Johnson & Johnson vaccine rollout paused over blood clot reports

Health authorities have recommended a “pause” in the use of another vaccine as they investigate reports of blood clots linked to the jab.

US health authorities have recommended a “pause” in the use of the Johnson & Johnson COVID-19 vaccine “out of an abundance of caution” as they investigate reports of blood clots linked to the jab.

The Food and Drug Administration and the Centers for Disease Control and Prevention are assessing the “potential significance” of six reported cases of a rare blood clot in patients who have received the shot, the FDA and CDC said in a joint statement.

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.

— U.S. FDA (@US_FDA) April 13, 2021

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“Until that process is complete, we are recommending this pause,” said Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr Anne Schuchat, Principal Deputy Director of the CDC.

The CDC and FDA are reviewing six reported US cases of a “rare and severe” blood clot, which all occured among women between the ages of 18 and 48, six to 13 days after vaccination.

The blood clots seen were of a type called cerebral venous sinus thrombosis (CVST) in combination with low levels of blood platelets (thrombocytopenia) — a type also discovered on very rare occasions in people who have had the AstraZeneca vaccine.

US authorities have recommended a pause in the Johnson & Johnson vaccine rollout after six cases of rare and severe blood clots. Picture: Patrick T. Fallon / AFP

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The FDA and CDC said that treatment of this specific type of blood clot is unique, so a pause was “important to ensure that the health care provider community is aware of the potential for these adverse events and can plan.”

The statement said that as of Monday more than 6.8 million doses of the J&J vaccine had been administered in the US.

“Right now, these adverse events appear to be extremely rare,” the FDA said.

The CDC will convene a meeting of its advisory committee on Wednesday “to further review these cases and assess their potential significance”. The FDA will review that analysis as it also investigates these cases.

A news conference is scheduled for later Tuesday morning local time.

The statement came just days after the European Union’s drug regulator said it was reviewing possible blood clot cases in people given the J&J shot.

Australia has ruled out using Johnson & Johnson’s COVID-19 vaccine as part of the immediate national rollout.

A spokesperson for Health Minister Greg Hunt said the Janssen vaccine was an adenovirus vaccine, the same type of vaccine as the AstraZeneca vaccine.

“The government does not intend to purchase any further adenovirus vaccines at this time,” the spokesperson said.

People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination were told to contact their health care provider.

— With AFP