FDA & CDC Call For Pause On Johnson & Johnson Vaccine

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Both the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) are pausing on using the vaccine at federal sites

Of the three current COVID-19 vaccines available in the United States, the single-dose Johnson & Johnson vaccine has seemingly been the one plagued by issues, especially after a manufacturing error in Baltimore recently resulted in 15 million doses being recalled earlier this month.

Now, both the Food and Drug Administration and the Centers for Disease Control and Prevention are putting the pause on the J&J vaccine for the foreseeable future after six recipients in the United States developed a rare disorder involving blood clots within two weeks of receiving the vaccine, according to a New York Times report, with both agencies calling on individual states to determine if the vaccine is safe for continued use.

Though it certainly sounds alarming, it’s worth noting that nearly 7 million people in the U.S. have received Johnson & Johnson shots so far, and “adverse events appear to be extremely rare,” per a joint statement released by both agencies. For comparison, between 3 and 9 women out of every 10,000 on hormonal birth control will experience a blood clot every year — still decidedly rare, to be clear — and all the hormonal contraceptive methods currently available on the market are believed to be safe and effective for the vast majority of otherwise healthy users.

As for the vaccine, the FDA and CDC are recommending a pause at federal-run vaccine sites “out of an abundance of caution,” explained Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research.

All six recipients who developed clots in combination with low platelets were adult women between the ages of 18 and 48. The NYT reports that one woman has died and a second woman, located in Nebraska, has been hospitalized in critical condition. CNN reports that the adverse reactions happened between 6 and 13 days after the patients received their vaccines.

Scientists and researchers from both agencies are working to determine concrete links between the “rare and severe” blood clot disorder and the vaccine, with the CDC holding a meeting of the Advisory Committee on Immunization Practices (ACIP) tomorrow to “further review these cases and assess their potential significance,” noted the joint statement. The agencies are recommending a pause “in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”

Johnson & Johnson has issued a statement in response to the CDC and FDA recommendations, sharing that they’re “working closely with medical experts and health authorities,” adding, “we strongly support the open communication of this information to healthcare professionals and the public.”

By all accounts, it seems that many states are following suit and pausing on administering the J&J vaccine. So far, officials in Ohio, New York, and Connecticut are halting use of the vaccine, and it seems likely that other states will do the same until the investigation is complete.

All three entities are advising recent recipients of the J&J vaccine to contact their health care providers if they develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination. But experts are advising Americans to remember that an adverse effect is still extremely rare, and that there’s very little need for concern on a broad scale.

“You’re talking about 1 per million, and when you give millions of doses of vaccines, you will see events like this that you couldn’t see in the clinical trial just because you didn’t have millions of people enrolled,” Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine at Grady Health System, told CNN. “But I want to congratulate the CDC and the FDA for very quickly jumping on it, halting the vaccinations until we know more, and really trying to understand what’s going on. I think vaccine safety has always been a priority — and I think this is exactly the right move until we understand what’s going on and what’s the way forward.”