An advisory committee of the U.S. Food and Drug Administration approved emergency use of a vaccine for covid-19 that could soon be rolled out to long-term care facilities and front-line health care workers within the next few days.
The advisory committee’s vote clears the way for the full agency to authorize use of the vaccine.
“FDA officials have said they plan to make a decision on approving this emergency authorization within four days of the meeting, though I hope to the good Lord above that they can approve it even faster than that,” Gov. Jim Justice said this week.
The question before the committee was, “Based on the totality of scientific evidence available, do the benefits of Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in individuals 16 years of age and older?”
The committee voted yes, 17 in favor, four against and 1 person abstained. The vote came after the committee met all day to discuss the safety and effectiveness of the vaccine. Over the course of the day, participants made clear that the vaccine will continue to be studied even though it is being made available right away because of the coronavirus pandemic.
“I think this is an epic day in U.S. Healthcare. We finally have a potential stopgap,” Todd Karpinski, the chief pharmacy officer for WVU Health System, said today on MetroNews’ “Talkline.”
“We hope to get started vaccinating next week to hopefully end this pandemic.”
There will be a limited supply of the COVID-19 vaccine when it first becomes available, so the vaccine will be distributed in phases, based on risk for contracting COVID-19.
West Virginia has made distribution of the vaccine a priority for nursing home residents and staff as well as for front-line healthcare workers.
Justice announced Monday that West Virginia officials have submitted the state’s initial Pfizer vaccine order to the U.S. Centers for Disease Control and Prevention, requesting the state’s maximum-allowed weekly ordering cap of 16,575 doses.
West Virginia plans to receive an initial allocation of about 60,000 doses of the Pfizer vaccine.
Five hubs around West Virginia would begin receiving shipments of vaccine supply via UPS shipment.
“I would anticipate within 24 hours after the (emergency use authorization) is granted we will get products on hand,” Karpinski said.
He said a clear plan has been developed for handling and distribution, including the ultra-cold storage required for the Pfizer vaccine.
“We’ll make sure to keep it stored correctly,” he said.
Karpinski said the focus for WVU Health Systems is workers in emergency departments and intensive care units. In Morgantown, he said, about 2,000 employees could be vaccinated with an initial dose.
The Pfizer vaccine calls for a second dose within a few weeks.
Supply chain questions about the Pfizer vaccine have arisen in recent days. It is the first of what’s hoped to be several vaccines soon rolling onto the market.
A similar vaccine produced by Moderna is expected to receive approval within the next week or so.
During a briefing Wednesday, Justice announced that the initial allocation of Moderna covid-19 vaccine that will be received in West Virginia has been increased to 32,600 doses.
While announcing the state’s initial allocation plan last week, Gov. Justice reported that West Virginia was supposed to receive 26,000 doses of the Moderna vaccine.
This is a developing story and will be updated.