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COVID-19 Vaccines Update: US Approval Vs Authorization as of December 3, 2021

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

Note: These data are as of Dec 3, 2021.
Source: COVID-19 Vaccines | FDA

References (Accessed Dec 3, 2021)

COVID-19 Vaccines | FDA.

Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters | FDA.

Coronavirus (COVID-19) Update: FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines | FDA.

Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued November 19 2021 (fda.gov).

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA.

Moderna COVID-19 Vaccine | FDA.

Moderna COVID-19 Vaccine EUA Letter of Authorization (fda.gov).

Janssen COVID-19 Vaccine | FDA

Janssen COVID-19 Vaccine EUA Letter of Authorization 11 19 2021 (fda.gov)

EUA amendment to support use of a Janssen COVID-19 Vaccine (fda.gov)


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About the author

Elaine Taylor
By: Elaine Taylor

Elaine has extensive regulatory experience and specializes in innovative and efficient regulatory strategies for drug development, including 505(b)(2) programs, regulatory agency meetings, responses to regulatory agencies, INDs, and NDAs/BLAs/MAAs. Previously, she was at Syneos Health and Camargo Pharmaceutical Services.

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