Federal regulators plan to pause shots of the Johnson & Johnson COVID-19 vaccine after six recipients developed atypical blood clots. Local elected officials expect the decision to create immediate setbacks in the city’s efforts to reach 5 million people with vaccines by June. They also worry about what the news might mean for confidence in the COVID-19 vaccines, even though the options from Moderna and Pfizer have not yielded similar atypical clots.
“This is a huge blow to vaccination in New York,” Councilmember Mark Levine, the chair of the City Council’s health committee, told Gothamist/WNYC. He anticipates tens of thousands of existing appointments will be canceled, and there may be a halt on certain vaccine programs.
Only six cases of atypical clots have been recorded out of 6.8 million shots given in the U.S.
State Health Commissioner Howard Zucker announced that administration of the Johnson & Johnson vaccine will be paused immediately across New York, pending an evaluation. New Jersey and Connecticut officials have announced similar pauses. Appointments slated with the shot at New York's mass vaccine sites—like the Javits Center—will be honored with the Pfizer vaccine.
"As the CDC and FDA have said, any adverse events related to the Johnson & Johnson vaccine 'appear to be extremely rare' and, 'People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider," Zucker said in a statement. White House COVID-19 Response Coordinator Jeff Zients said in a separate press release that the nation's supply of Moderna and Pfizer vaccines is large enough "to continue the current pace of vaccinations of 3 million shots per day."
The New York Times broke the news Tuesday morning, which was followed shortly by joint confirmation from Dr. Peter Marks of the U.S. Food and Drug Administration and Dr. Anne Schuchat the Centers for Disease Control and Prevention. Marks oversees vaccine approval for the FDA, while Schuchat is the CDC’s principal deputy director. The FDA held a press conference Tuesday morning to discuss the decision.
Their statement says six cases of atypical but severe blood clots have been recorded out of 6.8 million doses. All of the cases involved young women, ages 18 to 48, and occurred within two weeks of vaccination. These rare clots are unlike the ones doctors might see during atherosclerosis or other common cardiovascular diseases. These vaccine recipients had low amounts of platelets, the bloodstream proteins that help stop bleeding.
These atypical clots appear to be similar to the ones spotted overseas with the AstraZeneca vaccine. Last week, European medicine regulators announced a possible link between the AstraZeneca vaccine and these “very rare” blood clots, but concluded the benefits still outweigh the risks of COVID-19. Given those clots tend to happen in younger women, some European nations adjusted their practices to only give the AstraZeneca vaccine to people under 30 or 60 years of age.
One common thread between the jabs from AstraZeneca and Johnson & Johnson is that they’re both delivered by biotechnology called an adenoviral vector. The FDA review for the Johnson & Johnson clinical trials had actually picked up on a small sign of possible blood clots among the vaccine group.
That’s in contrast to the shots from Moderna and Pfizer, which rely on messenger RNA (mRNA) for delivery to our cells. In late February, the CDC reported that 50 million shots of Pfizer and Moderna had been given in clinical trials and the rollout without causing serious side effects, including blood clots.
Johnson & Johnson’s single shot doesn’t require the same deep freeze as the doses made by Pfizer and Moderna. State and city officials hoped these advantages would allow the vaccine campaign to reach more people, especially vulnerable New Yorkers.
New York City had launched a program to roll out the Johnson & Johnson option to homebound residents unable to visit vaccine sites. As of Tuesday, more than 6,000 vaccines had been administered. The city health department informed Gothamist/WNYC that 1,500 homebound appointments will be postponed.
"We will not be using Johnson and Johnson vaccine until it's cleared by the federal government," Mayor Bill de Blasio said Tuesday during his regular briefing at City Hall. "It means that all appointments that would've been for a Johnson and Johnson vaccine have been postponed. They're being rescheduled, wherever possible."
The city had deployed vaccination teams to senior housing complexes at Co-Op City in the Bronx and the Brighton Beach neighborhood of Brooklyn. The city had also planned to use the one-shot option to reach more homeless New Yorkers.
Levine says his “biggest concern is...what this will mean for confidence in vaccinations, period, overall.” He’s worried the pause will spiral into “hesitancy” in taking the Pfizer and Moderna shots, too. He hopes the bigger takeaway is that federal health authorities take safety concerns about the vaccines seriously.
Johnson & Johnson was already facing hurdles this week from a manufacturing mix-up that damaged 15 million doses. The compromised supply did not impact any current shots in circulation. Supplies had begun to dwindle this week, with states getting nearly 90% fewer doses than last week.
