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COVID-19 Vaccines: US Approvals Vs Authorization as of October 11, 2021

There is a lot of misinformation about whether or not the COVID-19 vaccines have “full” FDA approval or Emergency Use Authorization (EUA). The words approval and authorization are often used incorrectly; they are not interchangeable.

On March 27, 2020, the Secretary of health and Human Services (HHS) issued a declaration that there is a public health emergency. On the basis of the determination (effective on February 4, 2020), he also declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic.

The terms and definitions for EUA and Marketing Approval are presented in Table 1. Companies submit an EUA application for a drug, device, or biologic product and receive FDA authorization if the data meet the FDA requirements. In order to receive EUA for a COVID-19 vaccine, the FDA has determined that based on the totality of scientific evidence available to the FDA, it is reasonable to believe that a vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in each authorization, the known and potential benefits of the COVID‑19 vaccine outweigh its known and potential risks. Due to the emergency situation, the data requirements for EUA may be less complete (e.g., shorter duration of exposure, surrogate endpoints, fewer participants treated) than that required for approval through the standard Biologics License Application (BLA) that receives marketing approval. Even though these vaccines have EUA, they have been tested in tens of thousands of individuals. See References section below for links to the FDA webpages for additional information on each of the vaccines, including the data used for authorization or approval.

Table 1: Terms and definitions for Emergency Use Authorization and Approval for Marketing

Working under these unprecedented conditions, the FDA rigorously reviewed the data and has authorized three vaccines under EUA for various age groups and has recently approved one vaccine under a standard BLA. The current (as of Oct 11, 2021) authorization (EUA) and approval (BLA) status of these vaccines are presented in Table 2.

Table 2: Vaccines: Authorization or Approval Status as of October 11, 2021

Note: This data is as of Oct 11, 2021. The FDA has two advisory committee meetings scheduled for the Month of October and it is expected that the vaccines will get EUA for additional age groups and/or boosters.
Source: COVID-19 Vaccines | FDA

There are two planned advisory committee meetings in October 2021 where the Biological Products Advisory Committee will meet in open session to discuss COVID-19 vaccines. The outcome of these meetings could lead to additional EUAs for Moderna, Janssen, and Pfizer. The first will be held on October 14, and the topic will be to discuss EUA of the Moderna vaccine for the administration of a booster to individuals 18 years of age and older. On October 15, the committee will meet to discuss EUA of the Janssen vaccine for administration of a booster to individuals 18 years of age and older. On October 26, 2021 the committee will meet to discuss EUA for Pfizer vaccine in children 5-11 years of age. It is expected that after these committee meetings, the FDA will either issue an authorization (EUA) or deny it depending on the totality of the data and their evaluation of the known and potential benefits and risks.

It is challenging to stay abreast of the authorizations and approvals as the FDA continues to evaluate vaccines and medicines as quickly as possible and make them available to combat the COVID-19 pandemic.


REFERENCES:

Federal Register: Emergency Use Authorization Declaration. Accessed Oct 8, 2021

Emergency Use Authorization for Vaccines Explained | FDA. Accessed Oct 8, 2021

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine | FDA. Accessed Oct 7, 2021

COVID-19 Vaccines | FDA. Accessed Oct 8, 2021

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine | FDA Accessed Oct 8, 2021

Pfizer-BioNTech COVID-19 Vaccine EUA LOA reissued September 22 2021 (fda.gov). Accessed Oct 8, 2021

Moderna COVID-19 Vaccine | FDA. Accessed Oct 11, 2021

Janssen COVID-19 Vaccine | FDA. Accessed Oct 11, 2021

2021 Meeting Materials, Vaccines and Related Biological Products Advisory Committee | FDA. Accessed Oct 11, 2021


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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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