology https://www.medrxiv.org/content/10.1101/2021.12.21.21268209v1
Meryl Nass: Dr. Forshee is next. Dep Dir of office of biostats at FDA. Let's take a god look at the BEST collection of databases
Meryl Nass: And we get to see the nursing home database, which used to be called Genesis. Why has the name been changed? He at least admits they have data on 100s of millions of patients.
Meryl Nass: CMS medicare includes 36 million people. He actually sounds normal and does not appear to be hiding anything yet
Meryl Nass: 7.3 million people in the 12 million person VSD got a bivalent booster, even though only 1 in 6 americans too a bivalent booster. This shows it is dangerous to be in an HMO that is part of the VSD, like Kaiser, where Nicola sells the enrollees to the highest pharma bidder for performing clinical trials.
Meryl Nass: Forshee says there is NO signal for ischemic stroke in the medicare database. He provides what looks like a graph but has zero quantitative informatin. Why should we believe him?
Meryl Nass: Guess what? The Pfizer vax does not cause MIs, Bell's palsy, etc. On his slide 13 he claims you are less likely to have a stroke if vaccinated. Again no actuall numbers of cases are provided, so we are just supposed to believe him.
Meryl Nass: In summary, believe what we say. We refuse to show you the actual data and we only showed you a tiny slice of info from the VSD and Medicare.
Meryl Nass: We called our friends at Pfizer and our friends in different countries and all of them told us the vaccines are perfectly safe. Trust us. We worked very very hard to figure out how to spin this, and in the end decided the best way was to use the reliable Nicola and refuse to show you our BEST data.
Meryl Nass: Did everyone see the video that used "The Hall of the Mountain King" which speeds up as it goes? It starts with 95% efficacy and drops over time to zero. My point is that you can produce any level of efficacy you want depending how you choose the parameters to study. If you have not seen that 3 minute video, it is a must-see, especially as Fauci blinks.
Meryl Nass: Dr. Chatterji points out, intelligently, that if the combo vaccine is associated with double the rate of ischemic stroke, why not separate the two vaccines? Duh?
Meryl Nass: Forshee says they will do a study. Great. After thousands of additional strokes were caused this year.
Meryl Nass: Note again how no one looks happy. But no one ever starts screaming in the middle of one of these meetings and says "No more, I can't take it any more!"
Meryl Nass: These are true battle hardened vaccine warriors who can continue in battle despite the increasing injuries around them
Meryl Nass: Michael Nelson asks a good question; how do you do comparisons between databases? Forshee dodges with a nonspecific answer. Mentions myocarditis with a meaningless sentence.
Meryl Nass: Now Dr.Bagel appears, one of Fauci's lieutenants. (Beigel really) he wants everything disclosed. That is a hint he is hiding something.
Meryl Nass: Last year, he led the team implementing the Adaptive Covid-19 Treatment Trial (ACTT), the first large U.S. Covid-19 study launched after the first U.S. patients were identified. On Jan. 31, 2020, Beigel and colleagues submitted a synopsis of a trial design to the FDA. Three weeks later, the first ACTT site was activated. In less than a year, four phases of ACTT were launched to study the leading antiviral and anti-inflammatory candidates in hospitalized Covid-19 patients.
Meryl Nass: Beigel was instrumental in beating down the good covid drugs and elevating the garbage drugs for Fauci.
Meryl Nass: https://nihrecord.nih.gov/2021/04/30/niaid-researcher-discusses-outcomes-covid-antiviral-studies
Meryl Nass: You can find much of Dr. Bagel's work here: https://orcid.org/0000-0002-4879-4941
Meryl Nass: I am just helping him with full disclosure--he worked on remdesivir and moderna vaccines and many other things to manage the research portfolio on COVID to be sure we didn't beat the virus.
Meryl Nass: Why are we still talking titers when we know they are not a good reflection of immunity?
Meryl Nass: Correlates of protection analysis: wait a minute, there are no accepted correlates of protection.
