J&J to restart vaccine shipments to Europe after regulatory green light
Johnson & Johnson will restart shipments of its Covid-19 vaccine to Europe after the continent’s health agency concluded the benefits outweighed the risks even after it identified a “possible link” between the jab and rare blood clots.
The European Medicines Agency said on Tuesday that a rare combination of blood clots and low platelet count should be added to the list of side-effects from the J&J jab. However, it added that the overall benefits of the single-shot vaccine exceeded the risks of these reactions.
J&J said it would resume shipment of 200m vaccine doses to the EU, Norway and Iceland and update its information on the diagnosis and management of the “very rare adverse event”.
The European rollout of the J&J vaccine was delayed last week after US health agencies recommended it be paused while they investigated the side-effects, which were seen in eight out of more than 7m people who received the jab. The US Centers for Disease Control and Prevention will meet on Friday to decide its next steps.
Scientists have been racing to determine the cause of the rare reaction, and the EMA said that it did not yet know the exact mechanism.
Sabine Straus, chair of the EMA’s Pharmacovigilance Risk Assessment Committee (Prac), said it was “probably an immune response” similar to one seen sometimes in patients treated with heparin — called heparin induced thrombocytopenia — but that it was too early to know definitively.
She added that the combination of blood clots and low platelets had “a strong association” with both J&J and Oxford/AstraZeneca’s adenovirus-based vaccines. The regulator is also assessing data from Russia’s Sputnik vaccine, which uses similar technology.
The EMA said individuals should seek urgent medical help if they experience symptoms including shortness of breath, chest pain and leg swelling three weeks after vaccination with J&J’s jab.
Paul Stoffels, chief scientific officer at J&J, said: “We appreciate the rigorous review of the Prac and share the goal of raising awareness of the signs and symptoms of this very rare event.”
“We strongly believe in the positive benefits of our single-shot, easily transportable Covid-19 vaccine to help protect the health of people everywhere and reach communities in need globally,” he said.
The EMA said that all cases of the rare side-effects occurred in people under 60 years old, mainly women, and three weeks after vaccination.
“It’s very rare and very difficult for healthcare professionals to recognise these cases,” Straus said, adding that spotting cases early can prevent complications.
Sales of J&J’s Covid-19 vaccine hit $100m in the first three months of the year. The drugmaker does not sell its single-shot Covid-19 vaccine for profit.
The production of J&J’s vaccine at a plant in Baltimore was halted on Monday by the US Food and Drug Administration while it investigates the site run by Emergent BioSolutions that has been beset by manufacturing problems.
Also on Monday, the US House committee on oversight and reform launched a separate investigation into whether Emergent received contracts to manufacture vaccines “despite a long, documented history of inadequately trained staff and quality control issues”.
Joaquin Duato, vice-chair of J&J’s executive committee, said that the FDA’s assessment was expected to close this week and that J&J remained committed to ensuring that all substances used in its vaccine “meets our high quality standard”.