Do the safety and effectiveness data from clinical trials C4591001 support the approval of a COMIRNATY booster dose, to be used in individuals 16 years of age and older, at least 6 months after completion of the primary series? That was the first question raised in the FDA Hearing about the boosters. I give an impression of the video registration because I think that hardly anyone has watched it.
It has become a fairly long article based on a video that lasts more than 8 hours. First, the contributions that pass by during the Open Public Hearing.
The opinions in the Open Public Hearing Session
In the Open Public Hearing session, a number of experts and stakeholders (doctors and activists) each get three minutes to explain their point of view. Below is the youtube time code and most important keywords per head. It is tempting to only look at the medical status, but it is actually about the validity of the views.
Pfizer has researched the booster shots. Do the results provide the rationale to approve the booster shots for everyone aged 16 and older? (Keep in mind that the EMA approves boosters from the age of 18.)
Rajesh Gupta Ph.D. : Strongly advises against. The presence of antibodies is not a reliable target. Trials have not investigated infection. Little sense unless with the very vulnerable. Against vaccinating 16+.
Ben Newton - Goedkeuring vereist 50% effectiviteit, boosters zijn dus hard nodig om boven de 50% te blijven gezien de afnemende effectiviteit! Spreekt over "Het recht om gevaccineerd te worden" en "Iedere ongevaccineerde heeft de zelfde R0-waarde als een anti-vaxxer". [is dit een wetenschappelijke benadering...?]
Dr. Jessica Rose: Viral immunologist. Points to the sheer amount of side effects in VAERS: more than all vaccines combined in the past 10 years. Especially unacceptable for children. Variants only become more dangerous because of the booster shots. So don't do it.
Professional. Retsef Levi (URL)- Not satisfied with monitoring for side effects in Israel [research is being done, but will be corrected later]. Herd immunity not possible. Infection rates are still high and mortality is increasing despite the vaccines. First determine research and strategy. Until then: don't!
Dr. Joseph Fraiman - Need for larger trials. Gaining experiences with Covid and the vaccines. For people in their twenties, it cannot be demonstrated that Covid is more harmful than vaccines. Not enough evidence to give the boosters to everyone! Also look at other medications.
Steve Kirsch - Trial showed that there were 4 times as many heart attacks in vaccinated people. 20 deaths among vaccinated people; 14 in the placebo group. Vaccines cost more lives than they save. Myocarditis occurred in approximately 1:1000 boys. After vaccination at 1:317. After the booster he expects 1:25. Points to fraud in the trials. Very strongly against.
Dr. David Wiseman - Politicized topic. No studies, no proper effectiveness and certainly no mention of the boosters. Excess mortality increases in Israel with Booster roll-out. Menstrual problems. Gene therapy should be investigated for carcinogenicity for 5-10 years. In short: too little data, too many side effects, no insight into long-term effects, especially relevant for young people. Look at existing medications! In return for.
Kermit Kubitz - Noemt voordelen: "Boosters" zijn verkeerde naamgeving, normale vaccinatieprotocollen vereisen soms ook maanden tussen toediening. Boosters beschermen tegen varianten en ziek worden ondanks gevaccineerd zijn. Boosters beschermen tegen besmetting, dus ook van ongevaccineerden. Wereldwijde levering zal van goedkopere, meer conventionele vaccinaties komen en Biologisch E vaccins komen eraan [ik heb deze punten vrijwel letterlijk overgenomen want ik snap niet alles maar wat ik wel snap is niet waar]. Maar in elk geval: Vóór de boosters
Dr. Peter Doshi - Als er een Pandemie van Ongevaccineerden is, waarom dan een Booster? Er is geen onderzoek baar bijwerkingen van derde dosis. Verder worden alle waarschuwende geluiden van artsen en wetenschappers afgedaan als "het verspreiden van misinfromatie". Zorgelijke situatie, wat doet de FDA daaraan? Onder deze omstandigheden: Duidelijk tegen. Teveel onbekenden.
