Gottlieb reassures on Johnson & Johnson: FDA didn’t order vaccine off the market

Scott Gottlieb, former commissioner of the Food and Drug Administration (FDA), said the FDA’s decision to pause administration of the Johnson & Johnson vaccine was done out of caution, while acknowledging it was “an awkward regulatory step.”

“Let’s start with what the FDA didn’t do: They didn’t revoke the emergency use authorization, they didn’t order this off the market. This was a requested pause, which is an awkward regulatory step, but it reflects a level of caution not to appear too forcefully here,” Gottlieb said on CNBC’s “Squawk Box.”

Federal health officials called for a pause on administering the Johnson & Johnson vaccine on Tuesday, citing rare cases of blood clots in a handful of recipients.

Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.

— U.S. FDA (@US_FDA) April 13, 2021

Gottlieb, who served as FDA commissioner from 2017 to 2019, said the agency’s “concern would be that they’re only seeing the severe cases and they’re missing some of the more mild cases, and by taking this action it’s going to elicit more reporting. And that’s what they’re really after. They want to understand what the numerator is, make sure if it’s in fact six cases instead of a million.”

“Let’s start with what the FDA didn’t do: they didn’t revoke the EUA, they didn’t order this off the market. This was a requested pause which is an awkward regulatory step but it reflects a level of caution not to appear too forcefully here,” says @ScottGottliebMD on $JNJ vaccine pic.twitter.com/42Fg8OX8Ra

— Squawk Box (@SquawkCNBC) April 13, 2021

Gottlieb is a board member at Pfizer, which along with Moderna has had its coronavirus vaccine approved for emergency use in the U.S.

The Johnson & Johnson pause, Gottlieb said, could lead to the vaccine being restricted to certain demographics if it is allowed to be administered again, similar to how AstraZeneca’s vaccine has been recommended to use in people over the age of 30 in countries like the U.K. and South Korea.

Regulators in Europe previously said they have found a “possible link” between AstraZeneca and blood clots. The FDA has not approved AstraZeneca for emergency use in the U.S.

Gottlieb also raised concerns that regardless of whether a connection is found between the Johnson & Johnson vaccine and blood clots, the pause could still fuel vaccine hesitancy.