Full Vaccine Approvals Seen as Boon for Post-Pandemic Protection

U.S. availability of two fully approved Covid-19 shots sets the stage for normalizing vaccination post-pandemic and could beef up incentives for remaining holdouts, health policy professionals say.

Moderna Inc.‘s Spikevax joins the ranks of Pfizer Inc. and BioNTech’s Comirnaty as the second Covid-19 vaccine approved by the FDA and recommended by the Centers for Disease Control and Prevention. Lingering vaccine hesitancy means the country won’t see an immediate uptick in inoculation rates, but the government’s latest action could still ease distribution challenges, encourage more employers to offer boosters, and eventually sway Americans who are leery to get the shot.

“As we learn to live with the virus, this is a vaccine we’re going to need in the future,” said Syra Madad, senior director of NYC Health + Hospitals’ System-Wide Special Pathogens Program. FDA approval “will be important going forward in helping people feel confidence.”

The Food and Drug Administration’s first full approval of Pfizer‘s vaccine in August 2021 paved the way for the Biden administration and employers to more boldly push for vaccination requirements while encouraging Americans to get immunized. Approval of Moderna’s shot on Jan. 31 only furthers those efforts.

Full approval of a Covid vaccine “wasn’t just a one-off FDA decision. Now it’s a second one,” said Barbara Binzak Blumenfeld, a Buchanan Ingersoll & Rooney FDA attorney with a background in molecular biology and biomedical ethics.

But while the move marks an important milestone in cementing Covid-19 jabs as a routine vaccination, health and legal experts say it may not be enough in the short term to turn the tide against the virus.

“Anything we can do at this point to encourage the unvaccinated is going to be helpful,” said Harsha Thirumurthy, associate director of the University of Pennsylvania’s Center for Health Incentives and Behavioral Economics. But “I’m not very optimistic it’ll result in the large-scale increase in vaccination that we need to happen.”

The CDC estimates that about 64.5% of the U.S. population is fully vaccinated. Around 43% of those individuals have received a booster as well.

‘Stamp of Approval’

Three Covid-19 vaccines are available in the U.S., but one of them—Johnson & Johnson‘s—is still only authorized for emergency use.

The FDA can grant emergency use authorizations when the government has declared a public health emergency and if the benefit of an unapproved drug outweighs the risks. Full FDA approval is a longer road, Binzak Blumenfeld said, requiring additional review and studies into drug safety and efficacy.

The agency’s Moderna full approval “shows even greater acceptance of the vaccine by the government, for both safety and efficacy,” said Julie Swann, a North Carolina State University professor who led a government-backed team for supporting public health decision-making in the pandemic.

“Hundreds of millions of doses of Moderna’s vaccine have been administered, and this full review gives the stamp of approval,” she said.

Approval could prove helpful for employers wanting to offer jabs for workers in remote locations where there “could be difficulty” accessing a vaccine, Swann said. That’s because Moderna’s shots don’t require as low a storage temperature as Pfizer’s, making doses easier to ship.

And some employers, specifically those that were leery of issuing a mandate without a fully approved vaccine, may feel even more emboldened to require vaccination, she said.

The Supreme Court in January blocked a Biden administration rule that would have required 80 million workers to get shots or routinely tested. But large employers appear undeterred by the high court. Later that month, a Gartner Inc. report found that over one-third still planned to march ahead and implement vaccine requirements.

Swann added that vaccine coverage “may change” after the public health emergency ends, “so full approval makes it easier to ensure ongoing coverage by insurance companies including Medicare.”

Wait and See

Health and policy experts say notable increases in immunization spurred by Moderna’s approval won’t be immediate.

As of January, about 4% of the public said they would “wait and see” before getting a Covid-19 shot, according to Kaiser Family Foundation data. That segment would account for those who could be convinced by an FDA approval. The KFF found that 14% of respondents said they would “definitely not” get vaccinated and 3% would but “only if required.”

Misinformation, speed of vaccine development, perceived novelty of the technology and distrust of the American health system are among the culprits blamed for lagging vaccination rates. Skepticism increased during the omicron surge, as more vaccinated and boosted Americans counted themselves among the infected.

There’s “a desire to see more regulatory approvals of vaccines,” Thirumurthy said, but the number of “Americans still on the fence is a smaller number” than following the FDA’s full approval of Pfizer’s vaccine.

Yet as public health experts get a grasp on the next stages of the health crisis—whether it be new variants, a future endemic state or other possibilities—many agree that Covid-19 infections are here to stay. Vaccinations and boosters could become an annual need, much like flu shots, Madad said.

This makes FDA approval more meaningful in the years ahead “if and when we’re in a much more routine pattern, and can continue to save lives with this vaccine,” she said.