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WASHINGTON — Just days after Johnson & Johnson announced that 15 million doses of its coronavirus vaccine had been contaminated at a Baltimore plant, federal officials recommended that states stop using that vaccine altogether, citing reports of blood clots.
In a joint statement issued on Tuesday morning, the Food and Drug Administration and the Centers for Disease Control and Prevention said the agencies were acting “out of an abundance of caution,” noting that “adverse events appear to be extremely rare.”
There had been six such reports in the U.S., out of nearly 7 million doses administered. All six of the cases involved women between the ages of 18 and 48. One of those women died.
It’s not clear what factors led those women to become sick, or how many other people have suffered similar reactions. The lack of a clear understanding is why public health officials “need to pump the brakes and figure out what’s going on,” said Dr. George Rutherford III, an epidemiologist at the University of California, San Francisco, in an email to Yahoo News.
Public health officials did not say how long the pause would last, though during a press call on Tuesday to discuss the issue, Dr. Anne Schuchat, principal deputy director of the CDC, said the relevant agencies should “make some recommendations quickly.” The CDC’s Advisory Committee on Immunization Practices would meet on Wednesday to “review the data” on cases of blood clotting in people who received a Johnson & Johnson vaccination, she added.
The Biden administration is intent on not losing the vaccination momentum it has achieved over the last month, with 3 million people now being vaccinated daily. In an email following the FDA-CDC announcement, White House pandemic response coronavirus coordinator Jeff Zients said in a statement that there would be no “significant impact on our vaccination plans,” because the vast majority of vaccinations being administered in the U.S. come from Pfizer and Moderna. Zients noted that the Johnson & Johnson vaccine accounted for less than 5 percent of doses administered.
Tuesday’s announcement on the Johnson & Johnson vaccine was framed as a recommendation, not an order, but it led several states to cancel appointments for people who’d been expecting to receive that vaccine, adding yet another frustration to what has been, for many people, an immensely frustrating process.
In Washington, D.C., for example, the Department of Health told people who’d been preregistered to receive the Johnson & Johnson vaccine that in the wake of the FDA-CDC warning, it “has informed all of our vaccine providers to temporarily discontinue the use of Johnson & Johnson until the CDC and FDA can meet to discuss further.”
Health officials and elected leaders now have a tricky balance to strike: They need people to have confidence that coronavirus vaccines are safe, but they also have to acknowledge, without sowing fear, that people do sometimes have adverse effects. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during Tuesday’s press call that there had been no clotting issues associated with the Pfizer and Moderna vaccines.
Some wondered whether, given the exceedingly low risk of blood clotting, the pause was warranted, considering that the United States could be on the cusp of a fourth coronavirus wave. “What is INDUBITABLY true right now,” tweeted Dr. Megan L. Ranney of Brown University, “is that covid-19 cases are rising in the U.S. and across the world, and the J&J vaccine is very, very good at preventing disease / excellent at preventing severe disease and death.”
In a statement released Tuesday following the announcement, former President Donald Trump charged that President Biden did “a terrible disservice” in allowing the pause.
The decision on the pause, however, appears to have been made solely by scientists at the FDA and CDC. It would be unusual, if not unprecedented, for Biden, who has made acceleration of vaccinations a priority, to interfere in that decision.
Trump has long been upset that he has not gotten sufficient credit for development of the coronavirus vaccines during the final year of his administration. He made that clear in Tuesday’s statement, claiming Pfizer and the FDA waited until after November’s presidential election to announce approval of the vaccine in order to harm his political prospects. “They didn’t like me very much because I pushed them extremely hard,” Trump said in his statement.
Speaking during the morning’s press briefing, Schuchat, the CDC official, said a pause was necessary to “prepare the health care system to recognize and treat patients appropriately and to report severe events they may be seeing in people who’ve received the J&J vaccine.” Researchers want to understand if the six women had something in common that made them more susceptible to blood clotting.
“I think it was the right move,” Dr. Paul Offit of the Children’s Hospital of Philadelphia, a pioneer of vaccine science, told Yahoo News. “It is a rare but serious side effect, and we have other vaccines available that don’t cause this side effect.”
Europe experienced a similar scare last month over the AstraZeneca vaccine, which caused blood clotting in several dozen people, almost all of them women under 60. The vaccines manufactured by AstraZeneca and Johnson & Johnson both use an adenovirus to elicit an immune response. The vaccines manufactured by Pfizer and Moderna use a new, more sophisticated tool called messenger RNA.
Use of the AstraZeneca vaccine was halted, then started again, after the European Medicines Agency ruled that blood clotting associated with it was rare enough to merit its continued usage. The American review of the Johnson & Johnson vaccine could lead to the same conclusion.
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