Increases production capacity and deliveries of AstraZeneca, BioNTech / Pfizer and Moderna Covid-19 vaccines / Article / LSM.lv

The European Medicines Agency (EMA) has approved a number of important recommendations that will increase the production capacity and supply of Covid-19 vaccines to the European Union (EU), the State Agency of Medicines (NSA) reported.

New AstraZeneca Covid-19 vaccine plant

EZA has approved a new plant for the production of the active substance in the Covid-19 vaccine developed by AstraZeneca. This Halix plant is located in Leiden, the Netherlands, and with the approval of the plant, the active substance in AstraZeneca is produced in four licensed plants.

New BioNTech / Pfizer plant and more flexible storage conditions

EZA has also approved a new plant for the production of Covid-19 vaccine “Comirnaty” developed by BioNTech / Pfizer. The plant, located in Marburg, Germany, will produce both the active substance and the final product. Currently, the marketing authorization for this vaccine includes three production sites of the active substance that supply the EU.

In addition, the EZA Committee for Medicinal Products for Human Use has also given a positive opinion allowing the vials of this vaccine to be transported and stored at -25 to -15 degrees (ie temperatures in standard pharmaceutical freezers) for a single two-week period. It is an alternative to long-term storage of vials at temperatures from -90 to -60 degrees in special freezers. This is expected to facilitate the rapid introduction and distribution of the vaccine in the EU, reducing the need for ultra-low temperature storage at all stages of the vaccine supply chain.

Expansion of production of the “modern” Covid-19 vaccine

Already last week, the ESA recommended approving the addition of a new plant for the production of the active substance, intermediate and final product of the Moderna Covid-19 vaccine. The addition of a new production line at the Lonza plant in Vispa, Switzerland, as well as other changes approved by the ESA in the production process, are intended to increase production capacity and increase the supply of vaccines to the EU market.

These changes will be included in the publicly available information on these vaccines on the ESA website.

EZA is continuing negotiations with Covid-19 vaccine marketing authorization holders to find ways to expand production capacity for the supply of vaccines in the EU. The Agency will provide guidance and advice on the evidence needed to substantiate and speed up the processing of applications for new high-quality Covid-19 vaccines.

Like all medicines in the EU, Covid-19 vaccines can only be manufactured in approved facilities that are included in the marketing authorization after evaluation in accordance with regulatory requirements.
Thus, the manufacturer must obtain a manufacturing license from the national responsible authority in the Member State in which the pharmaceutical plant is located in order to ensure that the manufacturing process complies with the standards of good manufacturing practice. The national authorities carry out inspections of good manufacturing practice in cooperation with the ESA to verify the compliance of manufacturers with EU standards, the conditions of their license and registration certificate, if any.

In addition, the marketing authorization must provide convincing evidence of the plant’s ability to consistently ensure the production of high-quality vaccines in accordance with the approved specifications.

As soon as the relevant data are available, the company applies for the addition of a new plant to the registration certificate. This is done through a change request. EZA is ready to evaluate such requests quickly.

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