As the pharmaceutical company Moderna seeks final approval for its COVID-19 vaccine, Kelly Denson is proud to be one of the people who helped make it happen.
“A friend mentioned that the vaccine makers were looking for volunteers while we were social distancing, and I went down the rabbit hole of research,” says Denson, 41, who co-owns Skylark Realty.
At that point, the vaccine was in the final round of testing, having already been through two smaller trials gauging its safety and effectiveness. The late-stage trial involved some 30,000 participants. The next step for Moderna as well as Pfizer and AstraZeneca, which also have promising vaccines in the works, is seeking an emergency use authorization from the U.S. Food and Drug Administration, en route to full approval for widespread distribution. All three vaccines need two doses to be effective.
“Phase 3 trials have a lot of safety precautions, and by the time we get to that, we know the vaccine is safe, and it is at least somewhat effective,” says Dr. Susan Mims, a physician who also has a master’s degree in public health. On Dec. 1, Mims was named interim CEO of the Dogwood Health Trust; she previously chaired the Department of Community and Public Health at Mountain Area Health Education Center.
In drug trials, she explains, “The first two phases are small scale. Phase 1 will have just a few people, perhaps dozens. Phase 2 usually has several hundred people. By the time you get to Phase 3 … you’re looking to see how it works in a wide, diverse group of people.”
After spending several hours researching vaccine trials, Denson concluded that the Phase 3 test would be safe enough for her to participate. On Aug. 19, she drove to the test site in Spartanburg, S.C., and got the first shot. Since it was a double-blind study, no one knew which participants actually received the vaccine, so Denson had to wait to find out whether she’d develop antibodies. A prior test had found none, meaning she hadn’t had COVID-19.
After the shot, her arm was sore and she felt a little tired and achy, she says, but she was better by the next morning.
Ten days later, Denson went to LabCorp for a $10 antibody test. It came back positive, meaning she had, in fact, received the vaccine. Tests on two friends who did the study with her were negative.
In September, Denson got the second shot, which left her a little more sore and tired, but once again she felt better within a day.
“I feel confident I got the real vaccine, but I’m still taking precautions,” she says, pointing to the potential for resuming more normal activities after the vaccine has reached a significant percentage of the population, which could happen by early summer 2021. “It’s sad to miss Thanksgiving but, c’mon, we’re six months away. Let’s skip this singular year so we can have dozens more holiday seasons.”
A complex equation
Although all three vaccines appear to work, there are differences that could affect distribution. Pfizer’s product needs to be stored at minus 70 degrees Celsius, and Moderna’s at minus 20 Celsius. AstraZeneca’s vaccine, though slightly behind the other two in its development, is less expensive to produce and poses fewer logistical challenges, since it can be stored in conventional refrigeration units rather than specialized supercold freezers.
But AstraZeneca’s late-stage trial showed an interesting blip: The vaccine was less than 70% effective when two full doses were administered, but when the first shot was mistakenly given as a half dose followed by a full dose the second time, the effectiveness rate exceeded 90%. That’s just one more mystery in dealing with a virus we still know so little about, says Mims.
Another key question is how long each vaccine might convey immunity.
“We know that viruses can mutate, which is why we need to get a flu shot every year, and we don’t know whether that will be true for COVID,” she explains. “This is a new, or novel, virus.”
Right now, it looks as though the Pfizer and Moderna vaccines will reach the market first, with emergency use authorization expected for at least one of them later this month. Once that happens, however, there’ll be questions about how the vaccines will be distributed and who gets them when, Mims points out.
At a Dec. 1 press conference, Gov. Roy Cooper said the state will probably start getting the Pfizer vaccine later this month. The initial shipment is expected to be about 85,000 doses, with a similar amount of the Moderna vaccine to follow soon after. All of this is conditional on prompt FDA approval. As production ramps up, the state expects to receive weekly shipments of as-yet-unknown quantities of the vaccines.
At the same press conference, Health and Human Services Secretary Dr. Mandy Cohen said the first doses will be given to hospital, health care and long-term care workers. Those with two or more chronic conditions will be next, probably beginning sometime in January. As supplies increase, the vaccines will be made available to residents in long-term care, people over age 65 and others.
Eventually, additional vaccines may be approved that could be better suited to specific populations, notes Mims. And whichever one people receive, they’ll have to go back for the second shot even if the first one leaves them feeling fatigued and achy.
In Western North Carolina, health care providers will work together with the WNC Health Network to make the necessary decisions and optimize vaccine distribution, says spokesperson Adrienne Ammerman. Founded 25 years ago, the nonprofit works to improve communication and increase purchasing efficiency among the region’s hospitals and health systems.
Getting the word out
Among other things, the network helps hospitals and local government departments educate residents about health issues. The results of its studies, done every three years, are shared with all members, making it easier for providers in the most rural counties to obtain needed data.
Meetings have continued online throughout the pandemic, and since March, the WNC Health Network and WNC Health Communications Collaborative have been coordinating an educational campaign in Haywood, Jackson, Graham, Transylvania and Henderson counties aimed at preventing the spread of COVID-19.
“When a vaccine does become available, we’ll transition to vaccine communications,” says Ammerman. “The groundwork is already there, so we can be really effective in getting the word out.”
In addition, she continues, the lines of communication are open between medical and public health professionals, which will facilitate quicker logistical decisions.
Other concerns, though, might hinder those efforts.
A newly released study by The Commonwealth Fund outlines potential obstacles to a successful national rollout of COVID-19 vaccines. Citing data on both flu and H1N1 vaccination rates that “fell well below the 70% threshold that is believed to be necessary to reach herd immunity,” the study predicts that COVID vaccines will face similar challenges. Racial and cultural inequities are among the issues mentioned.
Closer to home, skepticism about vaccines in general — and particularly those produced on such an accelerated schedule — could prove to be yet another factor. A High Point University poll released Dec. 3 found North Carolina residents sharply divided: 42% of respondents said they’d get vaccinated if a vaccine were available within the next 12 months; 31% said they wouldn’t, and the remaining 27% were unsure or didn’t answer the question. The percentages were similar for a vaccine released within the next six months.
Meanwhile, Buncombe has consistently led all North Carolina counties in the number of schoolchildren whose parents claim a religious exemption to avoid the required vaccinations (see “Rise in Immunization Exemptions Threatens Community Health, Doctors Say,” Feb. 10, 2019, Xpress). It isn’t clear to what extent those concerns might extend to a COVID vaccine.
For her part, however, Denson harbors no such doubts. She posted on Facebook about her own experience, seeking to reassure folks who are skeptical about vaccines.
“I hope that in knowing that I have been given the vaccine and that it is safe and effective, it will give some of you a peace of mind that the future is bright and hopeful,” she wrote. “I look forward to hugging and dancing and live music and not wearing a mask and dinner parties and restaurants and so many things that make life the great joy that it is. And, friends, those things are not that far away. Don’t give up: Keep wearing your mask.”
Updated at 10:40 a.m. on Dec. 21 to include more information about local COVID-19 communications.