Pfizer: wants vaccine stored at higher temperatures
(CercleFinance.com) - Pfizer and BioNTech on Friday submitted new data to the US Food and Drug Administration demonstrating the stability of their Covid-19 vaccine when stored at higher temperatures.
The proposed update to the FDA would enable vaccine vials to be stored at temperatures of between -25°C and -15°C for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer.
Under the current labels for the Pfizer-BioNTech vaccine, the product must be stored in an ultra-cold freezer at temperatures between -80°C and -60°C for up to six months.
On Thursday, Pfizer and BioNTech announced that the first participants have been dosed in a global Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the vaccine in pregnant women.
The trial will include approximately 4,000 healthy pregnant women aged at least 18 years old, vaccinated during 24 to 34 weeks of gestation.
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