Filenews 18 May 2021
The European Medicines Agency (EMA) has proposed extending the storage time of the Pfizer/BioNTech vaccine against Covid-19 to normal refrigerator temperatures from five days to 31 days, which should help manage the logistical challenges that have arisen under the formulation procurement plan in Europe.
In particular, the Committee on Human Medicines of the European Medicines Agency (CHMP) recommended a change in the approved storage conditions of the Comirnaty vaccine for the treatment of COVID-19 developed by BioNTech and Pfizer, which will facilitate the handling of the vaccine in vaccination centres across the European Union.
The EMA adds that this change extends the approved storage period of the unopened thawed vial to 2-8 °C (i.e., in a normal refrigerator after removal from freezing conditions) from five days to one month (31 days).
The change was approved following an evaluation of additional study data submitted to the EMA by the marketing authorisation holder.
Increased flexibility in the storage and handling of the vaccine is expected to have a significant impact on the design and supply of Member States.
Source: iefimerida.gr
