(Adds details from FDA documents)
Feb 24 (Reuters) - Johnson & Johnson's one-shot
COVID-19 vaccine appeared safe and effective in trials, U.S.
Food and Drug Administration (FDA) staff said in documents
published on Wednesday, paving the way for its approval for
emergency use.
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 did so when
authorizing the Pfizer Inc and Moderna Inc
vaccines.
J&J's vaccine was 66% 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% in the United States to
66% in Latin America and 57% in South Africa, where a new
variant has spread, though the vaccine was 85% 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 in its briefing documents.
Three vaccine recipients had severe side effects in the
trial, but the FDA said that its analysis did not raise any
specific safety concerns that would preclude issuance of an
emergency use authorization.
J&J had not previously released details of its clinical
trial data beyond efficacy rates.
(Reporting by Manas Mishra in Bengaluru; Editing by Bernard
Orr)