One day after the U.S. Food and Drug Administration’s emergency-use authorization for the Pfizer-BioNTech Covid-19 vaccine, the FAA on Saturday determined that pilots can receive the vaccine under the conditions of their FAA-issued airman medical certification. In addition, the agency said, FAA air traffic controllers subject to FAA medical clearance can also receive the vaccine.
However, these pilots and controllers "with medical certifications or medical clearances" must wait 48 hours following the administration of this vaccine before conducting safety-sensitive aviation duties, meaning flying or controlling air traffic. This waiting period applies after each dose—the Pfizer vaccine requires two doses, 21 days apart for maximum effectiveness.
“The FAA anticipates taking no additional measures to ensure safety after the initial window for side effects closes,” it said. “However, the agency’s medical professionals will continuously monitor the initial distribution of the novel vaccine and documented clinical results and will adjust these recommendations as needed.”
Meanwhile, the FAA said it will evaluate vaccines from other manufacturers as they receive FDA authorization in the coming weeks and months and will advise pilots and air traffic controllers of any waiting periods required for those vaccines. The agency said it applies similar waiting periods after administration of other vaccines, including those for tuberculosis and typhoid.
In immediately approving the use of the Pfizer-BioNTech Covid-19 vaccine following the U.S. Food and Drug Administration’s emergency-use authorization, the FAA calmed growing concerns within the pilot community about the potential threat to their medical certificates should they get vaccinated against the pervasive virus.
The day after the FDA had announced emergency-use authorization on late Friday, December 11, the FAA had issued its announcement that pilots can receive the vaccine under the conditions of their FAA-issued airman medical certification. In addition, the agency said, FAA air traffic controllers subject to FAA medical clearance can also receive the vaccine.
However, these pilots and controllers "with medical certifications or medical clearances" must wait 48 hours following the administration of this vaccine before conducting safety-sensitive aviation duties, meaning flying or controlling air traffic. This waiting period applies after each dose—the Pfizer vaccine requires two doses, 21 days apart for maximum effectiveness.
“The FAA anticipates taking no additional measures to ensure safety after the initial window for side effects closes,” it said. “However, the agency’s medical professionals will continuously monitor the initial distribution of the novel vaccine and documented clinical results and will adjust these recommendations as needed.”
The FAA notice, which came on a Saturday afternoon, marked an unusual step for the agency, which typically takes up to a year before adding new vaccines to its approved list. But given the nature of the pandemic and recognizing the urgency of the action, the FAA made good on its promise to take swift action.
In the weeks leading up to the vaccine approval, the FAA had issued a statement that it was “closely monitoring the active vaccine trials and awaiting the outcome of the Vaccines and Related Biological Products Advisory Committee’s scheduled meeting” and while no final decisions were yet made, “we are prepared to evaluate the use of each vaccine by medical certificate holders as soon as an emergency use authorization is issued.”
That statement came as numerous pilots had expressed their concerns on chat boards and through outreach to a number of aviation associations. The Air Line Pilots Association had publicly urged the FAA to approve Covid-19 vaccines for pilots to avoid the risk to their medical certificates, while a number of other associations had discussed concerns with the agency.
Doug Carr, v-p regulatory and international affairs for NBAA, had stressed the importance of waiting until a vaccine is approved, noting that taking unauthorized medication could cause groundings. He had noted that this could hold true with participation in vaccine trials. But at the same time, he expressed the belief that the FAA was working to make the process manageable.
“We are grateful to the FAA for taking this immediate and proactive step to address medical certification concerns related to COVID-19 vaccinations that will aid in keeping the aviation industry moving forward,” said NBAA president and CEO Ed Bolen after the announcement of the first vaccine approval. “[FAA] Administrator [Steve] Dickson’s previous military and civilian aviation experience continues to offer him unique insights on pilot-focused challenges, which in this case have proven astute.”
The Pfizer-BioNTech vaccine was the first of many that have been on track for FDA review. Moderna's review was to follow a week later, and by mid-December well more than a dozen other candidates were in final-stage trials.
The FAA said it would evaluate vaccines as they receive FDA authorization and would similarly advise pilots and air traffic controllers of any waiting periods required for those vaccines.
The agency’s approach to the vaccines follows its pattern of how it has handled other vaccines. John McGraw, v-p of regulatory affairs for the National Air Transportation Association, said the FAA has approached the Covid-19 virus, for the most part, as it has other viruses such as the flu. “So far what we’ve heard from the FAA has been consistent with how they’ve treated things in the past,” he said.
The agency does recommend pilots schedule waiting periods after taking a vaccine, but “it is not a disqualifying event,” he said, adding that unless there were something truly unique about a particular vaccine, “I would expect the FAA to take the same posture” as the vaccines come up for review.
McGraw cautioned, however, “You do have a responsibility that you do feel fit to fly.”
As the vaccines become available, ALPA urged that pilots have priority access. Meanwhile, the first batches of vaccines were shipped almost immediately, the initial one from Michigan's Gerald R. Ford International Airport on December 13.
Leading up to that flight—a FedEx shipment—air carriers worked in concert with the FAA on the safe handling and transport of the vaccine, including trial runs. The FAA in October had formed a Covid-19 Vaccine Air Transport Team to ensure the system was ready and more recently issued a Safety Alert for Operators cautioning that carriers need to take several extraordinary safety measures when preparing to transport vaccines at temperatures of minus 70 deg C. Special handling is required because most transport requires an unusual amount of dry ice, which sublimates faster due to lower pressure at altitude and could replace oxygen needed by flight crew.
“Our team is enabling these efforts scientifically and in a disciplined but innovative fashion, by using the safety risk management tools that are part of our safety management systems,” Administrator Dickson told the Aero Club of Washington in December.
These efforts—from approving use to transporting the vaccine—do not stem from an “abstract concept for us,” Dickson stressed. “We know it will save lives. The FAA is grieving the loss of several of our own from Covid-19. We honor their memories—and their families—by continuing the agency’s important work, particularly as it relates to Covid-19 response and recovery and, now, vaccine distribution.”