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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

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.
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and Moderna Inc.
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vaccines, along with Johnson & Johnson’s
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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 in U.S. immunizations has led to dozens of incentive programs that aim to encourage people to get a shot by offering them lottery tickets, free doughnuts, and extra vacation days or paid time off from employers like American Airlines Group Inc.
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and McDonald’s Corp.
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(Some of these programs are already shutting down, often due to waning interest.)

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 to enforce its vaccine mandate, and Morgan Stanley
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is reportedly requiring immunization 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 mandatory vaccination would be on the table once a vaccine, or vaccines, is fully approved. President Joe Biden has said 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. 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, or the more worrisome view that the Johnson & Johnson single shot is not as “good” as the two-dose mRNA vaccines.

“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. A primary difference in the pricing rationale is that Moderna (and J&J) received funding from the National Institutes of Health for their clinical trials, while Pfizer did not. That’s why Pfizer, which developed its vaccine with the German biotech company BioNTech
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22UA,
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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 it will start requiring vaccination for students, faculty and staff once full approval is granted. Others including Pennsylvania State University are incentivizing students to get vaccinated, offering the chance to win a $1,000, or Barnes & Noble gift cards, or a football signed by the Penn State head coach. The school is also “strongly encouraging” everyone in its community to get vaccinated. 

“There’s a lot of indication that there are other universities that are [awaiting full FDA vaccine approval] to mandate,” said Dorit Rubinstein Reiss, a professor at the University of California Hastings College of the Law. 

University administrations, faculty and students are eager to return to some semblance of normalcy — and widespread vaccination could be key to this effort. The American College Health Association, which represents college health and wellness professionals, said in May that if campuses require vaccination and transmission in the off-campus community is low, then testing, masking and distancing requirements could be relaxed. 

That said, it’s likely going to take longer before we see widespread vaccination requirements for K-12 students. Pfizer’s vaccine most likely won’t be authorized for children 6 and over until autumn. (It was authorized in early May for 12- to 15-year-olds.)

States have the power to mandate vaccination as a condition of attending public or private school, but the courts are likely to limit states to mandating vaccines that have full FDA approval, according to Lawrence Gostin, director of the World Health Organization Collaborating Center on National & Global Health Law. 

It’s unlikely the Centers for Disease Control and Prevention would recommend a school mandate until there’s more data on the impact of the vaccine on young children, Gostin wrote in an email. The CDC is recommending that children and teens who are at least 12 get the vaccine. 

In a recent opinion piece published in JAMA, Gostin and two co-authors said they worried that COVID-19 vaccine mandates for children could create public backlash that would undermine the vaccine rollout. Once there’s longer-term safety data, including what is called “post-marketing surveillance data” on the vaccine, and high public acceptance of it, Gostin said he expects the CDC to recommend vaccination in children as a condition of going to school in person. — Jillian Berman

More employers — or at least several more — will make vaccination a requirement.

Heated emotions, worker shortages and legal questions have turned employer vaccination mandates into a tricky topic.

Full FDA approval might prompt more mandatory vaccination policies, but don’t expect a wave of companies requiring staff to get COVID-19 shots, said attorney Patricia Pryor.

“I don’t think it will be a lot more, quite honestly,” said Pryor, a principal at law firm Jackson Lewis, where she represents company management. “When we are in the situation we are in now, where employers are desperate to find workers, a lot of them can’t take the practical risk of chasing workers out.”

Even now, with emergency authorizations in place, guidance from federal workplace regulators and a recent court decision backing Houston Methodist’s mandatory vaccination policy are already clearing the way for bosses to insist on vaccination for in-person work.

Nevertheless, polling suggests many businesses aren’t forcing the issue. Just 3% of companies in a recent survey said they were requiring shots, and a 4.8% national average of small businesses said they were doing the same, according to Census Bureau data.

Even if it does little more than chip away at the margins, a full FDA stamp of approval could both sway management at some companies to consider a mandate and persuade some reluctant workers to get their shots, while dissuading others from seeking to fight the requirement in court, Pryor observed.

The now-dismissed lawsuit challenging the Houston Methodist system’s policy, as well as several other pending cases, argue employers cannot mandate vaccinations that are available only under emergency-use authorization. The case is being appealed. At least 150 workers have lost their jobs as a result of the hospital-system mandate.

It’s possible hospitals and healthcare providers will be the source of most future COVID-19 vaccine mandates, Pryor said. But that doesn’t make hospitals immune to larger economic forces. “They, like everyone, have that labor-shortage issue, and they’d better have a plan in place to address it,” she said. — Andrew Keshner

International travel mandates are setting the tone for airlines and cruise operators, but broad requirements aren’t expected in the U.S.

With Americans on the move again, pressure has built on travel companies to come up with policies toward vaccination.

Here’s how complicated some of the airline policies are:

• American Airlines Group Inc. AAL is not requiring vaccinations for staff or passengers, though a spokesperson said in a statement that the company is encouraging employees to get vaccinated and that employees will be required to do so if they are traveling to a destination that mandates COVID-19 immunization.

• Delta Air Lines Inc. DAL is requiring new but not current employees to be immunized. It doesn’t expect the U.S. government to require vaccines for domestic travel, but other countries might, according to a spokesperson.

That said, dozens of countries are requiring American travelers to be vaccinated, including Bermuda, Ecuador, Greece and France, according to reports.

And Celebrity Cruises Inc., a privately held cruise line, recently said all of its ships will have vaccinated crew members, and all guests from the U.S. who are at least 12 years old must be vaccinated, beginning Aug. 1. A ship that set sail on Saturday was the first to leave a U.S. port in more than a year, the company said.

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