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EU regulators approve increase in doses of virus vaccine vials

BRUSSELS (AP) – The European Medicines Agency on Friday approved doctors to withdraw another dose of each vial of coronavirus vaccine made by Pfizer-BioNTech in progress, which – combined with the purchase of 300 million additional serum photos – could accelerate the pace of vaccinations in the 27-nation bloc.

The European Medicines Agency has said that the Committee for Medicinal Products for Human Use recommends updating the vaccine product information to clarify that each vial contains six doses instead of the five recommended for the initial illumination of the Pfizer-BioNTech vaccine on 21


German Health Ministry spokesman Hano Kautz told reporters in Berlin that the change would take effect immediately, increasing available vaccine doses by 20%.

Many doctors in the EU are already withdrawing six doses of the vaccine from each vial, a practice that is already allowed in the United States, Britain and elsewhere.

Pharmaceutical companies regularly put more vaccines than needed in the vials so that a minimum dose can be ensured, even if there is some spillage.

The news came shortly after the EU executive said it had provided 300 million additional doses of the Pfizer-BioNTech vaccine. European Commission President Ursula von der Leyen said the new agreement to buy more doses would double the amount ordered by the 27-nation bloc.

The EU Commission later stated in a statement that it was proposing that Member States purchase an additional 200 million doses of the vaccine, with the possibility of acquiring another 100 million doses.

“This would allow the EU to buy 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, “the EU said. Von der Layen said that 75 million of the additional doses will be available in the second quarter, and the rest will be delivered in 2021.

Combined with a contract with Moderna for its vaccine, the EU already has the capacity to vaccinate 380 million people, said Von der Layen, more than 80% of its 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 only the Pfizer-BioNTech and Moderna vaccines have been approved for use in the unit so far.

At an online public meeting to discuss the work of the Vaccine Review Agency, EMA CEO Emer Cooke said the process of evaluating a third vaccine made by AstraZeneca could be completed by the end of January.

“This, of course, will depend on the data we receive and the progress of the assessment,” she said. “Once we actually receive the application, we will make a public announcement about it.”

Also Friday, Britain approved a vaccine developed by Moderna, the third to be licensed in the country.

The UK Department of Health said the vaccine met “strict standards for the safety, efficacy and quality of British regulators”.

The UK has ordered 10 million doses of the vaccine, although it is not expected to be delivered there by spring. So far, the UK has vaccinated 1.5 million people with the Pfizer-BioNTech and AstraZeneca-Oxford vaccines.

The European Commission’s announcement came amid growing criticism, especially in Germany, over the decision to allow the commission to deal with vaccine purchases for all EU member states. Vaccination programs in the EU have started slowly and some EU members have been quick to blame the European Commission for the alleged failure to deliver the exact number of doses.

The EU has defended its strategy, insisting that vaccination programs have just launched and that large deliveries are planned for around April.

“We were facing a situation in which we had a huge demand, but the production capacity was still not up to date. We now have a positive step forward, “von der Leyen said.

After Germany provided additional doses from BioNTech, a German company outside the agreements with the EU, von der Leyen indicated 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 or a parallel agreement,” she said. “So the framework in which we all work is a framework of 27. We negotiate together, we procure and we carry out this vaccination process together.”

But Kautz said the deal with BioNTech “is compatible with EU agreements.” The additional allocations we have provided do not violate the other contracts. “

“This is a prerequisite for the memoranda of understanding we have concluded,” Kautz told reporters in Berlin. “This will also not be affected by the delivery. No other EU Member State will receive vaccines later than BioNTech, for example, just because Germany has provided additional doses of vaccine or a commitment to additional doses of vaccine. “

Kautz made it clear that the 30 million doses provided bilaterally will be delivered after those ordered through the EU, although they are still expected this year.


Border reported by The Hague, The Netherlands. Geir Moulson and Frank Jordans contributed from Berlin.


Follow AP coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak

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