Did six people die during Pfizer's COVID-19 vaccine trial and is the FDA "not concerned"? Yes and no: Six participants died during the trial, but not from the vaccine. Of the six, just two were given the vaccine. The other four participants received a placebo. According to a briefing document from the U.S. Food and Drug Administration (FDA), which is monitoring developments closely: "All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate." The deaths, in other words, were not determined to be related to the administration of the vaccine. Approximately 44,000 people participated in the trial.
The claim appeared in an Instagram post (archived here) published by "Dr. Ben Tapper" on December 16, 2020. The post was prefaced with the message: "Nothing to see here. Keep scrolling." It included what looked to be a screenshot from RT, a media outlet based in and funded by Russia, with the following caption circled in yellow:
Six people die during Pfizer vaccine trials, FDA not concerned
Users on social media saw this:
The post clearly implied that the FDA is either unconcerned with reported deaths or, worse, trying to sweep them under the rug. That's not true. In fact, the FDA released a briefing document, dated December 10, 2020, that addressed the six deaths in detail. You can read the full text of that report here.
On page 41, the document states:
A total of six (2 vaccine, 4 placebo) of 43,448 enrolled participants (0.01%) died during the reporting period from April 29, 2020 (first participant, first visit) to November 14, 2020 (cutoff date). Both vaccine recipients were >55 years of age; one experienced a cardiac arrest 62 days after vaccination #2 and died 3 days later, and the other died from arteriosclerosis 3 days after vaccination #1. The placebo recipients died from myocardial infarction (n=1), hemorrhagic stroke (n=1) or unknown causes (n=2); three of the four deaths occurred in the older group (>55 years of age).
Significantly, it read:
All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate.
A second briefing document, also dated December 10, 2020, reached the same conclusion. It said:
None of these deaths were assessed by the investigator as related to study intervention.
Stated alternatively, six people died during Pfizer's trial but their deaths were not attributed to the vaccine and four of the six didn't even receive the vaccine -- they were part of the group that got a saline placebo.
Of course, vaccines are not zero risk. Although most common side effects are identified before a vaccine is licensed, it's always possible that early studies miss "rare adverse events," according to the FDA. Less common side effects may also pop up once millions of people receive the vaccine, which is why there is continuous monitoring, even after a vaccine is licensed.
On December 11, 2020, the FDA issued the first emergency use authorization for a COVID-19 vaccine. In a statement announcing the decision, the agency stressed that it had conducted a thorough safety study and that the Pfizer-BioNTech COVID-19 vaccine had met all statutory criteria. The data "support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine's use in millions of people 16 years of age and older," the FDA said.
