FDA staff: Johnson & Johnson's one-shot Covid-19 vaccine effective, safe
Health & ScienceBy Reuters | Wed,Feb 24 2021 17:17:46 UTC | 2 min read
Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken October 31, 2020. [Dado Ruvic, Illustration, 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 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 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 the issuance of an emergency use authorization.
J&J had not previously released details of its clinical trial data beyond efficacy rates.
ALSO READ
- Over two thirds of Africans infected by Covid virus since pandemic began - WHO
- Shanghai expands Covid-19 lockdown, life on hold in city of 26 million
- Drugmakers, scientists begin the hunt for long Covid treatments
- Let's continue observing Covid-19 containment measures, archbishop Muheria now urges Kenyans
- Kenyans react to the lifting of Covid-19 restrictions
Related Topics
LATEST STORIES

-
Africities Summit highlights limited access to family planning
Reproductive Health
By MACTILDA MBENYWE
-
Global smoking rates fall for first time, but rise for kids, Africa - report
Health & Science
By REUTERS
-
Uhuru to lead presidents, VIPs at Africities Summit in Kisumu
Health & Science
By MACTILDA MBENYWE
-
Vaccine delivers hope for families hit by malaria
Health & Science
By MERCY KAHENDA