Pfizer vaccine gets full approval from the FDA — what it means for travelers
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The U.S. Food and Drug Administration (FDA) announced it would grant full approval for the Pfizer-BioNTech COVID-19 vaccine in the United States on Aug. 23. The approval now replaces the emergency use authorizations (EUA), and the vaccine will now be marketed as Comirnaty rather than Pfizer.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” acting FDA commissioner Janet Woodcock said in a statement. The FDA said the vaccine underwent “thorough and thoughtful evaluation” and that the agency examined hundreds of thousands of pages of data and inspected manufacturing facilities.
The move comes as positive cases rise in the U.S. and some destinations mull new restrictions on travel. But now that one vaccine has won FDA approval, what does it mean for travel? Or does it mean anything at all? Here’s what we know so far — and what we don’t.
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Woodcock said that while Pfizer and two other vaccines available in the U.S. have been approved for emergency use authorization, “the public can be very confident that [the Pfizer vaccine] meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.”
The FDA said the Pfizer vaccine was 91% effective in preventing the COVID-19 disease during clinical trials. It’s important to note that the full approval only applies to the Pfizer vaccine — not Moderna or Johnson & Johnson, which are still under emergency use authorization.
According to U.S. Centers for Disease Control and Prevention (CDC) data, 92 million Americans have received the Pfizer vaccine.
The approval news comes shortly after the FDA authorized COVID-19 booster shots for people with weakened immune systems in mid-August.
The FDA classifies these individuals as people who have undergone solid organ transplants or those who are diagnosed with conditions “that are considered to have an equivalent level of immunocompromised.” Pfizer and Moderna booster shots are available starting Sept. 20, while the Johnson & Johnson booster shot is still in clinical trials.
But this final approval from the FDA takes away any doubt the government might have had about the efficacy of at least one of the vaccines.
The Pfizer vaccine is no longer only authorized for emergency use but is a fully-vetted vaccine in the eyes of the FDA. And the CDC told TPG that its Advisory Committee on Immunization Practices would discuss its updated recommendation of the vaccine on Aug. 30.
With these systems of checks and balances in place, it’s likely that at least some people waiting for FDA approval will be convinced to get vaccinated.
But beyond how people in the U.S. may personally feel about the COVID-19 vaccines, this approval could lead to broader implications for vaccine mandates in the travel and tourism spaces.
What the FDA approval means for travel
The FDA approval of the Pfizer vaccine could accomplish two critical tasks: persuading hesitant Americans to get vaccinated against COVID-19 and making it easier for travel and tourism companies to mandate vaccines.
Experts hope those on the fence will feel comfortable being vaccinated, and there is data that backs up that belief.
In one Kaiser study earlier this summer, 44% of Americans said they were “more likely to get vaccinated” if one of the vaccines currently authorized for emergency use received full approval from the FDA. According to data from Johns Hopkins University, 52% of Americans have been fully vaccinated against COVID-19. But unvaccinated pockets of the United States are experiencing dangerous surges of the virus.
At this point, it’s unclear what exactly full approval will mean for travel.
The surge in positive cases fueled by the delta variant has led states, cities and jurisdictions that fully reopened to impose new restrictions or vaccination requirements. While New York City fully reopened earlier this summer, it now requires require proof of vaccination to participate in many indoor activities. Proof of vaccinations and masks will also be required to attend Broadway shows.
And it’s not just cities requiring vaccinations: Royal Caribbean cruisers ages 12 and older will now have to show proof of vaccination to sail from Florida. (The cruise industry has been embroiled in a very public spat with Florida Gov. Ron DeSantis, who issued an executive order barring businesses from mandating vaccinations).
However, companies that were squeamish about requiring vaccinations might now be more inclined to do so — and could point to the FDA approval for cover. In the U.S., several airlines, Amtrak and theme parks such as Disney World have required employees to get vaccinated (but not travelers). But with full approval, it would not be outside the realm of possibility that more travel providers would require proof of vaccination.
There’s been little reaction from the travel industry about the FDA approval, but the U.S. Travel Association maintained vaccination was the “fastest path back to normalcy, including widespread travel.”
“Vaccines have proven safe and highly effective, and now with full FDA approval, there is no reason why anyone should further delay getting a shot,” said Tori Emerson Barnes, vice president at the U.S. Travel Association, in a statement on Aug. 23.
What about children?
Approving children for vaccination is crucial in the fight against the pandemic and could lead to more families feeling comfortable enough to book travel. Many parents have been waiting to hear about vaccinations for kids before booking family trips, and people traveling with unvaccinated children may be wondering what the FDA’s announcement means for their travel plans.
Vaccinated travelers with unvaccinated children or children ineligible for vaccination often have to navigate two different sets of rules, which can be confusing. While vaccinated adults may be able to forgo pre-travel restrictions, kids may have to jump through additional hoops, including, in some cases, pre-travel testing.
It’s important to note that the FDA’s approval only applies to people 16 and older. But in reading the approval, not much has changed for children 12 to 15. In mid-May, the agency announced it would expand emergency authorization for the use of the Pfizer COVID-19 vaccine for children aged 12 and up. That EUA remains in place even with the FDA’s most recent announcement. And, just remember that going forward, the Pfizer vaccine will be marketed as Comirnaty.
The Moderna and Johnson & Johnson vaccines are still only available to people 18 and older at this time, though trials are in progress.
Featured photo by Paul Chinn/The San Francisco Chronicle via Getty Images.
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