Gottlieb says FDA could lift pause on J&J vaccine with more restrictions and warnings

Gottlieb says FDA could lift J&J pause with restrictions, warnings
Gottlieb says FDA could lift J&J pause with r... 06:21

Washington — Dr. Scott Gottlieb, former head of the Food and Drug Administration (FDA), said Sunday that use of Johnson & Johnson's coronavirus vaccine could resume with restrictions on who can receive it and warnings about its adverse effects.

"You might see a situation where the vaccine does get reserved for use in older individuals who are both potentially at lower risk of this side effect and also at higher risk of a bad outcome from COVID. That's one possibility in terms of how the FDA would bring this back," Gottlieb said in an interview with "Face the Nation." "The other possibility is they just bring it back with additional warnings and advice to doctors and patients on what to be alert for so that if these cases do emerge, you can get patients into treatment more immediately and hopefully head off a bad outcome."

The FDA and Centers for Disease Control and Prevention (CDC) recommended last week a temporarily halt of Johnson & Johnson's single-dose vaccine after six women reported rare blood-clotting disorders, out of millions who have received it. The women, between the ages of 18 and 48, experienced symptoms six to 13 days after receiving their coronavirus shots.

While U.S. health officials said the adverse effects are incredibly rare, they urged Americans who have received Johnson & Johnson's vaccine to be aware of symptoms such as severe headaches, some difficulty in movement, chest discomfort and difficulty breathing. 

A CDC advisory committee convened last Wednesday to discuss the pause in Johnson & Johnson's vaccine, but members did not vote on whether to extend it, as there was insufficient data to issue final recommendations. Dr. Anthony Fauci, chief medical adviser to President Biden, said earlier on "Face the Nation" that a decision on whether to resume its use is likely to come later this week.

Gottlieb, who led the FDA from 2017 to 2019, said it was a "reasonable step" for the health agencies to pause use of the vaccines as they investigate the blood-clotting cases, but said Johnson & Johnson's shot plays an important role in the nation's vaccination program. 

"We need to find a pathway to bring this back to the market, with perhaps additional warnings, perhaps additional information on who's most indicated for this vaccine, given the fact that these risks do seem to be related to the vaccine, based on what we know now," he said, adding that the Johnson & Johnson shot being sidelined is unlikely to have a drastic impact on the availability of coronavirus vaccines.

In addition to Johnson & Johnson's vaccine requiring just one dose — coronavirus vaccines from Pfizer and Moderna each require two, spaced several weeks apart — it can also be stored in an easier environment than the other FDA-authorized shots, making it a "beneficial alternative" to the others, Gottlieb said. 

"The challenge now is going to be that we have to set up better logistics and try to reach communities that we know are hard to reach, where the J&J vaccine was making it easier and now we have to use the mRNA in those settings," he said. "But I do believe that J&J vaccine will be back on the market in a reasonable period of time, hopefully this week, and hopefully it will be, you know, able to be used in those populations given what we know about its safety profile."

Nearly 206 million doses of the coronavirus vaccines have been administered as of Saturday, according to the CDC, and close to 40% of the population has received at least one shot. Still, some areas of the country like Michigan have battled a surge in infections as new coronavirus variants spread to the U.S.

Pfizer and Moderna are working on booster shots that could protect against the new strains from the United Kingdom, Brazil and South Africa, all of which have been detected in the U.S. 

Gottlieb said he expects Americans will need another shot and cautioned against using a vaccine specific to the strain from South Africa, B. 1.351, which could lead to a loss of protection against the other variants. 

"The question of whether or not we use a vaccine that is specific to 1.351, which is in development by both Moderna and Pfizer, or you just use a third dose of the existing vaccine that needs to be worked out," he
said.