The European Medicines Agency has recommended extending the shelf life of Pfizer / BioNTech’s Covid-19 vaccine at normal refrigeration temperatures to 31 days from the previous 5 days, thus alleviating the logistical challenges during the delivery of this vaccine in the region.
This change extends the approved shelf life of the unopened thawed vial at 2 to 8 degrees Celsius (ie in a normal refrigerator after removal from freezing conditions) from five days to one month (31 days), the European Medicines Agency said. (EMA), adding that the advice of its Human Medicines Committee came after evaluating additional data provided by Pfizer and BioNTech from a study of the two stability companies.
“The EMA maintains an ongoing dialogue with the holders of marketing authorizations for Covid-19 vaccines as they seek to make production improvements to improve the spread of vaccines in the EU,” said the European Medicines Agency.
In February, U.S. drug authorities approved the storage and transportation of the Pfizer and BioNTech vaccine at standard freezing temperatures of -15 to -25 degrees Celsius for up to two weeks, instead of the ultra-low temperatures between -80 to -60 degrees Celsius, which are usually required for storage of this coronavirus vaccine.
The change in the way it is stored in the EU comes at a time when US and German manufacturers are seeking approval for immunization with their co-vaccine against Covid-19 in adolescents aged 12 to 15 years.
The United States and Canada have already begun vaccinating this age group with the Pfizer and BioNTech vaccine, which uses the Comirnaty brand.
By delivering a total of 200 million doses of vaccine, the EU is on track to meet its goal of immunizing 70% of its adult population by the summer, European Commission President Ursula von der Leyen said earlier this month.
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