Meryl Nass: The vaccine is claimed to still protect against severe disease. Let me add the secret ingredient that explains this: natural immunity. The UK report I blogged yesterday showed that about 98% of citizens have already been exposed to COVID, and it is this component of immunity that is stronger than what is obtained from the vaccines. Why has no one let the word natural or recovered immunity pass accross their lips?
Meryl Nass: His slide 12 does list the 3 major ways current covid vaccines have failed--and there is nothing waiting in the wings that can solve any of these profound problems.
Meryl Nass: He is surely a well practiced BSer. Op Warp Speed--we knew which vaccines to advance. That is a quote. Yes, they picked 4 platforms to advance that were all novel, that had never been used in human vaccines before (except an old military vaccine and a newly licened ebola vaccine) and then NIH, FDA and DOD decided the entire world should become guinea pigs for new vaccine platforms, using specially selelcted spike antigens whose toxicity was well known.
Meryl Nass: Let's start talking about vaccines that doa better job of inducing cell mediated immunity. Well, I recall this identical discussion with anthrax vaccines 25 years ago. you vaccinologists are slow to the post. Admit that you don't know what you are doing, most of your vaccines are far from ideal, and your only motivator is profit.
Meryl Nass: Now he is stumbling and mumbling a bit, getting into territory he is unfamiliar with? Mucosal immunity is an idea but no one has figured it out yet. I remember when the nasal spray flu mist vaccine was found to cause negative efficacy and taken off the marker for awhile. But fear not, FDA brought it back.
Meryl Nass: Basically, if I understand Dr. Bagel correctly, he was asked to give a talk on next-gen covid vaccines, but at the end of the day, we have achieved absolutely nothing to move forward into a better desiged vaccine. I guess if I had been asked to give this talk, I waould have waffled around just like he did: this is what we have, this is where we should go, send money so we can move in entirely new directions.
Meryl Nass: hildreth asked a good question and Bagel dodged it.
Meryl Nass: The young lady speaking for Moderna now is an anomaly. I recall her from a prior VRBPAC meeting. She actually has fun giving her presentation. You have to wonder what the Moderna employees are worth, given that most probably received stock as part of their employment packages--they are the ones who hit the jackpot.
Meryl Nass: Note that only about 50 subjects are in each group. Note that the robust response in the elderly is hard to believe.
Meryl Nass: Why are we still using neutralizing titers when it has been proven they cannot be relied on to reflect immunity. As in Israel.
Meryl Nass: How could they find large groups for whivh only 26 and 23% had had prior infection? Impossible in the UK over the past four months, when official UK government data acquired at the same time showed about 98% of adults had already been exposed to covid, not around 25%
Meryl Nass: This is why people refer to her employer as Murderna. They make use of prior natural immunity and pretend they don't. Dontcha love it?
Meryl Nass: The kids under 5 years are those who have proved they get no benefit, only risk from the shots. But Murderna enrolled over 4700 childreen.
Meryl Nass: Now they claim the bivalent booster caused fewer sie effects than the initial shots. How can that be when we know that boosters cause more side effects in all the other age groups? The answer is likely that Moderna knows how to massage their data.
Meryl Nass: Moderna worked at the speed of science to produce bivalent vaccine ready to be injected in only 2 months after FDA gave them the recipe.
Meryl Nass: Had liability been attached to these vaccines, Moderna would not have released the product until it learned it was safe. Because the country would have been bankrupted otherwise.
Meryl Nass: Dr. Das is back. I have a good idea. Let's use an unvaccinated control group a nd then see how efficcious these boosters are. Stop comparing one boosted group with another. What happened to placebos?
Meryl Nass: The rise in hospitalizations can be controlled depending how many "with" cases are counted as "due to" covid cases in hospitals.
Meryl Nass: Variant vaccines do not show a better response to current strains, despite claims. Why are so many of the lying presenteers young women?
Meryl Nass: Historical comparators are not comparable since the virus has become weaker and population immunity has increased. FDA should not allow such comparisons
Meryl Nass: It is hard to listen to Moderna and Pfizer always try to match each others' claims, until you find out that both were lying. GMRs are useless. Let's hear about something real like seroconversion
Meryl Nass: Even Paul Offit said that such minor differences in GMT are meaningless.
