The European Medicines Agency (EMA) has approved two additional manufacturing sites for the production of Pfizer-BioNTech’s Covid vaccine, as well as a new formula, as it considers rolling out the shots for those aged five to 11.
In a statement issued on Monday, the EU’s drug regulator revealed that its human medicines committee (CHMP) has given its seal of approval for two additional manufacturing sites for the production of Comirnaty, the Covid-19 jab developed by the US-German partnership of Pfizer and BioNTech.
The new plants will be located in Italy. One plant is in Monza, the other in Anagni. The statement states that the new sites can produce as many as 85 million more doses of EU-supplied drugs by 2021.
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“These recommendations do not require a European Commission decision and the sites can become operational immediately,”The notice was read.
The CHMP, according to the agency, was also mentioned. “approved a ready-to-use formulation of Comirnaty”With changes “provide improved storage, transport and logistic options for vaccine distribution and administration.”It will begin a gradual rollout in January next year.
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Separately, Monday’s notice from the EMA stated that the EMA has begun to evaluate a request for Comirnaty extension to minors aged between 5 and 11.
According to the watchdog, it would review the data regarding the jab and conduct a clinical study on that age group. The European Commission will review the data and make a decision.
Pfizer BioNTech, which shared data last month proving that the vaccine it developed is safe for this age group based on clinical trials and promised to seek approval from regulators for its implementation.
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