An advisory panel to the Centers for Disease Control and Prevention on Friday recommended the US resume the Johnson & Johnson Covid-19 vaccine, with the benefits outweighing the risks.
Panel members did not recommend U.S. regulators limit use of the vaccine based on age or gender, but suggested that the FDA consider adding a warning label for women under the age of 50.
The recommendation, accepted 10: 4 with one abstention by the CDC Advisory Committee on Immunization Practices, will pave the way for US regulators to end their recommended break in the use of the J&J shot earlier this weekend.
The single shot is an important tool for delivering life-saving vaccines to hard-to-reach places where reliable cooling may not be available, e.g. A second dose is given in tribal, poorer areas, and rural communities, and for people who may not be able to return, US health officials say.
The committee, an external panel of experts advising the CDC, decided last week to postpone a decision on the vaccine while officials continued to study cases of six women aged 18 to 48 who had combined cerebral venous sinus thrombosis (CVST ) developed with low platelets within about two weeks of receiving the shot.
The Food and Drug Administration and CDC on April 13 urged states to temporarily suspend use of J & J’s vaccine “out of caution” following reports of the rare blood clots. Within hours of the alert, more than a dozen states, as well as a few national pharmacies, suspended vaccinations with J & J’s vaccine, with some replacing scheduled appointments with either the Pfizer or Moderna vaccine.
Prior to Friday’s vote, the committee debated whether to recommend against J & J’s use of the vaccine or recommend it to U.S. regulators enforcing a warning label. The committee also considered limiting 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 draining from the brain and can eventually lead to bleeding and other brain damage. The blood clots are similar to those reported in some people who received the Covid-19 vaccine from AstraZeneca.
During the meeting on Friday, Dr. Tom Shimabukuro, a CDC official, said there have been no reports of the condition of those who received the Pfizer BioNTech mRNA vaccine. There have been three reports of CVST in patients receiving the Moderna vaccine, he said, even though the patients did not have the low platelet levels seen in the J&J recipients.
Platelets help the body form blood clots to heal wounds. US health officials warned against a treatment such as blood-thinning heparin in patients with low platelets, which could make their condition worse.
Rare blood clots with low platelets occur at a rate of 7 per 1 million vaccinations in women aged 18 to 49 years and 0.9 per 1 million in women aged 50 years and older with J&J vaccination. This is evident from a slide presented at the CDC panel meeting. CDC has confirmed a total of 15 cases of rare blood clots, including 12 women who developed blood clots in the brain. Three women have died and seven are staying in the hospital, according to slides.
There are no confirmed cases in men, although officials have stated that they are looking at potential additional cases.
Dr. Michael Streiff, a hematologist at Johns Hopkins University Medical School, said the condition is very rare under normal circumstances. “I can tell you from my experience treating these patients that I’ve just never seen it before,” he told the committee during a presentation on Friday.
A CDC model presented at the meeting showed that not resuming use of J & J’s vaccine would delay immunization for all adults who wish to receive the shots by 14 days.
J&J executives told the committee that the vaccine’s benefits still outweighed the risks, adding that the shots would prevent death and hospitalizations. They proposed a new warning label for the vaccine explaining the risk of blood clots.
“We could expect that if 1 million people in the US were vaccinated with the J&J single-dose vaccine, there would be more than 2,000 deaths and 6,000 fewer hospital stays associated with Covid,” said Dr. Joanne Waldstreicher, Chief Medical Officer of J & J.
Earlier this week, J&J announced that it would restart its vaccine rollout in Europe after regulators there backed the single vaccine by recommending adding a warning to the label. The European Medicines Agency has examined all available evidence, including reports from the United States.
Last week, U.S. health officials said they expected the break in using the vaccine would only be a few days, depending on what they learned from their investigation of the cases.
Before the CDC meeting, Dr. Wilbur Chen, a member of the committee, told CNBC that he saw “a great amount of evidence” that the benefits of the J&J vaccine still outweigh the risks.
“I think we are ready to use this vaccine. We had to take an important pause to review this safety information in order to consider the risks. But I think there is a great amount of evidence of this to be of benefit that risk far outweighs that, “Chen, a professor at the University of Maryland Medical School, told Worldwide Exchange.
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