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Thursday, December 10, 2020

Pfizer/BioNTech COVID-19 vaccine rollout marred by adverse events

 

  • The U.K. has received two reports of anaphylaxis and one report of a possible allergic reaction on the first day of the roll of the COVID-19 vaccine candidate from Pfizer Inc. (PFE) and BioNTech SE (BNTX), the officials there have said.
  • The anaphylaxis, an overreaction of the body’s immune system, is described by the country's National Health Service as severe and sometimes life-threatening.
  • Later in the day, the country’s regulator advised anyone with a history of anaphylaxis to a vaccine, medicine, or food not to get the vaccine. The late-stage clinical trials of the vaccine had left out people with a history of significant adverse reactions to vaccines or vaccine’s ingredients.
  • Ahead of the potential emergency use authorization by the FDA for the vaccine candidate, the issue has surfaced during the ongoing expert panel review, STATNews reports.
  • Paul Offit, a panelist as well as a reputed virologist in the panel has raised his concerns, noting ‘tens of millions of Americans will hesitate to get vaccinated due to medical history of severe allergy. Earlier, Associated Press had reported that 70% of the US population would have to be vaccinated to achieve herd immunity for the COVID-19 virus.
  • While ruling out any impact on EUA, Offit has said, “this issue is not going to die until we have better data,”
  • https://seekingalpha.com/news/3643552-pfizer-biontech-covidminus-19-vaccine-rollout-marred-adverse-events

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