Johnson & Johnson’s one-shot COVID-19 vaccine appeared safe and effective in trials, United States Food and Drug Administration (FDA) staff said in documents published on Wednesday, paving the way for the vaccine’s approval for emergency use.
J&J said in documents submitted to the FDA that its data suggested its vaccine was effective at preventing asymptomatic infections.
The vaccine was effective in reducing the risk of COVID-19 and preventing PCR-test confirmed COVID-19 at least 14 days after vaccination, the FDA said in its briefing documents.
Fourteen days after injection, only two vaccine recipients developed COVID-19 severe enough to need medical intervention, compared with 14 in the placebo group.
After 28 days, no vaccine recipients developed COVID severe enough to require medical intervention whereas seven in the placebo group did.