The FDA is the regulatory authority responsible for oversight of the safety, effectiveness, and quality of vaccines used in the U.S., and they have been working with drug manufacturers to make COVID-19 vaccines available as soon as possible. Multiple COVID-19 vaccines are currently under development. As of March 1, 2021, three drug manufacturers have submitted applications and been approved for Emergency Use Authorization (EUA):
- Pfizer approved for EUA on December 11, 2020.
- Moderna approved for EUA on December 18, 2020.
- J&J/Janssen approved for EUA on February 27, 2021.
Read more on Emergency Use Authorization.
What’s next? Once submitted, the FDA has a rigorous process to follow to evaluate the safety, effectiveness, and quality of the submitted COVID 19 vaccines. Read more in this FDA document to learn about the steps involved in vaccine development: Path for a COVID-19 Vaccine from Research to Emergency Use Authorization.
Once the FDA authorizes a COVID-19 vaccine, the Advisory Committee on Immunization Practices (ACIP) will quickly hold a public meeting to review all data and vote on whether to recommend the vaccine. If they vote to recommend, the ACIP will also determine who should receive and provide guidance on who should receive first, should there be a limited supply. These recommendations will go to the CDC director for approval before becoming official CDC policy.