Tuesday, October 26

CDC advisers recommend resuming Johnson & Johnson vaccine


(CNN) –– Vaccine advisers at the Centers for Disease Control and Prevention (CDC) voted Friday to resume Johnson & Johnson’s coronavirus vaccine. The decision was made after an emergency meeting in which cases of blood clots related to the vaccine were addressed.

Members of the Advisory Committee on Immunization Practices (ACIP) agreed that the benefits of the vaccine outweigh the risks of vaccine-related rare blood clots.

According to the words used during the vote: “The Janssen Covid-19 vaccine is recommended for people over 18 years of age in the US population under FDA emergency use authorization.”

«The vote is 10 in favor, four against and one abstention. The motion is successful, ”said Dr. José Romero, Arkansas Secretary of Health and President of ACIP.

Earlier, a Johnson & Johnson official told ACIP that the company agreed to revise the language on the label of its vaccine, which warns of the danger of blood clots. Also the pharmacist’s medical director, Dr. Joanne Waldstreicher, noted that Johnson & Johnson had written a text for the label, which was reviewed by the US Food and Drug Administration (FDA, for its acronym in English). In that text, the company acknowledges that the link of blood clots to its label is “credible.”

“We absolutely agree with the FDA in implementing a warning within our label and data sheets for patients and physicians describing this very unusual event. Including how it can be identified early and diagnosed and treated, ”Waldstreicher explained to the ACIP.

The text under review refers to blood clots in the brain combined with a blood clotting abnormality called thrombocytopenia. “Reports of adverse events after the use of the Janssen Covid-19 vaccine … suggest an increased risk of thrombosis,” it reads. And then he points out that the link between the vaccine and the clots is “plausible.”

The ACIP was convened to issue updated recommendations on the use of the vaccine and whether it is likely to be related to a rare blood clotting syndrome they call thrombosis with thrombocytopenia syndrome (TTS).

Other groups have called it vaccine-induced immune thrombotic thrombocytopenia, or VITT, but the ACIP sticks to more neutral language that does not presume that vaccines are causing the condition.

It is characterized by a rare type of blood clot in the brain, and possibly other large blood clots, along with a low number of blood clotting cells called platelets. Some blood specialists have said that they believe it is caused by an unusual immune reaction that attacks platelets, causing them to clump together.

The cases of six women who suffered from TTS, including one who died, led the CDC and FDA to recommend a pause in the administration of the vaccine in mid-April. Previously, the members of ACIP said they needed more time and more information before deciding whether and how to change the recommendations for administering the vaccine.

With information from Maggie Fox, Lauren Mascarenhas and Elizabeth Cohen, all from CNN.


cnnespanol.cnn.com

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