WASHINGTON (AP) – The US on Tuesday recommended a “break” in the use of Johnson & Johnson COVID-19 single-dose vaccine to investigate reports of rare but potentially dangerous blood clots, a development that could jeopardize the development of vaccines in worldwide .
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 said he expected the break to last a few days.
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.
Any slowdown in the dissemination of photographs could have far-reaching implications for the overall vaccination effort. The J&J vaccine has had a special promise for less affluent countries, as its single-dose regimen and relatively simple storage requirements would make it easier to use in the developing world.
The FDA said the cases under investigation appear to be similar to unusual clots that European authorities say are likely to be linked to another COVID-19 vaccine that has not yet been eliminated in the United States from AstraZeneca. European regulators have pointed out that the risk of AstraZeneca appears to be lower than the possibility of developing clots 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. The other two authorized vaccines, from Moderna and Pfizer, represent the majority of COVID-19 vaccines administered in the USA and are not affected by the break.
“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.
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.
Authorities have not seen similar clots after using Pfizer or Moderna vaccines, said Dr. Anne Schuchat of the CDC.
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.
While authorities are investigating whether the clots are really related to the J&J vaccine, Barnes stressed that Americans should be vaccinated as soon as possible using the other two vaccines available, from Pfizer and Moderna.
“If you have the chance to get vaccinated with them, we strongly encourage it. The risks of COVID are real and high, “said Barnes.
Jeff Zients, White House COVID-19 Response Coordinator, said 28 million doses of Pfizer and Moderna vaccines will be available to states this week, more than enough to keep the national pace of 3 million photos on day, despite the J&J break.
Asked if the government was overreacting to six cases out of more than 6 million vaccinations, Schuchat 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.
So far concerns about unusual blood clots have focused on the AstraZeneca vaccine, which has not yet received authorization in the US Last week, European regulators said they found a possible link between the shootings and a very rare type of clot. of blood that occurs along with low blood platelets, one that seems to occur more in younger people.
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.