NEW YORK (NewsNation Now) — Pfizer and German partner BioNTech presented new data to health regulators showing their vaccine could be stored for two weeks without the ultracold storage currently required, potentially allowing it to be kept in pharmacy freezers and making it easier to use.
The companies said Friday they’ve submitted findings from ongoing stability testing to the U.S. Food and Drug Administration (FDA), which has already greenlit the vaccine’s use. If the new storage temperatures are approved, it could send a strong signal to other regulators around the world that could potentially make the distribution of the shot in lower-income countries possible.
“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.
Pfizer and BioNTech want regulators to update temperature requirements on the current label, allowing vials to be stored at -13 to 5 degrees Fahrenheit (-25 to -15 degrees Celsius) maintaining potency for a total of two weeks.
The current label requires the vaccine to be stored at temperatures between -112 to -76 degrees Fahrenheit (-80 and -60 degrees Celsius) meaning it has to be shipped in specially designed containers. The thermal containers can serve as temporary storage for up to 30 days by repeatedly adding dry ice. The vaccine can remain stable in these ultra-cold temperatures for up to six months.
The shot’s cold-storage requirements set off logistical hurdles including a scramble for dry ice when there are no specialized freezers available, for instance in rural areas. Storing and then thawing and administering the two-dose vaccine is particularly challenging in developing countries.
The World Health Organization’s COVAX global vaccine-sharing program has so far limited the distribution of Pfizer BioNTech vaccines to just a few countries, partly out of concern over a lack of infrastructure in developing nations.
The WHO said it was hopeful 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 rollout of the vaccine easier in all countries, and particularly in low-income ones,” it said.
Pfizer and BioNTech’s vaccine, along with Moderna’s two-dose shot, has already won U.S. emergency-use authorization and is being widely distributed as part of the country’s mass vaccination efforts. A third vaccine, created by Johnson & Johnson, is expected to win FDA clearance for emergency use within two weeks.
Moderna, started out with similarly cold temperature requirements in early-stage studies before stability testing showed it could be stored at normal freezer temps. Its product, which like Pfizer’s is based on so-called messenger RNA molecules, is already cleared for storage at -13 to 5 degrees Fahrenheit.
“If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply,” Pfizer Chief Executive Albert Bourla said in a statement.
The update from the drugmakers comes as two studies from Israel found that the vaccine greatly reduced virus transmission, and the shot was backed by two of the South African government’s top advisers.
The new data also will be submitted to global regulatory agencies within the next few weeks, the two companies said. A BioNTech spokesperson declined to provide more details on the timing and which agencies would be contacted.
Deutsche Post, which has shipped COVID-19 vaccines to several European countries, Israel, Bahrain, Mexico and Singapore, among other states, said the updated temperatures would provide some relief but transportation would still not be easy. Air freight would likely no longer require dry ice on board, increasing storage capacity per plane, said a Deutsche spokesperson.
BioNTech has said it imposed long-term storage and transportation requirements at ultra-cold settings out of caution because it had started stability and durability tests on its vaccine relatively late.
The companies have been testing stability of vaccine batches manufactured at different times over the past nine months and continue to research ways to boost the vaccine’s “shelf life.”
Despite having launched vaccine development in January 2020, working simultaneously on four compounds, it did not decide until July which of the four to proceed with, and only then started stability tests.
Reuters and The Associated Press contributed to this article.