Meryl Nass: Sorry listeners, it is hard for me to take this seriously. Slide cc-17 is the "we will monitor the viruses and make better vaccines--just send money"
Meryl Nass: Pfizer is going with a 100 day timeline in future--the same as CEPI. Which is congruent with no human testing.
Meryl Nass: Pamela McInnes is mad. She feels like me--the GMT data are trash--give us actual numbers of cases prevented.
Meryl Nass: Dr. Swanson admits there are no head to head ddata comparing mono and bivalent vaccines with BA5. She is lost in the GMTs again. Admits she does not know if clinically meaningful and admits there are no correlates of protection.
Meryl Nass: Basically this whole show is a bait and switch. We give you worthless data that is cheap to generate and you pretend it is meaningful and supports what we want to do going forward.
Meryl Nass: Novavax--it works great no matter the variant.Of course, this is based on tose darn antibodies, which fail to reflect immunity, but hey--you let everyone else use these data so we will too.
Meryl Nass: Here is my article on bivalent boosters https://merylnass.substack.com/p/the-high-speed-bivalent-covid-boosters
Meryl Nass: I just lost the sound for 1-2 minutes. This is a new problem for me.
Meryl Nass: In the old days, it was the work of the FDA to tear apart these fake studies that look at irrelevant parameters. Now FDA probably tells them how to conduct studies that will get thrm through these meetings. Look at the tiny number of subjects in cc-19
Meryl Nass: His accent is interesting. He pronounces NOVAVAX as No Vax!
Meryl Nass: Dr. Ho at Columbia is famous for creating HIV drug cocktails and for relapsing on Paxlovid and being the first prominent person to admit it!
Meryl Nass: Remember that none of these bar graphs of neutralizing antibodies means anything. And all 3 companies use similar graphs.
Meryl Nass: Am I dreaming? I think when Novavax first presented to the VRBPAC, they promised that they had created a binding site to an invariable sequence in COVID. Now it seems that is not so, but maybe they get even better binding to new variants? Did I miss something?
Meryl Nass: There is method to their madness: "It is scientifically sound"
Meryl Nass: Are we buying new refrigerators or something that gets injected into you and is proven to cause myocarditis and other side effects?
Meryl Nass: I feel like this speaker trained at the encyclopedia travelling salesman school.
Meryl Nass: Haley Gans also woners how the vaccine could be this good? Note: almost no one has taken the novavax vax, and it costs about $500 per dose. Which means that marketing is hugely important to this company
Meryl Nass: They can't show youeffectiveness data because they have not been able to give enough doses to humans.
Meryl Nass: Here is my substack on the Novavax vaccine from last July. It was very difficult to find, seems to be beaten down by the search engines. https://merylnass.substack.com/p/novavax-vaccine-contains-1-mg-of
Meryl Nass: LUNCH BREAK FOR 25 MINUTES
Meryl Nass: I am not sure, but there may just have been an admission that CBER Director Peter marks has the ability to shut off sound for the entire zoom program. This might explain why there are so many audio hiccups.
Meryl Nass: Please go to the link I am about to provide. It includes emails sent by Peter Marks in summer 2021 regarding the speed of licensure of Comirnaty. Peter said he would be taking care of Marion Gruber and her deputy Philip Kruse --implying he felt there was a degree of insubordinarion. They may in fact have been fired and the alleged reason (no need for the first booster) is likely to have been a cover story--their departure may have been precipitated by their pushback on the timeline for Comirnaty's licensure. https://www.theepochtimes.com/mkt_app/health/fda-rushed-approval-for-pfizer-covid-19-vaccine-to-enable-vaccine-mandates-emails_5009661.html
Meryl Nass: Thank goodness someone is talking about vaccine injuries and the coverup of adverse event data (which happened again at the meeting this morning).
Meryl Nass: A vaccine-injured RN collaborated with Josh Guetzkow points out the extensive injury signals that were ignored by FDA and CDC.
