A JAB TO THE GUT
Clots put J&J shots on hold, but pros say plenty of other vax for U.S.
Johnson & Johnson coronavirus vaccinations came to an abrupt halt across the country Tuesday after federal health agencies warned that the one-shot inoculation may cause a rare — and potentially fatal — blood clot disorder, dealing a sharp blow to immunization efforts in the U.S. and beyond.
The Food and Drug Administration and the Centers for Disease Control and Prevention recommended the nationwide inoculation “pause” in a joint statement that revealed government scientists are investigating reports that six people developed blood clots in veins connected to the brain after receiving the J&J shot.
One of the recipients died and the other remains hospitalized in critical condition, the agencies said. All six are women between the ages of 18 and 48.
FDA and CDC officials stressed that they have not definitely concluded the J&J vaccine caused the blood clots. Scientists will use the pause to assess the safety of the shot, consider whether restrictions are necessary and issue guidance to health care providers on how to treat potentially vaccine-caused blood clots, officials said.
Dr. Janet Woodcock, the acting head of the FDA, said she expects the review to be concluded “within a matter of days.”
“I’d like to stress these events appear to be extremely rare,” Woodcock told reporters on a conference call, adding that nearly 7 million J&J shots have been administered in the U.S. without any serious side effects. “However, COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of adverse events following vaccination very seriously.”
Like most of his counterparts, Gov. Cuomo said he’s not taking any chances and ordered all staterun vaccination sites to “immediately” stop injecting J&J. New Yorkers who have appointments for J&J shots are expected to get Pfizer or Moderna instead, the governor said.
“Let’s put a pause, let’s advise health care workers to be aware of this, and in the meantime, we’ll use Pfizer and we’ll use Moderna,” Cuomo, who himself received the J&J vaccine last month, said during an unrelated event at an upstate cider brewery. “Then when they finish doing their work on the Johnson & Johnson, we’ll resume using Johnson & Johnson, but we do have enough Pfizer and we do have enough Moderna vaccination to keep our schedule.”
Federal- and city-run vaccination sites in New York won’t be offering J&J, either, with plans to line up those who booked the one-dose shot with Moderna or Pfizer as well. Most other states in the country are setting up similar rescheduling options.
The freeze could complicate rollouts of certain local efforts, like an initiative by the State University of New York to use 21,000 J&J doses to vaccinate as many students as possible before the end of the spring semester.
President Biden echoed Cuomo’s sentiment and noted that his administration has secured enough Moderna and Pfizer doses to inoculate every American adult.
“There is enough vaccine that is basically 100% unquestionable for every single, solitary American,” Biden said in the Oval Office.
Jeff Zients, the White House coronavirus task force coordinator, noted that J&J has accounted for less than 5% of all inoculations in the U.S. and said Tuesday’s pause won’t jeopardize Biden’s goal of administering 200 million shots by his 100th day in office.
Regardless, the J&J hiccup is disrupting immunization efforts.
J&J, which is headquartered in New Jersey, said it’s delaying an international rollout of its vaccine indefinitely in light of the blood clot dilemma.
Hundreds of thousands of J&J doses were supposed to arrive this week in European countries, where vaccination campaigns have been hampered by severe supply shortages, logistical headaches and concerns over blood clots developing in a small number of people who received another vaccine produced by AstraZeneca.
Meantime, COVID-19 infection rates and deaths are skyrocketing across Europe.
Dr. Anthony Fauci, the nation’s top infectious disease expert and Biden’s senior pandemic adviser, urged Americans who have
recently received the J&J shot to keep calm and said anyone who got the vaccine over three weeks ago is already out of the woods.
“Don’t get an anxiety reaction, because remember: It’s less than one in a million,” Fauci told reporters at the White House. “However, having said that, pay attention. Do you have symptoms?”
Anyone experiencing severe headaches, shortness of breath, chest discomfort or seizures after recently receiving the J&J shot should immediately contact a doctor, according to FDA and CDC officials.
Biden critics argued the J&J freeze could exacerbate vaccine hesitancy among Americans.
“The Biden administration did a terrible disservice to people throughout the world by allowing the FDA and CDC to call a ‘pause’ in the use of the Johnson & Johnson COVID-19 vaccine,” former President Donald Trump said in a statement. “The results of this vaccine have been extraordinary but now its reputation will be permanently challenged.”
Woodcock countered that the pause is necessary to make sure scientists can take their time studying the issue without risking more cases of blood clots.
She said doctors across the country must also get up to speed on new guidelines for treating patients who are admitted with blood clots. For instance, J&J recipients who develop blood clots should not be put on heparin, a common medicine that could be dangerous in this context, Woodcock said.
“It was clear to us that we needed to alert the public,” she added.
But even some Democrats sided with Trump in worrying that the J&J disruption could backfire. “I know this was done to maintain confidence in the vaccines. Worried it will have the opposite effect,” tweeted Manhattan Councilman Mark Levine, head of the City Council’s Health Committee. “NYC now has the biggest messaging challenge yet in vaccination. We have to do everything possible to avoid a collapse in confidence in vaccination overall.”