The FDA has granted full approval to the Pfizer vaccine — implications for travelers ahead.

On August 23, the U.S. Food and Drug Administration (FDA) announced that it would fully approve the Pfizer-BioNTech COVID-19 vaccine in the U.S. This approval replaces the previous emergency use authorizations (EUA), and the vaccine will now be known as Comirnaty instead of Pfizer.

Acting FDA commissioner Janet Woodcock remarked, "The approval of this vaccine marks a significant achievement in our ongoing fight against the COVID-19 pandemic." The FDA stated that the vaccine underwent a "thorough and thoughtful evaluation," reviewing hundreds of thousands of pages of data and inspecting manufacturing sites.

This decision comes as COVID-19 cases rise across the U.S., prompting some destinations to consider new travel restrictions. With one vaccine receiving FDA approval, what does this mean for travelers? Is there any impact at all? Here’s what we currently understand — and what remains unclear.

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Woodcock stated that although Pfizer and two other vaccines in the U.S. are under emergency use authorization, "the public can have great confidence that [the Pfizer vaccine] meets the FDA's rigorous standards for safety, efficacy, and manufacturing quality required for an approved product."

According to the FDA, the Pfizer vaccine demonstrated a 91% efficacy rate in preventing COVID-19 during clinical trials. It’s crucial to highlight that this full approval is specific to the Pfizer vaccine, while Moderna and Johnson & Johnson remain under emergency use authorization.

Data from the U.S. Centers for Disease Control and Prevention (CDC) indicates that 92 million Americans have received the Pfizer vaccine.

This approval announcement follows the FDA’s authorization of COVID-19 booster shots for individuals with compromised immune systems in mid-August.

The FDA identifies these individuals as those who have had solid organ transplants or are diagnosed with conditions that equate to a similar level of immunocompromise. Booster shots for Pfizer and Moderna will be available starting September 20, while the Johnson & Johnson booster is still undergoing clinical trials.

However, this final approval from the FDA eliminates any uncertainties the government might have had regarding the effectiveness of at least one vaccine.

The Pfizer vaccine is now not just under emergency use authorization but is recognized as a fully approved vaccine by the FDA. The CDC informed TPG that its Advisory Committee on Immunization Practices will review its updated vaccine recommendation on August 30.

With these checks and balances established, it’s probable that some individuals awaiting FDA approval will feel encouraged to get vaccinated.

Beyond individual sentiments in the U.S. regarding COVID-19 vaccines, this approval could have wider implications for vaccine mandates within the travel and tourism sectors.

Implications of FDA approval for travel

The FDA's approval of the Pfizer vaccine could serve two significant purposes: encouraging hesitant Americans to receive the COVID-19 vaccine and facilitating travel and tourism companies in enforcing vaccine mandates.

Experts are optimistic that those undecided will feel more comfortable getting vaccinated, supported by existing data.

A Kaiser study from earlier this summer found that 44% of Americans stated they would be "more inclined to get vaccinated" if one of the vaccines authorized for emergency use achieved full FDA approval. Data from Johns Hopkins University shows that 52% of Americans are fully vaccinated against COVID-19, yet some unvaccinated areas in the U.S. are facing severe virus surges.

At this moment, the implications of full approval for travel remain uncertain.

The rise in COVID-19 cases driven by the delta variant has prompted states, cities, and jurisdictions that had fully reopened to impose new restrictions or vaccination mandates. For example, while New York City reopened completely earlier this summer, it now requires proof of vaccination for many indoor activities. Additionally, proof of vaccination and masks will be mandatory for attending Broadway shows.

It's not just cities enforcing vaccination requirements: Royal Caribbean now mandates that cruisers aged 12 and older show proof of vaccination to sail from Florida. This comes amid a public dispute with Florida Gov. Ron DeSantis, who has issued an executive order prohibiting businesses from requiring vaccinations.

Nevertheless, companies that have been hesitant to enforce vaccination requirements may now feel more empowered to do so, potentially using the FDA approval as justification. In the U.S., several airlines, Amtrak, and theme parks like Disney World have mandated vaccinations for employees (though not for travelers). With full approval, it’s plausible that more travel providers will begin requiring proof of vaccination.

The travel industry's response to the FDA approval has been limited, but the U.S. Travel Association has reiterated that vaccination is the "quickest route back to normalcy, including a return to widespread travel."

"Vaccines have demonstrated safety and high efficacy, and now that they have full FDA approval, there’s no reason for anyone to postpone getting vaccinated," stated Tori Emerson Barnes, vice president of the U.S. Travel Association, in a statement on August 23.

What about vaccination for children?

Vaccinating children is essential in combating the pandemic and may encourage more families to feel confident about traveling. Many parents have been waiting for news on child vaccinations before planning family trips, and those traveling with unvaccinated children might be curious about the implications of the FDA's announcement for their travel arrangements.

Travelers who are vaccinated but have unvaccinated children or children not eligible for vaccination often face two different sets of rules, which can be quite confusing. While vaccinated adults may bypass some pre-travel restrictions, children might still need to fulfill additional requirements, including pre-travel testing in certain instances.

It’s crucial to understand that the FDA's approval applies only to individuals aged 16 and older. However, for children aged 12 to 15, not much has changed. In mid-May, the agency announced an expansion of emergency use authorization for the Pfizer COVID-19 vaccine for those 12 and older, and that EUA remains effective alongside the FDA's latest announcement. Additionally, the Pfizer vaccine will now be marketed as Comirnaty moving forward.

Currently, the Moderna and Johnson & Johnson vaccines are only authorized for individuals aged 18 and older, although trials are ongoing.