EU regulators are increasing the dose of virus vaccine

BRUSSELS (AP) – The European Union’s drug agency on Friday approved doctors taking another dose of each bottle of coronavirus vaccine produced by Pfizer-BioNTech, in a move that – combined with the purchase of 300 million additional photos of serum – could accelerate the pace of vaccinations in the bloc of 27 nations.

The European Medicines Agency stated that its Committee for Human Medicines had recommended that the information on the vaccine product be updated to clarify that each vial contains six doses instead of the five that were recommended when it first started the Pfizer-BioNTech vaccine on 21 December.

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

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

Pharmaceutical companies regularly put more vaccines in the vials than necessary, so that the minimum dose can be provided even if there is a certain leakage.

The news came shortly after the EU’s executive arm said it had secured 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 would double the amount ordered by the 27-nation bloc.

The EU Commission later detailed in a statement that it had offered Member States to purchase another 200 million doses of vaccine, with the option to purchase another 100 million doses.

“This would allow the EU to purchase up to 600 million doses of this vaccine, which is already used across the EU. The additional doses will be administered starting with the second quarter of 2021 “, said the EU. Von der Leyen said 75 million of the additional doses will be available in 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, said Von der Leyen, more than 80 percent of its population.

The EU has concluded six vaccination contracts for up to 2 billion doses, with Moderna, AstraZeneca-Oxford, Sanofi-GSK, Janssen Pharmaceutica NV, Pfizer-BioNTech and CureVac. But only Pfizer-BioNTech and Moderna vaccines have been approved for block use so far.

At an online public meeting to discuss the work of the Vaccine Drug Review Agency, EMA Executive Director Emer Cooke said the third vaccine evaluation process by AstraZeneca could be completed by end of January.

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

Also on Friday, the United Kingdom authorized the vaccine developed by Moderna, the third that is authorized for use in the country.

The UK Department of Health said the vaccine complied with “strict safety, efficacy and quality standards of the UK regulators”.

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

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

The EU has defended its strategy, insisting that vaccination programs have just begun and that large deliveries are expected in April.

“We faced a situation where we had a huge demand, but the production capacity had not kept up with it until now. Now we have a positive step forward, “said von der Leyen.

After Germany obtained additional doses from BioNTech, a German company outside the EU agreements, von der Leyen clarified that individual negotiations would violate the agreement accepted by all members of the bloc.

“We all agreed, legally binding, that there will be no parallel negotiations, no parallel contracts,” she said. “So the framework in which we all work is a framework of 27. Together we negotiate, together we procure and together we present this vaccination process.”

But Kautz said the agreement with BioNTech “is compatible with EU agreements. The additional allocations we have secured do not disrupt the other contracts. “

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

Kautz made it clear that 30 million bilaterally secured doses will be delivered on orders from 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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