U.S. health regulators on Friday lifted a recommended break on use of Johnson & Johnson’s Covid-19 vaccine, offering state and local officials support to distribute the doses, which are seen as critical to delivering life-saving shots to difficult communities. to reach.
The announcement by the Centers for Disease Control and Prevention and the Food and Drug Administration comes after the CDC’s Advisory Committee on Immunization Practices, known as ACIP, recommended Friday for continued use of the J&J vaccine, saying the benefits of the blow have outweighed the risk. The committee is an external group of experts that advises the CDC.
Advisory committee members did not recommend that U.S. regulators restrict J&J vaccine use based on age or gender, but proposed that the Food and Drug Administration consider adding a warning label for women. under the age of 50.
In a statement on Friday, the FDA and the CDC said they are confident the vaccine is safe and effective in preventing Covid-19.
“Safety is our top priority,” FDA Commissioner-in-Charge Dr Janet Woodcock said in a statement. “This pause was an example of our extensive security monitoring working as they were designed to work, identifying even this small number of cases.”
“We lifted the hiatus based on the FDA and CDC review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices,” Woodcock said. “We concluded that the known and potential benefits of the Janssen COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age and older.”
J & J’s Covid-19 vaccine, like Pfizer and Moderna shots, has received emergency use clearance from the FDA to begin distributing doses in the U.S. An EUA grants conditional clearance on the basis of two months of security data, pending another submission for full approval, which usually requires at least six months of data.
On April 13, the FDA and CDC asked states to temporarily suspend the use of J&J’s vaccine “out of abundance of caution” following reports that six women, ages 18 to 48, developed a cerebral venous sinus thrombosis in combination with low blood platelets. CVST occurs when a blood clot forms in the venous sinuses of the brain. It can prevent blood from flowing out of the brain and can eventually cause bleeding and other brain damage.
Within hours of the warning from US regulators, more than a dozen states, along with some national pharmacies, stopped vaccinating with J&J’s vaccine. Some locations have replaced J&J shots for scheduled appointments with Pfizer or Moderna vaccine.
The US government should have lifted the recommended pause shortly after the committee voted in favor.
Ahead of Friday’s vote, the committee discussed whether to recommend against the use of J&J’s vaccine or to approve it with US regulators who impose a warning label. The committee also considered limiting the use of the vaccine based on age or other risk factors.
During the meeting, CDC official Dr Tom Shimabukuro said there were no reports of the condition in those who received Pfizer-BioNTech mRNA vaccine. There have been three reports of CVST in patients who received the Moderna vaccine, he said, even though the patients did not have the low blood platelet level seen in J&J recipients.
Blood platelets help the body form clots to heal wounds. US health officials have warned that using a treatment such as anticoagulant heparin on those with low platelets could worsen their condition.
Rare blood clots with low platelets occur at a rate of 7 per 1 million vaccinations in women aged 18 to 49 for the J&J vaccine and 0.9 per 1 million in women aged 50 and over years, according to a slide presented at the CDC panel meeting. The CDC has confirmed 15 cases in total of rare blood clot conditions, including 12 women who developed blood clots in the brain. Three women died and 7 remained hospitalized, according to the presentation.
There are no confirmed cases in the men, although officials said they are looking into potential additional cases.
Dr Michael Streiff, a hematologist at Johns Hopkins University School of Medicine, said the condition is very rare under normal circumstances. “I can tell you from my experience, treating these patients, I’ve never seen this,” he told the committee during a presentation on Friday.
Earlier this week, J&J said it would resume rollout of its vaccine in Europe after regulators backed the single-injection vaccine with a recommendation to add a warning to the label. The European Medicines Agency researched all available evidence, he said, including reports from the United States.