The U.S. Food and Drug Administration did not conclude a cause-effect relationship between the…
A Facebook (FB) post by a local netizen claiming that the COVID-19 vaccine of pharmaceutical companies Pfizer Inc. and BioNTech SE had caused the deaths of six people during the trial phase is misleading.
The post, published on Dec. 13, included a screenshot of a live news report from RT - a Russian media group publicly funded by the Russian Federation. A news ticker read: “Six people die during vaccine Pfizer vaccine trials, FDA not concerned.”
A copy of the segment can be found in a Dec. 9 report of RT, where the same news ticker was shown.
While six participants did die, “none of these deaths were assessed by the investigator as related to study intervention,” according to a Dec. 10 briefing document on the Pfizer-BioNTech vaccine from the United States (U.S.) Food and Drug Administration (FDA).
In the FDA briefer about the Phase 2/3 trials of the vaccine involving 43,448 participants, two deaths were reported from the group that received the vaccine and four from the group that got the placebo, which is a saline solution.
In another FDA brief published on Dec. 10, it was reported that the person who died three days after getting the first dose had “baseline obesity and pre-existing atherosclerosis.” The other experienced cardiac arrest 60 days after getting a second dose of the vaccine, and died three days later.
Both were in the older age group of trial participants (56 and above).
Of the four deaths in the placebo group, the cause was “unknown for two of them” who were both in the younger age group (55 and below), while the other two participants both in the older age group died from “hemorrhagic stroke and myocardial infarction, respectively.”
The deaths account for 0.01% of the enrolled participants.
“All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate,” the second briefer read.
The FB user's misleading post said: “Ayan na Ang effect ..nagkakamatayan na..yan Ang real agenda ni billgates.depopulation. GMA .Ibalita niyo yan..Hindi puro pabango sa vaccine (This is the effect. People are dying. That’s the real agenda of Bill Gates, depopulation. GMA [News], report that, not just good things about the vaccine).”
In a Dec. 11 press release, the US FDA claimed that the vaccine’s benefits “outweigh its known and potential risks,” showing no reason for major concerns for illnesses or deaths in receiving the vaccine. The FDA issued an emergency use authorization that day, allowing it to be administered to individuals aged 16 and older.
The post has received over 500 interactions and has been viewed more than 23,000 times on the platform, according to Facebook’s monitoring tool.