Social media users have been sharing a post that makes several claims of serious negative health effects from the Pfizer-BioNTech COVID-19 vaccine, including that 6 people died during late-stage trials. These claims are partly false. Six people did die during the Pfizer-BioNTech vaccine trials, but only two of them were given the vaccine. The other four were given a safe placebo solution of salt and water. No causal relationship was established between the vaccine and the two deaths, which occurred in line with the normal death rate for the general population. The first person to get the vaccine in the UK is not in critical condition. Four cases of Bell’s Palsy (partial facial paralysis) were also not considered to necessarily be caused by the vaccine but the symptom will be under surveillance when the vaccine is distributed. Precautions have also been added for allergic reactions.
Six participants did die during the 44,000 person Pfizer vaccine trial, two of whom were given the vaccine while the other four people received a placebo (here).
Details of the deaths are laid out in FDA briefing documents, ahead of a Thursday meeting of outside experts to the FDA who will discuss whether to recommend the Pfizer shot for people aged 16 and older.
One of the vaccine recipients had a cardiac arrest 62 days after a second dose of the two-dose vaccination and died three days later. The other died from arteriosclerosis three days after a first dose of the vaccination. One of the placebo recipients died from myocardial infarction, another from haemorrhagic stroke and two others from unknown causes.
The FDA briefings clarify that the deaths were not deemed to be related to the vaccine: “None of these deaths were assessed by the investigator as related to study intervention”. They explain: “All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate.”
The FDA briefing documents also show that it is true that there were four cases of Bell’s Palsy among those who received the vaccine. Bell’s Palsy is a sudden weakness or freezing of muscles on one side of the face, which in most cases is temporary.
The briefing says that the frequency of Bell’s Palsy in the vaccine group is “consistent with the expected background rate in the general population”, adding there is “no clear basis upon which to conclude a causal relationship at this time”. The FDA said it would, however, recommend “surveillance” for cases of Bell’s Palsy as the vaccine is sent out to larger groups of people.
Britain’s medicine regulator, The Medicines and Healthcare Products Regulatory Agency (MHRA), has said that anyone with a history of anaphylaxis in reaction to a medicine or food, or with a history of significant allergies should not have the Pfizer-BioNTech vaccine. The advice comes after two reports of anaphylaxis and one report of a possible allergic reaction since the vaccine was rolled out on Dec. 8.
FIRST PERSON TO TAKE VACCINE NOT IN CRITICAL CONDITION
Margaret Keenan, the first person to receive the COVID-19 vaccine, was well enough to be discharged from hospital on Dec. 9. Videos from BBC News and Sky News show that she was far from being in a critical condition ( here , here ). In a statement on that same day Keenan said, “I feel great.” (here). There have been no credible reports of Keenan falling ill since Dec. 9.
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