Increased production capacity and supplies of AstraZeneca, Pfizer and Moderna vaccines

EZA has approved a new plant for the production of the active substance in 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.

EZA has also approved a new plant for the production of Covid-19 vaccine developed by BioNTech / Pfizer. This 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 Committee for Medicinal Products for Human Use (CHMP) has given a favorable opinion, allowing the vials to be transported and stored at -25 to -15 degrees Celsius for a single two-week period. It is an alternative to long-term storage of vials at -90 to -60 degrees Celsius in special freezers. The MAA explains that this could 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.

At the same time, the EZA last week recommended the approval of the addition of a new plant for the production of the active substance, intermediate and final product of the Moderna 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 expand production capacity and increase the supply of vaccines to the EU market.

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

As with any medicine in the EU, vaccines against Covid-19 should 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. ESA indicates its readiness to assess such requests expeditiously.