The Pfizer vaccine could get the European green light by the end of the year, already in mid-December, also for the age group between 5 and 11 years, in Italy almost 4 million children. On Monday 18 October, the European Medicines Agency launched the so-called “rolling review” on the application submitted by Pfizer-Biontech by examining the data submitted by the two companies, including the results of an ongoing clinical study.
Pfizer production sites in Monza and Anagni approved
This vaccine will be produced very soon also in Italy after yesterday the American giant always received the green light from Ema for two production sites, one in Monza and the other in Anagni: 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, which in the past took part in the filling phase of the AstraZeneca vaccine.
“Both sites will produce the finished product”, informs the EMA, filling – the so-called “fill and finish phase -” up to 85 million additional doses 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”.
With the green light of the EMA, Italy – according to Farmindustria – becomes more and more a protagonist in the production of vaccines: “Many do not know – recalls the president Massimo Scaccabarozzi -, but there are our excellences who deal with the quality control of vaccines , others that are part of the production of both mRna and adenovirus vaccines. Today’s is good news that is added, and demonstrates that we can be protagonists and that we have the strength as a pharmaceutical industry ».
Lower dose is expected for the age group 5-11 years
Going back to the vaccine for children between 5 and 11 years, if authorized the serum will be based on the new ‘ready-to-use’ formulation just approved by the European Medicines Agency, with its Committee for Medicinal Products for Human Use (Chmp ). This was explained by the two companies, the American Pfizer and the German BioNTech, in a note in which they express satisfaction for 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).