In a move that certainly must leave millions of Americans who received the Johnson & Johnson COVID-19 vaccine unsettled, the Centers for Disease Control and the Food and Drug Administration are urging a “pause” in its use.
It’s because there have been multiple reports of blood clots developing in recipients of the single-dose vaccine.
CNN reported the move was triggered by cases of a “rare and severe” type of blood clot in six patients, of more than 6 million recipients.
The cases occurred in women aged 18 to 48 about a week after vaccination.
A statement from Dr. Anne Schuchat of the CDC and Dr. Peter Marks of the FDA said, “CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance.”
They said the FDA “will review that analysis as it also investigates these cases.”
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” the statement said. “This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”
It’s not the first time such concerns have been raised about a COVID-19 vaccine. WND reported a week ago that Germany, France, Italy, Spain and several other nations suspended the use of AstraZeneca’s vaccine over concerns it is linked to blood clots.
The manufacturer denied any link, but an official with the European Union’s agency in charge of evaluating medicines believes there is a “clear association” between the two.
Reuters reported Marco Cavaleri, the chairman of the the European Medicines Agency team evaluating the vaccine, said that in his opinion, “we can now say it, it is clear that there is an association (of the brain blood clots) with the vaccine.”
And the problem appeared to be spreading, with the Canadian Press reporting a Quebec woman developed a blood clot after being treated with the AstraZeneca vaccine.
“The news came as Health Canada said it was investigating reports of clots linked to the Johnson & Johnson vaccine in the United States,” the report said.
Johnson & Johnson said in a statement, “We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.”
The company confirmed others have reported severe headache, abdominal pain, leg pain or shortness of breath after their vaccinations.
But Johnson & Johnson insisted such events are rare.
“You’re talking about 1 per million, and when you give millions of doses of vaccines, you will see events like this that you couldn’t see in the clinical trial just because you didn’t have millions of people enrolled,” said Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine at Grady Health System.
The doctor noted that the Johnson & Johnson and AstraZeneca vaccines are “adenovirus vector vaccines,” which are similar in makeup.
CNN reported the announcedment from the FDA and the CDC “means all federal health channels — mass vaccination sites, community health centers and the like — that were previously administering the Johnson & Johnson vaccine will immediately stop for the time being, according to a federal health official.”
The New York Post noted former President Trump, on whose watch COVID-19 vaccines were developed in record time, said the “pause” was a disservice.
“The results of this vaccine have been extraordinary but now it’s [sic] reputation will be permanently challenged. The people who have already taken the vaccine will be up in arms, and perhaps all of this was done for politics or perhaps it’s the FDA’s love for Pfizer,” he said.
Trump said the FDA, “especially with long time bureaucrats within, has to be controlled.”
“They should not be able to do such damage for possibly political reasons, or maybe because their friends at Pfizer have suggested it. They’ll do things like this to make themselves look important,” Trump said.
Fox News reported White House coronavirus adviser Dr. Anthony Fauci said the determination by the CDC and FDA shows that America’s health care system is careful.
He said those who have received the vaccine should pay attention to symptoms.
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