Johnson & Johnson delays vaccine rollout in Europe as US health agencies call for pause

Johnson & Johnson said it would delay the planned rollout of its Covid-19 vaccine in Europe after US health agencies called for a pause on the jab’s use in the US while they investigate several incidents of blood clots.

In a joint statement on Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were reviewing six reported US cases of “rare and severe” blood clots in individuals who had received the J&J vaccine. The individuals were all women aged between 18 and 48, who developed symptoms six to 13 days after vaccination. 

J&J said it was continuing to work closely with experts and regulators to assess the data. “We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine,” it said. 

The company’s shares were down 2.5 per cent on Tuesday.

J&J also said it was proactively halting its planned rollout in Europe, which was set to begin this week. The European Medicines Agency repeated on Tuesday it was reviewing a number of cases of blood clots in individuals who received the J&J vaccination, with a view to deciding whether “regulatory action may be necessary”. It has so far said there is no evidence of a causal link.

Almost 7m doses of the J&J jab have been administered in the US. Federal vaccine distribution sites will stop using the jab, and individual states are likely to follow suit. New York health commissioner Howard Zucker said in a statement on Tuesday morning that the state would follow the federal recommendation and suspend using the jabs “immediately” while the vaccine was evaluated.

Anyone with an existing appointment for the J&J vaccine at the state’s mass vaccination states would be given the Pfizer shot instead, Zucker said.

The CDC said it would review the cases at a meeting of its advisory committee on immunisation practices on Wednesday while the FDA also investigates the significance of the blood clots. 

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” the agencies said, adding that it was important for health bodies to properly understand and plan treatment for the particular type of blood clot.

The J&J vaccine is the only one-shot jab authorised for use in the US, with the Pfizer and Moderna vaccines each requiring two doses. Its authorisation in February was seen as a boon to efforts to accelerate vaccination rollouts.

However, the vaccine has hit some hurdles since then, including manufacturing problems at one of its supplier’s plants that ruined a batch. Use of the J&J jab had also been paused at a handful of vaccination sites in several states after reports of adverse events. 

The call to suspend the vaccine’s rollout because of blood clot fears follows similar issues with the Oxford/AstraZeneca jab, which were investigated by the EMA. Last week, the EMA concluded that very rare cases of unusual blood clots should be listed as a side effect of the AstraZeneca vaccine.

Both jabs are adenovirus-based vaccines. The Pfizer and Moderna shots use messenger RNA technology.

Eric Kremer, an expert in adenoviruses at the Montpellier Molecular Genetics Institute, said that while the side effect was “extremely rare”, the J&J cases did not look “encouraging”.

Cody Meissner, chief of paediatric infectious diseases at Tufts Children’s Hospital and a member of the FDA’s immunisation advisory panel, said: “It’s not completely surprising that there appears to be some association with blood clots because the AstraZeneca vaccine also used an adenovirus.”

Outside the US, South Africa has vaccinated just under 300,000 health workers with the J&J vaccine since February.

Pretoria has ordered 31m J&J doses for its mass rollout. South African local media reported on Tuesday that health experts were considering a pause on the local use of the J&J vaccine in light of the US and European investigations. South Africa’s health ministry did not immediately respond to a request for comment.

Norwegian authorities, which are due to decide whether to extend their suspension of the AstraZeneca vaccine on Thursday, said they would announce their response to the J&J jab at the same time.

Steinar Madsen, medical director of the Norwegian Medicines Agency, told state broadcaster NRK of the US move: “It is a dramatic measure, but there are cases that look like what we have seen in Europe with AstraZeneca and it is obvious that this needs to be looked at more closely.”

The CDC and FDA said the symptoms discovered in the six women — a cerebral venous sinus thrombosis with low levels of blood platelets — may require different treatment to typical blood clots and that anticoagulant drugs “may be dangerous”.

The White House insisted the pause would not prevent it hitting its target of overseeing 200m vaccinations in the Biden administration’s first 100 days. 

“This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 per cent of the recorded shots in arms in the United States to date,” Jeff Zients, the co-ordinator of the president’s Covid-19 task force, said in a statement.

“Based on actions taken by the president earlier this year, the United States has secured enough Pfizer and Moderna doses for 300m Americans.”

Additional reporting by Donato Paolo Mancini in Rome, Richard Milne in Oslo and Joseph Cotterill in Johannesburg