Misleading Reports on Deaths During Pfizer Vaccine Trial Go Viral
While the US FDA reported the deaths of two vaccine trial participants, it didn’t connect the deaths to the vaccine.
A misleading blog post about the deaths of people who participated in Pfizer’s COVID-19 vaccine trial has gone viral on social media. We found that while the US Food and Drug Administration (FDA) reported the deaths of two vaccine trial participants, it didn’t connect their deaths to the vaccine.
The headline of the viral blog post shared on a website called, Health and Money News, read “BREAKING: FDA announces 2 deaths of Pfizer vaccine trial participants from ‘serious adverse events’”.
The article was also shared on GreenMedInfo. Both the posts contained a screenshot of a report published on The Jerusalem Post, the headline for which was “FDA announces deaths of two Pfizer vaccine trial participants”. The Jerusalem Post has since changed its headline for the story.
WHAT WE FOUND OUT
The reports cite a recent briefing shared by the FDA on 10 December, following the meeting of its vaccine advisory panel. The panel later gave Pfizer’s COVID-19 vaccine the emergency use authorisation.
In the document, FDA talked about the safety data collected during Pfizer’s vaccine trials. It defines “serious adverse events” as deaths and non-fatal events, such as appendicitis.
Close to 44,000 people enrolled in Pfizer’s vaccine trial, of which 6 people died. The document mentioned that only two of those six people had received the vaccine and four had received a placebo (a mixture of salt and water).
According to the briefing document (page 41), both the vaccine recipients who died were older than 55 years. One person experiences a cardiac arrest 62 days after the second dose of the vaccination and died three days later. The other person died from arteriosclerosis (hardening of the arteries) three days after the first dose.
In another briefing released on the same day, FDA clearly mentions that the death were not related to the vaccine. “None of these deaths were assessed by the investigator as related to study intervention,” it said (page 50).
They go on to explain that “all deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate.”
It’s important to note that the US FDA has approved the Pfizer COVID-19 vaccine for emergency use. Pfizer has also applied for emergency authorisation of its vaccine candidate before the Drugs Controller General of India (DCGI).
Evidently, excerpts from an FDA briefing document were misreported to create a false and misleading narrative about deaths during the vaccine trials.
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