Pfizer and BioNTech just announced they got the approval of European health authorities for their COVID-19 vaccine to be stored at higher temperatures.
Medical news site Mass Device reported that based on data that showed stability in standard pharmaceutical freezers, the European Medicines Agency or EMA authorized storage of the Pfizer-BioNTech COVID-19 vaccine at -25°C to -15°C for a total of two weeks.
The Food and Drug Administration's (FDA) requirements include storage for two weeks in total at the same temperatures, alongside preferred storage set in an ultra-low temperature freezer from -80ºC to -60ºC.
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Vials of the Pfizer-BioNTech COVID-19 vaccine sit in a storage container
For Rapid Rollout of COVID-19 Vaccines
The Straight Times, which specified in a similar report that the said COVID-19 vaccine can be stored at normal freezer temperatures for short periods rather than in ultra-cold storage, said that such a change would contribute to the rapid rollout of vaccines across Europe where campaigns for vaccinations are delaying because of supply and logistical issues.
The EMA had given a favorable opinion to authorize transportation and storage of vials of this Pfizer-BioNTech vaccine at the aforementioned temperature "for a one-off two-week period."
The Amsterdam-based watchdog also said in its statement that this is a substitute to long-term storage of the vials at a temperature ranging from -90°C to -60°C in special freezers.
The regulator explained that because of this latest development, it is expected to expedite the vaccine's rapid rollout and distribution in the EU by lessening the requirement for ultra-low temperature cold storage conditions all over the supply chain. In late February, the United States made a similar decision on the Pfizer-BioNTech COVID-19 vaccine.
The high efficacy Pfizer vaccine against COVID-19 has been tempered by the difficulty of storing and transporting the jab because of the requirement for ultra-cold conditions.
More Accessible Across Europe
Pharmaceutical Processing World reported that as a result of the regulator's approval, vials of the said COVID-19 vaccine could be stored in all 27 member states of the EU at the updated temperatures as a substitute to the ultra-low requirement. This provides flexibility to distribution and inoculation.
According to Ugur Sahin, BioNTech CEO and co-Founder, from the beginning, the company's goal was to make the vaccine broadly available to people globally.
The company executive also said that this approval by the regulators would enable people to access essential additional channels for the distribution and administration of the Pfizer-BioNTech COVID-19 vaccine.
Sahin explained that it comes at an important point in time as governments now are more flexible in moving from immunizations in vaccination centers to a more decentralized vaccine rollout through local doctors, as well as general practitioners, to fast-track the path out of this global health crisis.
Very low-temperature storage requirements are developed to protect the mRNA in the vaccines. Leaked documents that the BMJ review specified that early struggles with the stability of the mRNA in the Pfizer-BioNTech vaccine, although those issues have since been addressed.
Albert Bourla, chairman and CEO of Pfizer said that they appreciate the collaboration with the regulator, as well as the other regulatory agencies globally as they work to guarantee that their vaccine can be shipped and stored in "increasingly flexible conditions."
This new storage choice in Europe will make the vaccine more accessible to people throughout the continent -- another vital step as this global fight against the pandemic continues.
A related report about the Pfizer-BioNTech COVID-19 vaccine storage is shown on CNBC Television's YouTube video below:
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