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Johnson and Johnson Vaccine Can Resume, Will Carry Warnings

The United States should resume Johnson & Johnson Covid-19 vaccinations, an advisory committee to the Centers for Disease Control and Prevention (CDC) recommended Friday, after an 11-day pause. Panel members voted 10 to 4 to recommend lifting the pause on the vaccine but advised adding a warning about the increased risk of very rare but severe blood clots.

Along with the Food and Drug Administration, the CDC recommended the pause on April 13 after receiving six reports of dangerous blood clots in the brain among the more than 7 million people who had received the Johnson & Johnson vaccination (disclosure: this writer is a woman over 50 who received the J&J vaccine on March 13th and has experienced no major side effects).

COVID vaccine distirbution
[Photo by Scott Olson/Getty Images]
The CDC’s advisory committee (called the Advisory Committee on Immunization Practices) met to review the available case data on April 14th and make a recommendation on how to proceed. Ultimately, however, the committee felt it didn’t have enough information to make a recommendation at that time, and instead decided to reconvene this week.

 

New information has also emerged, including reports of an additional nine confirmed cases, for a total of 15. Among the confirmed cases, three patients died, and seven others remain hospitalized. All cases were in women, and all but two were in women ages 18 to 49. Seven were among women in their 30s, occurring at a rate of 11.8 per million doses of the Johnson & Johnson vaccine administered. No medical conditions or medications linked the cases, including obesity or the use of birth control pills.

The group’s recommendation is not binding; it will now go to CDC director Dr. Rochelle Walensky who will decide whether to formally accept it. Walensky told the “TODAY” show she expects to “make a decision quickly.”

The extremely rare combination of blood clots and low platelet counts is being called “thrombosis with thrombocytopenia syndrome,” or TTS. Platelets are components in the blood that cause clotting; it’s unusual to have blood clots and low platelets at the same time. Symptoms generally began at least six days following administration of the Johnson & Johnson vaccine, usually with headaches, chills, fever, nausea, weakness, and stomach pain.

It is unclear when shots will resume. The Food and Drug Administration must also alter the language on the emergency use authorization for the Johnson & Johnson vaccine to reflect the potential risks.

 

 



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