Johnson & Johnson seeks emergency FDA authorization for single-dose coronavirus vaccine

Johnson & Johnson has applied to FDA for emergency use authorization of its coronavirus vaccine, which has demonstrated robust efficacy with a single dose. The move comes after results from a global study showed the company’s vaccine to be 66% effective overall against the virus and 85% effective in severe cases. No trial volunteer who received the vaccine was hospitalized or died, even in South Africa—where a resistant new strain of the virus is causing alarm. FDA scientists and independent experts will review the findings, which have yet to be peer reviewed or published, and a public meeting to discuss the evidence is scheduled for February 26. If granted regulatory approval, the Johnson & Johnson vaccine will be welcomed not only for its one-injection administration but also its longer shelf life and less stringent cold-storage requirement. It would be the third vaccine authorized in the United States.