US lifts pause on Johnson & Johnson vaccine
US health regulators have lifted an 11-day pause on the Johnson & Johnson (J&J) Covid-19 jab, but will put in 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 coagulum out of nearly eight million given the jab.
This week, Europe's drug regulator also ended restrictions on the J&J vaccine.
European regulators this month also linked similar, highly unusual blood clots to the AstraZeneca Covid-19 shot, but found the benefits of the drug outweighed any risks.
On Friday afternoon, the CDC and Food and Drug Administration swiftly followed the recommendation of the CDC advisory panel after it voted 10-4 to keep rolling out the vaccine for folks 18 years and older consistent with its original authorization.
The decision means at least 10 million doses of the J&J vaccine, shipped from the business's factory in the Netherlands, can be deployed over the US immediately.
The health officials on Friday identified nine more cases of the blood clots, increasing six cases already discovered since regulators first approved the jab as effective and safe in February.
All were women, most under the age of 50. Three died and seven remain in hospital.
About a dozen of the cases influenced women aged 30-39. Seven of the ladies were obese, two had high blood pressure, and two were utilizing oral contraceptives, according to health officials.
CDC officials who presented the info on Friday said a few cases of blood clots in men were being reviewed, too.
The officials also said it had been important for women be told about the potential risks of the vaccine so they could decide whether to get 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 generation that's most at risk [of the blood clot] that's getting vaccine predominantly to save lots of other peoples' lives and morbidity, not their own," she told AP new agency. "And I think we've a responsibility to be sure that they know this."
Symptoms can arise within three weeks of vaccination you need to include acute headaches, shortness of breath, and leg and abdominal pain.
US health officials are warning doctors that heparin, a common treatment for blood clots, can worsen the vaccine-linked condition.
The US paused make use of the single-dose shot earlier this month over a few reports of blood clotting in the brain post-vaccine in our midst women.
Following advice, all federal sites in america stopped using the vaccine.
It was not the first setback for J&J in its US coronavirus vaccine rollout. Last month, the ingredients for 15 million doses of the pharmaceutical giant's vaccine were ruined at a Baltimore facility.
Federal inspectors this week determined a series of problems at the Emergent BioSolutions plant, including cleanliness and safety issues.