The Johnson & Johnson COVID-19 vaccine rollout will continue in the U.S., with a label noting a potential risk of rare blood clots, The Food and Drug Administration announced at about 7 p.m. on April 23. The move came after after a committee of advisors to the Centers For Disease Control and Prevention voted to resume distribution after a 10-day pause. This means the one-shot vaccine is again available for all adults under emergency use authorization.
Doses may be back in circulation across the U.S. as early as this weekend. There are more than 9 million doses of J&J’s vaccine available and ready to be put into arms, a COVID-19 adviser to President Joe Biden told CNN on Friday.
The FDA and CDC made a joint decision to pause the rollout of this particular vaccine on April 13 “out of an abundance of caution” after six people reported rare blood-clotting conditions in the weeks after receiving the J&J vaccine. As of this writing, 15 women total are confirmed to have developed blood clots (known as thrombosis) combined with low blood platelet counts (known as thrombocytopenia, which can affect blood clotting), after receiving the one-dose vaccine, the CDC noted at the April 23 meeting of the Advisory Committee on Immunization Practices (ACIP). Three of the 15 women have died, seven remain hospitalized, and five have been discharged and are recuperating at home. Thirteen of the cases occurred in women ages 18 to 49. More than seven million J&J doses had been administered in the U.S. at the time of the pause, the CDC notes.
The ACIP committee noted in a presentation that the risk for the clotting condition, which the CDC has dubbed thrombosis with thrombocytopenia syndrome (TTS), appears highest in women under 50 years of age, though it’s extremely rare. Women between 30 and 39 years old have the greatest risk: 11.8 cases per million doses given.
Ultimately, the ACIP committee decided that the benefits of making the J&J vaccine available to all adults again outweigh the risks. At their meeting, a model presented by Sara Oliver, MD, a CDC scientist, predicted that if the J&J vaccine officially resumes, it could cause between 26 and 45 cases of TTS, but could prevent between 600 and 1,400 deaths, and 800 to 3,500 ICU admissions. The committee also noted that certain populations, particularly homeless, incarcerated, and homebound people, would be disproportionately impacted if J&J vaccine distribution remained on pause. Experts on the panel worried that these populations wouldn’t be as able or likely to return for a second dose of a COVID-19 vaccine.
In a statement sent to Refinery29 after the ACIP meeting, Johnson & Johnson said: “The Committee’s recommendation is an essential step toward continuing urgently needed vaccinations in a safe way for millions of people in the U.S. As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere."
The ACIP committee ultimately voted to continue to roll out the vaccine to all people over 18 with a warning label, prompting the FDA's decision to resume distribution. At the ACIP meeting, Johnson & Johnson proposed a disclaimer, using FDA-agreed language, that would state that the vaccine could lead to “an increased risk of thrombosis involving cerebral venous sinuses and other sites (including but not limited to the large blood vessels of the abdomen and the veins of the lower extremities) combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination.”
The ACIP considered a recommendation that would specifically caution women about their increased risk, but ultimately voted for a more general disclaimer.
In most of the reported cases of TTS reported so far, the blood clots occurred in an area of the brain where blood drains, a type of clot known as a cerebral venous sinus thrombosis, which can be fatal, says Jeffrey Schneider, MD, chief of Hematology and Oncology at NYU Langone Hospital--Long Island.
But this condition and other forms of TTS were rare enough that the experts agreed it was in the public’s best interest to resume the rollout while emphasizing the risks to people getting this shot.
Some say the pause was helpful, in that it instilled confidence that health officials were taking vaccine safety seriously, and gave officials time to gather enough data to make an informed decision. “This pause was essential to our ability to inform the public,” José R. Romero, MD, the chair of ACIP, said at the meeting. Still, many public health experts have expressed concern about the pause skewing public perception of the vaccine’s safety.
“I don’t think we should trivialize the risk,” Jesse L. Goodman, MD, the former FDA Chief Scientist and professor of medicine and infectious diseases at Georgetown University, said after the ACIP meeting. “But let’s keep the risk in perspective. The risk of dying from a car accident in your life is something like one in 100, the risk being struck by lightning is something like one in 15,000. I think people should be aware and if they have access to multiple vaccines and want to choose one over the other they should be able to do that, but I think the communication around understanding that this is a really small risk is very important.”
Both Johnson & Johnson and AstraZeneca (which is not yet available in the US) have been linked to rare blood clotting issues.
If you’ve had the J&J vaccine, know that the risk of TTS is incredibly rare, and there’s no need to panic. “If you’ve had the Johnson & Johnson vaccine, I’d say, ‘Congratulations,’ because that means you're protected from a severe disease that can lead to hospitalization and death,” Paul Pottinger, MD, a professor specializing in infectious disease at the University of Washington School of Medicine, told Refinery29 last week after the pause. If you do experience symptoms such as severe headaches, leg pain, abdominal pain, or shortness of breath within three weeks of getting your shot, however, call your doctor and tell them you’ve had the J&J vaccine.
This is a developing story. It will be updated as more information becomes available.