J&J's virus shot looks set for US approval

Reuters

Johnson & Johnson’s one-shot COVID-19 vaccine appeared safe and effective in trials, US Food and Drug Administration staff said in documents published on Wednesday, paving the way for its approval for emergency use.

The FDA’s panel of independent experts meets tomorrow to decide whether to approve the shot. While it is not bound to follow the advice of its experts, the FDA usually does.

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 percent efficacy rate.

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 percent 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 percent in the United States to 66 percent in Latin America and 57 percent in South Africa, where a new variant has spread, although the vaccine was 85 percent effective overall in stopping severe cases of the disease.

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.