US recommends pause to Johnson & Johnson Covid jab rollout over blood clot reports

13 April 2021, 12:32 | Updated: 14 April 2021, 05:08

By Nick Hardinges

@NHardinges

US health agencies have recommended pausing the rollout of the Johnson & Johnson coronavirus vaccine due to reports of blood clots.

The US Food and Drug Administration (FDA) said it will investigate six reported cases of "rare and severe" blood clots in women who have received the firm's Covid-19 jab.

More than 6.8 million Johnson & Johnson Covid shots have been administered in the US so far.

A joint statement issued by the FDA and Centres for Disease Control and Prevention (CDC) on Tuesday said the two organisations were reviewing the data on the drug.

However, the publication added that the "adverse events appear to be extremely rare".

They said the treatment for this specific type of blood clot is different from what would usually be administered.

The statement, posted on the FDA's Twitter account, read: "Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine.

"We are recommending a pause in the use of this vaccine out of an abundance of caution."

It added: "As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine.

"Right now, these adverse events appear to be extremely rare.

"Treatment of this specific type of blood clot is different from the treatment that might typically be administered.

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"CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.

"Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot."

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The US FDA will be holding an audio press conference at 10am EDT (3pm UK) during which it will update the public on the announcement.

The Twitter post added: "#COVID19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously."

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Unlike vaccines developed by Pfizer and Moderna, Johnson & Johnson’s vaccine requires only one dose. It can also be stored in a refrigerator, while both Pfizer and Moderna’s vaccine require ultra-cold storage and a two doses.