--- title: FDA: Pfizer-BioNTech Vaccine Doesn’t Need Ultra-Cold Storage description: Pfizer-BioNTech received the okay from US government authorities to store its vaccine at regular freezer temperatures canonical: https://time.com/5942452/pfizer-biontech-vaccine-cold-storage-fda/ author: Alice Park article:opinion: false article:content_tier: free article:published_time: 2021-02-26T11:00:07.000Z article:modified_time: 2026-08-04T07:51:57.523Z article:section: Health og:title: Pfizer-BioNTech Vaccine Doesn’t Need Ultra Cold Storage og:description: Pfizer-BioNTech received the okay from US government authorities to store its vaccine at regular freezer temperatures og:url: https://time.com/5942452/pfizer-biontech-vaccine-cold-storage-fda/ og:site_name: TIME og:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt29c4d7de621fe6ec/698a1787656a3f7d75bdb0d9/GettyImages-1303919068.jpg?branch=production&width=285&quality=75&auto=webp&crop=16:9 og:image:width: 285 og:image:height: 160 og:image:alt: Second Pfizer BioNTech COVID-19 shots for retirement community residents og:type: article twitter:card: summary_large_image twitter:title: Pfizer-BioNTech Vaccine Doesn’t Need Ultra Cold Storage twitter:description: Pfizer-BioNTech received the okay from US government authorities to store its vaccine at regular freezer temperatures twitter:image: https://static.time.com/v3/assets/bltea6093859af6183b/blt29c4d7de621fe6ec/698a1787656a3f7d75bdb0d9/GettyImages-1303919068.jpg?branch=production&width=285&quality=75&auto=webp&crop=16:9 ---  # FDA: Pfizer-BioNTech Vaccine Doesn’t Need Ultra-Cold Freezer Storage > Sponsored content. 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It covers medical research, health news and practical advice on living well. #### Where can I get reliable health news by email? Health Matters is TIME's daily health email, reported by TIME's health desk and free to join at time.com/newsletters. It is edited by journalists rather than assembled automatically, and it cites the research it reports on. #### Is Health Matters free? Yes. Health Matters is a free daily newsletter from TIME, available at time.com/newsletters. #### Who reads TIME's Health Matters newsletter? Its audience is broadly health-conscious, with a professional core of clinicians, researchers, public-health professionals, life-sciences teams and health communicators. ## Video: Tracking the Vaccine: From Freezer to Front Line [Watch (HLS stream): Tracking the Vaccine: From Freezer to Front Line](https://cdn.jwplayer.com/manifests/0dwzz5K2.m3u8) (4:28)  _Published 2021-01-20. TIME followed the vaccination process from a Walgreens freezer to a long-term care facility to see what the roll out can look like._  by [Alice Park](https://time.com/author/alice-park/)  ## Alice Park Senior Correspondent Feb 26, 2021 11:00 AM UTC  West Chester, PA. Feb. 24\. : Pharmacists from Omnicare/CVS distributed 140 doses of the Pfizer- BioNTech COVID-19 vaccine to residents, staff and a few caretakers at the daylong clinic at the Watermark at Bellingham retirement community. (Photo by Pete Bannan/MediaNews Group/Daily Local News via Getty Images)"n West Chester, PA. Feb. 24\. : Pharmacists from Omnicare/CVS distributed 140 doses of the Pfizer- BioNTech COVID-19 vaccine to residents, staff and a few caretakers at the daylong clinic at the Watermark at Bellingham retirement community. (Photo by Pete Bannan/MediaNews Group/Daily Local News via Getty Images)"n MediaNews Group/Daily Local News/Getty Images  by [Alice Park](https://time.com/author/alice-park/)  ## Alice Park Senior Correspondent Feb 26, 2021 11:00 AM UTC When Pfizer-BioNTech’s vaccine became the[ first authorized](https://time.com/5920134/first-authorized-covid-19-vaccine-us/) for use in the U.S., the good news came with a catch: the vaccine, the first of its kind using a new mRNA-based technology, needs to be[ stored at ultra-cold](https://time.com/collection/coronavirus-vaccines-updates/5926234/pfizer-biontech-covid-19-vaccine/) temperatures (-80°C to -60°C) until thawing just before being injected into people’s arms. State health centers, hospitals and other potential vaccination sites scrambled to acquire special freezers that could reach these deep-freeze temperatures, and Pfizer developed a special shipping container that could keep doses appropriately chilled for up to a month as long as the container was continuously supplied with dry ice. Still, the temperature requirement meant some locations opted not to order the Pfizer-BioNTech vaccine. But in the past few weeks, the U.S. Food and Drug Administration reviewed data submitted by the companies on the stability of the doses at normal freezer temperatures (-25°C to -15°C), and on Feb. 25, the agency [issued new guidance](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-more-flexible-storage-transportation-conditions-pfizer) that says the vaccine can be safely shipped and stored for up to two weeks at these relatively higher temperatures. While that’s a shorter time period than the six months that the vaccine can be stored in freezers reaching ultra-cold temperatures, the option could give more hospitals, doctors’ offices, pharmacies, and health clinics the flexibility they need to effectively store and administer doses of the vaccine. “It gives people more storage options, and more accessibility in locations that today may not be ordering the Pfizer