Johnson & Johnson’s single-dose COVID-19 vaccine has been deemed safe for emergency use after an FDA advisory committee met Friday and unanimously voted to recommend its use.
The FDA held a public hearing session, Friday, where independent doctors and researchers called in to address any questions and concerns with Johnson & Johnson‘s vaccine data and research. The Vaccines and Related Biological Products Advisory Committee then debated issues among themselves before unanimously voting that the vaccine is safe enough for Emergency Use Authorization (EUA.)
“Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” The FDA said in a statement. “The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution.”
While the vaccine has been recommended by the committee, it must still be approved for EUA, followed by a CDC recommendation for its use. An EUA allows the FDA to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency.
“We are extremely grateful to the VRBPAC members for their extensive review of the data supporting emergency use of Johnson & Johnson’s single-shot COVID-19 vaccine candidate,” Johnson & Johnson’s Chief Scientific Officer, Paul Stoffels, said. “We believe our COVID-19 vaccine candidate has the potential to help change the trajectory of the pandemic and stand ready to make it available to protect the public as soon as possible.”
If approved, Johnson & Johnson will join Pfizer and Moderna as the three COVID-19 vaccines authorized for emergency use in the U.S.