While the FDA is expected to grant emergency use approval for the Pfizer-BionTech COVID vaccine on Thursday after it released a preliminary assessment of test data that the panel of experts will use to assess the drug earlier today, the agency admitted on Tuesday that two participants in the phase 3 trials died. One of them was immunocompromised, according to the Jerusalem Post, citing data published earlier.
The FDA is expected to release two separate assessments of the trial data before a panel of experts meets to review the data and approve or deny Pfizer’s emergency approval request.
It also comes after the FDA warned of a “severe downpour reaction” commonly seen in patients after taking the second dose.
In the United States, there was at least one other trial participant who allegedly died shortly after receiving the second dose. The participant in this case was a priest from Philadelphia who participated in the Moderna trial. In the UK, two patients were critically ill during the AstraZeneca-Oxford vaccine trial (although Oxford later said the illnesses had nothing to do with the trial). In Brazil, authorities briefly halted a trial of Sinovac’s experimental COVID vaccine after the death of a participant.
Israel has purchased 8 million doses of the Pfizer vaccine (enough to immunize 4 million people), and although some health officials have suggested that vaccinations can begin as soon as doses arrive, the director general of the health ministry Chezy Levy told JPost that starting vaccination in any location before FDA approval was prohibited.
To be sure, it is not known whether the deceased participants succumbed to vaccine-related complications, or if they even received a vaccine (they could have been given a placebo). In the UK, which inoculated the first patients under “emergency use” approval on Tuesday, a 90-year-old grandmother and an 81-year-old man named “William Shakespeare” were among the first patients to receive the vaccine.
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