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European Medicines Agency Certifies New Production Plants For Astrazeneca And Pfizer

The plant of the company Halix in Leiden (Netherlands), which supposedly would have produced a part of the 29 million vaccines against the covid of the company AstraZeneca discovered last weekend in Italy , already has a green light from the European Agency of the Medicine (EMA) to make the active substance of the antidote. \

This means that if indeed – as the multinational advanced last Wednesday – 16 of the 29 million doses were destined for Europe, they could soon begin to be distributed among the Twenty-seven.

As announced by the EMA, the approval of this facility will bring the number of plants licensed to produce the active substance of the AstraZeneca vaccine to four.

“It is good news because it means that everything that has been manufactured in Leiden, in the Netherlands, all the batches sent to Agnani, have been bottled and are ready to (be distributed) so the moment the EMA gives its authorization in The next days or weeks will be ready ”, said Commissioner Thierry Breton during a press conference held together with the Minister of Industry, Reyes Maroto , after his visit to the Catalan company Reig Jofre, which is part of the supply chain of the Johnson & Johnson vaccine .

Breton has once again recognized the existence of problems with AstraZeneca, due to the delay in the shipment of antidotes, and recalled that the European Commission will use all the tools at its disposal, particularly the export control mechanism, so that the manufactured vaccines for the company “stay in Europe until it fulfills its commitments”.

BioNTech plant approved
In addition to the authorization to AstraZeneca, the EMA has also given the green light to the use of a factory in Marburg (Germany), acquired by the German company BioNTech from the Swiss Novartis in September 2020, for the production of Comirnaty, its vaccine against covid19.

This facility will produce both the active substance, the mRNA, and the finished product and, according to the company’s forecasts, the intention is to produce one million doses per year when it is fully operational. BioNTech / Pfizer currently has three active substance manufacturing plants supplying the EU.

In addition, the Committee for Medicinal Products for Human Use (CHMP) has also issued a positive opinion to allow the transport and storage of BioNTech / Pfizer vaccine vials at temperatures between -25 and -15 ° C, that is, the temperature of standard pharmaceutical freezers for a single time period of two weeks.

It is an alternative to long-term storage of vials at -90 to -60˚C in special freezers. With this change, the EMA hopes to facilitate “the rapid deployment and distribution of the vaccine in the EU by reducing the need for cold storage conditions at ultra-low temperatures throughout the supply chain.”

Green light to Modern
In addition to these two plants, the CHMP recommended last week to authorize a third facility for both the active substance and the finished product of Moderna’s vaccine . It is the Lonza factory, located in the Swiss town of Visp.

The objective, together with the adaptation of the manufacturing process, is to increase the production and supply capacity of this vaccine on the EU market. The health commissioner, Stella Kyriakides , has welcomed the EMA’s decision because it will allow “increasing production capacity” in the EU.

As with all other medicines in the EU, covid19 vaccines can only be manufactured at approved sites included in the marketing authorization after regulatory evaluation. This means that a manufacturer must have a manufacturing license from the competent national authority of the Member State in which the manufacturing site is located to ensure that the production process complies with the standards of good manufacturing practice.

To obtain such authorization, you must present strong evidence that the site is capable of consistently producing high-quality vaccines according to agreed specifications. Once the appropriate data is available, the company requests to add the new manufacturing site to the marketing authorization.

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