Once The Vaccine Leaves The Freezer The Clock Starts Ticking
Once the vaccine is removed from the deep freezer there is no turning back we dont want to waste any of these precious vaccine doses.
As you would expect, the vaccine needs to be thawed before it can be injected. Once this happens, it cannot be re-frozen it must be used.
The thawing process has rules. Frozen vials are transferred from the freezer to a fridge set at 2-8 to thaw. A pack of 195 vials, containing about 975 doses, may take three hours. But it can sit in the fridge for up to five days, if needed. To speed things up, it is possible to thaw the frozen vials for 30 minutes at temperatures up to 30. But then, the vaccine needs to be used within two hours.
Either way, people must be lined up ready to be vaccinated to avoid wastage.
Once thawed, the vaccine needs to be mixed gently. So the vaccinator needs to turn each vial up and down ten times. They cannot shake the vial as the vaccine is fragile.
Were Being Left Behind: Rural Hospitals Cant Afford Ultra
The late-stage contract with Controlant suggests that this issue wasnt fully thought through when the U.S. government signed the contract with Pfizer, said Ameet Sarpatwari, assistant professor of medicine at Harvard Medical School.
Somewhere the ball got dropped, he said. Instead of turning off , turning back on, it could have just been a continuous process. From a safety standpoint, that seems to be a better way to go.
He said the original contract with Pfizer could have left room for discussions over who would have oversight of maintaining the ultra-cold temperatures. A bit more of a systematic process that included transparency could have secured input from others that would have shown some details were insufficient with this contract, said Sarpatwari. Rather than being forced upon us, it could have been a decision of how we want to allocate that burden.
Pfizer did not respond to requests to explain why it decided to disconnect the remote temperature monitoring devices. The company is working very closely with Operation Warp Speed on ensuring a temperature monitoring solution for points of uses if our thermal shipper is the chosen method for frozen storage, spokesperson Amy Rose wrote in an email.
Update Provides Alternative Temperature For Transportation And Temporary Storage For Frozen Vials Before Dilution
Today, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC . The change is being reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine .
Pfizer submitted data to the FDA to support this alternative temperature for transportation and storage. This alternative temperature for transportation and storage of the undiluted vials is significant and allows the vials to be transported and stored under more flexible conditions. 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, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research.
Pfizer Inc. submitted data to the FDA to demonstrate that their COVID-19 vaccine remains stable after storage of the undiluted vials for up to two weeks at standard freezer temperature. The alternative temperature for storage of frozen vials is not applicable to the storage of thawed vials before dilution , or on the storage of thawed vials after dilution .
You May Like: Cheapest Shingles Shot
Fda In Brief: Fda Authorizes Longer Time For Refrigerator Storage Of Thawed Pfizer
- For Immediate Release:
- May 19, 2021
The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research
Making COVID-19 vaccines widely available is key to getting people vaccinated and bringing the pandemic to an end. Pfizer Inc. submitted data to the FDA to support storage of undiluted, thawed vials of its COVID-19 vaccine for up to one month at refrigerator temperatures. This change should make this vaccine more widely available to the American public by facilitating the ability of vaccine providers, such as community doctors offices, to receive, store and administer the vaccine.
Plus How To Make Sure Yours Has Been Properly Stored To Remain Effective
Joni Sweet is a freelance writer and editor who specializes in travel, health, and wellness. Her work has been published by Health, SELF, Healthline, National Geographic, Forbes, Lonely Planet, Thrillist, and dozens of other publications. When shes not traveling the world, she can be found practicing yoga, riding her bike, and looking for the best vegetarian food in the Hudson Valley.
- Pin
More than two million doses of the two new vaccines against COVID-19 have been put in people’s arms since December 14. But racing the shots to the frontline health care workers hasn’t been an easy featthe Pfizer-BioNTech vaccine specifically must be stored at subzero temperatures, creating a logistical puzzle of dry ice and specialized freezers. And while the Moderna vaccine remains stable at slightly balmier temperatures, it too must stay frozen throughout shipping and long-term storage.
So what’s the deal with these cold storage requirements? Here’s why it’s critical that the new COVID-19 vaccines are kept super chilly and how to make sure the one you get has been stored properly.
Recommended Reading: Tdap Vaccine Cvs
The Vaccine Cold Chain Explained
Getting a vaccine through clinical trials and approved by the FDA is a tedious, expensive, and time-consuming process. But its not the finish line for a Covid-19 immunization campaign. Its just one of the first hurdles.
Theres almost an assumption that once a vaccine is created and approved, then everyone is healthy and fine, but the operational component is pretty complex, said Caesar Djavaherian, an ER physician and chief clinical innovation officer at Carbon Health. Weve never tried to administer vaccines to 100 million Americans in a short period of time.
To prepare for that, Covid-19 vaccine production is already underway. The idea is that once a vaccine does get the green light, doses are ready to roll out right away. Operation Warp Speed, the $10 billion US government vaccine development effort, is aiming to have enough vaccines to immunize 20 million Americans in December, another 30 million in January, and another 50 million in February.
