Johnson & Johnson Vaccine Approved for Use Again with Warning, CDC Says

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Julie Mazziotta
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JUSTIN TALLIS/AFP via Getty Images Johnson & Johnson COVID-19 Vaccine

Johnson & Johnson's COVID-19 vaccine should be used in the U.S. again, the Centers for Disease Control said Friday, after they advised a pause in inoculations while they investigated six cases of a rare blood clotting condition in women who received the vaccine.

The benefits of the Johnson & Johnson vaccine outweigh the small risk of blood clotting, a CDC panel decided. Federal health officials are expected to quickly follow their recommendation and advise states to lift the pause on inoculations with the Johnson & Johnson vaccine.

The CDC has suggested adding a warning label to the vaccine stating that "most cases" of the condition, which they're calling thrombosis with thrombocytopenia syndrome, or TSS, have been in women between the ages of 18 and 49. Anyone who receives the vaccine will be warned to look out for symptoms like blurred vision, fainting, seizure and coma that could indicate they have TSS.

The CDC's Advisory Committee on Immunization Practices met for six hours on Friday to vote on updated recommendations for using the vaccine.

"This pause was essential to our ability to inform the public," Dr. José R. Romero, the chair of the advisory panel, said at the meeting, The New York Times reported.

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The CDC, in conjunction with the Food and Drug Administration, initially recommended a temporary halt on inoculations with the Johnson & Johnson vaccine on April 13 "out of an abundance of caution" after six women developed the rare blood clotting condition within two weeks of getting the single-dose vaccine. The cases were all in women between the ages of 18 and 48. One woman died and a second woman was hospitalized in critical condition.

In the week and a half since, the CDC has identified nine more cases, bringing the total up to 15. All of the cases have been in women, and 13 were in women between the ages of 18 and 49. Three women have died from TSS and seven have been hospitalized, with four still in critical care as of Friday.

"These cases are not just numbers to any of us, and we take them very seriously," Dr. Joanne Waldstreicher, the chief medical officer of Johnson & Johnson, said at the meeting. "These are people."

The cases were isolated and statistically low — more than 6.8 million Americans have received the Johnson & Johnson vaccine, meaning these incidents occurred in around 1 in 500,000 cases.

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"These events appear to be extremely rare. However, COVID-19 vaccine safety is a top priority for the federal government and we take all reports of adverse events following vaccination very seriously," FDA Acting Commissioner Janet Woodcock said in a press briefing on April 13.

Earlier this week, the European Medicines Agency also reapproved use of the Johnson & Johnson vaccine after looking into the cases of blood clotting. They determined that the slim risk of the disorder outweighed the severe risk of COVID-19 illness without vaccination.

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