BioNTech SE received approval from the European Medicines Agency (EMA) for the manufacture of the COVID-19 vaccine drug product at its facility in Marburg, one of BioNTech’s largest mRNA vaccine manufacturing sites in Europe with an annual production capacity of up to one billion doses of its COVID-19 vaccine, once fully operational.
 
Due to optimized operational efficiencies which were initiated last year, BioNTech has been able to increase the expected annual manufacturing capacity by 250 million doses.
 
A single mRNA batch of the current scale is sufficient to produce around eight million vaccine doses. Currently, 400 BioNTech employees work in Marburg. Based on the approval, first drug product batches of the vaccine can now be delivered to partner sites for sterile fill and finish, before distribution to the EU and countries worldwide. The first batches of vaccines manufactured at the Marburg site are expected to be delivered in the second half of April.
 
In total, 50,000 steps are required from manufacturing the mRNA to the bulk drug substance which then can be handed over for fill and finish. Materials and components for production arrive from a global supply chain that has been dramatically expanded in the last 12 months.
 
BioNTech’s manufacturing facility in Marburg is a GMP-certified manufacturing facility. The production of vaccines under GMP standards are a prerequisite for the validation of the manufacturing processes by the EMA.
 
The vaccine, which is based on BioNTech’s mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the EU, and the holder of emergency use authorizations or equivalent in the US, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

Pfizer and BioNTech also announced that the EMA approved storage of COMIRNATY, the companies’ COVID-19 vaccine, at -25°C to -15°C for a total of two weeks based on data showing the stability at these temperatures in standard pharmaceutical freezers.