European Medicines Agency or EMA announced that Comirnaty, the COVID-19 vaccine developed by Pfizer and BioNTech, can have more flexible storage conditions, including up to one month in a normal fridge.
The proposed change in the approved storage conditions, recommended by EMA’s human medicines committee or CHMP, will help in easy handling of the vaccine in vaccination centres across the European Union.
In a statement, the agency said the change extends the approved storage period of the unopened thawed vial at 2-8°C, i.e. in a normal fridge after taking out of deep-freeze conditions from five days to one month or 31 days.
The latest decision was based on assessment of additional stability study data submitted to EMA by the marketing authorisation holder.
The agency anticipates that increased flexibility in the storage and handling of the vaccine would have a significant impact on planning and logistics of vaccine roll-out in EU Member States.
The proposed changes will be implemented in updated product labeling.
EMA said it is in contact with COVID-19 vaccine developers as they seek to make manufacturing improvements to enhance vaccine distribution in the EU.
In the EU, Comirnaty is produced in BioNTech’s and Pfizer’s manufacturing sites in Europe. In early May, the EU secured a deal with Pfizer/BioNTech for 900 million doses of Comirnaty (BNT162b2) with an option for an additional 900 million up until 2023.
In late April, Pfizer and BioNTech had submitted a request to the EMA to expand conditional marketing authorization or CMA of their Covid vaccine Comirnaty (BNT162b2) to adolescents in the European Union. Comirnaty has already been granted CMA by the European Commission to prevent COVID-19 in people from 16 years of age.
Among others, Moderna COVID-19 Vaccine is approved for storage up to 1 month at refrigerated temperatures and up to 7 months in a standard freezer.
Johnson & Johnson’s vaccine is estimated to remain stable for two years at minus 15 degree celsius to minus 25 degree celsius and a maximum of three months at routine refrigeration at temperatures of 2 degree celsius to 8 degree celsius.
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