FDA Questions Reliability of Data Backing J & J’s Bid for Boosters

The US Food and Drug Administration (FDA) said Johnson & Johnson may have to put its thumb on the scale when making its case to an advisory panel on Friday to market boosters for its single-dose vaccine.

Johnson & Johnson, together with its partner Janssen, has asked the FDA to authorize a second dose to boost the effectiveness of their one-shot vaccine.

These second doses could be considered as soon as 2 to 3 months after the first dose for all Americans over 18 years of age.

A panel of advisors to the FDA will meet Friday to discuss whether data provided by the company supports an amendment to the vaccine’s emergency use authorization (EUA).