US health regulators have lifted an 11-day pause on the Johnson & Johnson (J&J) Covid-19 jab, but will add a warning label about the potential for extremely rare blood clots.
A Centers for Disease Control and Prevention (CDC) panel earlier approved restarting US rollout of the shot.
Fifteen vaccine recipients suffered from a dangerous blood clot out of nearly eight million given the shot.
This week, Europe’s drug regulator also ended restrictions on the J&J jab.
European regulators this month also linked similar, highly unusual blood clots to the AstraZeneca Covid-19 vaccine, but found the benefits of the shot outweighed any risks.
The CDC and Food and Drug Administration swiftly followed the recommendation of the CDC advisory panel after it voted 10-4 on Friday afternoon to lift the pause.
The health officials identified nine more cases of the blood clots, adding to six cases already identified since regulators first approved the jab as safe and effective in February.
All were women, most under age 50. Three died and seven remain in hospital.
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“This is an age group that is most at risk [of the blood clot] that is getting vaccine predominantly to save other peoples’ lives and morbidity, not their own.”
The US health officials said on Friday it was important for women be told about that potential risks of the vaccine so they could decide whether to seek alternatives.
Dr Sarah Long, of Drexel University College of Medicine, was among the panel members who voted against the proposal because she thought it did not go far enough in warning women.
“This is an age group that is most at risk [of the blood clot] that is getting vaccine predominantly to save other peoples’ lives and morbidity, not their own,” she said. “And I think we have a responsibility to be certain that they know this.”
The US paused use of the single-dose shot earlier this month over a few reports of blood clotting in the brain post-vaccine among US women.
Following the advice, all federal sites in the US stopped using the vaccine.
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