Pfizer and BioNTech Receive FDA Approval for COVID-19 Vaccine Comirnaty

Strategic Insights -

Pharmaceutical giants Pfizer Inc and BioNTech SE have secured approval from the US Food & Drug Administration for their COVID-19 vaccine, Comirnaty. The vaccine is designed for use in adults aged 65 and over, as well as individuals aged between 5 and 64 with underlying conditions that put them at high risk for severe COVID-19 outcomes. This approval is based on a supplemental biologics license application for the firms' LP.8.1-adapted monovalent COVID-19 vaccine, which was selected as the preferred sublineage of a monovalent JN.1-lineage-based vaccine for use in the US starting in autumn this year.

Key Takeaways:

  • Pfizer and BioNTech have received FDA approval for their COVID-19 vaccine, Comirnaty, for use in adults aged 65 and over and individuals aged 5-64 with underlying conditions.
  • The approval is based on a supplemental biologics license application for the LP.8.1-adapted monovalent COVID-19 vaccine, which was selected as the preferred sublineage by the FDA.
  • The vaccine will be available across the US "in the coming days" and has been distributed with around 5 billion doses to date.
  • BioNTech is the marketing authorisation holder for Comirnaty and its adapted vaccines in the US, EU, UK, and other countries.
  • Pfizer and BioNTech developed the vaccine using BioNTech's proprietary mRNA technology.

Statistics:

  • 5 billion doses of the Pfizer-BioNTech COVID-19 vaccine have been distributed to date.
  • The vaccine will be available across the US "in the coming days".
  • Shares in Pfizer were up 0.5% at USD25.04 on Wednesday afternoon, while shares in BioNTech were down 1.5% at EUR88.50.

Sources:

  • Alliance News
  • Pfizer Inc
  • BioNTech SE
  • US Food & Drug Administration