By Gregory Kane, J.D., M.B.A.
The FDA provided a list of information sponsors should submit with an emergency use authorization request.
The FDA released its nonbinding guidance for Emergency Use Authorization (EUA) for COVID-19 vaccines, including the key information and data that should be submitted by sponsors. Released without prior public comment due to the declared public health emergency, the guidance is subject to comment in accordance with the FDA’s good guidance practices (Notice, 85 FR 73485, November 18, 2020.).
Background. After the declaration of a public health emergency on January 31, 2020, the FDA gave notice that it would provide guidance documents related to the Coronavirus Disease 2019. In accordance with that announcement, the FDA has released its current recommendations regarding the data and information necessary to support EUA for investigational vaccines under section 564 of the Food, Drugs, and Cosmetics Act (FDC Act) (21 U.S.C. §301 et seq.). The guidance was released without prior public comment, but remains subject to comment in accordance with the FDA’s good guidance practices. The guidance also offers recommendation on the key information and data that should be submitted for an investigational new drug application or cross-referenced master file prior to submission of an EUA for review before the Vaccines and Related Biological Products Advisory Committee. The recommendations are specific to vaccines and are not applicable to drugs and biological products intended for treatment.
Guidance. The FDA may issue an EUA after statutory requirements are met, which include a determination that the product in question may be effective to prevent a serious or life-threatening disease or condition caused by COVID-19, that the benefits of the product outweigh the known and potential risks of the product, and that there is no adequate, approved and available alternative. As an EUA for a COVID-19 vaccine would allow for rapid and widespread deployment to millions of individuals, the FDA requires adequate manufacturing information to ensure its quality and consistency as well as an analysis of the vaccines benefits and risks based on data from at least one well-designed Phase 3 clinical trial. Following issuance of an EUA, a sponsor would be expected to continue to collect placebo-controlled data in any ongoing trials for as long as feasible as well as work towards the submission of a Biologics License Application as soon as possible.
The FDA recommends contacting the Center for Biologics Evaluation and Research’s Office of Vaccines Research and Review as early in development as possible. To complete a timely review of a request for an EUA, sponsor should provide in advance of submission of an EUA request a detailed description of the chemistry, manufacturing and controls information and data and any interim analysis that will be the basis of the submission.
In addition to information on the chemistry, manufacturing and controls, sponsors should submit the following information:
- a description of the product and its intended use including proposed dosing regimen;
- available data regarding safety and effectiveness of the product;
- a risks and benefits analysis;
- methodology for the mitigation of risks or optimization of benefits;
- recommended restrictions for safe use;
- contraindications or other situations calling for non-use;
- the need for the product, including approved alternative products;
- a description of the product’s FDA approval status;
- proposed package insert drafts; and
- nformation regarding the supply chain.
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