Johnson & Johnson's one-shot COVID-19 vaccine effective, safe - FDA staff
(Reuters) - The one-shot COVID-19 vaccine by Johnson & Johnson appeared safe and effective in trials, U.S.
The staff of the Food and Drug Administration (FDA) reported in documents published on Wednesday that pave the way for its emergency approval.
The FDA's independent expert panel meets on Friday to decide whether the shot should be approved.
Although it is not bound to follow the advice of its experts, FDA authorized the vaccines from Pfizer Inc. and Moderna Inc.
In a total trial involving nearly 44,000 persons, J&J's vaccine was 66 percent effective in preventing COVID 19 from multiple variants, the company said last month.
Its effectiveness ranged from 72% in the United States to 66% in Latin America and 57% in South Africa, where there is a new variant, although the overall vaccine was 85% effective in stopping severe disease cases.
In its briefing papers, the FDA stated that the vaccine was effective at reducing the risk of COVID-19 and preventing PCR-test confirmed COVID-19 at least 14 days after the vaccination.
There have been severe side effects in three vaccine recipients in a trial, but the FDA says its analysis does not raise any specific safety concerns that prevent an emergency use license from being issued.
Details of its clinical trial data had not previously exceeded efficacy rates.
(Manas Mishra's report in Bengaluru; Bernard Orr's report)