Why the FDA Restricted Use of Johnson & Johnson's COVID-19 Vaccine

Fact checked on May 6, 2022 by Rich Scherr, a journalist and fact-checker with more than three decades of experience.

Johnson & Johnson's COVID-19 vaccine is now restricted to only a select group of people, the U.S. Food and Drug Administration announced Thursday. The vaccine's emergency use authorization is limited to people ages 18 and older for whom other vaccines are not accessible or appropriate, or for people who would not get a COVID-19 vaccine otherwise.

In a statement announcing the change, the FDA said the new limitations are due to an increased risk of of the blood clotting condition thrombosis with thrombocytopenia syndrome (TTS), a rare but potentially fatal side effect that can occur one to two weeks following the J&J vaccine.

"We recognize that the Janssen [Johnson & Johnson] COVID-19 vaccine still has a role in the current pandemic response in the United States and across the global community," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in the statement. "Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals."

The J&J vaccine was initially paused in April 2021, also over concerns of TTS, to give health officials time to review more data. The pause was lifted a few days later.

The new restrictions are due to the "robustness" of the FDA's safety surveillance systems and the agency's "commitment to ensuring that science and data guide…decisions," Dr. Marks said. "The agency will continue to monitor the safety of the Janssen COVID-19 and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information."

Here's what to know about the new restrictions placed on the J&J vaccine, including why it has been limited and who may still receive it.

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Who Can Still Get the J&J Vaccine?

According to FDA guidance, the people in the following groups may still receive the J&J vaccine:

• People who experienced an anaphylactic reaction after having an mRNA COVID-19 vaccine, like those made by Moderna or Pfizer-BioNTech

• People who have personal concerns with receiving mRNA vaccines and would otherwise not receive a COVID-19 vaccine

• People who would not get vaccinated for COVID-19 because of limited access to mRNA COVID-19 vaccines

In a statement to CNN, the FDA confirmed that the J&J vaccine restrictions extend to booster doses of the J&J vaccine, as well.

The CDC's Advisory Committee on Immunization Practices hinted to these sentiments in December 2021, when it preferentially recommended the use of mRNA vaccines over the J&J shot for all people over the age of 18 in the U.S. Later, in March 2022, the CDC also recommended those who received a primary dose of the J&J vaccine should opt for an mRNA booster dose.

Health experts, too, stand firm in choosing mRNA vaccines over the J&J shot, due to smaller risk and higher efficacy. "We've always recommended that, if you initially go with the Johnson & Johnson vaccine, you're better off getting the Moderna or Pfizer booster shot," Thomas Russo, MD, professor and chief of infectious disease at the University at Buffalo in New York, told Health. "While the risks of TTS after the J&J vaccine are low, they're not zero and we have other options."

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Why Is J&J's Vaccine Restricted?

The FDA specifically cited an increased risk of TTS, a rare and potentially fatal blood-clotting condition, as the reason for the limitations on the J&J vaccine.

In April 2021, about two months after the J&J vaccine was granted emergency use authorization, the CDC and FDA issued a joint statement on incidences of a "rare and severe type of blood clot" showing up in individuals who had recently received the J&J vaccine. The type of blood clot, called a cerebral venous sinus thrombosis (CVST), occurs in the venous sinuses of the brain. The CVSTs were seen in combination with thrombocytopenia, or low blood platelet levels.

At the time of the joint statement—which also initiated a pause on administration of the vaccine—six cases of TTS had been observed, all in women ages 18-48, and all within two weeks after the vaccine was received. The pause was lifted 10 days later.

According to the most recent data from the Vaccine Adverse Event Reporting System (VAERS), there have been 60 confirmed cases of TTS—including the original six—and nine fatalities out of more than 18.7 million J&J shots administered.

According to Dr. Russo, the restriction really comes down to safety. "We have alternative vaccine options with better safety profiles," he said, adding that the restrictions don't necessarily outlaw the J&J vaccine. "[It's] just stronger wording that the mRNA vaccines are preferred."

And it seems that's been the general consensus across the U.S. recently anyway. "Over the last several months across the country, very little Johnson & Johnson vaccine has been used," William Schaffner, MD, an infectious disease specialist and professor at the Vanderbilt University School of Medicine, told Health. "There's not much [J&J] vaccine that has been initiated as part of the national and global vaccination program."