WASHINGTON (AP) – The US on Tuesday recommended a “break” in the use of the Johnson & Johnson COVID-19 single-dose vaccine to investigate reports of rare but potentially dangerous blood clots, triggering a global chain reaction and causing a obstacle in the global vaccination campaign.
The Centers for Disease Control and Prevention and the Food and Drug Administration have announced that they are investigating unusual clots that appeared 6 to 13 days after vaccination. The FDA commissioner in office said he expects the break to last a few days.
The decision sparked swift action in Europe and elsewhere as the drugmaker and regulators decided to stop using the J&J vaccine, at least for now. Hundreds of thousands of doses of the vaccine were to arrive in European countries this week. The European Union has been hit by a shortage of supplies, logistical problems and concerns about unusual blood clots in a small number of people who have received the AstraZeneca vaccine.
Any slowdown in the dissemination of photographs could have far-reaching implications for the overall vaccination effort. The J&J vaccine has had a huge promise, as its single-dose regimen and relatively simple storage requirements would make it easier to use, especially in less affluent countries.
The clots appeared in the veins that drain the blood from the brain and appeared together with low platelets, the fragments of blood that normally form clots. All six cases were in women between the ages of 18 and 48. One person has died and all cases remain under investigation.
More than 6.8 million doses of J&J vaccine have been administered in the United States, the vast majority without side effects or mild side effects.
The FDA said the cases under investigation appear similar to the clots that European authorities say are likely to be linked to the AstraZeneca vaccine, which is not yet clarified in the US. European authorities have pointed out that the risk of AstraZeneca appears to be lower than the possibility of developing clot from birth control pills.
Federally administered mass vaccination sites will discontinue the use of J&J fire and states and other providers are expected to follow. But authorities said they found no 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 to be extremely rare. However, the safety of the COVID-19 vaccine is a top priority, “said FDA Commissioner Janet Woodcock at a news conference.
Speaking at a White House news conference, Dr. Anthony Fauci, the nation’s leading infectious disease expert, said the break would allow the FDA and CDC to investigate coagulation cases “to try and understand some mechanisms.” and “to 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 continue to use the J&J vaccine if they decide that its benefits outweigh its risks for individual cases, said Dr. Peter Marks.
Agencies recommend that people who have been given the J&J vaccine contact their doctor if they have severe headaches, abdominal pain, leg pain, or difficulty breathing within three weeks.
J&J said in a statement that it is aware of reports of blood clots, but that no link has been established with its vaccine. The company also said it would delay the launch of the vaccine in Europe as a precautionary measure.
US health authorities have warned doctors not to use a typical clot treatment, heparin, which dilutes the blood. In this context, the administration of heparin can be dangerous and alternative treatments must be administered, said the FDA and CDC.
European authorities investigating AstraZeneca cases have concluded that the clots appear to be similar to a very rare abnormal immune response, which sometimes strikes people treated with heparin, leading to a temporary clotting disorder.
Although it is not yet clear whether reports between J&J beneficiaries are linked, doctors would treat these unusual types of clots, such as people who have a heparin reaction – with different types of blood thinners and sometimes an antibody infusion, he said. Dr. Geoffrey Barnes, a clot expert at the University of Michigan.
Even without J & J’s vaccine, White House officials say they are on track to have enough supplies to vaccinate most American adults by the 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 Jeff Zients, the White House’s COVID-19 response coordinator.
Asked if the government was overreacting to six cases out 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 for us to get the word out,” she said. That being said, the pandemic is quite severe and cases are growing in many places, and vaccination is critical.
States and cities moved quickly to implement the break. New York State Health Commissioner Dr. Howard Zucker said people with appointments for J&J vaccines at state mass vaccination clinics on Tuesday will receive the Pfizer vaccine in return.
The city of Dallas had planned to start a home vaccination program, using the J&J vaccine for the elderly or for the home. The city said it would discontinue the program until more guidance is released.
The J&J vaccine received an emergency use authorization from the FDA at the end of February, with great fanfare. However, the shooting is only a small part of the doses administered in the US J&J was affected by production delays and manufacturing errors at a Baltimore contractor plant.
Last week, the drug maker took over the plant to expand production in hopes of fulfilling its commitment to the US government to deliver about 100 million doses by the end of May.
Only about 9 million of the company’s doses have been delivered to states and are awaiting administration, according to CDC data.
The European Medicines Agency has emphasized 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. The United Kingdom has recommended that people under the age of 30 be offered alternatives.
But J&J and AstraZeneca vaccines are made with the same technology. The main COVID-19 vaccines train the body to recognize the peak 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 fell on J&J news, but some indices rose slightly until late in the morning. Johnson & Johnson shares fell nearly 3 percent, an unusually large drop for the drug giant, with more shares 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.