CDC and FDA recommend J&J vaccine pause

Photo courtesy of Wikimedia Commons

Photo courtesy of Wikimedia Commons

By Kessh Bhasiin ’22 & Zoe Greenberg ’23

Health & Science Editors 

The Centers for Disease Control and Prevention and the Food and Drug Administration recommended pausing the use of the Johnson & Johnson vaccine on Tuesday as they review six reported cases of blood clots forming in individuals days after they received the vaccine. 

The six cases of blood clotting are among more than 6.8 million doses of the J&J vaccine that have been administered in the U.S. In a joint statement released on Tuesday, the CDC and the FDA called the blood clotting “extremely rare” and said the decision to pause the use of the vaccine was made “out of an abundance of caution.” The organizations also decided to alert medical practitioners that if a patient comes in with symptoms of blood clotting, they should look into whether the patient has a recent history of vaccination.

The CDC and the FDA described the six people in the blood clotting cases as women between 18 and 48 who developed symptoms six to 13 days after getting vaccinated. The women suffered cerebral venous sinus thrombosis, a blood clot in the brain believed to have concurred with low counts of tiny blood clot-forming cells called platelets. 

“These blood clots are extremely rare — literally 1 in a million — and it is still unclear if the vaccine is causing them or is just correlated with them,” Assistant Professor of Biological Sciences Rebeccah Lijek said. “This pause is an example of scientists’ incredible care for patient safety, and it shows me that the oversight of COVID vaccine development and distribution is working! If anything, I hope that the public sees this as evidence to trust in the scientific process and the vaccines on the market.”

It is too early to say if health officials will advise against administering the J&J vaccine to women under 50 based on the six reports, an action similar to the one taken by some European countries in limiting AstraZeneca use to people over the age of 55. 

“This pause will allow scientists to look more closely at the new data and consider making changes to the vaccine recommendations. For example, since no blood clots have been reported in older vaccinated people, the FDA may recommend that the J&J vaccine be used only in people aged 55 [plus],” Lijek said. 

“It is entirely conceivable — making no predictions — that there may be some restriction in an age group or not. We don’t know that now. That’s the reason why [the CDC and the FDA] are working very hard to answer the question,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a White House briefing on Tuesday.

Urging people who have received or are scheduled to receive the J&J vaccine not to panic, Fauci appeared in a video for the White House during which he referred to the new complication as a “very rare” scenario. He further mentioned that out of the 121 million doses administered, only 6.85 million doses were of the J&J vaccine. According to Fauci, those scheduled to receive the J&J vaccine will now receive the Pfizer or the Moderna vaccine instead.