Meryl Nass: My sound went off again. The 4th speaker notes the censorship and injuries. She mentions the WSJ editorial this past weekend that is very important re the bivalent boosters. The FDA managed to screw up her slides--they keep trying all the tricks.
Meryl Nass: They appear to have completely hidden one of her slides, which FDA is unable to get onto the screen.
Meryl Nass: Husband and wife developed tinnitus after doses of vaccine--as did dread Greg poland, the US vax booster at Mayo. It turns out that tinnitus and 8h cranial nerve injuries were known to be problematic--because the Brighton Collaboration was asked to create a case definition around the start of the pandemic. What a coincidence. And guess who is on that Brighton committee for 8th nerve injuries? Dr. Robert Garry, a PhD spook who is one of the 5 authors of the Nature Medicine coverup of the origin of COVID that was birthed at a secret meeting with Tony Fauci and Francis Collins on Feb 1, 2020.
Meryl Nass: A new thing has happened today. People seem to break into the zoom. The last speaker had a "stop the shots" petition but I lost the sound so unable to send you there
Meryl Nass: An Indian scientist promises a mist vaccine for mucosae for both flu and COVID--this is a new phenom--scientists giving pitches for their future vaccines
Meryl Nass: Danielle Baker has difficulty speaking but can describe her injury and pain, humiliations, transverse myelitis.
Meryl Nass: Jerry Weir is a competent virology vaccine guy at FDA. Which also means he understands what is BS at this meeting. And he did not resign when the bivalent booster rolled out with no human testing.
Meryl Nass: The pretty colored variant maps are fun but have little relevance--take up time.
Meryl Nass: FDA did approve the antibody studies and they used validated studies but there was a lot of back and forth with FDA--a loose description of unhappiness. If FDA wants to be lazy it accepts poor quality information. On Weir's slide 9 he says the data will not be submitted to FDA--what? will better data be submitted? What does this mean?
Meryl Nass: The data are uniform and trend in the same direction--I guess he has never heard the term collusion or industrial intelligence
Meryl Nass: CDC's observational studies show the vaccines work great. But so many other studies don't. And not a single author of an unfavorable study was invited to present today.
Meryl Nass: Weir is waxing eloquent about the preponderance of the poor quality data to support additional bivalent boosters.
Meryl Nass: If the evidence was so good, why has the UK's top vaccine committee just published a report against giving vaccine to those under 50? I think they wanted to stop FDA from killing and maiming more people with these vaccines.
Meryl Nass: https://merylnass.substack.com/p/uk-government-discusses-its-covid
Meryl Nass: Note that no one has considered any of the dozen or so vaccine injured people who spoke during the public session. The FDA and its lackeys on this committee, who can expect lucrative pharma contracts for their work, evidence recklessness, negligence adn maliciousness.
Meryl Nass: He does not want to chase variants--except he does want to chase variants if it gives improvement and is feasible.
Meryl Nass: It is amazing how much fluff is embedded in these presentations.
Meryl Nass: I want to say, Well, Duh? Yes, you study the new microorganism with your usual tools. How novel. And you measure vaccine effectiveness--how novel.
Meryl Nass: You need robust data and it requires a coordinated effort. It sounds like he is mapping out an FDA where none has existed so far. He wants "systematic, standardized studies to make the best choice going forward." I feel like a student in a first yeaer public health class in HS or college.
Meryl Nass: This talk goes into the "Baffle them with Bullshit" category. How can the VRBPAC members stand this? Wonder if they closed their zoom windows and started snoring?
Meryl Nass: Paul Offitt says the T cell epitopes are conserved 80% between all the variants including the omicron variants, and this gives us considerable immunity to all, at least in terms of severe disease. This is a simple statement that could have wiped away 4 hours of waste this am.
Meryl Nass: Yet we saw not a single Tcell experiemnt presented today, unless it happened when my computer went off.
