EU regulators OK increasing doses from virus vaccine vials
BRUSSELS (AP) — The European Union’s drug agency on Friday approved doctors drawing one more dose from each vial of the coronavirus vaccine made by Pfizer-BioNTech, in a move that — combined with the purchase of 300 million extra shots of the serum — could speed up the pace of vaccinations in the 27-nation bloc.
The European Medicines Agency said its human medicines committee recommended updating the product information for the vaccine to clarify that each vial contains six doses instead of the five that were advised when it originally greenlighted the Pfizer-BioNTech vaccine on Dec. 21.
German Health Ministry spokesman Hanno Kautz told reporters in Berlin that the change would come into effect immediately, boosting available doses of the vaccine by 20%.
Many doctors across the EU have already been drawing six doses of the vaccine from each vial, a practice that is already permitted in the United States, Britain and elsewhere.
Pharmaceutical companies regularly put more vaccine than necessary into vials so that minimum dosage can be ensured even if there is some spillage.
The news came shortly after the EU’s executive arm said it had secured 300 million extra doses of the Pfizer-BioNTech vaccine. European Commission President Ursula von der Leyen said the new agreement to buy more doses will double the amount ordered by the 27-nation bloc.
The EU commission later detailed in a statement that it offered to member states to purchase an additional 200 million doses of the vaccine, with the option to acquire another 100 million doses.
“This would enable the EU to purchase up to 600 million doses of this vaccine, which is already being used across the EU. The additional doses will be delivered starting in the second quarter of 2021,” the EU said. Von der Leyen said 75 million of the extra doses would be available during the second quarter, with the rest being delivered throughout 2021.
Combined with a contract with Moderna for its vaccine, the EU now has the capacity to vaccinate 380 million people, Von der Leyen said, more than 80% of its population.
The EU has sealed six vaccine contracts for up to 2 billion doses, with Moderna, AstraZeneca-Oxford, Sanofi-GSK, Janssen Pharmaceutica NV, Pfizer-BioNTech and CureVac. But only the Pfizer-BioNTech and Moderna vaccines have been approved for use so far in the bloc.
At an online public meeting to discuss the drug agency’s work reviewing vaccines, EMA Executive Director Emer Cooke said the process of assessing a third vaccine, made by AstraZeneca, could be completed by the end of January.
“This will, of course, depend on the data we receive and the evaluation progress,” she said. “Once we actually receive the application, we will make a public announcement on this.”
Also Friday, Britain authorized the vaccine developed by Moderna, the third to be licensed for use in the country.
The U.K. Department of Health said the vaccine met British regulators’ “strict standards of safety, efficacy and quality.”
Britain has ordered 10 million doses of the vaccine, though it is not expected to be delivered there until spring. So far Britain has inoculated 1.5 million people with the Pfizer-BioNTech and AstraZeneca-Oxford vaccines.
The European Commission’s announcement came amid growing criticism, notably in Germany, about the decision to let the commission handle vaccine purchases for all EU member nations. Vaccination programs in the EU have gotten off to a slow start, and some EU members have been quick to blame the European Commission for a perceived failure to deliver the right number of doses.
The EU has defended its strategy, insisting that vaccination programs have just started and that large deliveries are foreseen for around April.
“We were faced with a situation where we had huge demand, but the production capacity had not kept pace with that as yet. Now, we have a positive step forward,” von der Leyen said.
After Germany secured extra doses from BioNTech, a German company, outside the EU agreements, von der Leyen made clear that individual negotiations would violate the agreement accepted by all the bloc’s members.
“We have all agreed, legally binding, that there would be no parallel negotiations, no parallel contract,” she said. “So the framework we are all working in is a framework of 27. Together we are negotiating, together we are procuring and together we are bringing forward this vaccination process.”
But Kautz said that the deal with BioNTech “is compatible with the EU agreements. The extra allocations we have secured do not disrupt the other contracts.”
“That is a precondition for the memorandums of understanding we concluded,” Kautz told reporters in Berlin. “Delivery also will not be affected by this. No other EU member state will get vaccines later from BioNTech, for example, just because Germany has secured additional doses of vaccine or a commitment for additional doses of vaccine.”
Kautz made clear that the bilaterally secured 30 million doses would be delivered after those ordered via the EU, though they are still expected this year.
Corder reported from The Hague, Netherlands. Geir Moulson and Frank Jordans contributed from Berlin.