Johnson & Johnson vaccine deemed safe and effective in documents released by FDA
Documents released by the Food and Drug Administration on Wednesday indicate that Johnson & Johnson’s Covid-19 vaccine is overall safe and highly effective — 86 percent — against the most severe outcomes of the illness.
The favorable review comes two days before a panel of independent advisers to the FDA is scheduled to discuss the company’s application for emergency use. It is widely expected that the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, will vote to recommend authorization of the vaccine.
“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,” or emergency use authorization, said John Grabenstein, a…