But at that point, vaccines have to go from factories to shipping facilities to trucks to hospitals, clinics, and pharmacies, and, eventually, into the arms of people all while without budging from narrow, specific temperature ranges.
This series of handoffs under strict temperature controls is known as the cold chain. Its this chain between the manufacturer and the clinic that represents one of the biggest challenges of the vaccine distribution effort, and each step could potentially become a weak link.
What Does The Requirement For Ultra
Dr. Cooke: Because the Pfizer COVID-19 mRNA vaccine requires an ultra-low freezing process, widescale distribution to the general public would be hard to achieve even if sufficient doses were available immediately.
That’s because the type of freezer needed to achieve these sub-zero temperatures aren’t found in drug stores or doctor offices, nor in most hospitals or clinics. Fortunately at Houston Methodist, we have many of these freezers, and this is why we’ll be one of the major sites in Houston distributing the vaccine.
In addition, there’s nuance in the specific storage-temperature guidelines for each of the two COVID-19 mRNA vaccines with Moderna’s vaccine having more flexibility than Pfizer’s.
Pfizer’s vaccine can only be kept in a refrigerator for about 5 days before the mRNA begins to degrade, while the Moderna vaccine remains stable for about 30 days in a refrigerator.
In addition, both vaccines will be delivered to hospitals in multi-dose vials, further complicating the temperature-related distribution logistics. Vials will need to be strategically thawed and the doses administered in a timely manner in order to reduce the chance that a vial remains in a refrigerator for too long.
You May Like: Does Cvs Pharmacy Give Tdap Vaccine
How Will Novant Health Ensure The Vaccines Are Stable While Theyre Being Prepared
Maki: Each COVID-19 vaccine has its own parameters for moving it from a storage temperature, allowing it to warm up and reconstituting it. Once the vial is open, or punctured, we have six hours to use it. So, if there are five doses per vial, once we take one dose out, we must administer the next four doses within six hours.
How Will Storage Temperature Requirements Impact Initial Vaccine Distribution
The types of freezers that can keep the current COVID-19 vaccines stable, especially Pfizers, are expensive and generally only found in hospitals and labs. A clinic, a nursing home, or even health departments may not have freezers that can hold things at -94°F, Dr. Talaat says.
Transportation and storage are two of the biggest hurdles for the worldwide immunization rollout. A Reuters report from last month called the vaccines complex requirements an obstacle for even the most sophisticated hospitals in the United States. Rural and underfunded healthcare providers without the resources to improve their cold storage face even greater obstacles.
Since Modernas vaccine holds up well in normal freezers, Pfizers subzero option will be the most difficult to ship. The company is currently shipping its vaccine in so-called pizza trays, which hold 195 vials that remain stable for a few weeks, thanks to a steady supply of dry ice.
Right now, the Pfizer vaccine is being stored at the companys production facilities and at freezer farms, huge storage sites equipped with specialty freezers about the size of refrigerators.
Vials of Moderna vaccine are still difficult to ship, but have caused fewer headaches so far. You go from specialty freezers that only labs and hospitals have to freezers that any clinic will have, Dr. Talaat explains. Both vaccines are already being distributed to government officials, healthcare workers, and nursing home residents.
You May Like: Cvs Tdap Booster
Why Supply Chains Are Even More Complicated For The Covid
All that said, health systems in the United States and around the world have been administering vaccines for decades, and there is plenty of experience and know-how for effectively bringing vaccines to people.
But again, the Covid-19 vaccination effort has to happen at an even larger scale than just about any other vaccination effort to date. And it cant seize infrastructure from existing vaccines, since immunizations for illnesses like measles, influenza, polio, and meningitis are still needed at the same time.
That means many of the things needed to distribute a Covid-19 vaccine have to be added to whats already on the market freezers, refrigeratedshipping containers, and remote temperature monitoring systems cant simply be cannibalized from other vaccine supply chains.
The scale of a Covid-19 vaccination campaign could also create other bottlenecks. Vaccine vials require a specific type of glass that can tolerate low temperatures and remain sterile, and there may not be enough of this glass to go around right away. Even the self-sealing rubber stoppers on the vials could face a shortfall. Syringes, personal protective equipment, and trained personnel to administer vaccines are already facing a crunch from dealing with the ongoing pandemic.
The problem is that these fragments of DNA and RNA are delicate. They can degrade quickly on their own, even at refrigerated temperatures. Thats why freezing them is so important for keeping them intact.
Related
The Last Leg Of The Chain In Clinics Doctors Offices And Pharmacies May Be The Hardest To Keep Cold
The trickiest part of the cold chain will likely be the end. Pfizer’s special cold boxes are designed to ship vaccines in increments of at least 1,000 doses at a time, which may make getting small batches of shots out to rural areas hard.
The vaccine can survive in the fridge for up to five days, but after that it has to be thrown out, because re-freezing doesn’t work.
That means in order to keep the vaccines chilled properly for the 15 days the briefcase can last, many places will likely resort to re-packing their shots on dry ice, which is already in short supply during the pandemic. The dry ice stock for the vaccines can be replenished safely three times during that two week period, but only if strict guidelines are followed.
