The U.S. Food and Drug Administration (FDA) has changed the end date for a key study on post-vaccination heart inflammation without notifying the public.
- Pfizer was supposed to complete a study on the occurrence of subclinical myocarditis, or heart inflammation, after receipt of its COVID-19 vaccine
- The completion date was listed by the FDA in 2021 as June 20, 2022
- After the deadline passed, the FDA quietly changed the date
- Under a list of postmarketing requirements for the Pfizer-BioNTech vaccine, the same study has an "original projected completion date" of June 30, 2023
Study
- The study is designed to "prospectively assess the incidence of subclinical myocarditis" after receipt of a third dose, or a booster, in people aged 16 to 30.
- Pfizer submitted a timetable to the FDA stating the company would submit a final protocol by Nov. 30, 2021, and complete the study by June 30, 2022. The final report was due to FDA by the end of 2022.
Signal for Myocarditis After New Booster
- The bivalent Pfizer vaccine triggered a safety signal for adults aged 18 to 35
- Safety signals indicate a vaccine may cause events but don’t establish causality
- Officials have stressed that the bivalents are similar to the original vaccines in defending the authorization without clinical data
- There was no signal for stroke after a flu shot alone
Panel Notified of CDC Analyses
- During the public comment portion of the meeting, any panel members watching were notified that the CDC's analyses of reports to a different surveillance system concluded hundreds of adverse events met the safety signal threshold, including approximately 500 with a signal larger than that for myocarditis.
- The CDC also detected more than a dozen stroke signals.
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