EU and BioNTech/Pfizer clash over reduced vaccine deliveries

A decision by Pfizer and BioNTech to reduce the number of vaccine vials they send to European countries has forced health officials to slow vaccination plans, with at least one EU member state threatening legal action as tensions over limited supplies mount.

The move by the manufacturers followed a ruling this month from the European Medicines Agency that six doses can be extracted from each BioNTech/Pfizer vial rather than five, after health professionals found there was often extra vaccine left over.

Pfizer and BioNTech’s contracts with governments are for set numbers of doses and the companies have responded to the adjusted guidance by reducing the number of vials they deliver. But to ensure that six doses are extracted, healthcare providers must use a special kind of needle, called a low dead volume syringe. 

Health officials across Europe have warned that this process is difficult and that the change in delivery volumes has left them unable to complete vaccination schedules for those who were first inoculated in December and earlier this month.

The health authority in the German city of Hamburg said the change meant they were now receiving about 20 per cent less vaccine than previously delivered.

“Previously we received six vials for every 30 doses of vaccine that we ordered. Now we’re only getting five,” said Melanie Leonhard, Hamburg’s health minister. “As a result of this additional tightening of supply, the situation for the regions is now even worse.” 

The impact of the new EMA guidance on doses per vial has been exacerbated by another drop in supply caused by Pfizer’s reconfiguration of its manufacturing plant in Belgium. That shortfall is expected to be resolved by the end of the week, but the two issues have strained relations between the companies and governments.

Italy said a 29 per cent drop in the number of BioNTech/Pfizer vaccine doses it was receiving was expected to continue beyond this week.

Domenico Arcuri, Italy’s Covid extraordinary commissioner, said the country planned to take legal action against Pfizer “in the coming days”.

“The vaccination campaign cannot be slowed down, especially when it comes to the administration of second doses to Italians who have already received the first one,” he said.

Pfizer said in a statement to the Financial Times that its agreements with governments had always been based on the delivery of doses and not the delivery of vials.

“We will supply to countries in line with our supply agreements and the label valid in the country and will fulfil our supply commitments in line with our existing agreements — which are always based on delivery of doses, not vials,” it said.

BioNTech referred the FT to the Pfizer statement and declined to comment further.

Given the EMA guidance, Pfizer thinks it is only fair to fulfil its contractual obligations with European countries and use the remaining doses to supply the developing world, according to a person familiar with the matter. The US Food and Drug Administration and the UK medicines regulator have both also advised that six doses can be extracted from each vial.

Pfizer and the European Commission held an emergency phone call on Tuesday where they discussed ways to ensure countries could all extract a sixth dose from each vial and the timelines for future deliveries, according to people briefed on the call.

Some EU member states are calling on Brussels to take a hard line with Pfizer and other vaccine suppliers.

“We need the commission to be not only a co-ordinator but a tough negotiator with pharma companies too, speaking on behalf of 450m Europeans,” said one EU diplomat. “Only a strong stance will get 70 per cent of the adult population vaccinated by summer,” the official added, referring to an EU target published by Brussels this week.

The commission said in a statement to the FT that the agreed-upon delivery of doses of the vaccine “has to be respected by the company”. It said the sixth-dose extraction was “very welcome” but stressed that no single dose or vial should be lost.

The UK’s supply contracts with BioNTech/Pfizer are also for doses rather than vials, and UK regulatory guidelines allow for a sixth dose to be extracted where possible. The government said it remained “in close contact” with all suppliers so it could achieve its target of immunising all those over 70 by February 15. 

Additional reporting by Sarah Neville in London

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