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Ukraine has changed the requirements for storing the Comirnaty/Pfizer-BioNTech vaccine at the request of the manufacturer

15 July 2021

In May 2021, after a series of new studies, the manufacturer of the Comirnaty vaccine, Pfizer, submitted a request for approval from national and international health regulators to extend the shelf life of its anti-covid vaccine, in particular, storage of undiluted medicine at temperatures from +2°C to +8°C for a month, instead of 5 days.

The European Medicines Agency, the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency and relevant authorities in other countries have reviewed this appeal and changed the requirements for storing the vaccine in their countries.

In Ukraine, the relevant amendments came into force in accordance with the order of the Ministry of health of Ukraine dated 09.06.2021 No. 1163 “On state registration (re - registration) of medicines (medical immunobiological preparations) and amendments to registration materials” -

Instructions for new batches of Comirnaty/Pfizer-BioNTech vaccine already contain updated storage temperature requirements - At the same time, according to the official letter from “Pfizer Export B.V.”, the extended shelf life also applies to previous batches of the vaccine that expire after April 30, 2021.

Therefore, according to the current instructions and recommendations of the manufacturer, the Comirnaty/Pfizer-BioNTech vaccine series available in Ukraine and the new series that will be delivered can be safely stored in vaccination points in conventional refrigerators, at temperatures from +2°C to + 8°C, for one month.