In a press release published by the European Medicines Agency on May 17, the committee recommends changes to the storage of the Pfizer / BioNtech vaccine. The aim is to facilitate its deployment within the European Union.
A month-long conversation in a classic refrigerator
The Pfizer / BioNtech messenger RNA vaccine is safe and effective. However, its conservation method created, at the beginning, some logistical and budgetary challenges. Indeed, the serum must be stored in polar temperatures reaching -70 ° C. As a result, some hospitals had to equip themselves with ” super freezer », An expensive piece of equipment that can accommodate a few thousand doses of the Covid-19 vaccine. Once out of the “ super freezer », The doses can now be stored in a conventional refrigerator for longer. This is important, since the relaxation of the Pfizer vaccine storage method will allow doses to be delivered more easily to the European continent.
Indeed, ” this change extends the approved storage period of the unopened thawed vial at 2-8 ° C “. In other words, according to the regulator, the shelf life of Pfizer vaccine increases from 5 days to 31 days after the vial is taken out of freezing conditions. During this period, it can be stored in a normal refrigerator.
How is such a change in conservation explained?
This decision follows a request made to the European Medicines Agency (EMA) by the marketing authorization holder for the Pfizer / BioNtech vaccine. The EMA has carried out an evaluation of the data concerning the serum stability study. Now that the change is approved, the product labeling will be updated, to give the user the new vaccine storage information. As the Agency points out, “ The EMA is in constant dialogue with licensees (…) as they seek to improve manufacturing in order to improve vaccine distribution “.
coronavirus
