A coronavirus vaccine may be available in record time, but experts predict pandemonium during the rollout

• Progress on a coronavirus vaccine is moving at record speed, with some experts predicting widespread availability by spring 2020.
• But without a solid plan for distribution, bioethicist Arthur Caplan told Business Insider "there will be fights about who gets priority."
• Clinics and pharmacies could be mobbed, with a vaccine black market emerging to meet demand.
• "There's a notion here that this is going to roll out organized by some central power in an orderly way, without panic," Caplan said. "None of which I believe."
• Visit Business Insider's homepage for more stories.

Progress on a viable coronavirus vaccine has been incredibly fast, with at least six candidates already in clinical trials and dozens more under preclinical evaluation, according to the World Health Organization.

Kizzmekia Corbett, a viral immunologist at the Vaccine Research Center, told CNN a coronavirus vaccine could be ready for emergency use authorization as early as fall 2020, and available to the US public in spring 2021.

Emergency use authorization, which allows medications to bypass final FDA approval, may be necessary for the coronavirus vaccine, in part, because of the short timeline anticipated for its rollout.

"The average length of time to make a vaccine is about 20 years," Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Pennsylvania, told Business Insider. That includes animal models, small-scale studies, and eventually, clinical trials involving tens of thousands of people over a period of years.

The final clinical trials for the rotavirus vaccine Offit developed, for example, enrolled over 60,000 children.

Bypassing the usual FDA approval process

To get to the finish line faster, some labs are fast-tracking clinical testing: Human trials for the first six vaccine candidates are already underway, and there's no shortage of volunteers.

In the US the likely strategy would be to give the vaccine to healthcare workers dealing with COVID-19 patients first, Offit said. Early recipients could also include people who work in pharmacies, grocery stores, and mass transit, and who are willing to take a vaccine that's still unlicensed.

"I think initially, that's where the CDC should weigh in," Offit said, "Say, 'Here are the groups that should get it first, and here's how it should get distributed.'"

Data gathered from this kind of phased roll-out would essentially replace information gleaned from large-scale clinical trials.

Lessons from the Ebola vaccine

Though several vaccines were in development when West Africa was hit with an ebola epidemic in 2014, none had completed the final hurdle to an FDA license: massive, randomized trials.

But the outbreak was so devastating that Merck's unlicensed vaccine, Ervebo, was approved for compassionate use in Guinea, where it was given to healthcare workers and others in close contact with Ebola patients.

It proved so effective that it was used in a subsequent outbreak in the Democratic Republic of the Congo. FDA approval for Ervebo finally arrived in December 2019.

Offit predicts a coronavirus vaccine will be distributed widely in the US on similar grounds.

"I honestly don't think it will be FDA-licensed when it rolls out," Offit told Business Insider. "It will be the first time a modern vaccine was distributed to the public without FDA licensure."

He said he could see people getting a coronavirus shot at their local pharmacy, much like we do the seasonal flu shot.

'There will be fights about who gets priority'

Arthur Caplan, director of New York University's Division of Medical Ethics, said the development of a successful coronavirus vaccine poses serious moral dilemmas.

Manufacturers may use human challenge trials, for example, in which healthy volunteers consent to take the vaccine and are then deliberately exposed to the virus. That would eliminate the need for placebos but puts participants at risk.

It also means that tens of thousands of people worldwide would be immunized before a vaccine is available for general use in the US.

"There's this idea that the vaccine is a get-out-of-jail-free card," Caplan told Business Insider. "But the reality is that we'll see the biggest ethical challenge the world has ever seen."

WHO director-general Tedros Adhanom has prioritized equitable access to any successful vaccine.

"Past experience has taught us that even when tools are available, they have not been available equally to all," Adhanom said. "We cannot allow that to happen."

Gavin Yamey, director of Duke University's Center for Policy Impact in Global Health, told Business Insider that an internationally agreed-upon distribution process could help prevent the kind of monopolization that occurred with the H1N1 flu vaccine in 2009.

As the H1N1 pandemic spread, wealthier countries placed large advance orders on a vaccine still in development, essentially buying out the global supply before it was ever produced.

WHO eventually negotiated with manufacturers and governments to donate vaccines to the developing world, but the incident raised concerns about equitable access.

A fairer system, Yamey said, could include rolling the coronavirus vaccine out first to countries where outbreaks are most severe. Internally, governments would prioritize healthcare workers and populations with serious risk factors — the elderly, immunocompromised, and individuals with underlying health conditions.

Caplan also emphasized focusing on populations that might otherwise be overlooked.

"There will be fights about who gets priority," he told Business Insider. "It makes sense to say, well, where's the worst impacted area? Or where is it likely to spread the most from?"

Among those potential hot zones, Caplan said, are "slums, refugee camps, and prisons."

How the US may roll out a coronavirus vaccine

Outside of the first batch of essential workers, the US is unlikely to see a federal decree about the order in which people get vaccinated, Caplan said.

"Governors may get into it," he said, adding that they may not follow advice from medical experts. "A lot of them aren't paying any attention to recommendations about closing down right now, right?"

Lawmakers may push for immunizing those in industries supporting America's food supply, Offit said, some of which have been hard-hit by the virus.

The CDC can make recommendations about immunizing the elderly and immunocompromised first, but it would be up to providers to follow those guidelines. A vaccine might simply be made available on a first-come, first-served basis.

"Even if there are guidelines, Wal-Mart might say, 'Hey, we've got the vaccine and it's good for our business. So we're going to sell it first. Forget about the guidelines," Caplan said.

The result could be chaos, with Americans mobbing clinics and pharmacies in different cities.

"If that virus is still causing as much panic [next year] as it is now, I think people will line up for that vaccine," Offit said. Some vaccine candidates require booster shots, doubling the pressure on manufacturers and possibly delaying full immunization.

Shortages might be avoided if a vaccine is easy to make or if more than one comes to market. But there's no guarantee the process will run smoothly.

"There's a notion here that this is going to roll out organized by some central power in an orderly way, without panic," Caplan said. "None of which I believe."

We could see a black market for the coronavirus vaccine emerge, he added.

"If you have people locked up long enough, and the world's economy is going to hell, there are some pretty high stakes there that would be attractive to criminals," Caplan said.

Offit and Caplan agree there's no roadmap for how a vaccine will be distributed, particularly given the way the federal government has handled the crisis so far.

"It's not like the world has a referee for this," Caplan said. Even after widespread distribution begins, he added, "it will probably be many years to get the whole world done."