No link between Pfizer/BioNTech vaccine and deaths during trials, FDA and Pfizer reports conclude
Claim:
Six people died while taking part in the Pfizer/BioNTech vaccine trials.
CONCLUSION:
The deaths of six Pfizer/BioNTech vaccine trial participants have caused concern over its safety. Lack of clarity in Malaysian news reports fuel confusion over the cause of death. Studies find that the deaths were unrelated to the vaccine and likely due to pre-existing medical conditions.
FULL REPORT:
The lack of context and clarity in Malaysian news reports may suggest that the vaccine trials caused the participants’ deaths. Based on studies conducted by Pfizer and reviewed by the FDA, this is untrue.
As of 28 Dec 2020, the report by mainstream news site Harian Metro has gathered nearly 35,000 Facebook interactions.
It highlights the report by the US Food and Drug Administration (FDA) that six participants died during the Pfizer vaccine trials, but fails to provide context to the report's conclusion.
Another post about the deaths by national news channel TV3 refers to the vaccine trial participants as “victims” (mangsa). This is misleading as it suggests without basis that the deaths were caused by ill-intent.
All members of the vaccine trials were willing participants representing two age groups: younger adults (18 to 55 years old) and older adults (above 55 years old). One of the eligibility requirements for participation was a “higher risk of acquiring COVID-19” due to pre-existing medical conditions.
It is true that six died out of the 43,448 participants of the Pfizer vaccine trials. Two of them were given vaccines while four were given placebos – also known as a “dummy pill” or “sugar pill” containing an inactive substance such as starch, sugar, or saline. In the case of the Pfizer placebo, it was a 0.9% saline solution. Controlled placebo groups are used to see whether a new treatment is better than no treatment at all.
Both Pfizer's and FDA's reports put the six deaths down to Serious Adverse Events (SAE) - unfortunate medical occurrences that have no causal relationship with the treatment.
Among the four participants who died in the placebo trial, two died from undetermined causes. The other two died from a heart attack and stroke leading to bleeding in the brain. Since all four received placebos, the studies concluded that their deaths were unrelated to the trials.
The two participants who died in the vaccine group were both in the above-55 age group.
One of them died three days after the first dose. FDA noted that the cause of death is likely due to pre-existing conditions of obesity and atherosclerosis – an underlying condition causing blood vessels to harden or thicken, and can lead to heart failure.
The other participant who died experienced cardiac arrest more than 60 days after receiving the second dose of the vaccine.
As the FDA announced the emergency procurement and use of the Pfizer/BioNTech vaccine in its December 11 press release, it noted that “the known and potential benefits outweigh the known and potential risks”.
In approving the vaccine, the FDA made the following conclusion about the deaths that occurred during trials: "All deaths represent events that occur in the general population of the age groups where they occurred at a similar rate."
This means they found that the deaths were not likely due to complications from the vaccine, but rather due to conditions that occur to people in general of those age groups; and that the death rate did not show a deviation from the norm.
Without explaining the context, the translations in Harian Metro and TV3 are easily misunderstood by the general public.
In the comments by readers, many already doubt the safety of the vaccine and some suggest they will not risk taking it.
Faqcheck Lab sees it necessary to highlight these issues as the information gaps fuel misinformation. This may also allow the posts to be manipulated by those intending to create confusion over the efficacy of the vaccines.
RELATED
In other matters related to concern over the vaccine, some Muslim commenters queried whether Islam permits Covid-19 vaccination. Malaysia’s Minister for Religious Affairs, Dr Zulkifli Mohamad Al-Bakri, allayed these concerns in an official Twitter post:
Special THANKS:
Julia Yeow & Parkaran Krishnan Kutty