Meryl Nass: Weir says "we follow the data we have" with the implication that his office should have required better quality data, and it didn't, and now he is pulling a Rumsfeld, going to war with the army he has. The data they have are the data FDA demanded--and it is crap. We need to say that out loud.
Meryl Nass: FDA could have required T cell studies and they could have demanded decent true efficacy trials. But they simply did not. Why didn't FDA withdraw the license of EUA if the mfrs refused to perform studies that are actually useful?
Meryl Nass: Short break.
Meryl Nass: The stroke issue is left up in the air. We were supposed to hear about the 50-100,000 people in nursing homes (the Genesis data, which is shared with Brown university) but if it got presented Nicola ran through it so fast, without identifying it, that I missed it. We KNOW there were lots of strokes and sudden deaths in nursing homes shortly after vaccination.
Meryl Nass: Tom Shimabukuro tries to sooth us by listing his methods at CDC such as CISA, and saying they take safety very seriously. They are aware of reports of "long covid" which is his incorrect term for vaccine injury. Now we KNOW that CDC has decided to misreport vaccine i njuries as long covid. We suspected it. Now Tommy has spilled the beans.
Meryl Nass: I hope Steve Kirsch heard what Tom Shimabukuro said, misrepresenting the dozen or so vaccine injuried people who reported to the FDA during the public session as suffering from long covid. This is a criminal misdiagnosis by one of the top vaccine safety officials at CDC. This is malfeasance. Tom is a sorry excuse for a doctor--but so are many of the others who spoke today.
Meryl Nass: Let me be clear. Tom S just deliberately misdiagnosed a huge number of people after hearing their stories and studying their cases. This is illegal.
Meryl Nass: Tom Shimabukuro did not make that up himself. He was instructed to call the vaccine injured 'long covid' by his bosses. Which includes Rochelle Walensky and probably other spin doctors. Tom is a person who does what he is told.
Meryl Nass: Perlman tells people to hold their comments due to time. He is a good facsimile of Arnold Monto.
Meryl Nass: Tom says they try to follow up serious adverse events. He is correct. They are required to follow up adverse events. But what I hear is that they rarely do this. The followup is done by contractors and maybe, with so many reported AEs (well over a million for covid shots) CDC and FDA can claim they lack the personnel to do so.
Meryl Nass: Tom S seems to be revealing that CDC is particularly interested in comorbidities--presumably to blame the adverse vaccine effect on them.
Meryl Nass: Hank Bernstein asks for T cell studies. That only took 7 hours until someone pointed out that usable data would be nice. Jerry Weir says the short answer is we don't have the data. WE don't have a standardized T cell response to look fot and determine the extent to which it contributes to protection. Well then, is FDA putting some $ into sorting this out?
Meryl Nass: Amanda asks about baby studies and yes moderna is jabbing babies 3-9 months of age, no placebo subjects yet, which is interesting--why avoid contemporaneous placebo subjects? Not to mention studying dangerous vaccines in babies is prohibited by the law on human subjects, which has special rules for children.
Meryl Nass: Great question Cody: Do we really want to stop asymptomatic infections? Beigel punts.
Meryl Nass: The coitte is SO practical. When it costs over $100/dose and over $500/vial the doctors are unlikely to buy vaccine for their offices. Moderna is working on single dose vials.
Meryl Nass: The question asks the committee to vote on using a bivalent vaccine as the single vaccine offered for both primary series and later booster doses. There has been no data presented today that would allow this committee to make an educated decision. The real safety of bivalent vs monovalent was not presented in a meaningful way. The duration of effect was not evaluated.
Meryl Nass: I hope the committee punts this dumb question back to FDA and tells them it is FDA's problem, not theirs.
Meryl Nass: "Despite how good these vaccines are, we need better vaccines"--Bruce Gellin. HMMM. What do you think that means?
Meryl Nass: 21 voting members. The discussion is over, ended very early, as I suspect everyone is equally as frustrated as I am and ready to go.
Meryl Nass: These people never disappoint. 21 of 21agree with something that no one understands and is a useless vaccine. Haang on your health on the decisions of this group --at your own risk. G'night
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