Dr. Michael Carome - No risk/benefit profile for the boosters. Unclear to what extent side effects are increasing. Protection against serious illness unclear. Quotes Lancet. More important to vaccinate poor countries. Speaks of 'highly effective'.
Kim Witczak - Goalposts continue to be moved. Trials are severely insufficient, involving several hundred people. Absurd as a basis for a global rollout. mRNA vaccines were never designed to stop infection or eradicate the virus. False pretenses: vaccines are said to be better than natural immunity, people were 'bribed' to be vaccinated, demonization of the unvaccinated. Once again accused of obstructing free speech and certainly of doctors and scientists. Side effects are enormous. The largest medical experiment ever. So against.
Lynda Dee - Scientific basis is lacking. Discusses approval protocols. So too little data.
Dr. Meg Seymour - Safety research is far too small and not representative. Only 12 patients over 65, while that is the most important group. Ages 16-17 are modeled based on the 18+ results. Three months is also too short to notice any effects. Methodological objections that cannot be scientifically justified. So very much against it.
Kathleen Cameron - Very pro-vax, wants vaccines for seniors and communities of color quickly. Requests an informed decision because vaccines are important and the impact of Covid-19 is terrible so we want to do everything we can.
Beth Battaglino - Promotional speech for the activities of her foundation. No opinion to express.
Brian Hujdich - Concerned about declining effectiveness, especially in relation to his own foundation that deals with HIV patients. Would like extra protection for HIV patients and others with a poorly functioning immune system. Before, to vaccinate everyone aged 16 and over so that HIV patients are protected.
Dr. Paul Alexander - Sterke kritiek op de evaluatie en monitoring. Wetenschappelijke onderbouwing is onvoldoende, te korte termijn. "We currently do not have the safety data". Teveel rode vlaggen bij dierproeven! Dus sterk tegen. Onder geen enkele voorwaarde kinderen vaccineren! Niet doen!
17-9-2021: FDA Advisory Board adviseert "onder voorwaarden"
On September 17, the FDA met to vote on approving the Booster shots. To be seen on this over 8-hour Youtube video. De video is een soms wat genante aaneenschakeling van oude mannen die tegen elkaar roepen dat ze op mute staan en andere technische problemen maar daarover later wat meer. Pfizer geeft online productpresentaties en onderzoeksresultaten met veel grafieken, "slides", "titers" en "anybodies" waarmee Amerikanen antilichamen aanduiden. Daarover worden vragen gesteld door FDA members. Hierbij is wegens tijdgebrek soms little room for difficult questions
When I watched that video at the time I thought 'that won't work'. The opponents unanimously pointed out the lack of data on safety and effectiveness - especially when it came to children and young people. (See above the key words from that first advisory round of the Open Public Hearing Session, with time codes after the YT video.) The tenor was extremely negative.
There were votes on the first request to get approval for the booster shots from the age of 16 three members for and 16 against.
Then to a second question. Plan B, so to speak: whether they could agree to booster shots for
- people aged 65 and over
- other high-risk groups, including people who have a high risk of infection due to their work
That turned out to be no problem at all, they voted UNANIMOUSLY FOR - which surprised me a bit after hearing the original objections.
22-9-2021: FDA conditionally allows
Five days later, on September 22, the FDA added the Booster shot to the Emergency Use Authorization for the Pfizer vaccine for the groups mentioned above.
Again in the Pfizer Fact Sheet the fixed condition that ALL serious side effects, regardless of whether the vaccine is suspected or not, must be reported.
Reporting must be done in the US to VAERS. There are research-based estimates that the underreporting in VAERS is a factor of 40. I doubt whether that factor also applies to the Covid vaccines because of the publicity surrounding the vaccines. Even if that factor is half, the conditions are not met in the US either. Apparently, this is not an obstacle to administering the product on a large scale.
4-10-2021: EMA is fine with it and promises to pay attention
After the FDA, the EMA can decide on application in Europe. The European Medicines Agency makes its recommendations for the boosters in Europe, a distinction is made between people with a weakened immune system and people with a normal immune system. She is thus leaving the age restrictions as set by the FDA.
