Johnson & Johnson's single-shot COVID-19 vaccine effective, safe and prevents severe cases: FDA
New Delhi | Jagran News Desk: A review by the US Food and Drug Administration (FDA) of the single-shot coronavirus vaccine developed by the drug maker, Johnson & Johnson, has found it safe and effective against the COVID-19. A briefing document published by the FDA said that the ongoing multi-national Phase 3 randomised, double-blind and placebo-controlled trials of the single-shot vaccine have found that it is about 66% effective at preventing moderate to severe COVID-19, and about 85% effective against the most serious illness.
This could pave way for J&J's single-shot vaccine to become the third vaccine in the US to get emergency use authorisation after Moderna and Pfizer vaccines. A decision on its approval will be taken in the next few days after FDA's meeting on Friday to discuss whether the evidence is strong enough to recommend the shot. Johnson & Johnson had sought emergency use authorisation for its vaccine on February 4.
The vaccine, known as Ad26.COV2.S is a replication-incompetent adenovirus type 26 (Ad26) vectored vaccine encoding a stabilised variant of the SARS-CoV-2 S protein.
"Vaccine efficacy (VE) against central laboratory-confirmed moderate to severe/critical COVID-19 across all geographic areas in which the trial was conducted was 66.9 per cent when considering cases occurring at least 14 days after the single-dose vaccination and 66.1 per cent when considering cases occurring at least 28 days after vaccination," the briefing document by the FDA stated.
According to the FDA, the effectiveness of the single-shot vaccine varied from 72 per cent in the US to 66 per cent in Latin America and 57 per cent in South Africa. However, the overall effectiveness of the vaccine in stopping sever cases of the deadly pathogen is found to be 85 per cent. J&J tested its single-dose option in 44,000 adults in the US, Latin America and South Africa.
Like other COVID-19 vaccines, the main side effects of the J&J shot are pain at the injection site and flu-like fever, fatigue and headache. No study participant experienced a severe allergic reaction, called anaphylaxis, which is a rare risk of some other COVID-19 shots, although one experienced a less serious reaction. The FDA said there were no serious side effects linked to the vaccine so far, although it recommended further monitoring for blood clots.
(With Agencies Inputs)
Posted By: Talibuddin Khan