Social media users shared a report making several claims of serious adverse health effects to the Pfizer-BioNTech COVID-19 vaccine, including that 6 people died in late-stage trials. These allegations are partly false. Six people did die during the Pfizer-BioNTech vaccine trials, but only two of them received the vaccine. The other four received a safe placebo solution of salt and water. No causal relationship was established between the vaccine and the two deaths, which occurred in accordance with the normal mortality rate for the general population. The first person to receive the vaccine in the UK is not in a critical condition. Four cases of Bell’s Palsy (partial facial paralysis) are also not considered necessary by the vaccine, but the symptom will be monitored when the vaccine is distributed. Precautions have also been added for allergic reactions.
The report (here) says: ‘Six people killed in Pfizer’s late trial of the COVID-19 # vaccine […] (4 out of 6 die from placebo injection, why would #Pfizer have to use a lethal #placebo without manipulating data […] Warning over UK vaccine deployment due to two NHS staff suffering ‘anaphylactic reaction’: Regulators urge people with ‘significant’ allergies not to get Pfizer injection […] Also, four people in the United States, who received the COVID-19 vaccine shot developed by Pfizer / BioNTech, developed Bell’s Palsy […] Update – Now the first woman to receive covid-19 vaccine in the UK is in critical condition. ”
Vaccinations with the Pfizer-BioNTech COVID-19 vaccine have started in the UK and the vaccine has also been approved for use in Bahrain and Canada (here). At the time of writing, discussions were underway with the US Food and Drug Administration (FDA) regarding the approval of the vaccine in the United States, after FDA staff said in the documentation that the efficacy and safety data of the vaccine meet the expectations for emergency use authorization. (here).
Reuters recently dismissed other allegations about the first person to receive the vaccine in the UK (here) and the vaccine itself (here, here, here).
Six participants did die during the Pfizer vaccine trial of 44,000 people, two of whom received the vaccine while the other four people received a placebo (here).
Details of the deaths are set out in the FDA information documents (here and here), ahead of a Thursday meeting of external experts at the FDA who will discuss whether they recommend the Pfizer survey for people 16 years 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 others die of arteriosclerosis three days after the first dose of vaccination. One of the placebo recipients died of myocardial infarction, another with bleeding and two others due to unknown causes.
The FDA briefing explains that the deaths are not associated with the vaccine: “None of these deaths were assessed by the investigator as related to study intervention”. They explain: “All deaths represent events that occur at the same rate in the general population of the age groups where they occurred.”
Social media reports that Pfizer used a “lethal placebo” to manipulate data. Pfizer documents show that the placebo (here) is a normal saline solution, specifically a 0.9% sodium chloride solution for injection, which means that it is merely a mixture of salt and water.
The FDA information documents also show that it is true that there were four cases of Bell’s Palsy among those who received the vaccine (here). Bell’s Palsy is a sudden weakness or freezing of muscles on one side of the face, which in most cases is temporary (here, here).
The briefing states that the frequency of Bell’s Palsy in the vaccine group ‘corresponds to the expected background rate in the general population’, and there is ‘no clear basis on which a causal link can be drawn at present’. However, the FDA said it would recommend “surveillance” for cases of Bell’s Palsy as the vaccine is sent to larger groups of people.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has stated that anyone with a history of anaphylaxis to a medicine or food, or with a history of significant allergies, is not a Pfizer-BioNTech vaccine should not have. The advice comes after two reports of anaphylaxis and one report of a possible allergic reaction since the vaccine was rolled out on December 8 (here, here).
FIRST PERSON TAKING BELKSTOUT IS NOT IN CRITICAL CONDITION
Margaret Keenan, the first person to receive the COVID-19 vaccine, was well enough on December 9 to be discharged from the hospital. Videos from BBC News and Sky News show that she has not been in a critical condition for a long time (here, here). In a statement on the same day, Keenan said, “I feel great.” (here). There have been no credible reports since December 9 (here, here) that Keenan became ill.
Partly false. Those with a history of significant allergies were advised not to take the vaccine, but no causal link was established between the vaccine and the two deaths, nor the four cases of Bell’s Palsy during the trial. The first person to take the vaccine in the UK is not in a critical condition. The placebo is a solution of salt and water.
This article was produced by the Reuters Fact Check team. Read more about our fact-checking work here.