US Food and Drug Administration staff have confirmed data showing Johnson & Johnson’s single-shot Covid-19 vaccine is safe and effective, and found it was nearly as effective at preventing severe disease caused by the variant first discovered in South Africa.
Scientists at the US regulator found in a report on Wednesday that the J&J jab was 82 per cent effective at preventing severe or critical disease at its trial site in South Africa, where the 501.V2 variant was prevalent. This compares with 86 per cent efficacy in participants in the US and 88 per cent in Brazil, from 28 days after vaccination.
The vaccine was less effective at preventing moderate to severe illness in the South African group, at 64 per cent, compared to 72 and 78 per cent at the sites in the US and in Brazil.
The FDA’s vaccine advisory group will meet on Friday to discuss the shot, which could receive its first emergency authorisation as early as the weekend. J&J said on Tuesday that it would have 4m shots to ship in the US immediately after approval.
The scientists also suggested in their report that the vaccine may have an impact on transmissibility of the virus, even by asymptomatic carriers. But they cautioned there is not yet enough evidence to be statistically significant.