Why Pfizer’s Ultra Cold COVID-19 Vaccine Won’t Be At Your Local Pharmacy Anytime Soon



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NEW YORK (Reuters) – Work to distribute the COVID-19 experimental vaccine developed by Pfizer Inc. and BioNTech SE It is being geared up after companies announced successful interim data on Monday, but it won’t reach local pharmacies for the general public any time soon.

The data, which sent US stocks to all-time highs [.N], showed that the two companies’ experimental vaccine is 90% 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.

See the graphic on the global COVID-19 tracker: https://graphics.reuters.com/world-coronavirus-tracker-and-maps/

ON ICE

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 It can be stored at 2-8 degrees C, the temperature of a normal refrigerator.

EXPANSION

Northwell Health, a major New York hospital system, is expanding its ultra-cold storage capacity. Although the vaccine can be deployed before it spoils, Northwell Pharmacy Director Onisis Stefas said the hospital decided that freezer access would ensure a smooth deployment.

Cold storage requirements could hamper Pfizer’s ability to reach rural healthcare systems and nursing homes, or less affluent countries, which may not have the funds for refrigeration units, experts said.

“If Pfizer’s is the only vaccine to be licensed in the next few months, we are concerned about fairness when it comes to spreading it to rural areas,” said Claire Hannan, executive director of the Association of Immunization Managers, a local lobby group. public health officials who handle vaccines.

Supplies for ultra-cold freezers are already limited as hospitals rush to stock up, Stefas said.

Some states have said they have a shortage of ultra-cold freezers, according to public documents the states filed with the U.S. Centers for Disease Control.

New Hampshire has purchased additional ultra-cold freezers and, like other states, is lobbying the Trump administration for additional funding, documents show.

California has also said that ultra-cold freezer supplies are limited and about half of state health departments are looking to buy or lease additional cold storage supplies.

He has proposed building an ultra-cold freezer distribution network, including mobile vaccination clinics, to reach underserved areas throughout the state. California said it will not provide vaccine supplies to facilities without adequate cold storage capabilities.

Without the additional equipment, clinicians will have a dilemma: store vaccines in standard refrigerators and put all 975 doses in each container of Pfizer vaccines in less than five days, or replenish with dry ice and open only twice a day to extend life. useful of vaccines. lapse, Hannan said.

“I think it will be difficult, but depending on the task and how important it is, people will do everything possible to make that happen,” said Stefas.

(Reporting by Carl O’Donnell in New York; additional reporting by Julie Steenhuysen in Chicago; edited by Caroline Humer, Josephine Mason and Matthew Lewis)



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