Converting Uncertainty to a ‘Yes’ after Explaining the Vaccine Approval Process

Coleman Cutchins, PharmD, at the UAA Alaska Airlines Center in Anchorage, Alaska.

The state of Alaska has been meticulous about protecting its residents from COVID-19. It was the first state to require a negative test for entry and the first to require a travel declaration, in which untested people entering the state must agree to take a test in the airport on arrival and self-isolate until they receive their results.

When the COVID-19 vaccines arrived in Alaska, the Department of Health and Social Services added vaccination to the infrastructure already in place in airports. Eligible people could get the vaccine before they left the building.

“This opportunity helps get people for whom convenience was the only barrier,” says Coleman Cutchins, PharmD, clinical pharmacist at the department.

Alaska was also the first to open vaccinations to anyone age 16 or older. Cutchins has made it his mission to persuade as many individuals as possible to seize this opportunity. Using real-time vaccination data, Cutchins and his colleagues at the department have developed targeted approaches to address vaccine hesitancy among all remaining holdouts.

Alaska Natives understand the consequences of a pandemic

“Overall, our rural areas are doing much better than urban areas,” Cutchins said. “Most of our urban areas are below the state average.”

In general, rural areas have a higher concentration of Alaska natives, while urban centers, such as Anchorage and Fairbanks, are more diverse. Cutchins noted that Alaska natives have a robust tribal health care system as well as several reasons to be eager to get vaccinated.

“They have been extremely cut off through the pandemic because of the risks associated with air travel,” he said.

The devastation caused by the Spanish flu is also still very much alive in the collective memory of Alaska natives. “A lot of these communities got hit very hard by the Spanish flu. Many elders in the villages grew up without a parent because of that. Those stories are still being told today. So, there’s a clear understanding in some of the villages of how bad this could get.”

Vaccine hesitancy in urban centers

In the cities, that understanding is less clear, and vaccine hesitancy is pervasive. Compared with some native communities, where nearly all eligible people have gotten the vaccine, in Anchorage just half are vaccinated. In Fairbanks, fewer than a third have rolled up their sleeves.

Cutchins and his colleagues have reached many of Alaska’s vaccine hesitant through virtual town halls. Each one targets a specific population, such as industries, including fishing and tourism; public schools, including teachers, parents, students, and school nurses; the medical community, in which the panel prepares other health professionals to counter vaccine hesitancy; and a town hall for the general public that focuses on the science behind the vaccine. In each town hall, Cutchins and several physician panelists counter misinformation, describe the FDA approval process, and explain how vaccines work.

Demystifying the FDA approval process

Concerns about FDA’s speedy emergency use authorization are among the most common ones voiced during town halls. As a result of explaining FDA’s process so many times, Cutchins has developed a presentation on it.

“I explain that with emergency use approval, no one skipped any steps, but that some steps that usually happen one after the other now happen in parallel,” Cutchins said. “But the biggest factor in getting the vaccine to market so fast was that they started manufacturing it before it was approved. If the studies had shown it wasn’t effective, we would have thrown away a lot of drugs.”

He uses the Johnson & Johnson (Janssen) vaccine as an example of exactly how the postmarket phase of a clinical trial ought to work. “That’s when we find those one-in-a-million side effects that never show up until the drug makes it to market,” he said. He added that ibuprofen had been on the U.S. market for 31 years before the FDA required a label change in 2015 to include a warning about the risk of GI bleeding and heart attack.

He also uses the concept of postmarket surveillance to counter the myth that the COVID-19 vaccine may cause infertility. “If that were truly happening, now that more than 200 million people have been vaccinated, we would have seen it by now,” he said.

After one of the sessions in which Cutchins explained the FDA process, he received an e-mail from a participant who thanked him for the clear explanation.

Putting adverse effects in perspective

When it comes to concerns about adverse effects, Cutchins offers perspective. He tells those who are vaccine hesitant that vaccines are among the safest medications around—safer even than OTC painkillers, which cause more hospitalizations and deaths than vaccines ever have. As for questions about long-term effects, he explains that the vaccine does its job and leaves your system within a few days. The medicine itself doesn’t linger there long term. Most vaccine adverse effects, he explains, happen within 2 weeks of getting the vaccine, but usually just a couple of days.

The town halls, in which Cutchins and his colleagues listen to each concern and address it head on, seem to have had the desired effect.

“I haven’t done one yet when someone hasn’t messaged me afterward and said, ‘You know what, I wasn’t sure before, but I’m going to get the vaccine now.’”