“There is enough vaccine, that is basically 100 percent unquestionable, for every single, solitary American,” he insisted.
The reaction prompted an intense debate among public health experts about whether guarding against such a rare disorder was worth the cost. Scores of vaccine appointments were canceled this week, and some public health officials feared that by fueling vaccine hesitancy and conspiracy theorists, the pause could prompt fewer Americans to get vaccinated — and expose them to far more risk.
Others said the F.D.A. and the C.D.C. simply had no choice.
“It’s incredibly challenging, but to ignore it would have been worse,” said Rachael Piltch-Loeb, an expert in health risk communication at the N.Y.U. School of Global Public Health. If the public suspected that the government was concealing serious potential side effects, she said, far more people might decide against vaccination.
Dr. Janet Woodcock, the acting commissioner of the F.D.A., said at a news conference that the pause might last only “a matter of days,” although she said that depended on “what we learn in the next few days.” Dr. Schuchat said the pause was enacted partly to “prepare the health care system to recognize and treat patients appropriately.”
Scientists with the F.D.A. and the C.D.C. will jointly examine possible links between the vaccine and the disorder and determine whether the F.D.A. should continue to allow emergency use of the vaccine for all adults or modify the authorization, possibly by limiting the vaccine to certain population groups. An emergency meeting of the C.D.C.’s outside vaccine advisory committee has been scheduled for Wednesday.
Despite Mr. Biden’s assurance, the pause will complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy. Regulators in Europe and elsewhere are concerned about a similar issue with another coronavirus vaccine, developed by AstraZeneca and Oxford University researchers.
At the news conference, Dr. Marks drew a link between the two vaccines, saying the clotting cases were “very, very similar.” The vaccines are based on similar technology, but AstraZeneca’s has not yet been authorized for emergency use in the United States.
cameratoo on April 13rd, 2021 at 14:22 UTC »
What up my fellow J&J’ers?
antihostile on April 13rd, 2021 at 11:46 UTC »
WASHINGTON — Federal health agencies on Tuesday called for an immediate pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the United States developed a rare disorder involving blood clots within about two weeks of vaccination.
All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition.
Nearly seven million people in the United States have received Johnson & Johnson shots so far, and roughly nine million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the C.D.C., said in a joint statement. “Right now, these adverse events appear to be extremely rare.”
While the move was framed as a recommendation to health practitioners in the states, the federal government is expected to pause administration of the vaccine at all federally run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same.
TheDarkDeciever on April 13rd, 2021 at 11:27 UTC »
All six cases were women between the ages of 18 and 48 within about two weeks of getting the vaccine.