FDA says 2 people died from Pfizer COVID-19 vaccine trial as vaccine safety concerns come to the forefront. Revelation buried in a 90-page document
How safe are COVID-19 vaccines? It depends on whom you ask. The issue of vaccine safety has been the subject of discussion since the coronavirus pandemic started at the beginning of this year. About a week ago, a new survey found that 60% of Americans say they would definitely or probably get vaccinated for the coronavirus if one were available, that was up from 51% who said this in September, according to Pew Research. That trend may likely be reversed following the latest announcement from the US Food and Drug Administration (FDA).
Today, the FDA admitted that two participants in the Phase 3 trials have died, according to a report published last night. The revelation about the deaths was buried on page 50 of the 90-page briefing document. The announcement comes ahead of the FDA’s Thursday meeting on the Pfizer vaccine. The agency said Tuesday that two trial participants had died after receiving it. One of the deceased individuals was immunocompromised, meaning the person’s immune defenses were low.
Below is how the FDA explained the six deaths:
“There were 6 participants, all in Phase 3, who died through the data cutoff date of 14 November 2020. This included 2 participants in the BNT162b2 group and 4 participants in the placebo group. None of these deaths were assessed by the investigator as related to study intervention.”
According to the FDA, the first person died 3 days after taken the first dose of the vaccine. The second person experienced an SAE of cardiac arrest 60 days after Dose 2 and died 3 days later. Below is how the FDA explained it:
“One participant in the older BNT162b2 group experienced an SAE of arteriosclerosis and died 3 days after Dose 1. The one participant in the older BNT162b2 group experienced an SAE of cardiac arrest 60 days after Dose 2 and died 3 days later.”
With the FDA expected to grant emergency-use approval for the Pfizer-BionTech COVID vaccine today after releasing a preliminary assessment of the trial data that the panel will use to assess the drug earlier today.
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 FDA admission comes after the agency warned of a “severe adverse reaction” frequently seen in patients after taking the second dose.
There has been at least one other trial participant who reportedly died not long after receiving the second dose in the U.S. 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.
December 10, 2020 Updates: FDA says it will quickly approve Pfizer’s COVID-19 vaccine for emergency use even after the agency admitted 2 people had died from the phase 3 vaccine trial.
December 16, 2020 Updates: Alaska healthcare worker was hospitalized with a ‘serious allergic reaction’ after receiving Pfizer’s COVID-19 vaccine. The person had no history of allergies.