The Ministry of Health announced an increase in the production capacity for vaccines against COVID-19 disease by the companies Janssen, Moderna and BioNTech / Pfizer.
Additional production unit for the vaccine against COVID-19 Janssen disease
The EMA Human Medicines Committee (CHMP) has approved an additional Janssen COVID-19 vaccine production unit developed by Janssen-Cilag International NV.
The plant located in Marcy-l’Étoile, France, operated by Sanofi Pasteur, will produce the final product.
This unit is expected to support the continued supply of Janssen COVID-19 vaccine.
Production escalation for Spikevax by Moderna
The CHMP also issued a favorable opinion on increasing production of the Spikevax vaccine, COVID-19 vaccine by Moderna, at the ROVI Contract Manufacturing plant in Madrid, Spain.
The increase in production includes a 50% escalation of the batch size of the final product and a second fill-and-finish line of the final product. These changes will enable the production of approximately 25 million additional doses of the Spikevax vaccine on a monthly basis in the European Union and in third countries through the COVID-19 Vaccines Global Access (COVAX) initiative.
Production escalation for Comirnaty by BioNTech / Pfizer
The Commission also approved an increase in production of the active ingredient in Comirnaty vaccine, COVID-19 vaccine by BioNTech / Pfizer, at Wyeth BioPharma’s Wyeth Pharmaceuticals plant in Andover, MA, USA .
This increase in capacity is expected to support Comirnaty’s continued supply to the European Union.
These recommendations do not require a decision of the European Commission and the changes can take effect immediately.
According to the same announcement, the EMA is in constant communication with all holders of the marketing authorization of vaccines against COVID-19, as they seek to expand their productive capacity for the supply of vaccines. The Agency provides guidance and recommendations on the documentation required to support and expedite applications for new units or to increase the capacity of existing units to produce high quality COVID-19 vaccines.