RE: Volume 990k30 Jun 2020 17:44
The guidance also discusses the importance of ensuring that the sizes of clinical trials are large enough to demonstrate the safety and effectiveness of a vaccine. It conveys that the FDA would expect that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated.
Additionally, after approval by the FDA, the safety of all vaccines, including a COVID-19 vaccine, continues to be closely monitored using various existing surveillance systems. The FDA may also require post-marketing studies to further assess known or potential serious risks.
The guidance also notes that, as more is learned about SARS-CoV-2 immunology and vaccine immune responses, consideration may be given to the FDA’s Accelerated Approval pathway for vaccine licensure. However, identification of an immune response or other measure that is reasonably likely to predict clinical benefit would be needed for a specific vaccine candidate to use of this pathway. Due to the current public health emergency, the guidance also addresses considerations regarding Emergency Use Authorization (EUA) of an investigational vaccine – making clear that an assessment regarding any potential EUA for a COVID-19 vaccine would be made on a case-by-case basis considering the target population, the characteristics of the product, and the totality of the relevant, available scientific evidence, including preclinical and human clinical study data on the product’s safety and effectiveness.