The United States can immediately resume use of Johnson & Johnson’s COVID-19 vaccine, key health regulators said on Friday, ending a 10-day break to investigate its link to extremely rare but potentially deadly blood clots.
The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration said the risks of experiencing the syndrome involving severe blood clots and low platelets as a result of the vaccine are very low. They found 15 cases in the 8 million shots fired.
“We are no longer recommending a pause in the use of this vaccine,” said CDC director Rochelle Walensky at a news conference. “Based on the in-depth analysis, there is likely to be an association, but the risk is very low.”
Senior US FDA officials said the decision took effect immediately, paving the way for gun firings as early as Saturday. The agency said it would warn of the risk in an updated form provided to vaccine recipients and suppliers.
The agencies made the decision after a meeting of external consultants from the CDC, who recommended that the Covid-19 vaccine break be ended.
In an analysis presented at the meeting, the CDC team said that the cases of the syndrome they found occurred at a rate of seven per million doses in women under 50, with the highest risk occurring among women aged 30 to 39. years old.
For women over 50 and for all men, clots appeared at a rate of one to one million doses, the analysis showed. In all, there were three deaths, officials said.
After a full-day meeting, the CDC panel voted 10-4 that the J&J vaccine be used as recommended in people 18 years of age or older, the parameters of their current FDA authorization.
Dr. Jesse Goodman, an infectious disease specialist at Georgetown University in Washington and a former FDA chief scientist, said the risk is not trivial, but still small.
“But we should keep that in perspective. I mean, the risk of dying in a car accident in your life is something like one in 100, the risk of being struck by lightning is something like one in 15,000,” said Goodman.
Unlike the highly effective vaccines of Pfizer Inc and Moderna Inc, which require two doses and must be kept frozen in deep-frozen temperatures, the J&J vaccine can be administered in a single dose and stored at regular refrigeration temperatures, making it a better one. option for harsh. – areas of reach.
Johnson & Johnson shares closed up 0.2% to $ 165.52.
“We will collaborate with health authorities around the world to educate health professionals and the public to ensure that this very rare event can be identified early and treated effectively,” said J&J scientific director Paul Stoffels, in a statement after the agencies made their announcement.
When the agencies announced the break, they asked doctors to avoid using the anticoagulant heparin, commonly administered to patients to dissolve blood clots, in people who received the J&J vaccine and were experiencing low blood clots and platelets.
In cases of blood clots induced by the vaccine, however, heparin appears to worsen the condition. Walensky said that doctors had heeded this warning, noting that the drug had not been used in any of the cases identified after the break began.
The US decision follows a similar one by the European Medicines Agency, which on Tuesday said the benefits of the J&J injection outweighed its risks and recommended adding a warning about unusual blood clots with low platelet counts on the vaccine’s product label. J&J resumed its launch there.
The J&J investigation followed an investigation in Europe of the AstraZeneca PLC vaccine, with which similar cases of blood clots were first identified. Dr. Peter Marks, of the FDA, said the cases look so similar that a doctor would not be able to tell which vaccine caused them.
Both the J&J vaccine and AstraZeneca use different versions of a cold virus to provide instructions on how to turn coronavirus proteins into cells to produce an immune response. Marks said studies are underway to determine whether adenovirus or something else is behind the rare blood clots.
Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, said the J&J vaccine will help advance the vaccination effort.
“Giving people the option of receiving a single dose vaccine will help vaccinate more people more quickly and better protect some populations, such as those who are homeless or incarcerated,” Moss said in an email.
J&J has faced several setbacks since its vaccine obtained emergency clearance in the U.S. in February, including scrutiny of declining production.
In the United States, 35% of adults are fully vaccinated and 53% received at least one injection, according to CDC data. The United States leads the world, with about 570,000 deaths from COVID-19.