Brussels (AFP) – The European Union’s Medicines Agency agreed on Friday to withdraw one additional dose from each vial of the Coronavirus vaccine manufactured by Pfizer – BioNTech, in a step – along with the purchase of 300 million additional doses of the vaccine – It could accelerate the pace of vaccinations in the 27-nation bloc.
The European Medicines Agency said the Human Medicines Committee recommended updating the vaccine product information to make it clear that each vial contains six doses instead of the five that was notified when it originally gave the green light the Pfizer-BioNTech vaccine on December 21.
A spokesman for the German Health Ministry, Hannu Kautz, told reporters in Berlin that the change would take effect immediately, boosting the available doses of the vaccine by 20%.
Many doctors across the European Union have already withdrawn six doses of the vaccine from each vial, a practice already permitted in the United States, Britain and elsewhere.
Pharmaceutical companies regularly put more vaccine than necessary in vials so that a minimum dose can be guaranteed even if there is some spillage.
The news came shortly after the European Union’s executive arm announced that it had acquired an additional 300 million doses of the Pfizer-BioNTech vaccine. European Commission President Ursula von der Leyen said that the new agreement to buy more doses will double the quantity requested by the 27-nation bloc.
The European Union Commission later clarified in a statement that it had offered member states to purchase 200 million additional doses of the vaccine, with an option to obtain another 100 million doses.
This will enable the European Union to purchase up to 600 million doses of this vaccine, which is already in use throughout the European Union. The additional doses will be delivered starting in the second quarter of 2021, the European Union said. Von der Leyen said an additional 75 million doses will be available during the second quarter, with the remainder delivered throughout 2021.
Along with a contract with the vaccine company Moderna, the European Union now has the capacity to vaccinate 380 million people, von der Leyen said, more than 80% of its population.
The European Union has entered into six vaccine contracts amounting to two billion doses, with Moderna, AstraZeneca-Oxford, Sanofi-GSK, Janssen Pharmaceutica NV, Pfizer-BioNTech and CureVac. However, only Pfizer-BioNTech and Moderna vaccines have been approved for use in the block so far.
In an online public meeting to discuss the Medicines Agency’s work on vaccine review, EMA Executive Director Imer Koc said that the evaluation process for a third vaccine, produced by AstraZeneca, could be completed by the end of January.
“Of course, this will depend on the data we receive and the progress of the assessment,” she said. “Once we actually receive the app, we’ll make a public announcement about it.”
On Friday, Britain also approved a vaccine developed by Moderna, the third licensed vaccine for use in the country.
The British Department of Health said the vaccine had met “the strict standards for safety, efficacy and quality of UK regulators”.
Britain has ordered 10 million doses of the vaccine, but it is not expected to deliver them there until 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 mounting criticism, particularly in Germany, over the decision to allow the commission to handle vaccine purchases for all European Union member states. Vaccination programs in the European Union got off to a slow start, and some EU members were quick to blame the European Commission for its perceived failure to deliver the correct number of doses.
The European Union has defended its strategy, insisting that vaccination programs have only just begun and that large quantities are expected to be delivered in April.
We were faced with a situation where we had high demand, but production capacity has not kept pace with that yet. “Now, we have a positive step forward,” said von der Leyen.
After Germany obtained additional doses from the German company BioNTech, outside of European Union agreements, von der Leyen made it clear that individual negotiations would violate the agreement all members of the bloc had accepted.
She said: “We all agreed, in a legally binding manner, that there would be no parallel negotiations, nor a parallel contract.” “So the framework in which we all work is one of 27. Together we negotiate, together we buy and work together to move forward with this immunization process.”
But Kautz said that the deal with BioNTech “is in compliance with European Union agreements. The additional provisions that we have secured do not disrupt other contracts.”
“This is a precondition for the Memoranda of Understanding that we have concluded,” Kautz told reporters in Berlin. “Delivery also will not be affected by this. No other EU country will receive vaccines at a later time from BioNTech, for example, just because Germany got additional doses of the vaccine or committed additional doses of the vaccine.”
Kautz explained that 30 million bilaterally guaranteed doses will be delivered after those ordered through the European Union, although it is still expected this year.
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Corder Report from The Hague, Netherlands. Gere Molson and Frank Jordan from Berlin contributed.
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