EU seeking ‘urgent clarification’ on Johnson & Johnson Covid vaccine delay

The European commission is seeking “urgent clarification” from Johnson & Johnson after the company’s “completely unexpected” announcement that it has decided to delay the deployment of its coronavirus vaccine across Europe following concerns in the US about a small number of blood clots.

The drug company said in a statement on Tuesday it had been “reviewing these cases with European health authorities” and had “made the decision to proactively delay the rollout of our vaccine in Europe”.

A commission official told Reuters the company had confirmed at a meeting on Friday it would aim to deliver 55m doses to the EU as contracted by the end of June. The official said the commission was “in contact with the company” to get clarification on the decision.

The EU’s drug regulator, the European Medicines Agency, approved the single-shot Johnson & Johnson vaccine last month and the company has committed to delivering at least 200m doses to the bloc this year. The UK has not approved the vaccine for use but has 30m doses on order.

A commission spokesman said the EU executive was looking into the matter but had no comment at this stage.

“This is worrying news – sounds like it may end up the same way as AstraZeneca,” an EU diplomat said. AstraZeneca has cut vaccine supplies to the bloc to 100m doses by the end of June from the 300m foreseen under its supply contract, causing a dispute with the EU that remains unresolved.

The US Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) earlier recommended a pause in the use of the Johnson & Johnson vaccine while investigations take place into six cases involving women who have experienced rare blood clotting events combined with low platelets in the days following vaccination. More than 6.8m doses of the vaccine have been administered in the US.

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The Johnson & Johnson vaccine is also being investigated by the EMA over the rare blood clotting cases that emerged in the US. On Tuesday it reiterated that any causal link was not yet clear. The clotting concerns mirror those of drug agencies in Europe and Australia over the AstraZeneca vaccine.

The bloc is relying on the Johnson & Johnson shot to help boost its rollout amid restrictions in some countries on who can get the Oxford/AstraZeneca vaccine.

The European commissioner in charge of the EU’s vaccination programme, Thierry Breton, said last week the bloc was due to receive 200m doses of the Pfizer/BioNTech vaccine in the next three months, along with 35m from Moderna, 70m from AstraZeneca, 55m from Johnson & Johnson and 10m from CureVac.

Spain’s health ministry said on Tuesday it was not aware of any changes to the planned first delivery of 300,000 Johnson & Johnson shots expected to arrive on Wednesday.

Reuters contributed to this report



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