Additive manufacturing unit for Janssen COVID-19 vaccine
The EMA Committee for Medicinal Products for Human Use (CHMP) has approved an additional manufacturing unit for Janssen COVID-19 vaccine developed by Janssen-Cilag International NV.
The facility, located in Marcy-l'Étoile, France, and operated by Sanofi Pasteur, will produce finished product.
This facility is expected to support the continued supply of Janssen's COVID-19 vaccine.
Scale up production for Spikevax by Moderna
The CHMP also issued a positive opinion to increase production of Spikevax, the vaccine against COVID-19 disease, by Moderna at the manufacturing facility operated by ROVI Contract Manufacturing, located in Madrid, Spain.
The production increase includes a 50% batch size scale-up of the finished product and a second fill-and-finish line for the finished product. These changes will enable the production on a monthly basis of approximately 25 million additional doses of Spikevax vaccine in the European Union and in third countries through the COVID-19 Vaccines Global Access (COVAX) initiative.
Increase in production for Comirnaty by BioNTech/Pfizer
The Commission also approved an increase in production of the active ingredient of Comirnaty, the COVID-19 vaccine, by BioNTech/Pfizer at the manufacturing facility operated by the Wyeth BioPharma division of Wyeth Pharmaceuticals, located in Andover, MA, USA.
This increase in capacity is expected to support the continued supply of Comirnaty in the European Union.
These recommendations do not require a decision by the European Commission and the changes can take effect immediately.
The EMA is in ongoing communication with all COVID-19 vaccine licensees as they seek to expand their capacity to supply vaccines. The Agency provides guidance and recommendations on the documentation required to support and expedite applications to add new facilities or increase the capacity of existing facilities to produce high quality COVID-19 vaccines.
(AF)
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