Just How Bad Was the Data For FDA Vaccine Booster Meeting?

The 17 September meeting of the FDA Vaccines and Related Biological Products Advisory Committee voted against recommending a third booster for the general US population. They did recommend it for the over-65s and specific at-risk groups.

There’s lots of general commentary on this. All I want to do is highlight two observations following review of all the formally-submitted presentations (links below).

  • The sub-trial that Pfizer performed for the 3rd booster was a phoned-in piece of crap. Overview of Phase 1-3 trials at p15 of Pfizer’s Evaluation of a Booster Dose (Third Dose)
    • Phase 1 study looked at 11 people 18-55; 12 people >65 (p16)
    • Phase 3 study looked at 312 18-55 year olds only, even though those at most risk from Covid and most likely to have declining efficacy are 65+, and those most likely to have risks exceeding benefits are <18
    • Worse, when Pfizer described the Phase 3 study population they hid the age group. It is mentioned in text at p7, but see p 23, and Table 3 and 4, for making sure it wasn’t obvious.
    • Pfizer just assumed a study of 18-55 years olds can be “In accordance with FDA guidance, safety and effectiveness of the booster dose demonstrated in 18 to 55 years of age can be extrapolated to 16 and 17 years of age and to 55 years of age and older” (CC-6, CC-27 Pfizer-BionTech, BNT162b2 [COMIRNATY® (COVID-19 Vaccine, mRNA)] Booster (Third) Dose )
    • They only examined data up to 1 month following the booster.
  • The Israel Ministry of Health presentation did a good job in the first half of showing vaccine failure and declining protection against severe illness (p1-16 Israel Ministry of Health, Booster protection against confirmed infections and severe disease – data from Israel ). But when it came to evaluating their 3rd Booster experience, it too was a phoned-in piece of crap:
    • the claimed efficacy of the 3rd dose is based on changes in confirmed infection rates….in days 12-25 after the booster. (p22-28)
    • the claimed efficacy for protection against severe illness is based on differences…on day 12 after the booster (p29)
    • comments on vaccine effectiveness, reproduction number and adverse events are all based on this short-term data (p30-41)
    • the conclusion is a puff piece based on effects at Day 12-25, presented as if it’s meaningful for a longer period.
Benefit only Days 12-25 MOH Israel FDA Presentation p 24

12-30 Day Improvements Consistent with Vaccine Hesitancy

No serious analyst denies that the vaccines provide short-term protection against infection, and longer-lasting but declining protection against hospitalisation and severe illness. The extent of that latter protection is coming under some pressure as people start to pull apart the data, some of which is clearly gamed by bureaucrats. The long term endpoints of both declines in benefit are unknown. Rather like long-term side effects.

From June or July many writers have been concerned the vaccines just provide a serum sugarhit with no lasting immunity, but with the possibility of unknown long-term adverse events. The data underlying boosters supports that concern.

Unless you want people to have constant immune supplementation, with continuing exposure to possible adverse events against a long-term trend of declining efficacy, 30 day benefit is meaningless.

The benefits that Pfizer and Israel MOH point to in their presentations are completely consistent with that view. They only examine booster effects up to one month after inoculation. Improvements? So what.

Unless you want people to have constant immune supplementation, with continuing exposure to possible adverse events against a long-term trend of declining efficacy on all measures, 30 day benefit is meaningless.

And so, we return to the principle of vaccine-hesitancy. It is a question of scientific prudence and risk-benefit analysis based on a true appreciation of the risk of death or serious illness from Covid, and on the limitations of the science and trials behind the vaccines.

Give us the data. Give us true long-term data. Stop the spin.

CDC: Updates to COVID-19 Epidemiology and COVID-19 Vaccines

Jonathan Sterne, University of Bristol, UK Real-world effectiveness of COVID-19 vaccines

FDA Review of Effectiveness and Safety of COMIRNATY (COVID-19 Vaccine, mRNA) Booster Dose Biologics License Application Supplement

FDA, Application for Licensure of a Booster Dose of COMIRNATY, COVID-19 Vaccine, mRNA

Israel Ministry of Health, Booster protection against confirmed infections and severe disease – data from Israel

FDA, Comirnaty (COVID-19 Vaccine, mRNA) Supplemental Biologics License Application for a booster dose in individuals 16 years of age and older

Pfizer-BionTech, BNT162b2 [COMIRNATY® (COVID-19 Vaccine, mRNA)] Booster (Third) Dose

FDA, FDA Briefing Document Application for licensure of a booster dose for COMIRNATY (COVID-19 Vaccine, mRNA)

Pfizer, BNT162b2 [COMIRNATY (COVID-19 Vaccine, mRNA)] Evaluation of a Booster Dose (Third Dose)

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