FDA Creates Booster Shot Clearance Path to Fight Virus Variants (1)

Companies with authorized Covid-19 vaccines can build on their existing applications and clinical trials if they need to create booster shots, the FDA said in guidance Monday to address virus variants.

The guidance means vaccine makers will have fewer regulatory hoops to jump through to develop booster shots, which create an additional level of protection for people against new strains of a virus. Scientists are monitoring SARS-CoV-2 variants in the U.S. and around the globe because some appear to spread faster and might lead to more serious Covid-19 symptoms.

Developers can use “booster studies” to test updated vaccines on people ...