In late April, Southern weekender destination Savannah, Georgia, was bracing for a post-lockdown “flood of tourists”—and with it, a subsequent surge in coronavirus cases. At that point, the county’s percentage of positive test results hovered around 2 percent. By the end of June, as long cooped-up travelers poured into the city from all along the Eastern Seaboard, the city’s percentage-positive rate nearly quadrupled, and in an attempt to re-flatten the curve, Savannah’s Mayor Van Johnson issued an executive mask mandate.
"Savannah is experiencing thousands of visitors on our streets, in our establishments and most of them are not wearing face coverings,” Johnson wrote in a letter to Georgia’s notoriously mask mandate-averse governor Brian Kemp. “Infection numbers have exploded over the last three weeks and there is no indication that this disturbing trend is reversing.” Since that point, the trolleys continue to circle, the bridesmaids continue to tour, and the number of people hospitalized with COVID-19 symptoms in Savannah has only continued to climb. But just a few miles from the heart of the tourist district, in a nondescript medical complex on Eisenhower Drive, Savannahians were volunteering, under the radar, to receive test injections of an experimental new COVID-19 vaccine. “That one we weren’t allowed to talk about,” Savannah physician Dr. Paul Bradley said of the 600-participant Moderna vaccine trial for COVID-19 that unfolded this spring across 10 U.S. sites, including Savannah.
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Out of the offices of his practice BCG Medical Group, Bradley—no stranger to clinical trials but certainly not accustomed to the general public taking interest in them—had been tapped as a principal vaccine trials investigator by Meridian Clinical Research on behalf of pharmaceutical company Moderna.
Bradley ran a site of the Phase 2 trials for Moderna’s vaccine candidate—mRNA-1273—considered a frontrunner in the American market and one of six trial vaccines to receive hundreds of millions in government funding. (So far, the U.S. Department of Health and Human Services has committed $955 million to the project.)
After a successful Phase 2, Moderna’s next step would be a 30,000-participant, 100-site Phase 3 trial, and last week, Bradley oversaw the big first step: the first human inoculation in a phase 3 U.S. COVID-19 vaccine trial.
The human was Dawn Baker, the nighttime news anchor for local Savannah TV station WTOC.
“I really wanted to be involved because with being an anchor for the newscast, it was very personal to me, reading this data every single day with the number of people, sick, the number of people who had passed away,” Baker told The Daily Beast.
“I have quite a few people I know who have been seriously ill with COVID. I have friends who have lost loved ones—even those young twentysomethings who were completely healthy. I have been extremely depressed, and stressed and worried these last six months, and sad about the people who have lost their lives, knowing that if they were in the hospital, they had to suffer alone,” she said.
The Savannah community has suffered a number of heartbreaking losses to COVID-19 since late March, but in a bold reminder of the virus’s impact, Baker’s fellow WTOC reporter and sports anchor Lyndsey Gough was hospitalized on a ventilator for COVID-19 within days of her 27th birthday. Over the rocky course of her recovery, she needed to have her appendix and part of her colon removed in an emergency surgery, her doctor telling her that the virus was “like a lightning strike” to her abdomen.
“The earliest she can think about coming back to work at any capacity in September, and that was what they told her in July,” Baker said of her colleague. “It's a long road for recovery. I just feel like we all should try to do something to help.”
RISKY BUSINESS
Ironically, the higher Savannah’s risk climbs, the more illuminating Savannah’s vaccine trial data will be.
According to Bradley, he and his fellow trial administrators are seeking traits of coronavirus risk and exposure. Recipients get the test vaccine in two doses and then proceed to be monitored by way of weekly calls and periodic in-person office visits. The ultimate test is to compare the rate of coronavirus infection and manifestation of symptoms in the placebo group versus the vaccine group.
“We’re looking for people who are, in general, at risk, who are out and about in the community, who have the potential to get COVID,” Bradley told The Daily Beast of the double-blind 50/50 placebo and vaccine study. “Health-care workers, firemen, policemen, store workers, teachers, as long as they are out and about.” Over time, researchers will clock the number of infections incurred by the placebo group versus that in the vaccinated group to determine effectiveness.
While the trial is slated to last two years, the hope is to have results definitive enough for the vaccine’s FDA approval much sooner—as soon as October, according to a recent statement from Moderna CEO Stephane Bancel.
Bradley and team were encouraged by Phase 1 and 2 results, and buoyed further by the enthusiasm of the Operation Warp Speed senior leadership team, including chief adviser Moncef Slaoui and COO General Gustave Perna, who visited the test site in Savannah last week. “So far,” Bradley said, “it looks like it’s going to work.”
But, test results are only part of the equation. Results will have to meet the criteria of regulating bodies like the FDA and, perhaps most challenging of all, gain the trust of the public.
‘TOUGH SELL’
As with clinical trials across the health-care industry, one of Bradley’s main challenges is to secure a participant pool with racial diversity that reflects the population. Adding to the challenge is the fact that minorities are less likely to enroll in clinical trials.
Thus, Baker’s role as the first Phase 3 vaccination was, in part, an outreach strategy. “I've got a lot of people who follow me, I'm on TV and on social media, but also with me being Black, he thought that maybe that would make them more comfortable with the process,” Baker said.
Johnson also helped get the word out about the trial, at press conferences and on social media. “Our demographics lend themselves to diversity within the study,” Johnson told The Daily Beast. “Savannah is a majority-minority community. If Savannah can play a pivotal role, even indirectly, of vaccines even being developed, and people not having to deal with the heartbreak and pain of COVID-19— if we help the world—we help ourselves.”
Bradley said trial enrollment saw “a huge spike in African-American participation” between Mayor Johnson discussing trial enrollment at press briefings and on social media, and Baker being the first injection.
“But we still need more,” he said. “More Asians, Latinos and African Americans. And often for minority populations, clinical trials are a tough sell.”
“I have been overwhelmed by people who have been very, very supportive,” Baker said of the response to her vaccine trial participation, “but I just stopped reading the comments because so many people on social media who looked like me had just trashed it. You know, they're talking about the Tuskegee experiment,” Baker said referring to a disturbingly unethical U.S. government-run syphilis study carried out on hundreds of Black men in Alabama from the 1930s to the early ‘70s.
While numbers of Black and Latinx Americans who plan to get vaccinated are significantly lower than white Americans, the problem of vaccine skepticism spans the population. In an April survey, 46 percent of Americans believed the vaccine probably or definitely be used by Bill Gates to mine data from recipients with microchips.
“Our parents who actually lived through that era had to make decisions about us getting vaccines,” Baker said. “A lot of us are alive because of the mumps, rubella, diphtheria, polio, all those other things [from vaccines] in our bodies. It's sad to me that in this day and time, people of all races don't trust government, and a lot of them don't trust medicine.
“And when you put those two together,” she added, “someone may come up with the perfect vaccine, but if the masses aren't willing to take it, what difference will it really make?”