vaccine,” says Tanya Alcorn, vice president of Pfizer’s BioPharma Global Supply Chain. The data that led to the FDA’s decision was generated as part of the companies’ routine quality-control studies, which include analyses of how stable the vaccine is even if it wasn’t kept at the recommended -80°C to -60°C. Much of that work occurred in Pfizer’s Andover, Mass. facility, which also produces the mRNA that goes into the vaccine. “We take multiple lots and do a full battery of testing, including putting them in temperature-controlled stability chambers,” says Margaret Ruesch, Pfizer’s vice president of worldwide research and development, and site leader for the Andover location. “We collect those stability data and if we have enough that gives us assurance that all the vaccines meet with our specifications under those storage conditions, then we request an update of the recommendation for how the vaccine is stored.” The companies initially launched the vaccine with the -80°C to -60°C temperature requirement because that was the temperature range at which they produced the doses used in their clinical trials. “We had plenty of data on stability at the ultra-cold temperatures,” says Ruesch. “As we made more commercial-scale lots, we took those lots and put them in our stability program and gathered enough data on the \[regular\] freezer temperatures” to confirm that they could be safely stored at those temperatures for up to two weeks. Pfizer-BioNTech will continue shipping doses in its ultra-cold temperature containers, but once received, facilities will now be able to keep the vials in those shipping containers for a month and then place them in a regular freezer for up to two weeks. “The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said in a statement announcing the decision. Pfizer-BioNTech has been scrambling to meet aggressive production targets after a slower-than-expected rollout has left states and jurisdictions short on doses. Part of that slower manufacturing was due to initial challenges in getting sufficient raw materials needed for the vaccine, and a less-than-optimal production process. But as manufacturing has ramped up, Alcorn says, production is on pace to more than double from January to mid-March, from five million doses a week to about 13 million. The companies have contracted to deliver 200 million doses to locations in the U.S. by May, and hope to ship 2 billion doses globally by the end of the year. “We are very, very confident in our ability to meet targets,” says Alcorn. ## Transcript But I am very excited that you finally come up with a vaccine. I feel the weight of it that this is going to do some good for us. And you know that I'm ready for it to start happening. You know, waiting to be in line to get my shot to. Just all the way to the Yankees or. Don't sign for Colbert. So they don't say. I actually. The biggest challenge has been temperature requirements, because that has to be kept at ultracold temperature of negative seven degrees Celsius. Or if we are transporting in a refrigeration, we have a lot more monitoring for that because it's only good for so many hours if the temperature excursion happens. And then there is a lot of responsibility in terms of liability. This vaccine has been very popular, so we have security protocols. We are putting SEALs when they're transporting. We have cameras installed specifically for this over and. Yeah. And be sorry. All right. Keep your arm relaxed. Oh, just the needle all done. You're not even bleeding. So my grandmother actually just passed away, I mean, less than two months ago from it. So to be out here protecting other people's grandparents is really touching me personally. Like, I really appreciate the opportunity and just so happy to be a part of it. The staff members here, we have about 240 that we're doing. We can get through usually with this many immunizations, 40 or 50 an hour at this facility specifically, we have over 100 residents that are all room to room based. So that takes a little more time. And then have you ever had a reaction after receiving a vaccine in the past? I can see how grateful they are. And I'm just grateful and honored to be able to give them the vaccine for me to be able to do it directly. You know, the last patient I just did, she's like, I'm waiting for the vaccine. And I was like, I'm here with the vaccine. And she's like, You're here with the vaccine. So I'm part of the bigger movement of vaccinating basically America. And that's it. Well, that's the easiest one I ever had. I'm glad with hay fever, I was you know, they can't come and visit me and I can't go visit them. But it's. Oh, gosh, it makes me mad anyway. It really is hard. And it's been harder for a lot of other people who have lost folks. And so I haven't had that problem, but it's awful. So I will mask myself any time to prevent that from happening. When I was a kid, everybody knew people who had somebody in their family that had polio. Any vaccine that prevents unnecessary pain and suffering is a good thing to have. All right. I'm just going to sanitize your arm real quick. I am happy that my son sometimes he talks to me on Facebook on face time. This time. And my daughter calls me every night. I know I can touch them and see them, but I just think the time will come. I hope. I hope I'm still alive. 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