Pfizer and BioNTech Announce CHMP Recommendation for Full Marketing Authorization of COMIRNATY in the EU

Strategic Insights -

Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the conversion of the conditional Marketing Authorization (cMA) for COMIRNATY to standard (also referred to as full) Marketing Authorization (MA) for all authorized indications and formulations. This decision applies to all existing COMIRNATY indications and formulations, including Pfizer and BioNTech's bivalent vaccines (COMIRNATY Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5) as booster doses for individuals aged 12 and older. In a separate action, the CHMP also recommended approval for COMIRNATY as a 10-g booster (third) dose given at least six months after completion of a primary series for children 5 through 11 years of age.

The conversion, if approved by the European Commission, will confirm the benefits of the vaccine continue to outweigh its potential risks. The CHMP's decision is based on the totality of available efficacy and safety data provided by Pfizer and BioNTech.

The safety of COMIRNATY, COMIRNATY Original/Omicron BA.1, and COMIRNATY Original/Omicron BA.4-5 has been evaluated by the EMA's CHMP, which concluded that the vaccine has a favorable safety profile. The CHMP has also recommended approval for the use of COMIRNATY as a booster dose in individuals aged 5 through 11 years.

Key Takeaways:

  • The CHMP has recommended the conversion of the conditional Marketing Authorization (cMA) for COMIRNATY to standard (also referred to as full) Marketing Authorization (MA).
  • The conversion applies to all existing COMIRNATY indications and formulations, including Pfizer and BioNTech's bivalent vaccines (COMIRNATY Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5).
  • The CHMP has also recommended approval for COMIRNATY as a 10-g booster (third) dose given at least six months after completion of a primary series for children 5 through 11 years of age.
  • COMIRNATY has been granted standard MA by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people aged 5 years and older.
  • The vaccine is administered as a 2-dose series, 3 weeks apart, with 30 micrograms per dose for adults and adolescents, and 10 micrograms per dose for children aged 5 to 11 years.
  • The CHMP has evaluated the safety of COMIRNATY, COMIRNATY Original/Omicron BA.1, and COMIRNATY Original/Omicron BA.4-5 and concluded that the vaccine has a favorable safety profile.

Statistics:

  • The conversion of the cMA to full MA applies to all existing COMIRNATY indications and formulations in the EU.
  • The CHMP has recommended approval for COMIRNATY as a 10-g booster (third) dose given at least six months after completion of a primary series for children 5 through 11 years of age.
  • COMIRNATY has been granted standard MA by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people aged 5 years and older.
  • The vaccine has been administered to millions of individuals worldwide, with a favorable safety profile.
  • The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.

Sources:

  • GlobeNewswire
  • Pfizer
  • BioNTech
  • European Medicines Agency (EMA)
  • Committee for Medicinal Products for Human Use (CHMP)
  • European Commission (EC)