WASHINGTON (AP) – The U.S. on Tuesday recommended a “pause” in the use of the Johnson & Johnson COVID-19 single-dose vaccine to investigate reports of rare but potentially dangerous blood clots, prompting a worldwide chain reaction. producing a reverse global vaccine campaign.
The Centers for Disease Control and Prevention and the Food and Drug Administration announced that they were investigating unusual clots that occurred 6 to 13 days after vaccination. The FDA acting commissioner said she hoped the break would last a few days.
The decision triggered swift action in Europe and elsewhere, as the drug maker and regulators decided to curb the use of the J&J vaccine, at least for now. Hundreds of thousands of doses of the vaccine should reach European countries this week. The European Union has been plagued by supply shortages, logistical problems and concerns about unusual blood clots in a small number of people who received the AstraZeneca vaccine.
Any slowdown in the spread of gunfire could have far-reaching implications for the global vaccination effort. The J&J vaccine had immense promise, as its single-dose regimen and relatively simple storage requirements would make it easier to use, especially in less affluent countries.
The clots occurred in the veins that drain blood from the brain and occurred along with the lower platelets, the fragments of blood that normally form clots. All six cases corresponded to women between 18 and 48 years of age. One person died and all cases are still being investigated.
In the United States, more than 6.8 million doses of the J&J vaccine have been administered, the vast majority without mild side effects.
The FDA said the cases investigated appear similar to clots that, according to European authorities, are possibly related to the AstraZeneca vaccine, which is not yet cleared in the US European regulators have stressed that the risk of AstraZeneca appears to be lower than possibility of developing clots from birth control pills.
Federally administered mass vaccination sites will pause the use of J&J firing and states and other providers are expected to continue. But authorities noted that they have not found any signs of clot problems with the most widely used COVID-19 vaccines in the United States, from Moderna and Pfizer.
“I would like to emphasize that these events seem extremely rare. However, the safety of the COVID-19 vaccine is a priority, “FDA Acting Commissioner Janet Woodcock told a news conference.
At a White House press conference, Dr. Anthony Fauci, the country’s top expert on infectious diseases, said the break would allow the FDA and CDC to investigate cases of clotting “to try to understand some of the mechanisms.” “make doctors more aware of this.”
A CDC committee will meet Wednesday to discuss the cases and the FDA has also launched an investigation into the cause of the clots and the low platelet count.
FDA officials stressed that Tuesday’s action was not a warrant. Doctors and patients could still use the J&J vaccine if they decide that its benefits outweigh its risks for individual cases, Dr. Peter Marks said.
Agencies recommend that people who receive the J&J vaccine contact their doctor if they have severe headaches, abdominal pain, leg pain, or shortness of breath within three weeks.
J&J said in a statement that it was aware of the blood clot reports, but that no link had been established with its vaccine. The company also said it would delay the launch of the vaccine in Europe as a precaution.
U.S. health authorities warned doctors not to use a typical clot treatment, anticoagulant heparin. “In this context, heparin administration can be dangerous and alternative treatments need to be done,” the FDA and CDC said.
European authorities investigating the AstraZeneca cases have concluded that clots appear to resemble a very rare abnormal immune response that sometimes affects people treated with heparin, leading to a temporary clotting disorder.
Although it is not yet clear whether reports among J&J recipients are related, doctors would treat this type of unusual clots as if they were treating people who have a heparin reaction, with different types of anticoagulants, and sometimes with a antibody infusion, said Dr. a clot expert at the University of Michigan.
Even without the J&J vaccine, White House officials said they are on track to have enough supplies to vaccinate most American adults over the summer.
“We believe there is enough vaccine in the system (Modern and Pfizer) for all Americans who want to get vaccinated before May 31 to do so,” said Jeff Zients, White House COVID-19 response coordinator .
Asked if the government was overreacting to six cases of more than 6 million vaccinations, Dr. Anne Schuchat, of the CDC, said the recommendations would come quickly.
Because these unusual clots require special treatment, “it was of the utmost importance to make the word known,” he said. “That said, the pandemic is pretty serious and cases are on the rise in many places and vaccination is critical.”
States and cities moved quickly to implement the pause. The New York State Commissioner of Health, Dr. Howard Zucker said people who make an appointment Tuesday for J&J vaccines at state-run mass vaccination clinics will get the Pfizer vaccine.
The city of Dallas had planned to start a vaccination program at home using the J&J vaccine for the elderly or at home. The city said it will pause the program until more guidance is released.
The J&J vaccine received emergency authorization from the FDA in late February with great encouragement. However, the shooting represents only a small fraction of the doses administered in the U.S. J&J has been affected by production delays and manufacturing errors at a Baltimore contractor’s plant.
Last week, the pharmacist took over the facility to increase production in hopes of fulfilling its commitment to the U.S. government to supply about 100 million doses by the end of May.
According to CDC data, only about 9 million doses of the company have been delivered to the states and are pending administration.
The European Medicines Agency points out that the benefits of receiving the vaccine outweigh the risks for most people. But several countries have imposed limits on who can get the vaccine. Britain recommended that alternatives be offered to those under 30.
But the J&J and AstraZeneca vaccines are made with the same technology. Major COVID-19 vaccines train the body to recognize the ear protein that coats the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the ear gene to the body. J&J uses a human adenovirus to create its vaccine while AstraZeneca uses a version for chimpanzees.
U.S. stock markets initially fell on J&J news, but some indices rose slightly in the late hours of the morning. Shares of Johnson & Johnson fell nearly 3 percent, an unusually large decline for the drug giant, with more stocks changing hands in the first two hours than on an average day.
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Associated Press writers Emily Wagster Pettus, Karen Matthews, Jill Bleed and Linda A. Johnson contributed to this report.