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 in the US.
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.
The FDA’s panel of independent experts will meet later this week to decide whether to approve the Johnson & Johnson shot.Credit:Getty
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.
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.
