US calls for pause on J&J's Covid-19 vaccine after 6 clotting cases

US calls for pause on J&J's Covid-19 vaccine after 6 clotting cases

US federal health agencies on Tuesday recommended pausing the use of Johnson & Johnson’s Covid-19 vaccine after six women under 50 given the shot developed rare blood clots, dealing a fresh setback to efforts to tackle the pandemic.

Following the news, Johnson & Johnson (J&J) said it was delaying the rollout of the vaccine to Europe, a week after regulators there said they were reviewing rare blood clots in four recipients of the shot in the United States. The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca’s vaccine and a similar rare blood clotting problem that led to a small number of deaths.

The USFDA said one person had died from the rare blood clotting condition after taking the J&J vaccine and another was in a critical condition. Immunology experts stressed the risk posed by the J&J vaccine appeared extremely low, and that the shot remained a valuable tool against the risks of Covid-19. However they acknowledged the need for health officials to proceed with caution to understand the best ways to mitigate any risk.

“Even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about,” Dr Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email.

“People are asking me if they should cancel their J&J vaccine appointments and I have told them not to but I know many will and this will stall progress in controlling the pandemic.” US health officials said during a press briefing there had been no similar blood clot cases reported among recipients of the Pfizer/BioNTech of Moderna vaccines. An advisory committee to the US Centers for Disease Control and Prevention will meet on Wednesday to review the cases, and the FDA will review the analysis, the agencies said in a joint statement.

All six cases involved women between the ages of 18 and 48, and the symptoms occurred six to 13 days after vaccination. In the cases, a type of blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets (thrombocytopenia).
J&J said it was working closely with regulators and noted no clear causal relationship had been established between the cases and the vaccine made by its Janssen unit. “The FDA recommendation to pause the administration of the J&J vaccine out of an abundance of caution makes sense in terms of the nature of the unusual and serious side effect not seen with the other vaccines,” said Dr. Robert Klugman at the UMass Memorial Medical Center in Massachusetts in an email. J&J’s shares were down 2.6 per cent in early New York trade.