My previous blog on COVID-19 vaccines as of October 11, 2021 clarified and discussed the differences in terms and definitions for Emergency Use Authorization (EUA) and “full” FDA approval and presented a table of EUA and approved COVID-19 vaccines in the United States. Since October 11, there have been numerous additions to the EUAs including populations/age groups and boosters.
The FDA has authorized three COVID-19 vaccines (Pfizer, Moderna, and Janssen) under EUA for various age groups and has approved one vaccine (Pfizer) under a standard BLA for ages 16 years and older. The Pfizer and Moderna COVID-19 vaccines are messenger RNA (mRNA) vaccines that contain a synthetic piece of mRNA that instructs cells in the body to make copies of the distinctive “spike” protein of the SARS-CoV-2 virus. These copies of the spike protein do not cause disease; it causes the immune system to produce an immune response against SARS-CoV-2. The Janssen COVID-19 vaccine contains a piece of a modified virus that is not the virus that causes COVID-19. This modified virus (vector virus) causes cells in the body to create an immune response against SARS-CoV-2. As noted in the table below, all these vaccines have received EUA for booster shots and interestingly these vaccines are allowed to be “mixed or matched” for the booster shot.
Children as young as 5 years old can now receive the Pfizer COVID-19 vaccine. There are studies currently underway in children as young as 2 to 5 years old and 6 months to 2 years old. The studies in children take time and are being done incrementally to find the right dose level and ensure the safety of the children. Some estimate there could be a vaccine for children under 5 by the end of the year.
The EUA and approval (BLA) status of these COVID-19 vaccines as of December 3, 2021 are presented in the table below. I will continue to update this table periodically with new information and approvals.
COVID-19 Vaccines: Authorization or Approval Status as of December 3, 2021
References (Accessed Dec 3, 2021)
Contact us if you have any questions or need assistance with your drug or device development program. Our seasoned experts from industry and regulatory agencies provide consulting and operational support at all stages of development for a wide range of global programs.