A Centers for Disease Control and Prevention advisory panel recommended the United States resume use of the Johnson & Johnson COVID-19 vaccine on Friday, saying that the benefits outweigh the risks.
Though members of the panel did not recommend U.S. regulators restrict the use of the vaccine based on gender or age, they did propose that the Food and Drug Administration (FDA) add a warning label for women under age 50. The recommendation, which the CDC’s Advisory Committee on Immunization Practices adopted 10-4 with one member abstaining, paved the way for U.S. regulators to lift their recommended pause on the vaccine on Monday. U.S. health officials say that the single shot is a critical tool in getting vaccines to hard-to-reach places that may not have reliable refrigeration, such as poorer neighborhoods and rural communities, as well as to people who may not be able to come back for a second dose.
The committee, an outside panel of experts that advises the CDC, postponed a decision on the vaccine last week while officials continued to investigate cases of six women, ages 18 to 48, who developed cerebral venous sinus thrombosis (CVST) in combination with low blood platelets within about two weeks of receiving the vaccine. On April 13, the FDA and CDC asked states to temporarily pause use of J&J’s vaccine “out of an abundance of caution” following reports of the rare blood clots. Within hours of the warning, over a dozen states halted the use with the J&J vaccine, some replacing scheduled appointments with either the Pfizer or Moderna vaccine.
CVST occurs when a blood clot forms in the brain’s venous sinuses. It can prevent blood from draining out of the brain, which may cause hemorrhages and other brain damage. The clots are similar to those reported in some individuals who received AstraZeneca’s coronavirus vaccine. Dr. Tom Shimabukuro, a CDC official, said that there have been no reports of the condition in those who received the Pfizer mRNA vaccine. He said there were three reports of CVST in patients who received the Moderna vaccine, but the patients did not have the low level of blood platelets seen in the J&J recipients.
Dr. Michael Streiff, who is a hematologist at Johns Hopkins University School of Medicine, said that the condition is very rare in normal circumstances. “I can tell you from my experience, treating these patients, I’ve just never seen it,” he told the CDC committee during a presentation. J&J executives told the committee that the benefits of its vaccine still outweigh the risks, adding that the shots would prevent deaths and hospitalization. They suggested adding a new warning label for the vaccine that explains the risk of blood clots.
Committee member and University of Maryland School of Medicine professor Dr. Wilbur Chen said before the meeting that he saw “a huge amount of evidence” that the benefits of the J&J vaccine still outweigh its risks, according to CNBC. “I think that there is a willingness for us to use this vaccine. We did need to make an important pause to be able to look at this safety information to be able to consider the risks. But certainly, I think there’s a huge amount of evidence that the benefit greatly outweighs this risk,” Chen told “Worldwide Exchange.”
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