EU Increases Mfg Capacity, Supply of COVID-19 VaccinesBy
The European Medicines Agency has approved facilities and/or facility expansions in the European Union for COVID-19 vaccines from Pfizer/BioNTech, Moderna, and AstraZeneca.
A new facility at BioNTech’s site in Marburg, Germany was approved for the production of Comirnaty, the COVID-19 vaccine developed by Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company. The EMA approved the manufacturing of the COVID-19 vaccine drug product at the Marburg facility, and as part of that process, the EMA also approved the production of the drug substance, the mRNA, at the Marburg site
The facility will produce both the active substance and the finished product, which will provide the companies with annual production capacity of up to one billion doses for their COVID-19 vaccine, once the facility is fully operational. Due to optimized operational efficiencies, which were initiated last year (2020), BioNTech has been able to increase the expected annual manufacturing capacity by 250 million doses.
Currently, 400 BioNTech employees work in Marburg, 200 of them in 24/7 shifts in order to maximize the production’s output. Based on the approval by the EMA, the first drug-product batches of the vaccine can now be delivered to partner sites for sterile fill-finish before distribution to the EU and countries globally. The first batches of vaccines manufactured at the Marburg site are expected to be delivered in the second half of April (April 2021). BioNTech plans to be able to produce up to 250 million doses of the vaccine in the first half of 2021.
In addition to the new manufacturing facility, the EMA’s CHMP has also given a positive opinion to allow transportation and storage of vials of this vaccine at temperatures between -25 ˚C to -15 ˚C (i.e., the temperature of standard pharmaceutical freezers) for a one-off period of two weeks. This is an alternative to the long-term storage of the vials at a temperature between -90 ˚C to -60˚C in special freezers. It is expected to facilitate the rapid roll-out and distribution of the vaccine in the EU by reducing the need for ultra-low temperature cold-storage conditions.
The EMA also approved the addition of a new manufacturing site for the production of active substance and finished-product intermediates for Moderna’s COVID-19 vaccine. The addition of the new manufacturing lines at a Lonza facility, located in Visp, Switzerland, together with other changes to the manufacturing processes that were greenlighted by the CHMP, are intended to scale up production capacity and increase supply of the vaccine for the EU market.
AstraZeneca received approved for a new manufacturing site for its COVID-19 vaccine in Leiden, the Netherlands. This brings the total number of manufacturing sites licensed for the production of the active substance of AstraZeneca’s COVID-19 vaccine to four.
Source: European Medicines Agency, Pfizer, BioNTech (EU), and BioNTech (Marburg facility)