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, transportation and logistics options for vaccine distribution and administration,” hopes the agency.
If licensed, Pfizer-BioNTech’s Covid vaccine for 5-11 year olds will be based on the newly approved ‘ready-to-use’ formulation. This was explained by the two companies, the American Pfizer and the German BioNTech, in a note in which they express satisfaction with the positive opinion received by the EU regulatory body for the new formulation, which does not require dilution of the concentrate and will be available in a pack of 10 vials (60 doses in total). The two companies therefore also envisage a possible use for children of the new formulation, which “will be adapted to allow a lower dose level, equal to 10 micrograms after dilution”. While for the population in which the vaccine has already been approved, therefore from 12 years of age, the new formulation “will be available in a phased implementation starting from the beginning of 2022”.
This new ‘version’ of the vaccine “helps ensure simplified handling,” Pfizer and BioNTech explain. “All other aspects, including antigen and vaccine lipids, remain unchanged. The thawed vial contains 6 doses, which can be administered directly. In addition, the new formulation allows for longer storage, for 10 weeks, at refrigerator temperature. 2 to 8 ° C “, while the current one could be for 31 days. After the first injection, the ampoules with the new formulation can be stored and transported at a temperature between 2 and 30 ° C and used within 12 hours (against the current 6).
Pfizer vaccine, Ema evaluation in children 5-11 years old is underway
The European Medicines Agency EMA has announced that it has begun evaluating 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 study 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 first authorized 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 continues, explaining that the Committee for Medicinal Products for Human Use (CHMP) has “approved two additional production sites for Comirnaty *”, the two Italian factories in fact. 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. From the Italian sites “up to 85 million additional doses will arrive 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”.