FDA remains skeptical about booster shots despite new Pfizer data suggesting efficacy declines

fda remains skeptical about booster shots despite new pfizer data suggesting efficacy declines

Sumary of FDA remains skeptical about booster shots despite new Pfizer data suggesting efficacy declines:

  • The U.S. Food and Drug Administration (FDA) remains skeptical of COVID-19 vaccine booster shots ahead of an advisory committee meeting on Friday despite Pfizer-BioNTech releasing new data suggesting the need for them.
  • The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet at the end of the week to discuss data on potential third doses.
  • Members will vote on whether or not booster doses are safe and effective and if they should be approved for all Americans.
  • New data from Pfizer published on Wednesday suggests that efficacy of the regular two-dose regimen declines from 96.2 percent to 83.7 percent after six months, but that a booster dose increased immune responses.
  • Documents ahead of an FDA advisory committee about COVID-19 vaccine booster shots were published on Wednesday.
  • At the time, Pfizer said its early data suggested people who received booster doses between six and 12 months after their final dose had high levels of protection.
  • The company filed for emergency use authorization for booster doses in late August and submitted data, made public on Wednesday.
  • emerging data suggest that vaccine protection may wane approximately six to eight months following the second dose, and evidence is building to suggest that administration of booster doses of COVID-19 mRNA vaccines is potentially an urgent emerging public health issue,’ the authors wrote.

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