Arkansas, Ohio Govs Hope FDA Full Approval of COVID Vaccine Will Increase Inoculation Rate

Governors of Arkansas and Ohio are hoping that FDA full approval for certain COVID-19 vaccines will increase the number of people receiving the vaccines, as the states have faced a climbing number of cases and hospitalizations.

Gov. Asa Hutchinson and Gov. Mike DeWine, both Republicans, have appealed for the FDA to give vaccines full approval, rather than just approval for emergency use, as they feel it will help combat vaccine hesitancy and allow more businesses to require vaccinations.

"That is one of the stated reasons that we hear most often from people who are not getting vaccinated," DeWine said, after speaking to residents across Ohio. "And my concern is that the FDA not moving from emergency use to full approval, some people are not being vaccinated who would be vaccinated and those people are going to die."

Hutchinson cited similar reluctance from Arkansas citizens against getting the vaccine.

"Anytime you have low vaccination rates, you want to eliminate every objection that people have, and one of the objections that's been expressed is that this is only approved under emergency use authorization," Hutchinson said.

For more reporting from the Associated Press, see below:

Mike DeWine vaccine rates
Ohio Gov. Mike DeWine said the FDA not approving COVID vaccines for full use caused him to be concerned that "some people are not being vaccinated who would be vaccinated and those people are going to die." Above, DeWine gives his victory speech after winning the Ohio gubernatorial race at the Ohio Republican Party's election night party at the Sheraton Capitol Square on Nov. 6, 2018 in Columbus, Ohio. Justin Merriman/Getty Images

It's a topic that Hutchinson has confronted as he holds town halls throughout Arkansas, which leads the nation in new cases per capita but has one of the lowest vaccination rates. Only about 35 percent of the state's population is fully vaccinated.

All three vaccines authorized for use in the U.S. went through a fast-track approval process—but that didn't skip the normal massive testing required of any vaccine. Pfizer and Moderna have applied for full approval, and a Pfizer decision is expected soon.

The Pfizer, Moderna and Johnson & Johnson vaccines were studied in tens of thousands of people to show they prevented symptomatic coronavirus infections—especially serious illness—and that they were safe. Once widespread use began, the Food and Drug Administration and the U.S. Centers for Disease Control and Prevention beefed up usual surveillance to catch any side effects too rare to have occurred in even those large studies.

The FDA's acting commissioner, Dr. Janet Woodcock, was asked by a Senate committee this week about people hesitant to get a vaccine that wasn't fully approved.

"We did not cut any corners," she replied. "Compared to other vaccines they'd be looking at, these have really gotten the full-court press as far as evaluation and study."

In Ohio, with less than half the population vaccinated, DeWine has been exhausting every avenue to get shots in people's arms. The state recently completed a five-week $1 million lottery drawing for adults or a full-ride scholarship to a Ohio university for those under 18 who receive their first COVID-19 shot.

Last week, DeWine announced plans for an incentive that gives smaller amounts of money to increase the odds of more people winning. But that's on hold as the governor and his administration urge full FDA approval to appease a segment of the unvaccinated community who might budge.

In Kansas, Democratic Gov. Laura Kelly has pinned hopes of avoiding renewed mask mandates and other restrictions on getting more people vaccinated. After a call with governors and the White House this week, she said the Biden administration is "fully aware" that governors want full approval of the COVID-19 vaccines.

"It would eliminate one variable that seems to be used as an excuse to not get vaccinated," Kelly said.

The governors' efforts are happening against the backdrop of rising cases in every state due to the rampant spread of the Delta variant.

At the same time, lawmakers in GOP-controlled legislatures are moving forward with legislation that limits businesses' and schools' ability to mandate vaccines, specifically targeting COVID-19 vaccines that haven't yet received the full FDA stamp of approval.

In Ohio, GOP Sen. Andrew Brenner pushed through a last-minute provision that would prohibit state public schools and universities from mandating vaccines without full FDA approval.

"When I introduced this amendment, I'm looking at it from individual liberty," Brenner said. But, he added, "while it has been given emergency use authorization, typical vaccines take about 10 years of trials and testing to know the side effects and everything."

However, the COVID-19 vaccines were the result of more than a decade of behind-the-scenes research and huge injections of funding that laid the groundwork for them to be rolled out so quickly.

Hutchinson noted full approval of the vaccines could encourage more hospitals and businesses to require vaccinations.

The FDA has never before had as much evidence to use in deciding whether to approve a vaccine as it has for the Pfizer and Moderna shots. More than 188 million doses of the Pfizer-BioNTech vaccine have been given in the U.S., and more than 137 million doses of the Moderna vaccine. The FDA also can consider evidence from multiple other countries that are successfully using the shots.

Pfizer recently announced the FDA deemed its application eligible for "priority review" and would decide no later than January. But the agency is widely expected to finish its work far sooner.

Full approval carries the FDA's strongest endorsement of a product, and, among other steps, it usually requires six months of safety follow-up. For emergency use, the agency required two months of safety follow-up, the period when side effects are most likely to occur. The agency also will perform detailed inspections of vaccine manufacturing plants.

Health experts say they view the holdouts awaiting full approval as more reachable than others clinging to misinformation or those who are outright hostile about vaccines.

"There's clearly a degree of thoughtfulness in understanding the FDA approval process and waiting for that to happen," said Dr. Cam Patterson, chancellor of the University of Arkansas for Medical Sciences, which has been stretched thin by the latest surge in Arkansas cases.

"My hope and my expectation is they will follow that train of logic into the doctor's office to get the shot once the FDA gives full approval for the vaccines."

Asa Hutchinson vaccination rates
Facing growing vaccine hesitancy, governors in states hard hit by the coronavirus pandemic are asking federal regulators to grant full approval to the shots in the hope that will persuade more people to get them. In this July 15 file photo, Arkansas Gov. Asa Hutchinson speaks during a town hall meeting in Texarkana, Arkansas. Kelsi Brinkmeyer/The Texarkana Gazette via AP, File