Pfizer vaccine demands deep freeze
Conn. grapples with need for super-chilled storage for COVID-19 treatment
It is the injection moment that gives some people pause, that cold swab of the skin prior to the prick of the needle.
If all goes right several weeks from now, the nation’s newest vaccine will be delivered from a colder source yet: “ultra-low” freezers that can maintain temperatures approaching 100 degrees Fahrenheit below zero — for the Connecticut clinics that have them.
On Monday, Pfizer and BioNTech released results of clinical trials of a proposed vaccine against the virus that causes COVID-19. Pfizer has already begun production with plans to ship 50 million doses by the end of 2020, if the Food & Drug Administration issues an emergency approval this month. Another 50 million would go out by March, with Pfizer eyeing as many as 1.3 billion doses by the end of next year. Inoculation requires a pair of shots spaced three weeks apart for each recipient.
One big detail has emerged from Pfizer’s updates the past few months, and again on Monday — a storage requirement that the vaccine be kept frozen at temperatures far below what standard medical freezers can reach, with the vaccine’s active ingredient beginning to lose potency at temperatures above 94 degrees below zero.
That is well beyond the lowest temperature for which the Centers for Disease Control & Prevention gives guidance on the storage of frozen vaccines, including the triple measles, mumps and rubella vaccine. According to the CDC, if the “cold chain” is not rigorously maintained, vaccine potency may be lost and render a batch useless.
The temperature challenge is counterbalanced by the 90-percent-plus efficacy rate Pfizer’s early clinical data suggests, an eye-popping margin above the FDA’s target of better than 50 percent. Other vaccines are at earlier stages in development that can be shelved merely chilled or even at room temperature, including one from Inovio Pharmaceuticals outside Philadelphia whose CEO
spoke Monday about the Pfizer accomplishment and the attendant distribution challenges.
“Efficacy is probably No. 1. Right behind that — probably in the same level — is the safety,” said Inovio CEO Joseph Kim, speaking on a conference call Monday. “Next is having enough supplies, and having the logistics of distribution in accordance, right? So if you’re trying to deliver a vaccine ... that requires deep ‘cold chain’ like minus 70 or minus 80 Celsius, you are not going to be able to do that in most of the regions and most of the countries outside the U.S. And even the U.S., it is going to be a significant heavy lift to distribute those vaccines.”
The $12,000 fridge
A Pfizer spokesperson did not respond to a query on specific steps the manufacturer is taking to ensure the vaccines are kept within the ultra-frozen temperature zone to keep them viable. Pfizer’s Groton lab, which focuses on drug safety and efficacy, is playing a major part in the development of a COVID-19 vaccine, with the New York City-based company’s lead vaccine facility located in Pearl River, N.Y.
“There’s a whole suite of very experienced and talented people at Pfizer who are ... working on this,” said John Burkhardt, Pfizer’s site director in Groton who is global head of drug safety research and development, speaking Monday on a conference call. “It’s going to be important to work with the authorities, with state governments and others, to provide that supply chain. ... We do share the concern that its something that needs to be done very precisely and very correctly.”
Several manufacturers sell ultra-low temperature freezers for storage of medication and tissue samples, including Thermo Fisher Scientific, Avantor, PHC, and So-Lo, with prices ranging anywhere from $12,000 to approaching $30,000. The units have roughly the same size and appearance as a kitchen refrigerator or chest freezer.
But packages will have to ensure doses stay within the recommended range of temperatures, with CDC recommending the use of “digital data loggers” with sensors next to vials packed in dry ice. In the event of temperature “excursions” outside allowable ranges, CDC instructs clinicians to label affected vaccine stocks “do not use” and separate them, but not to discard those stocks.
Pfizer did not state whether it will utilize freezer trucks for mass shipments of vaccines stored in dry ice. Greenwich-based XPO Logistics is among the larger contractors with 175 million cubic feet of refrigerated storage across 400 warehouses, according to a list by the industry trade publication Transport Topics.
“Initially, we think that we would be partnering with health-care systems or individual hospitals [and] local health departments to decide who has the capacity to store it,” said Dr. Reginald Eadie, CEO of Trinity Health of New England and co-chair of Lamont’s COVID-19 Task Force, speaking Monday. “We did not comfortably have the capacity to store thousands — but now we do and we will by the time the vaccine is available.”
Planning ‘on the fly’
In its draft plan last month to the CDC for the mass distribution of vaccines in Connecticut, the state Department of Public Health indicated it rely on the Connecticut Immunization Information System already in place — dubbed CT WiZ — to steer any vaccines with “ultra-cold” storage requirements directly to clinics, rather than through intermediary distribution depots.
Eadie held open the possibility that hospitals and clinics will be able to get federal funding to underwrite the purchase of equipment. Trinity Health’s hospitals include Saint Mary’s Hospital in Waterbury and Saint Francis Hospital in Hartford.
A spokesperson with Yale-New Haven Health affiliate Greenwich Hospital said the group has ultra-low temperature freezers but is investigating getting more across its system, which includes Bridgeport Hospital and Lawrence + Memorial Hospital in New London.
A spokesperson with Nuvance Health did not provide details on the freezer stock at its medical centers, which include Danbury Hospital, Norwalk Hospital, New Milford Hospital and Sharon Hospital.
“Nuvance Health is working on securing all of the necessary supplies to be able to receive, preserve, and distribute the COVID-19 vaccine,” stated Nuvance spokesperson Amy Forni in an email response to a query. “That includes the required freezers.”
In an October meeting, Lamont’s task force discussed briefly the cold-storage requirements for vaccines, including the ultra-frozen needs that the Pfizer vaccine demands. The task force’s scientific subgroup includes a government affairs executive with the Healthcare Distribution Alliance, whose members include McKesson. The largest distributor of flu vaccine in the United States, McKesson announced in August it will be the primary distributor of other vaccines to follow Pfizer’s as they are approved.
Michael Mozzer, a DPH planning specialist, told the COVID-19 Vaccine Task Force last month that the department has been expecting varying storage requirements for vaccines from different manufacturers, including the likelihood of ultra-low freezers.
“Ultra-cold chain ... is requiring us to essentially develop a lot of things on the fly,” Mozzer said in October.