An advisory committee from the Centers for Disease Control and Prevention on Friday recommended the United States resume using the Johnson and Johnson Covid-19 vaccine, saying the benefits outweighed the risk.
The recommendation, which was adopted 10-4 with an abstention, by the CDC’s Advisory Committee on Immunization Practices, will pave the way for US regulators to lift the recommended break on J&J shot use as early as this weekend.
Single shot is a vital tool for obtaining life-saving vaccines in hard-to-reach places that may not have reliable refrigeration, such as tribal lands, poorer neighborhoods and rural communities, as well as for people who may not be able to return. for a second dose, US health officials say.
The committee, an external group of experts advising the CDC, decided to postpone a decision on the vaccine last week as officials continued to investigate the cases of six women, ages 18 to 48, who developed thrombosis. sinus venous, or CVST, in combination with low platelets within approximately two weeks of receiving the injection.
The Food and Drug Administration and the CDC on April 13 asked states to temporarily suspend the use of the J&J vaccine “out of plenty of caution” following reports of rare blood clots. Within hours of the warning, more than a dozen states and some national pharmacies stopped vaccinations with the J&J vaccine, some replacing scheduled appointments with Pfizer or Moderna vaccine.
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.
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. The blood clots are similar to those reported in some individuals who have received AstraZeneca’s Covid-19 vaccine.
During the meeting on Friday, Dr Tom Shimabukuro, a CDC official, said there have been no reports of the condition in those who received the 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 slides.
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.
A CDC model presented at the meeting showed that failure to resume use of the J&J vaccine would delay immunization for all adults intending to undergo the vaccines by 14 days.
J&J executives told the committee that the benefits of his vaccine still outweighed the risks, adding that the shots would have prevented deaths and hospitalizations. They suggested a new warning label for the vaccine that explains the risk of blood clots.
“We could expect that if 1 million people in the United States were vaccinated with the J&J single-dose vaccine, there would be over 2,000 fewer deaths and 6,000 Covid-related hospitalizations,” said Dr. Joanne Waldstreicher, chief physician at J&J. official.
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.
Last week, US health officials said they expected the vaccine use pause to last only a matter of days, depending on what they learned in their investigation of the cases.
Prior to the CDC meeting, Dr. Wilbur Chen, a committee member, told CNBC he saw “a huge amount of evidence” that the benefits of the J&J vaccine still outweighed its risks.
“I think there is a willingness on our part to use this vaccine. We had to take a major break to be able to look at this safety information to be able to consider the risks. But certainly, I think there is a huge amount of evidence that the benefit far outweighs this risk, ”Chen, a professor at the University of Maryland School of Medicine, told Worldwide Exchange.
This is an evolving story. Please check back for updates.