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Vaccines

Pfizer and BioNTech Initiate Rolling Submission for COVID-19 Vaccine BLA for US FDA Approval

Strategic Insights

— 1 min read

Pfizer Inc and BioNTech SE have announced a rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older, with a request for priority review. The vaccine is currently available in the US under the FDA's Emergency Use Authorization (EUA). The companies are submitting nonclinical and clinical data, including the results from the pivotal Phase 3 clinical trial, to support licensure of the COVID-19 vaccine.

Key Takeaways:

  • Pfizer and BioNTech have initiated a rolling submission of a BLA to the US FDA for their COVID-19 vaccine, seeking approval for use in individuals 16 years of age and older.
  • The vaccine is currently available in the US under the FDA's EUA, and the companies are submitting nonclinical and clinical data to support licensure.
  • The data submitted includes the most recent analyses from the pivotal Phase 3 clinical trial, showing the vaccine's efficacy and favorable safety profile up to six months after the second dose.
  • The companies have also submitted an application to expand the EUA to include individuals 12 to 15 years of age and plan to submit a supplemental BLA upon receipt of required data six months after the second vaccine dose.
  • BioNTech is the Marketing Authorization Holder in the EU and the holder of emergency use authorizations or equivalent in the US, UK, Canada, and other countries.

Statistics:

  • The vaccine has shown efficacy and a favorable safety profile in individuals 16 years of age and older up to six months after the second dose.
  • The companies are submitting nonclinical and clinical data to support licensure of the COVID-19 vaccine.
  • The vaccine is currently available in the US and other countries under emergency use authorizations or equivalent.
  • BioNTech is the Marketing Authorization Holder in the EU and the holder of emergency use authorizations or equivalent in several countries.

Sources:

  • "M2 PHARMA-May 10, 2021-Pfizer and BioNTech commence rolling submission of COVID-19 vaccine BLA for US FDA approval (C)2021 M2 COMMUNICATIONS"

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