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Tuesday, February 7, 2023

US Lifts Pause On J&J Vaccine But With Warning Label

US health regulators have lifted an 11-day pause on the Johnson & Johnson (J&J) Covid-19 jab, but with the label of rare blot clot risks.

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Divya Dhadd
Divya Dhadd

UNITED STATES: The 11-day pause on the Johnson & Johnson (J&J) COVID-19 jab in the US has been lifted, however, the health regulators will add a warning label about the potential for extremely rare blood clots. Out of nearly eight million given the jab, fifteen recipients suffered from a dangerous blood clot. 

Europe’s drug regulator also ended restrictions on the J&J vaccine this week. Health regulators in Europe also linked the AstraZeneca Covid-19 shot to similar, highly unusual blood clots, but found the benefits of the drug outweighed any risks. 

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The decision to roll out the vaccine for people 18 years of age and older in line in the US means at least 10 million doses of the J&J vaccine, shipped from the company’s factory in the Netherlands, can be deployed across the US immediately.

Most blood clotting cases were among mid-aged women

On Friday, the health officials identified nine more cases of blood clots, other than the previous six cases. All were women, most under the age of 50. Around a dozen of the cases affected women of age 30-19. Health officials said that seven women were obese, two suffered high blood pressure and, two were using oral contraceptives.

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CDC officials said a few cases of blood clots in due to J&J men were being reviewed, too. Dr. Sarah Long, of Drexel University College of Medicine, was among the panel members who voted against the proposal as she thought it did not go far enough in warning women. She said, “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 added that it was their responsibility to be certain that women know the possible repercussions. Symptoms include headaches, shortness of breath, and leg and abdominal pain, and are observed within three weeks of vaccination. 

Also Read: Rare Blood Clotting Brings Johnson & Johnson Vaccine On Hold

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Earlier this month, the US paused the use of the single-dose shot after a few reports of blood clotting in the brain, among US women, post the vaccine. However, it was not the first setback for J&J in its US coronavirus vaccine rollout. Last month at a Baltimore facility, the ingredients for up to 15 million doses of the J&J vaccine were ruined at a Baltimore facility.

This week, federal inspectors identified a series of problems including safety issues at the Emergent BioSolutions plant.


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