The American company Pfizer and German company Biontech announced Friday that they have submitted new data to the US Food and Drug Administration (FDA) indicating that the Covid-19 vaccine is stable when stored between 25 degrees below zero and 15 degrees below zero degrees, and they said that the data may allow storage at normal temperatures with devices Cooling and freezing in pharmacies.
If the new data are approved, easing the requirements will significantly reduce the transportation and storage burdens, as the vaccine must now be stored at minus 70 degrees Celsius, which is especially challenging in low-income countries that do not have the infrastructure necessary for storage in extreme temperatures. Coldness.
The data was provided to the US Food and Drug Administration to support a proposed amendment to the emergency authorization recommendations to allow vaccine vials to be stored at these temperatures for up to two weeks in total as an alternative to storage in ultra-low temperature refrigerators.
Ojur Shaheen, CEO and co-founder of Biontek, said: “Our top priority has been to quickly develop a safe and effective vaccine and make it available to the world’s most vulnerable people in order to save lives. At the same time, we have been continuously collecting data that could allow storage at about -20 ° C. ”
He added, “The data provided may facilitate the circulation of our vaccine in pharmacies and allow vaccination centers more flexibility. We will continue to use our experience to develop potential new formulations that could make our vaccine easier to transport and use. ”
The two companies confirmed that the new data will also be submitted to global regulators within a few weeks.
Source: Al Arabiya | Al-Arabiya.net channel