With the FDA expected to grant emergency-use approval for the Pfizer-BionTech COVID vaccine Thursday after releasing a preliminary assessment of the trial data that the panel will use to assess the drug earlier today, the agency has admitted Tuesday that two participants in the Phase 3 trials have died. One of them was immunocompromised, according to the Jerusalem Post, citing data released 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 either approve Pfizer’s request for emergency approval, or deny it.
This also comes after the FDA warned of a “severe averse reaction” frequently seen in patients after taking the second dose.
In the US, there has been at least one other trial participant who reportedly died not long after receiving the second dose. The participant in that case was a priest in Philadelphia who participated in the Moderna trial. In the UK, two patients were seriously sickened during the trial of the AstraZeneca-Oxford vaccine (though Oxford later said the illnesses had nothing to do with the trial). While In Brazil, authorities briefly halted a trial of Sinovac’s experimental COVID vaccine after a participant died.
Israel has purchased 8 million doses of the Pfizer vaccine (enough to vaccinate 4 million people), and while some health officials have suggested that vaccinations could begin as soon as the doses arrive, Health Ministry director-general Chezy Levy told the JPost that beginning vaccination in any place ahead of FDA approval was forbidden.
To be sure, it’s unclear whether the participants who died succumbed to vaccine-related complications, or whether they even received a vaccine at all (they could have received a placebo). In the UK, which innoculated the first patients under the ’emergency use’ approval on Tuesday, a 90-year-old grandmother and 81-year-old man named “William Shakespeare” were among the first patients to receive the vaccine.