European Medicines Agency Recommends COVID-19 Vaccine for Children 5-12 Years Old

Strategic Insights -

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the administration of the Pfizer-BioNTech COVID-19 vaccine, COMIRNATY, in children 5 to under 12 years of age. This decision is based on scientific evidence, including results from a Phase 2/3 trial that included approximately 4,500 children in this age group. The trial demonstrated a favorable safety profile, robust immune responses, and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection. If approved, COMIRNATY will be the first COVID-19 vaccine authorized in the European Union for individuals 5 to under 12 years of age.

Key Takeaways:

  • The CHMP has recommended the COVID-19 vaccine, COMIRNATY, for children 5 to under 12 years of age, citing a favorable safety profile and robust immune responses in a Phase 2/3 trial.
  • The trial included approximately 4,500 children in this age group, who received a two-dose regimen of 10ug doses administered 21 days apart.
  • The vaccine efficacy rate was 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose.
  • Pfizer and BioNTech continue to supply the vaccine under their existing supply agreement with the European Commission (EC), with sufficient volume for pediatric doses available.
  • The companies do not expect the introduction of pediatric doses in the United States and the European Union to impact existing supply agreements with governments and international health organizations.
  • Pfizer and BioNTech have submitted requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world.
  • Eurordis-Rare Diseases Europe is a patient association that represents rare diseases patients in Europe and has welcomed the CHMP's recommendation.

Statistics:

  • Approximately 4,500 children 5 to under 12 years of age participated in the Phase 2/3 trial.
  • The vaccine efficacy rate was 90.7% in participants without prior SARS-CoV-2 infection.
  • The COVID-19 vaccine, COMIRNATY, has received Conditional Marketing Authorization in the European Union for adults aged 16 and older.

Sources:

  • Pfizer Inc. and BioNTech SE. (2021, December 3). Pfizer and BioNTech Announce CHMP Recommends Approval of COVID-19 Vaccine in Children 5-12 Years Old.
  • European Medicines Agency. (2021, December 3). CHMP recommends approval of COVID-19 vaccine in children 5-12 years old.
  • Contify.com. (2021, December 3). Pfizer and BioNTech Announce CHMP Recommends Approval of COVID-19 Vaccine in Children 5-12 Years Old.
  • BioNTech SE. (2021, December 3). CHMP Recommends Approval of COVID-19 Vaccine in Children 5-12 Years Old.