EU regulators approve increasing doses of virus vaccine bottles

BRUSSELS (AP) – The European Union’s drug agency on Friday approved doctors who withdrew another dose from each vial of Pfizer-BioNTech’s coronavirus vaccine, in a move that – combined with the purchase of 300 million extra serum injections – could speed up the rate of vaccination in the 27-country bloc.

The European Medicines Agency said its human medicines committee recommended updating the product information for the vaccine to clarify that each bottle contains six doses instead of the five that were advised when it originally gave the green light to the Pfizer-BioNTech vaccine on 21 December. December.

German Ministry of Health 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Many doctors across the EU have already withdrawn six doses of the vaccine from each vial, a practice that is already permitted in the United States, Britain and elsewhere.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 in vials so that the minimum dosage can be guaranteed even if there is a spill.

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 deal to buy more doses would double the amount requested by the 27-nation bloc.

The EU commission later detailed in a statement that offered member states to purchase 200 million additional doses of the vaccine, with the option to purchase another 100 million doses.

“This would allow the EU to buy up to 600 million doses of this vaccine, which is already being used across the EU. Additional doses will be delivered from the second quarter of 2021, ”said the EU. Von der Leyen said 75 million of the extra doses will be available during the second quarter, with the remainder being delivered over 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% of its population.

The EU has closed 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 block.

At an online public meeting to discuss the work of the drug agency reviewing vaccines, EMA Executive Director Emer Cooke said that the process of evaluating a third vaccine 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. “As soon as we receive the application, we will make a public announcement about it.”

Also on Friday, Britain authorized the vaccine developed by Moderna, the third to be licensed for use in the country.

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

Britain has ordered 10 million doses of the vaccine, although it is not due 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, especially in Germany, about the decision to allow the commission to handle vaccine purchases for all EU member countries. Vaccination programs in the EU got off to a slow start and some EU members were quick to blame the European Commission for a perceived failure to deliver the right number of doses.

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

“We were facing a situation of great demand, but the production capacity has not yet kept pace. Now, we have a positive step forward, ”said von der Leyen.

After Germany obtained extra doses of BioNTech, a German company, outside 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 contracts,” she said. “So the structure we’re all working on is a structure of 27. Together, we are negotiating, together we are acquiring and, together, we are presenting this vaccination process.”

But Kautz said the agreement with BioNTech “is compatible with EU agreements. The extra allocations we guarantee do not interrupt other contracts. “

“This is a precondition for the memoranda of understanding that we have concluded,” Kautz told reporters in Berlin. “Delivery will also not be affected by this. No other EU member state will obtain vaccines later on from BioNTech, for example, just because Germany has secured additional doses of vaccine or a commitment to additional doses of vaccine. “

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

___

Corder reported from The Hague, Holland. 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

.Source