FDA issues updated guidance on adapting Covid-19 vaccines, tests and therapeutics for coronavirus variants
CNNCNN — The US Food and Drug Administration has issued updated guidance for companies that plan to adapt their Covid-19 medical products – including vaccines, tests and therapeutics – to address the emergence of coronavirus variants. The agency said in an announcement on Monday that it expects that “manufacturing information will remain generally the same” for authorized Covid-19 vaccines that may be updated to target variants. “For clinical data, the guidance recommends that a determination of effectiveness be supported by data from clinical immunogenicity studies, which would compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine,” the agency noted in its announcement. According to the FDA guidance, studies to assess the effectiveness of a Covid-19 vaccine’s primary shot and booster dose should compare the immune response induced by the modified version of the vaccine to the original vaccine, and researchers should conduct a “booster study” in which the modified vaccine is administered to those who previously received the original vaccine. FDA officials said during Monday’s call that some of the updated guidance for Covid-19 vaccines is modeled after what is already done for the development of seasonal influenza vaccines.