As U.S. regulators weigh giving the final stamp of approval for certain covid-19 vaccines, governors in states hard-hit by the pandemic hope the move will help persuade the many holdouts in their states to finally get shots.
The governors of Arkansas and Ohio -- where cases and hospitalizations are climbing -- have appealed publicly in recent days for full approval, saying it would help combat vaccine hesitancy and also could clear the way for more businesses to require their employees to be inoculated.
It's a topic that Republican Gov. Asa 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% of the state's population is fully vaccinated.
"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," said Hutchinson, who recently took over as chairman of the National Governors Association.
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All three vaccines authorized for use in the U.S. went through a fast-track approval process -- but that didn't skip the extensive 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 infections -- especially serious illness -- and were safe. Once widespread use began, the Food and Drug Administration and the U.S. Centers for Disease Control and Prevention beefed up the 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 said. "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, Republican Gov. Mike 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 younger than 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.
"That is one of the stated reasons that we hear most often from people who are not getting vaccinated," DeWine said. "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."
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.
"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 because of 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.
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 approval.
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"When I introduced this amendment, I'm looking at it from individual liberty," Brenner said. "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.
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 other countries that are successfully using the shots.
Pfizer recently announced that 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.
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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 follow-up for two months, 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 its state's 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."
'SELF-INFLICTED PAIN'
In Alabama, when asked what more could be done to encourage residents to get shots during the latest spike in infections, Republican Gov. Kay Ivey had run out of ideas for how to persuade people in a state with the lowest vaccination rate in the nation.
"I don't know, you tell me," the governor said Thursday in Birmingham. "Folks [are] supposed to have common sense."
She did, however, have this message for her state: "It's time to start blaming the unvaccinated folks, not the regular folks. It's the unvaccinated folks that are letting us down."
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Pointing to the nearly 10,000 new cases of coronavirus in Alabama over the past two weeks, Ivey said, "Almost 100% of the new hospitalizations are with unvaccinated folks. And the deaths are certainly occurring with the unvaccinated folks," she told reporters. "These folks are choosing a horrible lifestyle of self-inflicted pain."
The governor's statements -- her most forceful to date about the importance of the shots -- were made as vaccinations have plummeted in Alabama. The state has less than 34% of its population fully vaccinated, and nearly 500,000 people remain only partially vaccinated, according to data compiled by The Washington Post.
Just 6,118 people were inoculated Wednesday, according to Alabama's vaccine dashboard -- a considerable drop from the record 45,181 shots administered on a single day in April.
There have been more than 565,000 coronavirus cases and about 11,400 deaths in Alabama. The state has seen a 70% increase in daily cases in the past seven days. Alabama also has its highest hospitalization rate since April, state data shows.
Among those who have died of the virus, a vast majority were unvaccinated, according to data from the Alabama Department of Public Health. More than 96% of the more than 500 coronavirus deaths in the state since April involved unvaccinated people, AL.com reported.
Ivey's comments echo the concerns of physicians and public-health officials who have faced challenges in boosting vaccine confidence in the state. Brytney Cobia, a physician at Grandview Medical Center in Birmingham, detailed on Facebook how numerous "young healthy people" have been admitted to the hospital "with very serious covid infections."
"One of the last things they do before they're intubated is beg me for the vaccine. I hold their hand and tell them that I'm sorry, but it's too late," she wrote.
CONCERN FOR LOUISIANA
In Louisiana, with more than 1,000 people hospitalized, Gov. John Bel Edwards on Friday encouraged everyone, whether vaccinated or not, to wear masks indoors if they can't stay distanced from others.
But the Democratic governor stopped short of issuing a mask mandate or new restrictions on activities and businesses during the state's fourth spike, driven by the highly contagious delta variant.
Louisiana -- which has among the nation's lowest vaccination rates -- is seeing thousands of new confirmed cases each day, and its hospitalizations have surged in recent weeks.
Edwards said Louisiana has been labeled a "state of concern" by the White House.
"We've effectively lost six months of progress over the last two or three weeks," said Dr. Joe Kanter, the governor's chief public-health adviser.
Edwards placed the blame squarely on people refusing to get immunized in a state where only about 48% of those eligible have gotten at least one shot.
"It pains me to say this, but this one is on us. This surge is on us. How bad it gets, how long it stays bad, how many people ultimately die -- on us," the governor said.
In addition to a return to mask-wearing indoors, Louisiana's health department is suggesting even those who are vaccinated should get tested if they have been exposed to the illness and recommending that people work from home if possible.
Edwards is requiring masks to be worn in state buildings under his control if social distancing isn't possible.
The governor's latest recommendations represent a break from some of the guidance offered by the CDC. But Edwards and state health officials said the severity and speed of Louisiana's latest surge warrants such a response.
The soaring hospitalizations are putting medical staffs in Louisiana under stress, as public-health leaders and state officials continue pleading for people to get the shots that can prevent the disease.
"Our staff is feeling stretched. Our staff is also as you can imagine disheartened that we are going through this not one, two, three, but four times," said Dr. Katherine Baumgarten, medical director of infection prevention for the 40-hospital Ochsner Health system. "This time it is even harder because we know that this is largely preventable."
More than 90% of all new cases, hospitalizations and deaths are among those who aren't fully vaccinated, Kanter said.
New Orleans Mayor LaToya Cantrell and Shreveport Mayor Adrian Perkins also told their cities' residents this week that they should mask up indoors, regardless of vaccination status.
"We cannot afford to lose one more person, and we cannot afford to go into another shutdown," Perkins said.
Information for this article was contributed by Andrew DeMillo, Farnoush Amiri, Lauran Neergaard, John Hanna and Melinda Deslatte of The Associated Press; and by Timothy Bella and Maria Luisa Paul of The Washington Post.
