Pfizer Wants Higher Temperature Storage For COVID-19 Vaccine
Pfizer Inc and BioNTech SE are seeking the intervention of the US health regulatory agency, Food and Drug Administration (FDA) in a bid to relax requirements for their COVID-19 vaccine to be stored at ultra-low temperatures.
As contained in a report, on Friday, by Reuters, the quest of the two drugmakers is a bid to potentially allowing the vaccine to be kept in pharmacy freezers.
According to the report, an approval by the FDA could send a strong signal to other regulators around the world that may potentially ease distribution of the shot in lower-income countries.
Pfizer Inc and BioNTech SE have reportedly submitted new temperature data to the FDA to support an update to the current label that would allow vaccine vials to be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for a total of two weeks.
The current label requires the vaccine to be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), meaning it has to be shipped in specially designed containers.
Reuters reported that the shot’s cold-storage requirements set off a scramble among states in the US at the beginning of the rollout for dry ice, in which it can be stored temporarily when there are no specialised freezers available, for instance in rural areas.
Pfizer/BioNTech’s vaccine, along with Moderna Inc’s two-dose shot, has already won US emergency-use authorisation and is being widely distributed as part of the country’s mass vaccination efforts.
The update from the drugmakers comes as two studies from Israel found that the vaccine greatly reduced virus transmission, and the shot was reportedly backed by one of South African government’s top advisers.
According to the two companies, the new data also will be submitted to global regulatory agencies within the next few weeks.
“The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,” BioNTech Chief Executive Ugur Sahin said.
BioNTech has said it imposed long-term storage and transportation requirements of minus 70 degrees out of caution because it had started stability and durability tests on its vaccine relatively late.
Even though it launched its COVID-19 vaccine development programme as early as January 2020, working on four compounds in parallel, it did not decide until July which of the four to proceed with, and only then started stability tests.
If approved, the less onerous storage requirements would provide significant logistical relief for the roll-out of the vaccine worldwide, particularly in lower-income countries that do not have the necessary infrastructure to maintain ultra-cold conditions.
The COVAX global vaccine-sharing programme by the World Health Organisation (WHO) was said to have limited the distribution of Pfizer-BioNTech vaccines to just a few countries, partly out of concern over a lack of infrastructure in developing nations.
However, the global health regulatory agency expressed the hope that eased requirements could broaden its reach.
“We are aware of reports of this and look forward to seeing the data. If proven correct, this could make roll-out of the vaccine easier in all countries, and particularly in low-income ones,” it said.