Extra: J&J asks FDA for authorization of its Covid-19 vaccine

FDA staff and outside advisors to review data. Emergency Use Authorization likely before end of February

Late Thursday, Johnson & Johnson announced it had filed for Emergency Use Authorization of its single-shot Covid-19 vaccine.

Based on how the two existing emergency use authorized vaccines were handled, we can expect the FDA to schedule review by its outside advisers within 2-3 weeks. If both FDA staff scientists and the independent advisers confirm that the vaccine’s benefits outweigh any risks, the vaccine could be cleared for distribution by early March.

The J&J vaccine is based on a harmless adenovirus vector and prompts cells to appear to the immune system to be coronavirus, even though they are not. This helps the body build up immunity to fight against infection with actual coronavirus.