The European Medicines Agency (EMA) made a recommendation on Monday (local time) that the COVID-19 vaccine developed by Pfizer and BioNTech can be stored at between two and eight degrees Celsius – the same temperature range as a regular refrigerator – for 31 days. With a huge increase from the previous recommendation of five days after removing them from ultra-low temperature freezer, their distribution will become much easier.
The EMA said in the Monday statement that the change in the storage period of the unopened vial after removing it from ultra-low refrigerator was made based on the assessment of additional stability study data submitted by Pfizer. Upon this decision, health authorities in EU countries can ship the vaccine in regular refrigerator cars to remote destinations that take over five days of driving.
Pfizer was initially approved for emergency use with strict conditions, such as “up to six months at ultra-low temperatures,” to expedite its COVID-19 vaccine development. However, with the submission of additional research results, its storage conditions have become more relaxed. In February, the U.S. Food and Drug Administration (FDA) allowed the Pfizer vaccine to be stored at between minus 15 to minus 25 degrees Celsius – the same temperature range as a regular freezer – for up to two weeks. The vaccine that can be stored in a regular refrigerator for a longer period of time will be also launched soon. “We developed a vaccine that can be stably stored at two to eight degrees Celsius for up to six months. We are preparing data to obtain approval from regulatory authorities,” Ugur Sahin, the CEO of BioNTech that jointly developed the vaccine with Pfizer, said at the press conference in early May.
South Korea’s current policy regarding the Pfizer vaccine is storing at two to eight degrees Celsius for five days. According to the Ministry of Food and Drug Safety, a drug approval change is needed for South Korea to change the storage conditions similarly to that of Europe. As of Tuesday, Pfizer has not filed an application for approval change to the South Korean disease control authorities. “Once approval change is granted, the Pfizer vaccine is likely to be administered at vaccination centers, as well as commissioned medical institutions,” said Kim Kim-nam, the head of the COVID-19 vaccination management team.
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