FDA Advisors Recommend Emergency Use of Johnson & Johnson COVID-19 Vaccine

Vaccines could start reaching patients next week, after FDA and CDC leaders make final decision.

The FDA’s panel of outside virology, immunology and epidemiology advisors voted unanimously (22-0) to recommend that the Johnson & Johnson (Janssen) COVID-19 vaccine be authorized for emergency use in the United States for people 18 and older.

The vaccines are effective with a single shot, and the doses can be stored at normal freezer temperatures - no special equipment needed. This makes the vaccine potentially more useful for distribution to remote or other hard-to-reach or underserved communities.

With the FDA scientific advisors recommending authorization, the next step is a decision by Acting FDA Commissioner Janet Woodcock. That is likely to be announced over the weekend, which also is when the CDC’s Advisory Committee on Immunization Practices will meet and affirm whether the new vaccine should be implemented as part of the nation’s pandemic response. After that recommendation and the CDC director’s approval, distribution begins.

The vaccine uses a harmless cold virus (that cannot replicate) to deliver instructions to the immune system that help it fight the novel coronavirus. In a large clinical trial, it was overwhelmingly effective at preventing severe illness and death - with experts noting that it appears to have some effect against the newer, more concerning coronavirus variants.

The company says it has 4 million doses ready to ship immediately and will deliver 20 million doses by the end of March. The government has contracted with Johnson & Johnson for 100 million doses to be delivered by early summer.