EMA: In case of weakened immune system boosters only for vulnerable people
For the weakened, although there is no direct evidence that the ability to produce antibodies - as demonstrated with the booster - in these patients protects against COVID-19, it is expected that the extra dose could increase protection in at least some patients.
So nothing is weighed against possible side effects here, only possible effectiveness is looked at and the wish seems to be the father of expectation.
EMA belooft "de gegevens die naar voren komen over de doeltreffendheid ervan blijven monitoren." Wat er met de gegevens over de bijwerkingen gebeurt wordt niet vermeld. Dat die meldingen ook in Nederland zwaar achterblijven is inmiddels old news.
EMA: with a normal immune system, everyone from the age of 18...!?
The EMA concludes that booster doses may be used for non-vulnerable patients from 18 years and older. Ze vermelden wel nog dat het risico op inflammatoire hartaandoeningen of andere zeer zeldzame bijwerkingen na een booster niet bekend is en zorgvuldig wordt gecontroleerd (zie wat NL betreft de Lareb-link hierboven). Maar dan wordt in Nederland gezegd: "De EMA heeft het goedgekeurd, dus..."
EMA website: AUTHORIZED!
AUTHORISED! Not a word about mandatory reports or about conditions.
Elders op de site wordt wel degelijk gemeld dat het een voorwaardelijke handelsvergunning betreft "omdat het geneesmiddel voorziet in een onvervulde medische behoefte"; het is immers noodzakelijk om het gat te vullen dat niet door andere medicijnen wordt gevuld. Daarom mag het met te little data on the market .
Maar dan maakt een mooi groen blok met "AUTHORISED" toch echt meer indruk!
Was een gele driehoek niet meer op zijn plaats geweest? En niet "AUTHORIZED" maar "CONDITIONAL APPROVAL"?
But didn't Pfizer already have Full Approval...?
Anyone who reads the FDA's press release dated August 23 could understand that the Pfizer vaccine has long since been approved.
Lees je wat strikter, dan staat er dat de FDA nu "Comirnaty" heeft goedgekeurd. voorheen 'Pfizer-BioNTech CoOVID-19 Vaccine', het eerste Covid-19 vaccin.
The vaccine will also remain available (like Pfizer-BioNTech CoOVID-19 Vaccine) under Emergency Use Authorization, including 12-15 year olds and as a booster dose for immunocompromised people.
But I admit, it is very conveniently formulated and beneficial for the willingness to vaccinate.
How worrisome is it?
Het heeft niet zo heel veel zin om naar de hele Q&A met Pfizer te luisteren. De vragenstellers willen graag kundig overkomen op Pfizer en stellen lange vragen. Ze noemen elkaar allemaal ook steevast "Doctor" wat op een gegeven moment iets kolderieks krijgt. De antwoorden van Pfizer zijn bij tijd en wijle niet te volgen en toch blijven mensen geïnteresseerd toekijken, vermoedelijk bang dat er met hun eigen verbinding iets niet klopt. Alleen een technicus durft een paar keer in te grijpen.
So much for the teaching, then also some entertainment. A small impression (I skip the screencam during the detailed question, at the bottom left of the screen I typed a comment here and there):
videolink: https://virusvaria.nl/wp-content/uploads/2021/11/FDA-pfizer-booster.mp4
The last hour is still informative, the members give an explanation of their vote. In any case, the most important argument in favor is to ensure fewer infections so that the pressure on healthcare is reduced. Apparently something has been missed in terms of protection against infections.
Additional studies on this topic:
Waning Immunity after the BNT162b2 Vaccine in Israel https://www.nejm.org/doi/pdf/10.1056/NEJMoa2114228
Swedish study shows covid vaccines drop below zero efficacy on spread by about 200 days https://boriquagato.substack.com/p/swedish-study-shows-covid-vaccines?s=03
In it a link to:
Pre-print Effectiveness of Covid-19 vaccination against risk of symptomatic infection,
hospitalization, and death up to 9 months: a Swedish total-population cohort study
There was also a remarkably outspoken supporter who made himself heard a number of times:
