Pfizer-BioNTech want full FDA approval for their vaccine — will a ‘yes’ improve vaccine hesitancy?

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Approximately five months after Pfizer
PFE,
+1.00%
and BioNTech
BNTX,
+9.35%
received emergency use authorization from the Food and Drug Administration for their COVID-19 vaccine, the companies are now seeking full FDA approval for a shot that’s already been delivered 170 million times in America.

Is full FDA approval the vote of approval that many reluctant Americans need to hear before they get the shot? Some public opinion experts are doubtful, underscoring the persistent challenges in addressing vaccine hesitancy.

“I don’t think it’s going to have a major impact,” said Brian Castrucci, president and CEO of the de Beaumont Foundation, a foundation that’s focused on public health matters and public opinion around the vaccine.

Still, he added, any FDA approval addresses one concern he commonly hears in focus groups: that vaccines are supposedly untested and have been introduced to the public with too little scrutiny. “This will be one less arrow in the concern quiver,” he said.

“I think there are some people who could be convinced to get it once it’s approved by the FDA,” said Liz Hamel, vice president and director of public opinion and survey research at the Kaiser Family Foundation.

The foundation’s latest installment in an ongoing poll on public attitudes towards the vaccine asked an open-ended question to people who said they were open to getting it, but hadn’t yet scheduled an appointment.

Six people out of several hundred cited the fact that no vaccines have full FDA yet, according to Hamel.


Of the people who had concerns about being vaccinated in the most recent Kaiser Family Foundation poll, 48% said they were worried about side effects that would force them to miss work.

To be clear, vaccination rates are rising while polls suggest vaccine hesitancy is slipping. 57% of the country’s adult population has received at least one shot and nearly 42% are fully vaccinated, according to the U.S. Centers for Disease Control and Prevention.

Meanwhile, the number of people in a “wait and see” frame of mind on the vaccine has been shrinking, according to the Kaiser Family Foundation’s ongoing tracker of public attitudes. 15% of people had a “wait and see” approach in April, down from 17% in March and 39% in December.

But the question is how many more people, at this point, are open to getting the shot at some point in the future.

The same Kaiser poll shows the people saying they’d get the shot “only if required” decreasing at a smaller rate, from 9% in December to 6% in April. And the amount of people in the “definitely not” camp have been stuck the past couple months between 13% and 15%, the data shows.

“The ‘hard no’ group has been really consistent since December,” Hamel noted.
The Moderna
MRNA,
+1.65%
vaccine and the Johnson & Johnson
JNJ,
+0.45%
vaccine are both being used on the public after the FDA granted emergency use authorization.

The emergency use authorization process isn’t any less stringent than full approval, according a blog post from Dr. Malia Jones, an associate scientist in health geography working at the University of Wisconsin-Madison Applied Population Laboratory. “It is made based on sound scientific data. It’s just not as large a dataset as would be submitted for a full FDA approval,” she wrote.

The distinction has taken on importance in other parts of the vaccination debate. Lawsuits challenging employers requiring workers to be vaccinated all premise their legal arguments on the fact that the COVID-19 vaccines are available to the public via emergency use authorization. The cases are pending.

Whenever full FDA approval comes, Castrucci foresees a potential argument for the skeptics being “well, see that’s just the government telling us it’s safe.” That’s the challenge when it comes to vaccine hesitancy, he said. “There are groups of people who are just hellbent on spreading misinformation and warping facts to erode confidence in these vaccines to prolong the pandemic.”

It’s getting to the point where no single line of argument, strategy or occurrence is going to sway hesitant people, Castrucci and Hamel said.

Castrucci said it’s important to “stop blaming and shaming” and instead be sure reluctant Americans hear about the importance of the vaccination from credible messengers. He said that boils down to the five ‘P’s’ — physicians, pharmacists, parents, peers and pastors.

“The more people get vaccinated, the closer we get to the point of the unmovable no,” he said. Still, he added, “this is not a sprint, this is a marathon.”

Some people may be holding out for reasons that have nothing to do with skepticism in the science, Hamel noted.

Of the people who had concerns about being vaccinated in the most recent Kaiser poll, 48% said they were worried about side effects that would force them to miss work. (The CDC notes common side effects can include pain, fatigue and chills, especially after the second shot.)

The vaccine is free for everyone, but 32% still said they were worried about out-of-pocket costs. The people voicing these financial concerns were often Black and Hispanic, Hamel said. She and others say that’s an access problem, instead of demand.

When it comes to getting people to vaccination sites now, Hamel said, “we are at the stage where most interventions are going to be moving smaller percentages … Now is the time every tool in the toolbox needs to come out.”



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