FDA Panel Recommends Approval of J&J Vaccine

An FDA advisory panel says Johnson & Johnson's vaccine should be considered a two-dose vaccine rather than the one-and-done shot that had received initial authorization.

The panel decided unanimously that the 15 million Americans who got a single dose of the "one and done" J&J vaccine would be substantially better protected with a second one.  The Vaccines and Related Biological Products Advisory Committee voted 19-0, to support what J&J describes as a booster at least two months after the initial shot.

The panel says data from J&J and real-world experience show that the single shot provides less protection against COVID-19 than the Moderna and Pfizer-BioNTech vaccines, which are both two-dose regimens.

The Centers for Disease Control and Prevention has found that the J&J vaccine is only 68% effective against hospitalization in most adults.  Vaccine effectiveness for all people is highest in Moderna vaccine recipients, at 95%, followed by Pfizer-BioNTech at 80% and J&J at 60%, according to a report published by the CDC in September.

The two mRNA vaccines are more effective, even considering that their strength seems to wane over time according to Dr. Amanda Cohn with CDC’s National Center for Immunizations and Respiratory Diseases. Booster shots have already been approved for people who received the Pfizer-BioNTech vaccine.

The panel's decisions on both the Moderna and J&J supplementary shots still need to be verified by a different advisory panel as well as top federal officials. The CDC advisory panel is expected to meet Oct. 20 and 21 to discuss extra doses for Moderna and J&J recipients.

The CDC continues to recommend that people receive extra doses of the same vaccine they got the first time.

(Photo Getty images)

Photo: Getty Images

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