J&J’s Covid-19 Vaccine Is Safe and Effective: FDA

eAwaz Medicine

New Brunswick – The Food and Drug Administration has said Johnson & Johnson’s Covid-19 vaccine data indicate that it is overall safe and highly effective — 86 percent — against the most severe outcomes of the illness. It comes two days before a panel of independent FDA advisers are scheduled to discuss the company’s application for emergency use. It is expected they will vote to recommend authorization of the vaccine. 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. John Grabenstein, a former executive director of medical affairs for vaccines at Merck and a former Department of Defense immunologist, said: “The FDA went so far as to say the vaccine has a ‘favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA. In other words, it is green light.” If the FDA authorizes the Johnson & Johnson vaccine for emergency use, Johnson & Johnson’s said it would be able to provide 20 million shots by the end of March, and additional 100 million doses by summer. The company reported results of its phase 3 clinical trials in late January, says in the US, their shot was 72 percent effective in preventing moderate to severe disease. It was also found to be 85 percent effective in preventing severe disease. The best thing is, it is a single dose vaccine and easy to handle.