Virus World

(Reuters) - Pfizer Inc and BioNTech SE have submitted new temperature data to the U.S. health regulator which they said on Friday could allow their COVID-19 vaccine to be stored in pharmacy freezers rather than in ultra-cold storage facilities.  If approved, the less onerous storage requirements would provide a significant logistical relief for the roll-out of the vaccine, particularly in lower-income countries that do not have the necessary infrastructure. Pfizer/BioNTech's vaccine, along with Moderna Inc's two-dose shot, won the U.S. emergency use authorization (EUA) and is being widely distributed as part of the country's mass vaccination efforts. The new data has been submitted to the U.S. Food and Drug Administration to support a proposed update to the current EUA 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 as an alternative for storage in an ultra-low temperature freezer.

"The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility," BioNTech Chief Executive Officer Ugur Sahin said. Pfizer/BioNTech's current label requires the vaccine to be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), calling for it to be shipped in specially designed containers. The new data also will be submitted to global regulatory agencies within the next few weeks, the two companies said. A BioNTech spokeswoman declined to provide more details on the timing and which agencies would be contacted.

A week after Pfizer posted impressive early coronavirus vaccine efficacy numbers, Moderna took the spotlight early Monday with impressive findings of its own. But separate from its big announcement, the mRNA biotech said its vaccine can be kept at refrigerated temperatures for 30 days, reducing hurdles for a potential large-scale rollout. Moderna’s mRNA vaccine, mRNA-1273, can be stored at 36 degrees to 46 degrees Fahrenheit for up to 30 days, the company reported Monday, up from a prior estimate of just a week. It's also stable for 12 hours at room temperature. For longer-term storage and shipping, the vaccine needs to be kept at freezer temperatures of -4 degrees Fahrenheit, a temperature that distributors are familiar with, Moderna CEO Stéphane Bancel said on CNBC Monday. Bancel also stressed that Moderna’s vaccine won’t require dilution before it's administered to patients. That's a “big differentiator of our product," Bancel said on CNBC.

Pfizer’s vaccine, another frontrunner, requires colder storage at -94 degrees Fahrenheit and will only last for 24 hours at refrigerated temperatures. But the company has an aggressive plan to tap experienced shipping partners to transport doses in newly designed, GPS-enabled storage containers. Moderna’s stability profile will “likely make it easier to widely distribute compared to Pfizer’s BNT162b2,” Barclays analysts wrote to clients Monday. Pfizer is working on a powder version of its vaccine that's stable at room temperature, the analysts noted.  While Moderna and Pfizer are the only two players to post early efficacy numbers so far, a host of other players are advancing vaccines expected to be stable at refrigerated temperatures.  CureVac, a German biotech in mid-stage testing, said last week its vaccine is stable for at least three months at refrigerated temperatures, and up to 24 hours at room temperature. The stability profile “has the potential both to enable decentralized storage and to significantly facilitate large-scale vaccination efforts during the current pandemic," chief production officer Florian von der Mülbe said in a statement. Other vaccines using various technologies, such as programs from Sanofi, AstraZeneca, Novavax and Johnson & Johnson, are also eying refrigerated storage.  On the heels of its early data release Monday, Moderna said it’s on track to have about 20 million doses of its vaccine ready to ship in the U.S. by the end of the year. It’s expecting to be able to produce 500 million to 1 billion doses next year.  

Moderna's release  (November 16, 2020):

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-longer-shelf-life-its-covid-19-vaccine