FDA wants to simplify the use and updating of Covid-19 vaccines

The US Food and Drug Administration wants to simplify the Covid-19 vaccine process to look more like what happens with the flu vaccine, according to documents posted Monday. That could include streamlining the vaccine composition, immunization schedules and periodic updates of Covid-19 vaccines.   The FDA said it expects to assess circulating strains of the coronavirus at least annually and decide in June which strains to select for the fall season, much like the process to update annual flu vaccines.   Moving forward, the agency said, most people may need only one dose of the latest Covid-19 shot to restore protection, regardless of how many shots they’ve gotten before. Two doses may be needed for people who are very young and haven’t been exposed, or for the elderly or immune-compromised, according to the FDA’s briefing document for its vaccine advisers.   The agency is urging a shift toward only one vaccine composition rather than a combination of monovalent vaccines – which are currently used for primary shots and target only one strain – and bivalent vaccines, which are currently used for booster doses and target more than one strain.   “This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication,” the FDA said.   The agency’s independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, are scheduled to meet Thursday to discuss the future of Covid-19 vaccine regimens and will be asked to vote on whether they recommend parts of FDA’s plan.