August 27, 2021 / Care

FDA’s Full Approval of Pfizer-BioNTech’s COVID-19 Vaccine Comarnaty: What Does It Mean?

We were excited to learn of the news of the FDA’s full approval of Pfizer-BioNTech’s Covid-19 vaccine, now marketed under the name Comarnaty, on Monday August 23, 2021. This is the first fully approved Covid-19 vaccine in the US, with Moderna and Janssen/Johnson & Johnson still available widely under Emergency Use Authorization (EUA).

Here are the things you need to know about the FDA’s recent approval:

  • The FDA approval for Comarnaty applies to people ages 16 years and older. This approval is based on clinical trial data of approximately 20,000 vaccine and 20,000 placebo recipients ages 16 years and up. Of those participants, at least 12,000 recipients have been followed for six months post-injection or longer.
  • People ages 12-15 may continue to receive vaccination under EUA. There is no current EUA or approval for people under age 12 to receive Covid-19 vaccination and studies of vaccine efficacy and safety in this group are ongoing.
  • The FDA’s approval of a third booster shot applies to both the fully approved vaccine in people 16+, as well as people ages 12-15, who are immunocompromised and at higher risk.

As always, if you have questions about vaccination and your specific health status, talk to your neuromuscular doctor and medical team for additional guidance.

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