Green light from EMA: More vaccine production in Europe

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With the decision, bottlenecks in the supply of the AstraZeneca vaccine could be eased in the short term, as the pre-produced vaccine doses could be delivered quickly. Both companies have already produced, but were not allowed to deliver without EMA approval. It is not known how large the supplies are.

The first vaccines produced there are to be transported from the Marburg plant for bottling to Belgium within the next few days. As the Mainz company announced on Friday, the vaccines finally have to be labeled and packaged.

After these last work steps, which take place in the Pfizer plant in Puurs, final quality tests are then scheduled again, including by the Paul Ehrlich Institute (PEI) and the company’s own control. The delivery of the first vaccines manufactured in Marburg to the vaccination centers is planned for the second half of April.

Brussels hopes to catch up on backlogs

EU Health Commissioner Stella Kyriakides welcomed the approval of the two plants and hopes that at least part of the backlogs from AstraZeneca can be made up. “We now expect the vaccines that are manufactured in this plant to be shipped to the EU member states in the next few days, as part of AstraZeneca’s contractual commitment and commitments to the citizens of Europe,” said the Commissioner in Brussels. Some EU states are particularly hard hit by the “disappointing delivery cuts” by the British-Swedish manufacturer.

Unclear who will get the vaccine

The company had repeatedly cut its pledges and promised 30 million cans by March 30, but only 17 million were shipped. It is unclear, however, whether the vaccination doses produced by Halix will also be delivered to the EU or whether they are intended for the UK.

If the Commission has its way, the entire production will initially be delivered to the EU countries. Because AstraZeneca vaccine produced in the EU should not be allowed to be brought out of Europe for the time being. According to EU Internal Market Commissioner Thierry Breton, this regulation should apply until the pharmaceutical company fulfills its delivery agreements. All other suppliers did their job well, he emphasized. The EU has a problem with AstraZeneca. The company has drastically reduced its deliveries due to production delays.

Halix has been producing the vaccine for weeks, but only recently applied to the EMA for approval for the EU. So far, only one plant in Belgium has been officially approved for the production of AstraZeneca in the EU. The vaccine is also made in the US and the UK.

Biontech vaccine: Less strong cooling

Another decision by the EMA on Friday represents a not insignificant relief for vaccinating the European population: As a result, the Biontech vaccine may in future be temporarily stored at less low temperatures. This also enables vaccination by general practitioners, as special freezers are no longer required for this. As the EMA announced on Friday, the vaccine can be stored for up to two weeks at temperatures between minus 25 and minus 15 degrees and thus in standard pharmaceutical freezers in pharmacies, for example.

Until now, long-term storage in special freezers at between minus 90 and minus 60 degrees was required for the vaccine, which prevented it from being used by general practitioners and in poor countries.

Biontech: an important step

Biontech boss Ugur Sahin said the approval was an important step on the way to the goal of making the vaccine available to people around the world. It comes “at exactly the right time, as governments now have more flexibility to move from vaccination in vaccination centers to a more decentralized distribution of vaccines by local doctors and general practitioners in order to accelerate our way out of the pandemic”.





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Green light EMA vaccine production Europe

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