FDA issues new guidance for Pfizer/BioNTech COVID-19 vaccine storage

The U.S. Food and Drug Administration has revisited data on the stability of the Pfizer/BioNTech COVID-19 doses at normal pharmaceutical freezer temperatures (-25°C to -15°C).

This data showcased that undiluted frozen vials of the mRNA-based vaccine can be stored at temperatures of -25°C to -15°C for a total period of up to two weeks, which a considerably warmer storage temperature than the previous guidance stating that the vaccine must be stored in ultra-low temperatures between -80ºC and -60ºC for up to six months.

Vials can be transported and stored at temperatures of -25°C to -15°C for 2 weeks

Issuing its new guidance on the 25th of February, the FDA said that the Pfizer/BioNTech COVID-19 vaccine is safe to ship and store at temperatures of -25°C to -15°C (-13°F to 5°F) for the duration of two weeks. Vials stored at -25°C to -15°C for up to two weeks may be returned one time to the recommended storage condition of -80ºC to -60ºC. However, the total cumulative time the vials are stored at -25°C to -15°C should be tracked and should not exceed 2 weeks.

According to the new guidance, the COVID-19 vaccine can also be transported at -25°C to -15°C, but any hours used for transport at this temperature range must count against the maximum 2-week limit.

Greater access to the Pfizer/BioNTech COVID-19 Vaccine

Whilst the two-week timeline presents a relatively short window of normal freezer temperature storage, much shorter than the previously indicated six months of ultra-low temperature storage requirement, the possibility to keep the vaccines at standard temperatures even for a short period can open up more opportunities for hospitals, GP surgeries, vaccination centers and pharmacies to obtain and administer the vaccine.

Tanya Alcorn, VP of Pfizer’s BioPharma Global Supply Chain stated:

“It gives people more storage options, and more accessibility in locations that today may not be ordering the Pfizer vaccine”.

The added flexibility of storage is especially significant since the Pfizer/BioNTech COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.3 mL each) 3 weeks apart.

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