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On October 6, the FDA issued updated industry guidance on “Authorizing the Emergency Use of Vaccines to Prevent COVID-19,” updating the previous guidance issued in June. The updated guidance, which is “being implemented immediately” and “without prior public comment,” aims to “provide sponsors of Emergency Use Authorization (EUA) applications for COVID-19 vaccines with recommendations on the data and the information necessary to support the issuance of a USA … of an investigational vaccine to prevent COVID-19 during the COVID-19 public health emergency ”.
In its guidance, the FDA explained that while “[t]there are currently no FDA-cleared vaccines here to prevent COVID-19 ”,[c]Commercial vaccine manufacturers and other entities are developing COVID-19 vaccine candidates using different technologies, including RNA, DNA, protein, and viral vector vaccines. “Current FDA recommendations are” specific to COVID-19 vaccines, which are complex biologics that are intended to be administered to millions of people, including healthy people, to prevent disease “and” are not necessarily applicable to drugs and biologics intended to treat COVID-19. “
To be approved, a US application must show that: (i) SARS-CoV-2 “may cause a serious or life-threatening disease or condition”; (ii) “it is reasonable to believe that the product may be effective in preventing, diagnosing or treating such a serious or life-threatening disease or condition”; (iii) the “known and potential benefits of the product, when used to diagnose, prevent or treat the identified serious or life-threatening disease or condition, outweigh the known and potential risks”; and (iv) “there is no suitable, approved and available alternative for the product.” US applications will be evaluated “on a case-by-case basis taking into account the target population, product characteristics, data from preclinical and human clinical studies on the product, and all available scientific evidence relevant to the product.” In particular, the FDA emphasized that “for a COVID-19 vaccine for which there is adequate manufacturing information to ensure quality and consistency, the issuance of an EUA would require a determination by the FDA that the benefits of the vaccine outweigh its risks based on data from at least one well-designed phase 3 clinical trial demonstrating the safety and efficacy of the vaccine in a clear and convincing way. “
The guide also provides an overview of the information that must be submitted in a US application for a COVID-19 vaccine, including detailed information on regulation, chemistry, manufacturing, controls, safety, and effectiveness. It also explains that “the FDA hopes to convene the VRBPAC [Vaccines and Related Biological Products Advisory Committee] for consideration of any US request for a COVID-19 vaccine ”at a public meeting. An appendix describes the “Presentation of Information in Preparation for a VRBPAC Meeting” and provides information on the advisory committee meeting process.
