Covid: EMA allows stocking Pfizer vaccine in standard refrigerators

Published by Cécile D., Laurent P. · Published on 20 May 2021 at 10h42
This Friday March 26, the European Medicines Agency announced Pfizer/BioNTech Covid vaccine can be stored at higher temperatures than recommended so far, for two weeks, making storage easier. An authorization following recommendations issued in mid-February by the American laboratory in terms of storage.

Good news likely to store Pfizer/BioNTech Covid vaccine more easily… This Friday March 26, the European Medicines Agency has announced Pfizer vaccine can now be store at higher temperatures than those recommended so far (-70°C or -94°F) for at least two weeks. Storage temperatures expected to make distribution easier.

The release reads they have “also given a positive opinion to allow transportation and storage of vials of this vaccine at temperatures between -25 to -15˚C (i.e. the temperature of standard pharmaceutical freezers) for a one-off period of two weeks”. Still according to the agency, “this is an alternative to the long-term storage of the vials at a temperature between -90 to -60˚C in special freezers”. A statement giving an official framework to both laboratories’ recommendations as they announced on February 19 what the European regulator has just approved.

These data were first submitted to the FDA – the Food and Drug Administration – showing the stability of the vaccine if stored between -25 and -15°C. Temperatures equating to standard medical freezers. So far, conditions instated in the European Union recommend storage between -80 and -60°C, putting shipping logistics and preservation in a difficult situation.

Data have been then analyzed by the American regulator, and by the European regulator this Friday. Note that so far, three other vaccines have been approved in Europe in addition to Pfizer: Moderna, AstraZeneca, and Johnson & Johnson. The first one is to be stored at -70°C, the second at higher temperatures, and the third one in an average refrigerator.

Easier storage

Following these studies, the health bodies have had to make a decision to make storing Pfizer vaccine easier, and therefore improve the vaccination campaign even more. This Monday May 17, the European Medicines Agency (EMA) has allowed storing the Pfizer-BioNTech vaccine in refrigerator at temperatures between 2°C (35.6°F) and 8°C (46.4°F) up to one month if the bottle has not been opened.

This authorization enables GPs to stock and inject the mRNA vaccine to their patients. "We have a unique network enabling us - with pharmacists and nurses - to vaccinated 500,000 people per day. It could double the current pace. Gear up!" Union Française pour une Médecine Libre [French Union Trade for Free Medicine] President Dr. Jérôme Marty tells Le Parisien.

Health Minister Olivier Véran does not seem convinced. On May 17, in the evening, he said on BFMTV: "So far, in the city, there will be Moderna (Editor's note: starting from next week). Then, if the vaccinal strategy is to last, with a third dose for instance, we may switch for it".

In rural areas, the possibility to store Pfizer vacicne in a standard refrigerator is to widely make caretakers' lives easier. "In our 12 vaccination centers, we should get deliveries twice a day, coming from the centralizing hospital enjoying super freezers. For sure it would be easier", Gers departmental council says, delighted.

This news is also a relief for many developing countries as they are facing many difficulties to organize their vaccination campaigns as they lack of material. Voxmapp founder - a French start-up working with the United Nations Development  Programme - Lorenzo Delesgues explains to Le Parisien: "in countries such as Tanzania, Ethiopia, Nepal, they struggle to dispatch in remote areas because of the weak road and electric infrastructures to bring the vaccine as close as possible to inhabitants. In Afghanistan, authorities have - so far - decided to only accept vaccines that can be stored at -4°C and above. I do not know if this announcement will make them change their minds, but it is heading well".

Practical information

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