Pfizer told Business Insider that the cold briefcases should not be opened more than twice a day in order to keep the proper chill, and any time they are, they should be closed within 1 minute.
Given that in order to be fully effective, the Pfizer vaccine requires two doses administered three weeks apart, the timing is going to be tight, especially in rural areas.
The company is signaling its chilling issue may only be temporary, though.
Pfizer’s chief scientific officer told Business Insider earlier this week that the company is looking into a “powder format” vaccine for next year that could likely be kept alongside many other shots in the fridge.
Also Check: Can I Get A Tdap Shot At Cvs
Fact Check: Mrna Vaccines Kept At Very Cold Temperatures So That They Do Not Break Apart Covid
10 Min Read
With hundreds of thousands of views social media, posts referring to Pfizer and BioNTechs COVID-19 vaccine candidate claim that any vaccine that needs to be shipped and stored at -80 degrees isnt a vaccine but rather a transfection agent, kept alive so it can infect your cells and transfer genetic material. Alleging that the vaccine will be used for genetic manipulation of humans on a massive scale, this claim is false.
The claim originated in a Nov. 15 tweet from a user known as The Disruptive Physician with the handle @DocEvenhouse . Facebook and Instagram sharing screenshots of the tweet can be found here , here and here .
Sign Up For The Latest From Science News
Headlines and summaries of the latest Science News articles, delivered to your inbox
Thank you for signing up!
There was a problem signing you up.
The uracil problem can be dealt with by adding a modified version of the nucleotide, which Toll-like receptors overlook, sparing the RNA from an initial immune system attack so that the vaccine has a better chance of making the protein that will build immune defenses against the virus. Exactly which modified version of uracil the companies may have introduced into the vaccine could also affect RNA stability, and thus the temperature at which each vaccine needs to be stored.
Finally, by itself, an RNA molecule is beneath a cells notice because its just too small, Mishra says. So the companies coat the mRNA with an emulsion of lipids, creating little bubbles known as lipid nanoparticles. Those nanoparticles need to big enough that cells will grab them, bring them inside and break open the particle to release the RNA.
Some types of lipids stand up to heat better than others. Its like regular oil versus fat. You know how lard is solid at room temperature while oil is liquid, Mishra says. For nanoparticles, what theyre made of makes a giant difference in how stable they will be in general to the things inside. The lipids the companies used could make a big difference in the vaccines ability to stand heat.
Questions or comments on this article? E-mail us at
Don’t Miss: Tdap Cvs
Why Do Covid Vaccines Need To Be Kept So Cold
It has to do with a very important ingredient: messenger RNA . The mRNA in the vaccines is genetic material that teaches our immune cells how to make the spike protein found on the virus that causes COVID-19, according to the Centers for Disease Control and Prevention . The immune system responds by creating antibodies against that specific spike protein, ultimately learning how to protect the body against the virus in the future.
“mRNA rapidly degrades. There are also enzymes in the environment and all around us that break down mRNA,” Lisa Morici, PhD, associate professor in the microbiology and immunology department at Tulane University School of Medicine, where she studies novel vaccine platforms, tells Health.
Vaccine-makers also coat the mRNA in lipid nanoparticles. These tiny bubbles of fat help carry the mRNA to our cells and offer a degree of protection against enzymes that could destroy the fragile genetic material.
“It’s like an M& M,” Timothy Lise, PharmD, executive director of pharmacy services for New Jersey’s Atlantic Health System, where he has served an integral role in distributing the COVID-19 vaccine, tells Health. “If you have chocolate in your hand, it’s going to melt, but with the candy coating on the outside, it doesn’t.”
The lipid nanoparticle coating isn’t quite enough to protect the mRNA, though. That’s where the cold storage comes into play. The enzymes that break down mRNA “don’t work at really, really cold temperatures,” explains Morici.
Then Each Vial Is Split Into Individual Doses
One of the challenges with the Pfizer vaccine is that it comes in multi-dose vials, containing enough vaccine for five or six doses.
Nearly all current vaccines in our national immunisation program are single-use. Many come already prepackaged in the needle and syringe. So for many vaccinators, drawing up and giving a vaccine from a multi-dose vial will be new. This too has rules.
The vaccinator first needs to clean the top of the vial with an antiseptic swab. This is important to ensure the vials remain free from contamination.
Then the vaccinator injects a set amount of sterile saline into the vial, through the top, to dilute the vaccine. Care must be taken not to introduce contaminants during this part of the process.
The vial then needs to be turned up and down ten times to make sure the saline mixes with the vaccine. Again, the clock is ticking. Once the vaccinator injects the saline into the vial and mixes it, the vaccine must be used within six hours. After that, any unused vaccine must be discarded.
The vaccinator must then take a new needle and syringe, clean the top of the vial again and draw up 0.3 millilitres of vaccine from the vial. This is a new volume for our vaccinators to get used to as most vaccines given as part of our current immunisation program are 0.5 millilitres.
Once the 0.3 millilitres is in the syringe, it is ready to be injected into the upper arm.
Don’t Miss: Cvs Pharmacy Tdap