Johnson & Johnson’s single-shot coronavirus vaccine effective and safe: US FDA
- The jab was effective in reducing the risk of the illness and preventing PCR-test confirmed Covid-19 at least 14 days after vaccination, the FDA said
- The FDA’s panel of independent experts meets on Friday to decide whether to approve the shot
The FDA’s panel of independent experts meets on Friday to decide whether to approve the shot. While it is not bound to follow the advice of its experts, the FDA usually does and has authorised vaccines from Pfizer and Moderna.
J&J said in documents submitted to the FDA that its data suggested its vaccine was effective at preventing asymptomatic infections. It said that in a preliminary analysis of its trial, it found 16 cases of asymptomatic cases in the placebo group versus two in the vaccine group, or an 88 per cent efficacy rate.
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One-shot coronavirus vaccine by Johnson & Johnson is safe and effective, US FDA finds
While asymptomatic infection was not the primary goal of the trial, which studied the vaccine’s ability to stop moderate to severe Covid-19, the reduction of asymptomatic cases implies the shot can also cut transmission of the disease.
J&J’s vaccine was 66 per cent effective in preventing Covid-19 against multiple variants in a global trial involving nearly 44,000 people, the company said last month.
Its effectiveness varied from 72 per cent in the United States to 66 per cent in Latin America and 57 per cent in South Africa, where a new variant has spread, though the vaccine was 85 per cent effective overall in stopping severe cases of the disease.
The vaccine was effective in reducing the risk of the illness and preventing PCR-test confirmed Covid-19 at least 14 days after vaccination, the FDA said in its briefing documents.