Johnson & Johnson’s Single-Dose COVID-19 Vaccine Safe And Effective: FDA

The vaccine was 66.1% effective in preventing moderate to severe disease and appeared safe, the US Food and Drug Administration said on Wednesday

Single-shot coronavirus vaccine, developed by the drug maker Johnson & Johnson, has been by the US Food and Drug Administration (FDA) as safe and effective against COVID-19.

A briefing paper published by the FDA stated that the ongoing multi-national single-shot vaccine phase 3 randomized, double-blind and placebo-controlled trials have found that it is approximately 66 per cent effective in preventing moderate to severe COVID-19 and approximately 85 per cent effective against the most severe disease.

This could pave the way for the single-shot vaccine from J&J to become the third vaccine in the US to receive authorization for emergency use after vaccines from Moderna and Pfizer. In the next few days, a decision on its approval will be taken to discuss if the evidence is strong enough to recommend the shot. On February 4, Johnson & Johnson sought emergency use authorization for its vaccine.

The vaccine, known as Ad26.COV2.S is a vectored type 26 (Ad26) replication-incompetent adenovirus encoding a stabilised version of the SARS-CoV-2 S protein.

‘Central laboratory-confirmed moderate to severe/critical COVID-19 vaccine efficacy (VE) across all geographical areas in which the trial was conducted was 66.9% when considering cases occurring at least 14 days after single-dose vaccination and 66.1% when considering cases occurring at least 28 days after vaccination,’ the FDA briefing document stated.

According to the FDA, the efficacy of the single-shot vaccine ranged from 72 per cent in the US to 66 per cent in Latin America and 57 per cent in South Africa. However, the overall efficacy of the vaccine in preventing sever cases of the deadly pathogen is found to be 85 per cent. In the US, Latin America and South Africa, J&J tested its single-dose option in 44,000 adults.

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.

Facebook Comments