Scant evidence links J&J vaccine, blood clots, drugmaker's scientists say

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There's insufficient evidence of a causal relationship between Johnson & Johnson's COVID-19 vaccine and rare cases of blood clots at this time, scientists from the drugmaker wrote in a letter published in The New England Journal of Medicine April 16. 

Every state has suspended use of Johnson & Johnson's COVID-19 vaccine, and the drugmaker halted clinical trials after an April 13 recommendation by the CDC, The Hill reported. The CDC and FDA recommended the U.S. pause use of the vaccine while they review reports of rare and serious blood clots in six of the roughly 6.8 million people who've received the shot. 

"We continue to work closely with experts and regulators to assess the data, and we support the open communication of this information to health care professionals and the public," the researchers wrote. 

They added that out of more than 75,000 participants in a clinical trial for the vaccine, one case of cerebral venous sinus thrombosis, a type of rare blood clot, combined with low blood platelet counts, was seen, and Johnson & Johnson paused the trial to review the case. When "no clear causality was established," the drugmaker resumed the trial. 

A CDC independent advisory panel delayed April 14 making a recommendation for the vaccine's use in order to gather more information on the blood clot cases. 

The panel will meet again April 23 to provide guidance on the vaccine, CDC director Rochelle Walensky, MD, said April 16, according to The Hill. During a White House briefing, Dr. Walensky thanked the CDC panel for its "commitment to science" and said the time between meetings will give the CDC a chance to further review the cases and conduct a full risk assessment.

More articles on pharmacy:
J&J vaccine pause continues: Why Fauci thinks it could be a good thing
Moderna vaccine 90% effective after 6 months, study shows
9 things to know about the J&J, AstraZeneca COVID-19 vaccines & blood clots

 

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