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FDA Approves Two New COVID Vaccines


On Monday September 11th, the Food and Drug Administration formally approved mRNA vaccines from Moderna and Pfizer that provide protection against the Omicron variant XBB1.5 of SARS-CoV-19 virus.

The decision to approve the monovalent vaccines that will replace the previous bivalent products was based on an intensive review of field data confirming efficacy and safety.  The technology used to produce the two new vaccines is similar to the previous products.  The new vaccine will effectively neutralize EG.5 and BA.2.86 strains and will provide protection against currently circulating COVID-19 variants.


The vaccines have been approved for:


  • Individuals 5 years of age and older irrespective of previous vaccination.


  • Individuals 6 months through 4 years of age who have been previously vaccinated.

  • Unvaccinated individuals 6 months through 4 years of age


Following approval of the two vaccines by the FDA, the U.S. Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices met on September 12th and finalized recommendations for recipients including those who are immunocompromised or have other predisposing factors.