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The State of the Emergency Use Authorization: COVID-19 Vaccine Could Reach Hartford Friday
December 09, 2020
The special freezers that can keep Pfizer’s COVID-19 vaccine at the required minus-100 degrees are in place. Now, says Hartford HealthCare‘s director of pharmacy, the wait for the first supply after the vaccine’s expected emergency use authorization from the Food and Drug Administration is almost over.
“Here at Hartford HealthCare, we’ll be prepared and ready to receive the vaccine as early as Friday,” said Eric Arlia at a Dec. 9 media briefing. The (Centers for Disease Control and Prevention) has told us they will ship the vaccine within 24 hours of approval. So we have teams ready, even if it comes over the weekend.”
Hartford HealthCare’s first shipment, destined for Hartford Hospital, will be distributed to healthcare workers at the system’s acute-care facilities.
“The Pfizer vaccine is one that’s ultra-frozen,” said Arlia, “and we have the capacity to store it. It’s good for five days in the refrigerator, so as our healthcare providers begin to sign up for our clinics, we’ll defrost the appropriate amount of vaccine and position it in place.”
But first, the emergency use authorization. After the FDA declared the vaccine safe and effective earlier this week, the next step is an all-day meeting Dec. 10 of an external expert committee that will review vaccine data from Pfizer and its partner, German startup BioNTech. Its vote will determine if the FDA authorizes the first-available COVID-19 vaccine. Most experts anticipate minimal suspense, with an FDA emergency use authorization possibly by the end of the day.
“We’re all very excited with the updates this week,” said Arlia. “It’s all very positive. We do expect that emergency use authorization of the Pfizer vaccine is imminent after Thursday’s hearing.”
An emergency use authorization is a relatively new fast-track approval for much-needed vaccines. The first, in 2005, allowed an anthrax vaccine only for military personnel. Four years later, during the H1N1 pandemic, Tamiflu was allowed for infants. Much credit for the emergency use authorization, however, belongs to activists in the 1980s and 1990s during the HIV/AIDS pandemic who staged “die-in” events at the FDA’s headquarters to protest the agency’s slow review of the first drugs developed to treat the human immunodeficiency virus.
Arlia said Hartford HealthCare could receive its first shipment of Pfizer’s COVID-19 vaccine Dec. 11, pending the review committee’s vote.
“That would probably be the first day it would be approved for emergency use,” he said. “The CDC has told us that they will ship the vaccine within 24 hours of approval.”
The CDC’s initial allotment of the Pfizer vaccine will be split between healthcare facilities and nursing homes.
“For the first few weeks,” said Arlia, “we’ll be focused on our side of the equation, mostly on our healthcare providers who have the highest risk of exposure — ones that treat COVID patients or work in units that treat COVID patients.”
As more supplies arrive, distribution will be aided by an executive order by Gov. Ned Lamont allowing pharmacists to administer the vaccine. Much like flu vaccines, COVID-19 vaccines eventually will be available at local pharmacies.
“This is going to be a huge advantage,” said Arlia. “Our team of pharmacists at Hartford HealthCare is very excited and enthusiastic about participating in the effort. More than 50 of our pharmacists have signed up and volunteered to be part of the vaccination process.”