BRUSSELS (AP) – The European Union Medicines Agency on Friday approved doctors withdrawing one more dose from each vial of Pfizer-BioNTech’s coronavirus vaccine, in a move that – coupled with the purchase of 300 million additional injections of the serum – could accelerate the rate of vaccinations in the 27-country bloc.
The European Medicines Agency said its committee on medicines for human use recommends updating the product information for the vaccine to clarify that each vial contains six doses instead of the five recommended when it originally gave the green light to the Pfizer BioNTech vaccine on December 21.
German Health Ministry spokesman Hanno Kautz told reporters in Berlin that the change would take effect immediately, increasing available doses of the vaccine by 20%.
Many doctors across the EU already collect six doses of the vaccine from each vial, a practice already permitted in the United States, Great Britain and elsewhere.
Pharmaceutical companies regularly bottle more vaccine than necessary so that a minimum dose can be guaranteed, even if something is spilled.
The news came shortly after the EU executive arm said it had received an additional 300 million 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-country bloc.
The EU commission later stated in a statement that it offered member states to purchase an additional 200 million doses of the vaccine, with the option of obtaining an additional 100 million doses.
“This would allow the EU to purchase up to 600 million doses of this vaccine, which is already in use across the EU. The additional doses will be delivered from the second quarter of 2021, ”said the EU. Von der Leyen said 75 million of the additional doses would be available during the second quarter, with the remainder in 2021.
Coupled with a contract with Moderna for its vaccine, the EU now has the capacity to vaccinate 380 million people, Von der Leyen said, representing more than 80% of the population.
The EU has signed six vaccine contracts for up to 2 billion doses, with Moderna, AstraZeneca-Oxford, Sanofi-GSK, Janssen Pharmaceutica NV, Pfizer-BioNTech and CureVac. But so far, only the Pfizer-BioNTech and Moderna vaccines have been approved for use on the block.
At an online public meeting to discuss the drug agency’s work on vaccines, EMA Director Emer Cooke said the process of evaluating a third vaccine made by AstraZeneca could be completed by the end of January.
“This of course depends on the data we receive and the progress of the evaluation,” she said. “Once we actually receive the application, we will make a public announcement.”
Also on Friday, Britain gave permission for the vaccine developed by Moderna, the third vaccine to be licensed for use in the country.
The UK Department of Health said the vaccine met the UK regulators’ “strict standards of safety, efficacy and quality”.
Britain has ordered 10 million doses of the vaccine, although it won’t be delivered there until the spring. So far, Britain has vaccinated 1.5 million people with the Pfizer-BioNTech and AstraZeneca-Oxford vaccines.
The European Commission’s announcement came amid growing criticism, particularly in Germany, over its decision to let the commission handle vaccine purchases for all EU member states. Vaccination programs in the EU have been slow to get underway, and some EU members have been quick to blame the European Commission for allegedly failing to provide the correct number of doses.
The EU has defended its strategy, insisting that vaccination programs have just started and major deliveries are expected around April.
“We were faced with a situation where we had enormous demand, but production capacity had not yet kept pace. Now we have a positive step forward, ”said von der Leyen.
After Germany obtained additional doses from BioNTech, a German company, outside of the EU agreements, von der Leyen made it clear that individual negotiations would violate the agreement accepted by all members of the bloc.
“We all agreed, legally binding, that there would be no parallel negotiations, no parallel contract,” she said. “So the framework that we all work in is a framework of 27. Together we negotiate, together we buy and together we bring this vaccination process forward.”
But Kautz said the deal with BioNTech “is compatible with EU agreements. The additional allocations we have obtained do not disrupt the other contracts. “
“That is a prerequisite for the memoranda of understanding that we have negotiated,” Kautz told reporters in Berlin. “Delivery is also not affected by this. No other EU member state will subsequently receive vaccines from BioNTech, for example, just because Germany has provided additional vaccine doses or made a commitment to additional vaccine doses. “
Kautz made it clear that the bilaterally secured 30 million doses would be delivered following the orders placed through the EU, although they are still expected this year.
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Corder reported from The Hague, the Netherlands. Geir Moulson and Frank Jordans contributed from Berlin.
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