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.
The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine. This week, Europe’s drug regulator also ended restrictions on the J&J vaccine. 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 continue rolling out the vaccine for people 18 years of age and older in line with its original authorisation. The decision 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. The health officials on Friday 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 the age of 50. Three died and seven remain in hospital.
About a dozen of the cases affected women aged 30-39. Seven of the women were obese, two had high blood pressure, and two were using oral contraceptives, according to health officials.