FDA Grants Pfizer Vaccine Full Approval
The agency is fast-tracking Moderna’s request, while Astra Zeneca is delaying its application
August 29, 2021
Last week, the Food and Drug Administration granted full approval to the COVID-19 vaccine developed by Pfizer and BioNTech, making the vaccine the first in the US to gain full authorization. Days later, biotech firm Moderna announced it has completed its submission to the FDA for full approval of its COVID-19 vaccine, expected to be granted in a matter of weeks.
Previously both the Pfizer-BioNTech and Moderna vaccines were being administered in the US under emergency use authorizations, which the FDA granted to both in December 2020. However what the Pfizer-BioNTech vaccine has been granted, and what Moderna is seeking, is a Biologic License Application, or a request for full approval.
Meanwhile, biopharma company AstraZeneca has announced plans to skip emergency use authorization in the US and start the process of getting full FDA approval for its COVID-19 vaccine later this year.
Full approval from US regulators could boost public acceptance, and spur more vaccination mandates from corporations. Already the list of major corporations that will require proof of vaccination from some or all of their employees includes giants such as Walt Disney, Google, Microsoft and Walmart.
While the idea of requiring vaccinations for workers gathers steam, the response among airlines has been mixed. United Airlines, which had been an early advocate of mandates, announced that it is requiring virtually all of its 67,000 US employees to be vaccinated against the COVID-19 by no later than Oct. 25, or risk termination.
United has been joined by Hawaiian Air and low-cost carrier Frontier. However American Airlines and Southwest have stuck with “encouraging employees to be vaccinated,” but not making it a condition of employment.
Delta finds itself firmly astride the fence. The carrier – along with United – has been requiring all new hires to be vaccinated since May. But in an interview with CNBC earlier this month, CEO Ed Bastian argued, “It’s very difficult for us to come in and mandate a vaccine that isn’t even federally approved yet.”
Now that at least one vaccine has received the FDA’s blessing, more travel industry players may find it easier to demand workers be vaccinated. Indeed in many jurisdictions, even paying customers will need to provide proof they have been inoculated.
As of Aug. 17, New York state began requiring patrons of dining establishments, gyms and indoor entertainment venues – theatres, concert halls and the like – to show some kind of vaccination record. See more details here.
The vaccines New York recognizes are those “authorized for emergency use by the FDA or WHO.” Including vaccines OK’d by the World Health Organization means recipients of the AstraZeneca shots – over a billion worldwide thus far – are eligible to eat, drink and be merry in the state of New York.
But that may not be the case everywhere in the country – or around the world, for that matter.
The AstraZeneca vaccine is less expensive and easier to handle and has already seen over a billion doses distributed in more than 170 countries. However, fully vaccinated travelers from those countries may not be able to travel everywhere because the vaccine they have received is not on the list.
The discrepancy has prompted WHO to call on governments worldwide to recognize any COVID-19 vaccine it has authorized for emergency use. Following suit, the World Travel and Tourism Council is urging health authorities to develop an international standard for which vaccines are acceptable in all jurisdictions.
“The failure of countries to agree on a common list of all approved and recognized vaccines is of huge concern to WTTC, as we know every day travel is curbed, more cash-strapped travel and tourism businesses face even greater strain,” said Virginia Messina, senior vice president of WTTC, in a statement.
Now that the FDA has granted a full license to the Pfizer-BioNTech vaccine, with Moderna apparently not far behind, concerns grow that the delay in getting the AstraZeneca shot on the FDA list may mean America “will effectively remain off-limits” to the travelers from countries where that jab is common – even if Washington lifts the current travel bans in favor of travel lanes for the fully-vaccinated.
Even so, the entire picture may not be so clear-cut in other regions of the world either. For example, the AZ vaccine manufactured in Europe is approved for use in most EU countries. However, due to regulatory rules, the same vaccine made in India (under the brand name Covashield) is OK in Germany but not in Liechtenstein.
As of now, for airline passengers entering the US, the same travel limitations apply regardless of vaccination status. The administration continues to keep its ban on non-essential travel from a number of countries, including most of Europe and the UK, China, India and Brazil.
For everyone else, PCR testing, both pre-departure and after arrival, remains the order of the day for entry into the US, according to the CDC.