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Vaccines

FDA Approves Pfizer-BioNTech COVID-19 Bivalent Vaccine Booster Dose

Strategic Insights

— 1 min read

Pfizer Inc. and BioNTech SE announced on Wednesday that the US Food and Drug Administration (FDA) has approved a 30-microgram booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which targets both the original and Omicron BA.4/BA.5 strains. The companies emphasized that they will continue to provide both the original and bivalent vaccinations under their current supply contract with the US government. The Advisory Committee on Immunization Practices is likely to endorse a proposal from the Centers for Disease Control and Prevention (CDC) for booster immunizations for those 12 years of age and older. Pfizer and BioNTech will start supplying bivalent dosages according to US regulatory regulations, and eligible US citizens will continue to receive the shot without charge.

Key Takeaways:

  • The FDA has approved a 30-microgram booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which targets both the original and Omicron BA.4/BA.5 strains.
  • Pfizer and BioNTech will continue to provide both the original and bivalent vaccinations under their current supply contract with the US government.
  • The Advisory Committee on Immunization Practices is likely to endorse a proposal from the CDC for booster immunizations for those 12 years of age and older.
  • Pfizer and BioNTech will start supplying bivalent dosages according to US regulatory regulations.
  • Eligible US citizens will continue to receive the shot without charge.
  • The FDA will receive an application for an Omicron-adapted bivalent vaccination for children between the ages of 5 and 11 in the first few days of October.
  • Pfizer and BioNTech are collaborating with the FDA to submit a request for an Omicron-adapted bivalent vaccination for children between the ages of 6 months and 4 years.

Statistics:

  • The booster dose approved by the FDA is 30 micrograms.
  • The bivalent vaccine targets both the original and Omicron BA.4/BA.5 strains.
  • Pfizer and BioNTech will continue to provide both the original and bivalent vaccinations under their current supply contract.
  • The FDA approval is for booster immunizations for those 12 years of age and older.
  • The eligible age range for the Omicron-adapted bivalent vaccination for children is between 5 and 11 years old.

Sources:

  • Pfizer Inc.
  • BioNTech SE
  • US Food and Drug Administration (FDA)
  • Advisory Committee on Immunization Practices
  • Centers for Disease Control and Prevention (CDC)
  • US government

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