Updated Nov. 19 at 6:45 p.m.: Northeast Georgia Health System officials say they have the freezer capacity to store up to 80,000 doses of a COVID-19 vaccine, as public health officials hope the first doses may arrive in the area by the middle of December.
“This is probably one of the most massive efforts in health care that has ever occurred in this country,” said Dr. Zachary Taylor, who heads District 2 Public Health. “We’re talking about vaccinating over 300 million people in a short period of time. There will be some hiccups, but we will be adjusting our processes and what we’re doing as we learn more and go through this process.”
At the local level, Melissa Frank, Northeast Georgia Health System’s director of pharmacy, said a group with representatives including law enforcement, EMS, the poultry federation and Good News Clinics will meet at the end of the month for logistics planning.
VACCINE TRIALS APPEAR SUCCESSFUL
Pfizer Inc. said a final analysis of clinical trial data showed its COVID-19 vaccine was 95% effective, paving the way for the company to apply this week for the first U.S. regulatory authorization for a coronavirus shot.
The U.S. drugmaker and partner BioNTech SE said their vaccine protected people of all ages and ethnicities, with no significant safety problems so far in a trial that includes almost 44,000 participants.
The update is the latest in a string of promising developments on the vaccine front in recent days. Moderna Inc.'s rival shot appears equally effective, judging from data published earlier this week, and a third contender, from AstraZeneca Plc and the University of Oxford, is expected to release trial results soon.
Pfizer and its German partner now plan a filing with the U.S. Food and Drug Administration by Friday, Nov. 20, at the latest, BioNTech Chief Executive Officer Ugur Sahin said in a Bloomberg Television interview. Documents have already been filed with the European Medicines Agency, which is conducting a rolling review, he said.
HOW WILL THE ROLLOUT WORK LOCALLY?
Taylor said the FDA will probably take seven to 10 days to review the emergency use authorization.
“As soon as they approve that emergency use authorization, then I think Pfizer has on hand some vaccine that they can start shipping,” Taylor said. “Hopefully, we’ll start seeing (vaccine) here in our area sometime in the middle of December,” Taylor said.
According to the Georgia Department of Public Health vaccine draft plan, there will be three phases for the rollout. The first will have limited quantities released to certain dispensing partners "to ensure vaccination of our Tier 1 targeted populations," which include first responders, emergency personnel, frontline essential workers and more.
According to the draft plan, there is no charge for the vaccine.
"The vaccines have been paid for with federal funds at no cost to the patient nor provider, which means that no one may be charged a fee for (the) vaccine itself," according to the draft plan.
Providers, however, can charge a maximum $21.93 fee to administer each dose, but the fee must be waived if the family cannot afford the fee, according to the plan.
The Pfizer vaccine requires “ultra-cold storage,” which the draft plan defines as -60 to -80 degrees Celsius.
Frank said they have two freezers at their disposal capable of holding up to 80,000 doses at the required temperature.
“All of the vaccine will be housed here at Gainesville, and we will just plan a process for getting those health care workers immunized as soon as we can,” Frank said regarding NGHS’ distribution. “We’re already in conversations about just logistics and answering questions as we can.”
Taylor said Northeast Georgia Health System was the only provider he was aware of in the North Georgia area that has the requisite ultra-cold storage.
He said transport of the vaccine will likely be packaged with dry ice, which should be able to hold for seven-10 days if it is replenished.
The second phase of rollout will see more vaccine doses released to "pandemic vaccination providers who agree to serve as mass pandemic vaccination sites, providers who serve” senior adults, patients with chronic medical conditions and others.
The third phase will make the vaccine widely available.
"(The Centers for Disease Control and Prevention) has shared that vaccines may be available as both single-dose and 2 dose series," according to the draft plan. "There will likely be different brands and preparations with varying administration schedules."
An optimistic estimate would be widespread vaccination by early spring to early summer, Taylor said. One caveat, however: The vaccine candidates will likely not be approved under the emergency use authorization for children under 18 or pregnant women.
Tribune News Service contributed to this report.