פאַרגרעסערן אין קאַפּאַציטעט פון וואַקסאַנען מאַנופאַקטורינג און צושטעלן COVID-19 וואַקסינז פֿון BioNTech / Pfizer און Moderna

EMA ס קאַמיטי פֿאַר מעדאַקיישאַנז (טשמפּ) has adopted two important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.

Scaled-up processes for BioNTech/Pfizer’s COVID-19 vaccine

EMA has approved an increase in batch size and associated process scale up at Pfizer’s vaccine manufacturing site in Puurs, Belgium. The recommendation by the Agency’s Committee for Human Medicines (טשמפּ) is expected to have a significant impact on the supply of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer, in the European Union.

Based on the review of the data submitted by BioNTech Manufacturing GmbH, the application to increase the batch size of the finished product manufactured at the Puurs site has been approved. EMA’s decision reaffirms that the Puurs facility is capable of consistently producing high-quality vaccines and enables Pfizer/BioNTech to scale up the production process at this site.

די דיסקרייבד ענדערונגען וועלן זיין אַרייַנגערעכנט אין די עפנטלעך פאַראַנען אינפֿאָרמאַציע אויף דעם וואַקצין אויף EMA ס וועבזייטל.

New filling manufacturing line for COVID-19 vaccine Moderna

די טשמפּ also recommended the approval of a new filling line at Moderna’s finished product manufacturing site for the EU in Rovi, Spain. The new line will enable an increase in finished product fill activities, to synchronize with the אַקטיוו מאַטעריע scale-up process at the active substance manufacturing site (Lonza, Visp) approved last month.

די דיסקרייבד ענדערונגען וועלן זיין אַרייַנגערעכנט אין די עפנטלעך פאַראַנען אינפֿאָרמאַציע אויף דעם וואַקצין אויף EMA ס וועבזייטל.

EMA is in continuous dialogue with all marketing authorization holders of COVID-19 vaccines as they seek to expand their production capacity for the supply of vaccines in the EU. The Agency provides guidance and advice on the evidence required to support and expedite applications to add new sites or increase the capacity of existing sites for the manufacture of high-quality COVID-19 vaccines.

אַדווערטייזמאַנט

פֿאַרבונדענע צופרידן

• קאָמירנאַטי: EPAR
• COVID-19 Vaccine Moderna: EPAR

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