Johnson & Johnson delays rollout of Covid-19 vaccine in Europe as it reviews clotting cases in US

Johnson & Johnson said on Tuesday it would delay the rollout of its Covid-19 vaccine in Europe and was reviewing cases of extremely rare blood clots in people after they received the shot.

Dr Glynn told the Oireachtas Health Committee today that the European Medicines Agency has been monitoring the situation surrounding Johnson & Johnson’s vaccine and its possible link to blood clots. Nphet and other public health colleagues will be monitoring the situation for further data.

US federal health agency FDA on Tuesday recommended pausing the use of the Covid-19 vaccine as six women under 50 developed rare blood clots after receiving the shot, dealing a fresh setback to efforts to tackle the pandemic.

The rare disorder, which involved blood clots, developed within two weeks of vaccination. All six of the recipients were women, between the ages of 18 and 48.

The FDA described the recommended pause as a decision “out of an abundance of caution” and said the cases were “extremely rare”.

They wrote in a statement online; “As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the US CDC & FDA are reviewing data involving 6 reported US cases of a rare & severe type of blood clot in individuals after receiving the vaccine.

"Right now, these adverse events appear to be extremely rare.

Health officials in the US will meet on Wednesday to further review the cases and assess their significance. The FDA said it will review the analysis and also investigate the cases.

They added; “Until that process is complete, we are recommending this pause.

"This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”

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 (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

The CDC and FDA said the adverse events appeared to be extremely rare.

"I think this is a very low risk issue, 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 Johnson & Johnson vaccine appointments and I have told them not to but I know many will and this will stall progress in controlling the pandemic."

Johnson & Johnson said it was working closely with regulators and noted no clear causal relationship had been established between the cases and the Covid-19 vaccine made by its Janssen unit.

One woman died and a second in Nebraska has been hospitalized in a critical condition, the New York Times reported, citing officials.

"The FDA recommendation to pause the administration of the Johnson and Johnson 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.

"While the incidence is very low, the severity and potential for brain damage and other blood clot-related injuries is of great concern."

The US move comes less than a week after Europe's drugs regulator said it was reviewing rare blood clots in four people in the United States who had received the Johnson & Johnson shot.

The Johnson & Johnson and AstraZeneca vaccines both use an adenovirus vector - a harmless cold virus that instructs human cells to produce a protein found on the surface of the coronavirus, thereby spurring the immune system to prepare an arsenal against the Covid-19-causing virus.

Among leading global Covid-19 vaccine developers, China's CanSino Biological and Russia's Gamaleya Institute with its Sputnik V vaccine are also relying on this approach. The Pfizer/BioNtech and Moderna vaccines use mRNA technology.

Reuters