Work to disseminate the experimental COVID-19 vaccine developed by Pfizer Inc and BioNTech is in full swing after the companies announced successful interim data on Monday. However, it will no longer be available to the general public in local pharmacies shortly.
The data, which shot US stocks to record highs, showed that the two companies’ experimental vaccine is 90% effective against COVID-19. They are still waiting for security data that may come in later this month.
Pfizer and BioNTech need to get regulators to sign the shot before vaccines can be shipped to those deemed most urgent by the government. Healthcare workers and those living in nursing homes are likely to be high on this list.
However, the vaccine’s complex and extremely cold storage requirements are an obstacle to even the most demanding hospitals in the United States, and can affect when and where it is available in rural areas or poor countries with scarce resources.
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, has to be kept at minus 70 degrees Celsius or below.
“The cold chain will be one of the toughest parts of getting this vaccination out,” said Amesh Adalja, senior scientist at the Johns Hopkins Center for Health Security.
“This will be a challenge in all situations as hospitals, even in large cities, do not have storage facilities for a vaccine at this extremely low temperature.”
In fact, one of the most prestigious US hospitals, the Mayo Clinic in Rochester, Minnesota, said it does not currently have this capability.
“We’re talking about a vaccine that needs to be stored at minus 70 or 80. This is a huge logistical problem not only in the US but also outside of the western world,” said Dr. Gregory Poland, virologist and vaccine researcher at Mayo Clinic.
“We are a large medical center and we don’t have such storage capacity. That goes for everyone. This is a logistical obstacle.”
Pfizer spokeswoman Kim Bencker said the company is working closely with the US government and state officials to ship the vaccine from its distribution centers in the US, Germany and Belgium around the globe.
The detailed plan calls for the use of dry ice to transport frozen vaccine bottles by air and land at the recommended temperatures for up to 10 days, she said.
State and local health care providers are responsible for storing and administering vaccines after they are dispensed.
They can be kept for up to six months or five days at 2-8 degrees Celsius in an extremely low-temperature freezer – a type of refrigeration commonly available in hospitals, Bencker said.
The Pfizer storage units can also be filled with ice for up to 15 days, she said.
However, at normal refrigeration temperatures of slightly above freezing point, the shots will spoil in about five days.
Ugur Sahin, CEO of BioNTech, told Reuters that the companies are looking at whether they can extend this for two weeks.
Moderna Inc’s vaccine, which is working on a vaccine based on similar technology, doesn’t 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 ° C, the temperature of a regular refrigerator.
Northwell Health, a major New York hospital system, is expanding its ultra-cold storage capacity. While it is possible to use the vaccine before it spoils, Northwell’s chief pharmacy officer Onisis Stefas said the hospital had decided that freezer access would ensure a smooth rollout.
The cold store requirements could affect Pfizer’s ability to reach rural health systems and nursing homes or less affluent countries that may not have the funding for the refrigeration units, experts say.
“If Pfizer’s is the only vaccine approved in the next few months, we will worry about equity in its spread in rural areas,” said Claire Hannan, executive director of the Association of Immunization Managers, a lobby group for local public health officials who do deal with vaccines.
The supply of ultra-cold freezers is already limited, with hospitals struggling to stock up, Stefas said.
Some states have identified a shortage of ultra-cold freezers, according to public documents that states have filed with the U.S. Centers for Disease Control.
New Hampshire has bought additional ultra-cold freezers and, like other states, is lobbying the Trump administration for additional funding, the documents show.
California has also said that supplies of ultra-cold freezers are limited, and about half of state health officials are considering buying or leasing additional supplies of cold storage rooms.
It has been proposed to build a distribution network for ultracold freezers, including mobile vaccination clinics, to reach underserved areas across the state. California said it will not provide vaccine supplies to facilities without adequate cold storage facilities.
Without the extra equipment, doctors face a dilemma: store vaccines in standard refrigerators and put all 975 doses in each Pfizer vaccine container in less than five days, or fill them up with dry ice and only open them twice a day to maximize the life of the Vaccines extend range, Hannan said.
“I think it will be difficult, but based on the task and how important it is, people will do their best for their ability to achieve this,” said Stefas.
(Except for the headline, this story was not edited by GossipMantri staff and posted from a syndicated feed.)