MW Full FDA approval of Pfizer's and Moderna's COVID-19 shots would reinvigorate the U.S. vaccination push -- but it could still be months away
Jaimy LeeJillian BermanAndrew Keshner
Upgrade from emergency-use authorizations could open the door to vaccine mandates from more employers -- including the U.S. military -- and schools
The "full" approval of Pfizer's and Moderna's COVID-19 vaccines will almost certainly boost sagging vaccination rates in the U.S., though the Food and Drug Administration's decision might not come until the end of the year.
The Pfizer Inc. $(PFE)$ and Moderna Inc. $(MRNA)$ vaccines, along with Johnson & Johnson's $(JNJ)$ COVID-19 shot, have received emergency-use authorization, a less rigorous category of approval granted by the FDA that allowed the vaccines to be distributed more quickly during a critical stage of the public health emergency.
Though an FDA decision isn't required until the end of the year, people are already evaluating how a formal approval would impact lagging vaccination rates in the U.S. amid a murky landscape for required immunization in the U.S.
More than 153 million people in the U.S., or roughly 46% of the total population, have voluntarily chosen to get vaccinated, according to data from the Centers for Disease Control and Prevention.
But a recent slowdown
All signs point to a boost, whatever its magnitude, in the ongoing COVID-19 vaccination campaign in the U.S. if and when the vaccines are formally approved.
Approval will allow drug manufacturers to advertise their vaccines and, in some cases, set their own prices. It may also mean that employers and schools will have an established legal precedent to require vaccination, and it could tip people in the wait-and-see category to get vaccinated once they know the vaccines have gone through a more rigorous regulatory screening.
"A third of people who are unvaccinated said that they'd be more likely to get the vaccine if ... one of the vaccines received full approval from the FDA," said Liz Hamel, director of public opinion and survey research at the Henry J. Kaiser Family Foundation, which has studied COVID-19 vaccine hesitancy.
A full FDA approval could help the lagging vaccination rate in the U.S.
About 12% of unvaccinated people in the U.S. are part of the wait-and-see group, according to the Kaiser Family Foundation. They tend to be young adults and Black adults.
For some people, approval sounds safer than emergency authorization. "We hear people say, it's just experimental at this point. It's not approved yet," Hamel said. "They hear terms like 'emergency,' and then they are just still cautious."
Arkansas Gov. Asa Hutchinson said the state needs full approval to combat vaccine hesitancy. "It was approved as emergency use," the Republican told "Face the Nation" this weekend. "And so, for that reason, you can't mandate it."
An FDA approval for a COVID-19 vaccine requires six months of follow-up data from the clinical trial, three times the two months' worth of follow-up data used to inform emergency authorization.
The regulator has 60 days after the companies submit their applications to decide if it is going to grant "priority review," a designation that requires the federal agency to make a decision whether or not to approve the vaccine within six months. Pfizer said it submitted its application on May 7; Moderna followed, on June 1, with its submission.
Between 6% and 7% of unvaccinated Americans say they'll get a shot only if they are required by an employer or a school, or to travel. While some employers already require vaccinations -- the Houston Methodist hospital system in Texas went to legal lengths for returning employees -- these kinds of requirements are not the norm.
The U.S. military, with its 1.3 million active-duty members, has not required vaccination but has suggested he would leave that decision in the hands of the military brass.
"Some people will respond to incentives, and some will respond to requirements," the Kaiser Family Foundation's Hamel said.
We'll see TV ads promoting vaccines.
Right now, drug companies are limited in what they are allowed to say about their vaccines based on the rules of emergency authorization. They can't advertise the vaccines to the public or to prescribers -- or proactively explain the safety and effectiveness of their shots.
"You essentially have to stick to the script that's in the EUA," said Cody Powers, a COVID-19 vaccine expert at ZS, a pharmaceutical consulting firm. "You can't make explicit claims about safety and effectiveness."
If and when FDA approvals are granted, companies like Moderna and Pfizer may stay cautious in their approach to marketing COVID-19 vaccines in the U.S. Traditionally, pharmaceutical companies hold off on putting out direct-to-consumer ads for six months after approval as a result of concerns about aggressive marketing practices. In this case, there likely will be worries about corporate profit motivations during a global pandemic.
"If they feel like they're jeopardizing both their own perception and the success of overall inoculations in the U.S., they might step back," Powers said.
Drug manufacturers usually start with disease-awareness campaigns for new products and then later launch brand campaigns that seek to either raise awareness of their particular offering or to differentiate it.
But this moment in time is very different. The American public already knows about the vaccines and their makers. In fact, many people are well-versed in efficacy rates from the clinical trials and even how the FDA regulatory process works. That means we already have perceptions of each vaccine, whether that's sillier ones, like the TikTok idea that Pfizer's vaccine is for "hot" people .
"When you can make claims about the vaccine, then all the promotional machinery around that claim turns on," Powers said. "It's a really weird situation for most manufacturers, where they're actually having to make decisions about whether to just roll with what they've inherited or try to change people's perceptions."
The price of at least one vaccine may eventually go up.
Moderna will also gain more control over the pricing of its vaccine once it is approved, according to remarks made earlier this month by CEO Stéphane Bancel.
The price of Moderna's shot works out to $15 per dose, in comparison with the $19.50 charged by Pfizer , had more price-setting freedom.
With approval, "we should be able to go into the private market," Moderna's Bancel told investors. "The price is pretty low because at the time the deal was done there was no clinical data." -- Jaimy Lee
Colleges are going to lead the way when it comes to requiring vaccines in educational settings.
Hundreds of colleges in the U.S. have announced vaccine requirements for students and, less often, employees. But full FDA approval is expected to broaden both the number of schools mandating vaccination and the scope of the requirements in place.
The California Institute of Technology said everyone in its community to get vaccinated.
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June 28, 2021 17:36 ET (21:36 GMT)
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