FAA Issues Guidance for Pilots on First COVID-19 Vaccine

The very fluid situation surrounding emergency-use authorization of the COVID-19 vaccine from Pfizer-BioNTech has moved fast in the last few days, and initially, pilots, unions, and aviation associations were in a holding pattern awaiting guidance from the Federal Aviation Administration (FAA). The question to be answered was whether pilots—especially those who make their living flying professionally—could fly after receiving doses of the vaccine without medically disqualifying themselves.

On Saturday morning, FAA issued their guidance that clarifies use of COVID-19 vaccines by pilots and air traffic controllers. “The COVID-19 public health emergency has driven extraordinary global efforts to develop an effective and safe vaccine. Some of the vaccines in clinical testing are using novel technology, such as mRNA. After careful review of available data regarding safety profiles, the FAA Office of Aerospace Medicine (AAM) has adopted the policy as both safe and operationally responsive to this unique situation, that holders of FAA-issued Airman Medical Certificates or Medical Clearances may receive the Pfizer-BioNTech COVID-19 vaccine; however, a 48-hour no-fly/no safety-related duty interval must be observed after each dose.”

In their guidance, FAA made clear that their Office of Aerospace Medicine will be monitoring the patient response to the Pfizer-BioNTech vaccine and may adjust their policy as necessary to ensure aviation safety. Additional vaccines will be evaluated separately as emergency use authorizations (EUAs) are issued.

On December 10, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted 17 to 4 in support of the FDA granting the EUA for the companies’ COVID-19 mRNA vaccine. That vote led to the FDA granting the Pfizer vaccine a EUA on Friday night that allows the vaccine to start being distributed and given to the public.

In a comment to Flying Magazine, Stephen D. Leonard, MD, FACS, chairman of the Experimental Aircraft Association’s Aeromedical Advisory Council, said that “all available information suggests that these new vaccines are very safe and remarkably effective. The only side effects have been the usual flu shot side effects of temporary soreness at the injection site and perhaps a day or two of mild, generalized aches and fatigue. Given the potential severity of COVID-19 infection and the terrible toll it has taken on our lives and our economy, I strongly recommend that everyone take this vaccine, to protect themselves and to end this pandemic. I certainly will, as soon as it is available to me.”

Other major aviation associations are now disseminating this information to their memberships. AOPA president and CEO Mark Baker stated, “We applaud the FAA Office of Aerospace Medicine for carefully reviewing the data and quickly releasing a policy that allows pilots and air traffic controllers to receive the vaccine and continue working and flying after a brief period, and that FAA anticipates taking no additional measures to ensure safety after the initial window for side effects closes.”

The National Business Aviation Association (NBAA) welcomed prompt action by FAA Administrator Steve Dickson and acting Federal Air Surgeon Dr. Brett Wyrick to ensure business aviation pilots may be vaccinated against COVID-19 without risk to their medical certificate. Without such an order, pilots receiving vaccines that have not received full FDA approval risked invalidating their medical certificates. “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.

While not a full FDA approval, the EUA for the Pfizer-BioNTech COVID-19 vaccine “holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 vaccine because the vaccine’s known and potential benefits outweigh its known and potential risks,” Marks said.

The FDA website clearly described precisely how the Pfizer-BioNTech vaccine works. “The Pfizer-BioNTech COVID-19 vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2,” the FDA said.