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- The FDA describes the deaths of vaccine trial participants as serious adverse events, it didn’t say that two participants died from serious adverse events.
- A report from the FDA said that two people who had received the vaccine had died but it didn’t say the vaccine caused their deaths.
A recent blog post about the deaths of people who volunteered for Pfizer’s COVID-19 vaccine trial sounds scary but it’s misleading, and lacking context.
"BREAKING," the headline of the story on a blog called Health and Money News says. "FDA announces 2 deaths of Pfizer vaccine trial participants from ‘serious adverse events.’"
The story goes on to say that "a newly released document on the FDA website shows that 2 participants died as a result of ‘serious adverse events’ from the experimental Covid vaccine."
But that’s not quite right.
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Here’s what you should know.
The Food and Drug Administration recently released a briefing document for the Dec. 10 meeting of its vaccine advisory panel, which recommended that the FDA give Pfizer’s COVID-19 vaccine emergency use authorization.
The document details safety data collected during Pfizer’s vaccine trials, including "serious adverse events," which the FDA defines as "any undesirable experience associated with the use of a medical product in a patient."
Serious adverse events include deaths and non-fatal events, such as appendicitis.
Among 43,448 people enrolled in Pfizer’s vaccine trial, six people died. Two of those people had received the vaccine and four had received a placebo.
According to the briefing document, both vaccine recipients who died were older than 55. One person suffered a heart attack 62 days after the second dose of the vaccination and died three days later. The other person, who had "baseline obesity and pre-existing arteriosclerosis" — a hardening of the arteries — died from arteriosclerosis three days after the first dose.
All six deaths, including those of the placebo recipients, "represent events that occur in the general population of the age groups where they occurred, at a similar rate," the document says.
In other words, none of the deaths were attributed to the vaccine, and the briefing document endorsed its emergency-use authorization, saying it had a "favorable safety profile, with no specific safety concerns."
According to the document, only three serious adverse events were determined by an investigator to be related to the vaccine or how the vaccine was administered: a shoulder injury, an irregular heartbeat, and swollen lymph nodes.
The blog post says that the FDA announced that two Pfizer vaccine trial participants had died from serious adverse events.
A report from the FDA said that while two people who had received the vaccine had died, it didn’t say the vaccine caused their deaths, as this blog post suggests.
We rate this post Mostly False.
Health and Money News, BREAKING: FDA announces 2 deaths of Pfizer vaccine trial participants from ‘serious adverse events,’ Dec. 8, 2020
FDA briefing document for Dec. 10, 2020, committee meeting
The New York Times, F.D.A. advisory panel gives green light to Pfizer vaccine, Dec. 10, 2020
FDA, What is a serious adverse event?, Feb. 1, 2016
Politico, FDA says Pfizer vaccine is safe and effective, Dec. 8, 2020
Bloomberg, Pfizer shot effective, safe, FDA staff says before meeting, Dec. 8, 2020
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