This fall, the Shelby County Health Department will be carefully watching several drive-thru flu shot clinics that will be test runs for how it will mobilize crews to inoculate masses against COVID-19.

The Centers for Disease Control on Wednesday, Sept. 2, told all 50 state health departments to begin laying the groundwork for how they will distribute COVID-19 vaccines expected to arrive in late October or early November.

“We’ll use the influenza vaccine as a surrogate for the COVID vaccine,” said David Sweat, epidemiologist at the Shelby County Health Department.

The drive-thru sites will be set up under the state health department’s Fight Flu TN campaign Nov. 19. All health departments in the state will administer free flu vaccines that day to bolster immunity heading into what could be an inauspicious flu season.

The conundrum for health officials across the nation is that the U.S. does not yet have a COVID-19 vaccine that has passed the FDA’s three human trial phases. To have one manufactured and shipped in large volumes to cover all 50 states by November could mean late-stage clinical trials would have to be halted before they are finished.

“At this point in time, there are a number of candidate vaccines that are under development, and different vaccine manufacturers are still going through their clinical trials. At this point, we don’t have a candidate vaccine,” Sweat said. “We do not have a vaccine that has demonstrated efficacy.” 

All candidates in the final phase of clinical testing also require two doses, he said, plus two checks for antibodies, all of which add time.

Stacey Schultz-Cherry, world expert on influenza at St. Jude Children’s Research Hospital, agrees it’s important to start planning for the distribution of vaccines.

“It’s very exciting to watch the vaccine development, how quickly things have moved, but we absolutely cannot put out a vaccine unless it’s safe.”

Safety regulatory boards, independent of the federal government, she said, monitor the data.

“If it is overwhelmingly positive, they potentially have the ability to end some of these trials,” Schultz-Cherry said.

The FDA could approve emergency-use authorization as it has done with several drugs to fight COVID-19.

“That’s a big gap, and a lot of things have to fall into place,” she said.

One of the worries of closing early, Schultz-Cherry says, is it could limit minority participation in the trials.

Each phase of the trial requires increasingly larger pools of people. At Phase 3, data from tens of thousands of people is analyzed.

“And at least some numbers I’ve seen so far, only about one in five trial participants are minority members,” she said.

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Because Black and Latinx people suffer disproportionately from COVID-19, large pools of data from generally healthy, white adults could diminish overall confidence in the vaccine.

In Shelby County, 60% of fatalities are among African Americans.

Pfizer, which has a vaccine in Phase 3, said Thursday it has enrolled 23,000 people and was hoping for at least 30,000.

It also said its trial was in a “very advanced stage” and that a significant number had already received a second dose.

It expects to know by the end of October if its vaccine is safe and effective.

In late August, Pfizer said it intended to supply up to 100 million doses worldwide by the end of the year and 1.3 billion doses by the end of 2021.

Missteps at the CDC and FDA, including emergency-use authorization of therapies like hydroxychloroquine, which later had to be walked back, create worries that people will lose faith in the agencies’ ability to be independent and rubber-stamp vaccines that have not been proven.

“I think it’s crucial right now, more than ever in our country and in medicine, to be transparent about this stuff and to have data that we can throw out there to give people confidence that they can take this vaccine – that it’ll be at least partly effective, and that it’ll be safe,” said Dr. Stephen Threlkeld, infectious disease doctor treating COVID-19 patients at Baptist Memorial Hospital-Memphis.

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In the initial stages of drug trials, he said young, healthy people are recruited because “they tolerate things better. We don’t want untoward side effects, or if we do, we want somebody that’s going to do better with them.”

The third stage is different, he says.

“We go out to larger groups of people and particularly elderly and maybe people who were somewhat immune suppressed and other groups that might have a bigger payoff for the vaccines, but bigger safety concerns at baseline. I think that’s very unlikely to happen.”

Clay Jackson, a physician at West Cancer Center, says a vaccine by late October is possible “only if the usual regulatory practice is put on warp-speed, fast track.”

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People could be put at risk of side effects that couldn’t be known unless the trial lasted longer and people could be observed for weeks, maybe months after receiving the shots, he said.

Shortening this phase of the trial “is a bad idea,” Threlkeld said.

“Right now, the death rate in this country is not so high that we need to jump over hurdles of safety and advocacy to try to get the vaccine to people.”

For as much as the government has been criticized in its handling of the pandemic, its response to getting a vaccine quickly has been admirable, he says, including that the National Institutes of Health has pledged millions of dollars in support of vaccines “close to the finish line.”

NIH has pledged to give the makers of several categories of vaccines funding so they can begin manufacturing the vaccines before they are approved, allowing them to start flowing across the globe immediately after they are approved.

“That may be hundreds of millions, up to a billion dollars of expenditure, and it’s a gamble on whether or not these vaccines will end up working in the Phase 3 trials,” Threlkeld said.

With a vaccine that is a “trillion-dollar problem,” he said, “throwing a billion dollars at it is a thousand-to-one payoff if you can make this work. And most people are fairly optimistic that it will.”

Schultz-Cherry notes that St. Jude’s studies of antibodies in its own employees who were infected so far show the length of time antibodies last varies widely by individual.

Knowing how long they last, she said, would inform how the vaccine is made.

“How long do we expect them to last? Is it like the flu vaccine where we may have to have new coronavirus every year until this thing is done circulating or has changed? Or is it going to be like measles, where you get the series of three shots and then, basically, there is long-term protection?”

From what Jackson’s seen, immunity appears to be at least four months.

“We are hoping that any approved vaccine can at least match that benchmark.”