FDA Advisory Panel Recommends Against Routine Pfizer/BioNTech Booster Shot

elderly man, face mask
To boost or not to boost, that is the question

The Pfizer COVID-19 vaccine primary series is two shots, three weeks apart. Since the vaccine is not as effective as hoped, the question before the committee was whether to give a booster at least six months after the primary series to everyone 16 years of age and older. The advisory panel, which does not set FDA or CDC vaccination policy, said “No.” The vote was 16 to 2.

The question for the panel thereafter was whether a booster would be OK or recommended (I”m paraphrasing) for 1) those 65 and older, and 2) those individuals at high risk for severe disease (e.g., one or more comorbidities). The answer was a unanimous “Yes.”

The 18 voting panelists were predominantly professors and/or physicians at well-known universities and medical schools.

For all the details of the Sept 17 meeting, see the eight-hour long affair on YouTube. I much appreciate the transparency. The committee is called The Vaccines and Related Biological Products Advisory Committee. Despite all the data presented, I recall no mention of p value.

The voting members considered two primary sources of data before voting on the two questions.

One source was a Pfizer study of only 330 vaccinated subjects who got the booster. Forty-four subjects were eventually excluded from analysis for various reasons. I would have rejected the study simply for the small sample size. We shouldn’t set policy for 330 million American citizens based on a study of 330 subjects unless the results are strong and unequivocal. IIRC, the average follow-up time of this study cohort was just 2.6 month. We got no report on how many infections, hospitalizations, or deaths were avoided by use of the booster. There wasn’te even a control group. Vaccine effectiveness was judged simply and only by a rise in neutralizing antibodies in the blood compared pre- and post-booster. Pfizer did monitor for short-term adverse effects, and they were no worse (maybe a little better) than with the primary series.

The various available vaccines likely have different adverse effect profiles

The other data considered by the panel were presented by two Israeli scientists or public heath officials (Ministry of Health), who spoke about the Israeli booster experience. Remember that Israel got about a three-month start on extensive population vaccination compared to most countries, yet they have very high delta variant numbers now starting around May, 2021. IIRC, the Israelis started boosting 60+ year olds only six weeks ago and soon thereafter added those 50 to 60, regardless of comorbidities. The Israelis shared data supporting the idea that the booster is effective against infection and severe disease, especially in those 60+. After 2.8 million booster doses, there were only 19 “serious reports” of adverse events (not necessarily related to the booster).

Only one person brought up the lack of long-term safety data, simply mentioning that some experts (even the FDA) recommend five to 15 years of follow-up for autoimmune disease and cancer for gene therapy products.

I don’t know how this advisory committee voted on the original Emergency Use Authorization (EUA). Surely the lack of long-term safety data would have come up then.

Approval of a therapy under EUA requires that no other safe and effective therapy is available. If ivermectin, fluvoxamine, or hydrochloroquine proved effective the EUAs for Moderna vaccine, J&J vaccine, and future EUA for the Pfizer booster would be invalid. No one uttered the words ivermectin, fluvoxamine, or hydroxychloroquine at this meeting. I guess that’s water under the bridge for them.

If the emergency vaccines turn out to be a huge mistake, I’m sure the committee members are immune to liability.

Steve Parker, M.D.

PS: Here’s an interesting video from Russell Brand:

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