FDA Approves Vaccine Booster Dose Of mRNA COVID-19 Vaccines For Small, Vulnerable Group

  • The FDA has authorized a third COVID-19 vaccine booster shot to immunocompromised individuals who have already received two mRNA shots, citing their need for extra protection from the infection.
  • The agency amended the emergency use authorizations for vaccines from Pfizer Inc PFEBioNTech SE BNTX and Moderna Inc MRNA to allow an additional dose in certain individuals, specifically for recipients of solid organ transplants or those diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
  • Regulators emphasized that the action does not apply to people who are not immunocompromised and that other fully vaccinated individuals do not need an additional dose right now.
  • Acting FDA Commissioner Janet Woodcock suggested the new authorization results from a “science-based, rigorous process.”
  • She also said, “after a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines.”
  • The FDA added that immunocompromised individuals should also consider monoclonal antibody treatment options if they contract or become exposed to COVID-19, even though post-exposure prophylaxis is not a substitute for vaccination.
  • The CDC’s advisory panel on immunizations is set to convene Friday morning to discuss recommending the booster shot.
  • Price Action: PFE shares are up 0.17% at $47.32, MRNA stock is +1.83% at $398.57, BNTX stock is up 2.50% at $383.38 during the premarket session on the last check Friday.
  • Related content: Benzinga's Full FDA Calendar.
  • Photo by x3 from Pixabay
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