The European Medicines Agency (EMA) has ordered a batch of vaccines manufactured by Johnson & Johnson in the US to be kept off the EU market and destroyed.
The agency has not revealed how many vaccines are involved, but Belgium’s health minister Frank Vandenbroucke (Vooruit) put the figure in the millions, and described the incident as “a serious setback” in the vaccination campaign.
The problem arose at the Emergent Biosolutions manufacturing plant in Maryland in the US, which makes the active substance for the J&J vaccine as well as that of AstraZeneca.
The active substance became contaminated with materials intended for another vaccine, rendering them unusable.
The EMA stresses that the vaccines in question were never intended for the EU market.
However, as a precaution, the supervisory authorities in Belgium and the Netherlands, who oversee batch release in the EU, have decided to embargo and destroy all vaccines made using active substance made at around the same time as the Emergent problem.
The EU had been looking forward to receiving a shipment of 55 million J&J doses at the end of this month. The delivery would have given a boost to the vaccination campaign across the continent, as the J&J vaccine requires only one dose for the person to be fully protected.
That quantity is now likely to be much lower.
Speaking on VRT radio this morning, Vandenbroucke said the problem could mean a delay of three weeks in allowing Belgium to meet its vaccination targets.
“We had hoped at the very beginning to have 1.4 million doses of the Johnson & Johnson vaccine by the end of June,” he said.
“But by the end of June we will only have 450,000. It was already included in our planning that the 1.4 million would not arrive, but this could mean a delay of three weeks,” said Vandenbroucke.
“We also don’t know how many vaccines Johnson & Johnson will deliver in July. We’ll see where we are at the end of June, beginning of July. But let’s remain optimistic and not panic.”