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by Tiziana Di Giovannandrea

18 October 2021 The European Medicines Agency (Ema) has approved a formula of Comirnaty, Pfizer-BioNTech's vaccine against Covid, ready for use. The formula does not require dilution prior to administration, will be available in packs of 10 vials (60 doses) and can be stored refrigerated 2-8 C for up to 10 weeks. The current concentrated formulation requires dilution prior to administration, is available in packs of 195 vials (1,170 doses) and can be stored at 2-8 C for up to one month.



The EMA, in a note, explained: "These differences will provide better storage, transport and logistics options for the distribution and administration of the vaccine. The new formulation will be available in a phased launch starting in early 2022".



With regard to the request, which Pfizer has submitted to the EMA, for authorization for vaccination for the age group between 5 and 11, the European Medicines Agency has started the evaluation of the administration of the Covid vaccine. 19 Comirnaty, by Pfizer / BioNTech in children aged 5 to 11 years. The vaccine is currently authorized for use in people 12 years of age and older, explains the European Agency. Currently, no vaccines have been authorized in Europe for the 5/11 age group.



The

EMA's

Committee for Medicinal Products for Human Use

(

CHMP

) will review data on the vaccine, including the results of an ongoing clinical study involving children aged 5 to 11 years, in order to decide whether to recommend extending the vaccine. use. The CHMP opinion will then be forwarded to the European Commission, which will issue a final decision. The EMA will communicate the outcome of its assessment, which is expected in a couple of months, unless additional information is required. 



The Pfizer and BioNTech companies, presenting their study together with the request for authorization to the European Medicines Agency-Ema, have shown that with the vaccine they produce, the amount of vaccine administered to children is considerably lower than that given to adults, in fact the dosage is equal to one third of that inoculated to the older ones.



In addition, EMA's Committee for Human Medicines (CHMP) has approved two additional sites for the production of Comirnaty, the Covid-19 vaccine developed by BioNTech and Pfizer, in Italy. One site, located in Monza, is managed by Patheon Italia Spa while the other is located in Anagni and is managed by Catalent Anagni Srl. Both sites will produce the finished product. The two sites will produce up to 85 million additional doses to supply the European Union.

Keywords: ema, pfizer, comirnaty, vaccine, vaccines, origins, sites, formula, one, children, authorization, request, pfizer-biontech, other, examination