The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EVA) has adopted a number of important recommendations to increase the production capacity and supply of COVID-19 vaccines to European Union (EU) countries.
New AstraZeneca COVID-19 vaccine production site
A new AstraZeneca COVID-19 vaccine active ingredient manufacturing site has been approved at the Halix plant in Leiden, the Netherlands. Following this approval, the total number of licensed manufacturing sites for the active substance reached four.
New BioNTech and Pfizer COVID-19 vaccine production site and more flexible storage conditions
A new COVID-19 vaccine, Comirnaty, developed by BioNTech and Pfizer, has been approved. Both the active substance and the final product will be produced in Marburg, Germany. The active substance currently supplied to the EU is manufactured in three locations included in the registration certificate.
In addition to the new vaccine site, the CHMP was in favor of transporting and storing the vaccine vials at -25 to -15 ° C (ie standard pharmaceutical freezer temperatures) for a single period of two weeks. It is an alternative to long-term storage of bottles in special freezers at temperatures from -90 to -60˚C. This is expected to facilitate the mass production and distribution of the vaccine in the EU by reducing the need for very low temperature storage conditions throughout the supply chain.
New Moderna COVID-19 vaccine production site and expansion
Last month, the CHMP recommended the approval of a new manufacturing site for the active substance and intermediates of the Moderna COVID-19 vaccine. In order to increase production capacity and supply the vaccine to the EU market, Lonza is opening new production lines in Vispe, Switzerland, and will make other changes to the production process, which have been given the green light by the Committee.
The changes described will be included in the public information on vaccines published on the EEA website.
The EEA is in regular contact with COVID-19 vaccine marketing authorization holders, who aim to increase their production and supply to the EU. The Agency shall provide guidance and advice on the evidence to be provided to substantiate and expedite the processing of applications for the inclusion of new high quality COVID-19 vaccine production sites.
As with all medicines in the EU, COVID-19 vaccines can only be produced in approved sites included in the marketing authorization after appropriate evaluation.
To do this, the manufacturer must hold a manufacturing license issued by the competent authority of the Member State in which the medicinal product is manufactured. This ensures that the production process complies with Good Manufacturing Practice (GMP) standards. National competent bodies carry out GMP inspections in coordination with the EEA. They check that manufacturers comply with EU standards, licensing requirements and, if available, registration certificates.
In addition, in order to obtain a marketing authorization, strong evidence must be provided that it is possible to produce high-quality vaccines in accordance with harmonized specifications on an ongoing basis at the manufacturing site concerned.
Upon receipt of the required data, the company submits a request to add a new production site to those already indicated in the registration certificate. This is done by requesting changes. The EEA is ready to assess such requests promptly.
Prepared according to EEA information