Fact check: Claim misinterprets data from a 2021 Pfizer report (usatoday.com)
Sudiksha Kochi
USA TODAY
The claim: A Pfizer trial reports 42,000 adverse events and 1,200 fatalities As health care officials continue to urge Americansto get vaccinated and the coronavirus has led to more than 1 million deaths in the U.S., some online posts falsely claim the Pfizer COVID-19 vaccine makes people sick and kills them.
"So the leak distracted from the Pfizer dump. 46,000 people took the vaccine in a trial period...42,000 had adverse affects (sic) and 1200 died," reads an Instagram post shared May 5. "FDA rules that one death in 30 days closes the trial down...it didn't...why?"
These allegations were made three days after more than 80,000 pages of Pfizer COVID-19 data was made public. The data was release as part of an ongoing Freedom of Information Act lawsuit, according to Abigail Capobianco, a spokesperson for the Food and Drug Administration.
The post generated over 1,000 likes in less than three weeks. Similar posts have amassed thousands of interactions on Facebook, Instagram and Twitter.
But the claim is false.
USA TODAY could not verify which document or trial the post was referencing. But experts told USA TODAY the claim is based off a misinterpretation of data from a post-surveillance data report Pfizer published in 2021. The data in the report, which includes deaths and adverse events, does not specify whether the vaccine caused any of these health outcomes.
USA TODAY reached out to the social media users who shared the claim for comment.
Adverse events, fatalities not linked to vaccineIt is unclear which Pfizer trial the post is referencing, and whether the trial was part of the recent data release. Both the FDA and Pfizer refused to comment on the claim.
But experts told USA TODAY the claim is based off a misinterpretation of data from a post-surveillance data report published in 2021, in which Pfizer tracked cases of adverse events and fatalities disclosed by thousands of people who received the vaccine between Dec. 1, 2020 to Feb. 28, 2021.
Among this group, the report shows there were 42,086 reports of adverse events and 1,223 reports of fatalities within a certain period of time following vaccination, Jeffrey Morris, the director of the Division of Biostatistics at the University of Pennsylvania, told USA TODAY.
But this data does not mean there is a causal relationship between the vaccine and these events, Dr. Patrick Jackson, an infectious disease specialist at the University of Virginia, told USA TODAY. Someone could have naturally passed away or experienced an adverse reaction from another medical condition, he said.
"Anyone can place these reports and there's no real way to know how these events might have occurred," Jackson said. "The point of this data is for researchers to detect unusual signals that need to be explored further. It is not meant to be conclusive."
In fact, as the report's authors explain, "many external factors influence whether or not an AE (adverse event) is reported," it is not appropriate to "make between-drug comparisons" using the data.
In addition, it is unclear where the 46,000 figure cited in the post originates from, Morris said.
USA TODAY has debunked similar claims that 45,000 people died from vaccine-related complications and that 1 million COVID-vaccine injuries are reported in a CDC database.
Our rating: FalseBased on our research, we rate FALSE the claim that a Pfizer trial reports 42,000 adverse events and 1,200 fatalities. USA TODAY could not verify which clinical trial the post was referencing, and whether it was part of the recent data release. But experts said the claim is based off a misinterpretation of a Pfizer 2021 post-surveillance report. The data in that report does not specify whether the Pfizer vaccine caused any health problems.
Our fact-check sources:- Jeffrey Morris, May 24, Phone interview with USA TODAY
- Dr. Richard Martinello, May 24, Email exchange with USA TODAY
- Dr. Patrick Jackson, May 24, Phone interview with USA TODAY
- Australian Associated Press, March 17, Anti-vaxxers misrepresent Pfizer report to say 1200 died in the first months of rollout
- USA TODAY, Jan 5., Fact check: Reports of adverse events due to COVID-19 vaccines are unverified
- USA TODAY, Sept. 10, Fact check: There is no evidence 45,000 people died from vaccine-related complications
- USA TODAY, May 13, 1 million Americans have died of COVID. Here's one valuable life we lost in each state.
- Abigail Capobianco, May 6, Email exchange with USA TODAY
- Pfizer, accessed May 27, 5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
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