Johnson & Johnson’s one-shot coronavirus vaccine appeared safe and effective in trials, US Food and Drug Administration (FDA) staff said in documents published on Wednesday, paving the way for emergency authorization in the US.
An advisory panel of independent experts will meet on Friday to decide whether to recommend the vaccine be authorized. While the FDA is not bound to follow the advice of its experts, the agency did so when authorizing the Pfizer and Moderna vaccines late last year.
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.
In a trial of more than 44,000 participants, federal regulators said the vaccine was 72% effective in the US, 66% effective in Latin America and 57% effective in South Africa, where the B1351 variant is widespread.
The vaccine was 85% effective at preventing severe cases of Covid-19. The vaccine’s efficacy rate held across Asian, Black, white and Latino trial participants.
J&J’s vaccine study raised alarms about how evolutionary changes in the coronavirus, called variants, could affect the efficacy of vaccines. Scientists are still studying how long the vaccine protects people against Covid-19.
Further, the FDA said “uncertainty” remains about the degree to which J&J’s vaccine prevents asymptomatic transmission of the coronavirus, though it presented promising data.