WASHINGTON (AP) – The US on Tuesday recommended a “pause” in the use of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of rare but potentially dangerous blood clots, alleviate a worldwide chain reaction and a setback for global vaccine campaign.
The Centers for Disease Control & Prevention and the Food and Drug Administration have announced that they are investigating unusual blood clots that occurred 6 to 13 days after vaccination. The acting FDA commissioner said she expected the break to last several days.
The decision caused rapid action in Europe and elsewhere, as drug manufacturers and regulators stopped using the J&J vaccine, at least for the time being. Hundreds of thousands of doses of the vaccine would arrive in European countries this week. The European Union has been plagued by stock shortages, logistical problems and concerns about unusual blood clots in a small number of people who have received the AstraZeneca vaccine.
Any slowdown in the spread of the shots could have far-reaching implications for the global vaccination effort. The J&J vaccine has made a big promise because the single dose dose and relatively simple storage requirements would make it easier to use, especially in less affluent countries.
The blood clots appeared in veins draining blood from the brain and coexisted with low platelets, the fragments in blood that normally clot. All six cases were in women between 18 and 48 years of age. One person is dead and all cases are being investigated.
More than 6.8 million doses of the J&J vaccine have been given in the US, the vast majority with no or mild side effects.
The FDA said the cases being investigated looked similar to the blood clots that European authorities said were possibly linked to the AstraZeneca vaccine, which had not yet been cleared in the US. European regulators have stressed that the AstraZeneca risk seems lower than the possibility of developing blood clots. of birth control pills.
Massively managed vaccination sites will disrupt the use of the J&J survey, and states and other providers are expected to follow suit. But authorities stressed that they found no signs of clotting problems with the most widely used COVID-19 vaccines in the US – from Moderna and Pfizer.
‘I would like to emphasize that these events are extremely rare. However, the safety of the COVID-19 vaccine is a top priority, “Acting FDA Commissioner Janet Woodcock said at a news conference.
At a news conference in the White House, dr. Anthony Fauci, the country’s top expert on infectious diseases, said the FDA and the CDC would be able to investigate clotting cases “to try to understand some of the mechanisms” and “to make doctors more aware of this.”
A CDC committee will meet Wednesday to discuss the issues, and the FDA has also launched an investigation into the cause of the blood clots and the low platelet count.
FDA officials stressed that Tuesday’s actions were not a mandate. Doctors and patients can still use the vaccination of J&J if they decide that its benefits outweigh the risks for individual cases, said Dr. Peter Marks said.
The agencies recommend that people who have received the J&J vaccine contact their doctor if they experience severe headaches, abdominal pain, leg pain or shortness of breath within three weeks.
J&J said in a statement that they are aware of the reports of blood clots, but that there is no connection with the vaccine. The company also said it would delay the supply of its vaccine in Europe.
US health authorities have warned doctors against using a typical blood clot treatment, the blood thinner heparin. “In this environment, administration of heparin can be dangerous and alternative treatments must be given,” the FDA and CDC said.
European authorities investigating the AstraZeneca investigations have concluded that blood clots are similar to 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 if the reports among J&J recipients are related, doctors will treat these types of unusual blood clots as people who treat the heparin reaction – with different types of blood thinners and sometimes an antibody infusion, said Dr. Geoffrey Barnes said. a lump expert at the University of Michigan.
Even without the vaccination of J&J, White House officials have said they are on track to have enough supplies to vaccinate most American adults by summer.
“We believe there is enough vaccine in the system – Moderna and Pfizer – for all Americans who want to be vaccinated by May 31 to do so,” said White House response coordinator Jeff Zients.
The CDC’s dr. Anne Schuchat, when asked if the government is responding to six cases out of more than 6 million vaccinations, says the recommendations will come quickly.
Since these unusual blood clots need special treatment, ‘it was of utmost importance to us to articulate the word’, she said. “That said, the pandemic is quite severe and the cases are increasing in many places, and the vaccination is critical.”
States and cities moved quickly to implement the pause. Howard Zucker, New York State health commissioner, said people with Tuesday appointments for J&J vaccines at state-run mass vaccination clinics would rather get the Pfizer vaccine.
The city of Dallas was planning to start a vaccination program with the J&J vaccine for homebound or elderly people. The city said it will suspend the program until more guidance is announced.
The J&J vaccine received emergency approval from the FDA in late February with great fanfare. Yet the shot makes up only a small fraction of the doses applied in the US J&J, plagued by production delays and manufacturing defects in a Baltimore contractor’s plant.
Last week, the drugmaker took over the facility to scale up production in hopes of fulfilling its commitment to the U.S. government to provide about 100 million doses by the end of May.
Only about 9 million of the company’s doses have been delivered to states awaiting administration, according to CDC statements.
The European Medicines Agency stressed that the benefits of receiving the vaccine outweigh the risks for most people. But several countries have set limits on who can receive the vaccine. Britain has recommended that people be offered under 30 alternatives.
But the J&J and AstraZeneca vaccines are manufactured using the same technology. Leading COVID-19 vaccines train the body to recognize the vein protein that covers the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the spike gene into the body. J&J uses a human adenovirus to create its vaccine, while AstraZeneca uses a chimpanzee version.
US stock markets initially declined on the J&J news, but some indices rose slightly late in the morning. Johnson & Johnson’s shares fell nearly 3 percent, an extraordinarily large drop for the drug giant, while more shares changed hands in the first two hours than on an average day.
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Associated Press authors Emily Wagster Pettus, Karen Matthews, Jill Bleed, and Linda A. Johnson contributed to this report.