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Work to distribute the COVID-19 experimental vaccine developed by Pfizer Inc and BioNTech SE is being prepared after the companies announced successful interim data on Monday, but it will not reach local pharmacies to the general public anytime soon.
The data, which sent US equities to record highs, showed that the two companies’ experimental vaccine is 90 percent effective in preventing COVID-19. They are still waiting for data on security, which could arrive later this month.
Pfizer and BioNTech need regulators to approve the vaccine before it can begin shipping vaccines to those the government deems most in need. Healthcare workers and people who live in nursing homes will likely top that list.
But the vaccine’s complex, super-cold storage requirements are a stumbling block for even the most sophisticated hospitals in the United States and can affect when and where it is available in rural areas or poor countries where resources are scarce.
The main problem is that the vaccine, which is based on a novel technology that uses synthetic mRNA to activate the immune system against the virus, must be kept at minus 70 degrees Celsius (-94 F) or less.
“The cold chain will be one of the most challenging aspects of administering this vaccine,” said Amesh Adalja, principal investigator at the Johns Hopkins Center for Health Security.
“This will be challenging in all settings because hospitals, even in large cities, do not have storage facilities for a vaccine at that ultra-low temperature.”
In fact, one of the most prestigious American hospitals, the Mayo Clinic in Rochester, Minnesota, said it currently does not have that capacity.
“We’re talking about a vaccine that needs storage at minus 70 or 80. That’s a tremendous logistical problem not just in the United States but outside of the Western world,” said Dr. Gregory Poland, virologist and vaccine researcher at the Mayo Clinic .
“We are a major medical center and we do not have storage capacity like this. That will be true for everyone. This is a logistical hurdle.”
Pfizer spokeswoman Kim Bencker said the company was working closely with the US government and state officials on how to ship the vaccine from its distribution centers in the United States, Germany, and Belgium throughout the world.
The detailed plan includes the use of dry ice to transport frozen vaccine vials both by air and by land at recommended temperatures for up to 10 days, he said.
State and local health care providers are responsible for storing and administering vaccines once they are delivered.
They can be kept in an ultra-low temperature freezer for up to six months, or for five days at 2-8 degrees C, a type of refrigeration commonly available in hospitals, Bencker said.
Pfizer storage units can also be filled with ice for up to 15 days, he said.
But the injections will go bad in about five days at normal refrigeration temperatures slightly above freezing. BioNTech CEO Ugur Sahin told Reuters the companies are looking at whether they can extend that for two weeks.
The Moderna Inc vaccine, which is working on a vaccine based on similar technology, does not need to be stored at such a low temperature.
Other vaccines, including those from Johnson & Johnson and Novavax Inc, can be stored at 2-8 degrees C, the temperature of a normal refrigerator.
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