Pfizer vaccine ready to use, Ema ok: it can be kept in the fridge

Green light from Ema experts to a new formulation of Pfizer / BioNTech’s anti-Covid vaccine, ready to use and storable at temperatures of a normal refrigerator for up to 2 and a half months. The new version of Comirnaty * will be available from the beginning of 2022, with a gradual launch. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency – announced the same Ema – has approved “a formulation of Comirnaty that does not require dilution before administration”, which “will be available in packs of 10 vials (60 doses) and can be stored at 2-8 ° C for up to 10 weeks. The current concentrated formulation – reminds the EU regulatory body – requires dilution before administration, is available in packs of 195 vials (1,170 doses) and can be stored at 2-8 ° C for a maximum of one month “. “These differences will provide better storage, transport and logistics options for vaccine distribution and administration,” hopes the agency. Pfizer vaccine, Ema evaluation for children aged 5-11 underway The European Medicines Agency Ema announces it has started to evaluate the green light request for Pfizer / BioNTech’s anti-Covid vaccine in children aged 5-11. In recent days, the two companies had announced that they had presented the data for this age group to the EU regulatory body, to obtain the extension of the use of the vaccine. “The EMA – reads a note – has begun evaluating an application to extend the use of the Comirnaty * vaccine to children between the ages of 5 and 11” and a verdict could come in “a couple of months”. What is the process? The CHMP Committee for Medicinal Products for Human Use, explains the regulatory body, “will review data on the vaccine, including the results of an ongoing clinical trial involving children aged 5 to 11 years, in order to decide whether to recommend to extend its use. The CHMP opinion will then be forwarded to the European Commission, which will issue a final decision “. Comirnaty is currently licensed for use aged 12 and over. As for the possible extension of use in 5-11 year olds, “the EMA will communicate the outcome of its evaluation, expected in a couple of months, unless additional information is needed”, reports the European agency, recalling that this vaccine was authorized for the first time in the EU in December 2020 Italy will produce Pfizer vaccine in Monza and Anagni Italy will produce Pfizer / BioNTech’s anti-Covid vaccine in Monza and Anagni, the EMA still communicates, explaining that the Committee for medicinal products for human use (CHMP) has “approved two additional production sites for Comirnaty *”, the two Italian factories. The first is the one managed by Patheon Italia Spa in Monza. The other is the pole managed by Catalent in Anagni, in the Frosinone area. “Both sites will produce the finished product”, informs the EMA. “Up to 85 million additional doses will arrive from Italian sites to supply the EU in 2021”. These recommendations, explains the EMA, “do not require a decision by the European Commission and the sites can become operational immediately”.