The Deaths During Pfizer’s Trial Are Not Vaccine-Related
Six people died in the trial, but none were linked to the vaccine itself
On Thursday, at the Food and Drug Administration’s special advisory hearing to discuss emergency use approval for Pfizer’s Covid-19 vaccine, experts addressed a very large elephant in the room: that six people died during Pfizer’s trial. This information is publicly available in two briefing documents for the vaccine hearing published on the FDA website.
In the hearing, experts explained that of the six people who died during Pfizer’s trial of 44,000 people, four had received a placebo injection (a saline solution) and not the vaccine. One person who received the vaccine died shortly after going into cardiac arrest 62 days after receiving the second dose of the two-dose vaccine. The other person died from arteriosclerotic disease, which causes the walls of the arteries to harden, three days after they received the first dose of the vaccine and had baseline obesity. Both people in the vaccine group who died were over age 55.
“Neither of these deaths were considered related to the vaccine,” said Susan Wollersheim, MD, of the FDA Center for Biologics Evaluation and Research, during the hearing.
One of the FDA briefing documents notes: “All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate.”
With this context, the deaths that occurred during Pfizer’s trials should not be alarming. Unfortunately, some posts on social media are presenting this news without that context, raising unjustified concerns about the safety of Pfizer’s vaccine.
If you share or discuss this news, it’s critical that you include the context surrounding these deaths to avoid raising unwarranted alarm about the safety of the Pfizer vaccine. Pfizer’s full data shows that the vaccine is 95% effective, including 94% efficacy in people over the age of 65, and it has submitted more than two months of safety data to the FDA. The FDA is expected to make its decision to approve the vaccine on Thursday after the hearing.