Is the FDA “doubling down” on a failed strategy?

As part of its post-marketing requirements, Pfizer is legally obligated to conduct a study involving people aged 16 to 30 to look at rates of subclinical myocarditis (i.e. underlying damage to the heart muscle without causing symptoms).

The final report was due 31 Dec 2022, but that deadline lapsed, and the FDA said nothing.  There was no mention of the study, neither in the briefing notes ahead of the VRBPAC meeting, or during the meeting.

I asked the FDA directly for access to Pfizer’s study, but the agency said in an email, “You may submit a FOIA request for this information, or if you would like it more quickly, you can reach out to the manufacturer directly.”

So, now as it stands, millions of young people will receive boosters, mandated or not, without knowing if the vaccine is causing subclinical myocarditis.

rwmalonemd.substack Is the FDA “doubling down” on a failed strategy?