FDA may decline new COVID vaccine EUA requests

Regulatory NewsRegulatory News | 25 May 2021 |  By 

The US Food and Drug Administration’s (FDA’s) updated emergency use authorization (EUA) for COVID-19 vaccines says the agency may decline EUA requests from developers that have not yet met with the agency to discuss their vaccines.
This announcement was made by the agency in a 25 May tweet from the account of FDA’s Center for Biologics Evaluation and Research (CBER). The revised guidance supersedes versions issued on 22 February 2021 and October 2020. All versions of the guidance were made immediately effective for the duration of the public health emergency of the COVID-19 pandemic. (RELATED: FDA issues COVID-19 vaccine EUA guidance after clash with White House, Regulatory Focus, 6 October 2020; FDA updates EUA guidance, addressing vaccines against COVID variants, Regulatory Focus, 22 February 2021).
The revised guidance was issued on the same day that multiple media outlets reported that Ocugen, Inc. had submitted its master file to FDA in anticipation of requesting an EUA for the whole-virion inactivated COVID-19 vaccine Covaxin. Ocugen is the US partner for India-based Bharat Biotech, which developed the vaccine; the master file submission was reported in a 19 May Ocugen Securities and Exchange Commission filing that reports the pathway for a US EUA for Covaxin as “in development.”
The updated guidance has a new section on how it will prioritize requests for issuance of an EUA. The guidance said that when FDA assesses investigational COVID-19 vaccines for use under an EUA, their review includes a “stringent” evaluation of product quality, including whether the facilities producing the product meet appropriate standards, and an evaluation of the conduct of clinical trials and the assessment of the data integrity of the trials.
Early interactions with the agency are “critical,” according to the guidance, and FDA may decline to review an EUA if it is not feasible for the agency to verify any of these characteristics.
Further, the agency said that “for the remainder of the current pandemic, it may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged in an ongoing manner with the agency.”
Currently, over 100 different vaccines against COVID-19 are being studied in more than 700 trials registered at ClinicalTrials.gov. To date, FDA has issued EUAs for COVID-19 vaccines marketed by Pfizer and the German firm BioNTech, Moderna, and Janssen, the vaccines unit of Johnson & Johnson.  (RELATED: COVID-19 therapeutics tracker,  Regulatory Focus, 21 May 2021).
Revised EUA 


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