Race for Covid-19 vaccine slows as U.S. officials tap the brakes

Race for Covid-19 vaccine slows as U.S. officials tap the brakes

US regulators rein in vaccine rush

The US Food and Drug Administration has released stricter guidelines for drug developers who might seek an emergency-use authorization (EUA) for the COVID-19 vaccine. Manufacturers must now collect safety data on at least half of their clinical-trial participants for two months after they receive their final dose. (Most of the vaccine frontrunners require two doses.) And immunologist Moncef Slaoui — the science leader of the US government’s ambitious vaccine project, Operation Warp Speed — says the effort has urged manufacturers to refrain from pursuing an EUA until they are “able to immunize at least a relevant fraction of the population”. Approval of a vaccine that wasn’t widely available would be “a major disappointment” to the public, says Slaoui.
STAT | 5 min read