Fauci says FDA data shows J&J vaccine should have been two shots

President Biden’s chief medical adviser, Anthony Fauci, said on Sunday that the Johnson & Johnson COVID-19 vaccine likely should have been a two-dose shot instead of a single inoculation. 

ABC’s Martha Raddatz asked Fauci on “This Week” if the millions of Americans who received the Johnson & Johnson (J&J) COVID-19 vaccine should be concerned after a Food and Drug Administration (FDA) advisory committee voted unanimously to recommend adults receive a booster shot of the vaccine.

“No, not at all, Martha. I think that they should feel good about it because what the advisers to the FDA felt is that, given the data that they saw, very likely this should have been a two-dose vaccine to begin with,” Fauci said.

“So the idea of making a recommendation that people who originally received J&J should receive a second dose 18 or older with none of the restrictions about whether or not you’re at a high risk or not at a high risk is that everyone who received that first dose of J&J who are 18 and older should receive it,” he added.

Last week, an FDA advisory committee met to vote on whether to recommend Americans receive a booster shot of the Johnson & Johnson vaccine. The FDA, which had to rely on data provided by the vaccine maker given that trial data had not been provided to the agency in time, decided to vote on recommending it despite the sample size of 17 people. 

The FDA is expected to make a decision on the advisory committee’s recommendation soon. If approved, it would allow adults who received the vaccine to get a booster shot as early as two months after their initial dose.

The recommendation is unique because it does not provide the same constraints on who is allowed to get the booster shot as recommendations for Pfizer and Moderna do. An FDA panel voted last week to recommend booster shots for individuals who got both doses of the Moderna vaccine to several groups: those whose employment represents serious risk of COVID-19, people over the age of 65, and people who have a higher risk of severe COVID-19 and are between the ages of 18 and 64 years old.

Individuals in those categories who received both doses of the Pfizer shot were last month approved to get a booster.