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Citing blood clot risks, CDC advisers recommend mRNA pandemic vaccines over J&J shot
by Eric Sagonowsky |
Dec 16, 2021 3:47pm

At a meeting Thursday, members of the CDC's Advisory Committee on Immunization Practices reviewed data showing that nine deaths—in people ages 28 to 62—have been linked to the J&J shot through September.

Ever since federal officials briefly halted Johnson & Johnson's COVID-19 vaccine rollout this spring, the shot has seen limited use in the U.S. Now, the program is hitting another major setback.

Citing new data on the risk of potentially deadly blood clots associated with the J&J shot, Centers for Disease Control and Prevention (CDC) vaccine advisers have recommended use of mRNA shots from Pfizer and Moderna over J&J's vaccine, The Washington Post reports.

At a meeting Thursday, members of the CDC's Advisory Committee on Immunization Practices (ACIP) reviewed data showing that nine deaths—in people ages 28 to 62—have been linked to the J&J shot through September. Among the deaths, seven were women and two were men, the Post reports.

The recommendation follows a tough stretch for J&J's shot since its emergency use authorization. It hit the scene in the spring with great fanfare as the first one-and-done pandemic vaccine, but, shortly into the rollout, officials flagged a risk of rare blood clots. They paused the rollout to investigate and cleared it once again 10 days later.

The vaccine never really recovered in the U.S. About 17 million doses have been administered, the CDC says, far shy of the 284 million doses for the Pfizer-BioNTech shot and 186 million for the Moderna vaccine.

Meanwhile, Pfizer and Moderna are reaping monumental sales from their COVID-19 shots. During the first nine months of 2021, Pfizer reported more than $24 billion in sales for its BioNTech-partnered Comirnaty, while Moderna's Spikevax pulled in $10.7 billion during that time. J&J's COVID-19 vaccine, by comparison, generated $766 million during the first nine months of 2021, the company said.
 






FDA adds rare bleeding risk to J&J shot side effects

The FDA revised the fact sheet for Johnson & Johnson's COVID-19 vaccine Jan. 11 to include new information about the risk of a rare bleeding disorder.

"Reports of adverse events following use of the Janssen COVID-19 vaccine under emergency use authorization suggest an increased risk of immune thrombocytopenia during the 42 days following vaccination," the FDA said in a letter to Janssen Biotech, J&J's biotech arm.

Immune thrombocytopenia can cause easy or excessive bruising and bleeding, though the FDA said the chance of developing this disorder after vaccination is very low.

The new warning comes about a month after the CDC recommended Americans receive Pfizer or Modern's COVID-19 vaccine over Johnson & Johnson's due to concerns about the rare risk of blood clots following the shot.

https://www.fda.gov/media/155391/download