FDA Approves COVID-19 Vaccine for 12- to 15-Year-Olds and Updates Food Safety Regulations

Strategic Insights -

The U.S. Food and Drug Administration has announced several key updates, including the approval of COMIRNATY (COVID-19 Vaccine, mRNA) for individuals between 12 and 15 years old, as well as the finalization of guidance for animal food facilities to develop a food safety plan. The agency has also authorized numerous COVID-19 testing options, with a total of 438 tests and sample collection devices approved for emergency use.

Key Takeaways:

  • The FDA has approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 in individuals 12 through 15 years of age, following a thorough analysis of safety and effectiveness data.
  • The approval of COMIRNATY for this age group follows emergency use authorization granted in May 2021 for the Pfizer-BioNTech COVID-19 Vaccine.
  • The FDA has finalized Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, which aims to help animal food facilities develop a food safety plan to prevent or minimize hazards that could cause illness or injury.
  • The agency is hosting virtual town halls for test developers for SARS-CoV-2 on July 27 and August 24, during which they will share information and answer questions about test development and validation.
  • As of today, 438 COVID-19 tests and sample collection devices are authorized by the FDA under emergency use authorizations, including 303 molecular tests, 85 antibody and other immune response tests, and 49 antigen tests.
  • The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs, and has also authorized 1021 revisions to EUA authorizations.

Statistics:

  • 438 COVID-19 tests and sample collection devices are authorized for emergency use.
  • 303 molecular tests and 85 antibody and other immune response tests are authorized for emergency use.
  • 49 antigen tests and 1 diagnostic breath test are authorized for emergency use.
  • The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs.
  • 1021 revisions to EUA authorizations have been made.

Sources:

  • The U.S. Food and Drug Administration (https://www.fda.gov/)
  • The U.S. Department of Health and Human Services (https://www.hhs.gov/)