Since the onset of the COVID-19 public health emergency, the Federal Aviation Administration (FAA) has worked proactively with other U.S. government agencies, air carriers, and other aviation stakeholders to enable the safe and efficient transportation by air of critical medical supplies and personnel. As part of the U.S. Department of Transportation's overall efforts, the FAA established the FAA COVID-19 Vaccine Air Transport Team in October 2020 to aid in the safe, expeditious, and efficient transportation of vaccines.
Several vaccines need continued cold temperatures during transport, which may require dry ice (a hazardous material) to maintain very low temperature. The FAA works with manufacturers, air carriers and other aviation stakeholders to provide guidance on implementing current regulatory requirements for safely transporting large quantities of dry ice in air cargo. In addition to mitigating safety hazards related to transporting vaccines by air, the FAA works with stakeholders to determine any additional needs for air navigation services support. This includes prioritizing flights carrying COVID-19 vaccines, as well as offering around-the-clock air traffic services to keep air cargo moving seamlessly and providing personnel critical to the nation's response to and recovery from COVID-19.
The Vaccine Team employs a multi-disciplinary, integrated approach to coordinate FAA planning and preparedness for flights carrying COVID-19 vaccines. The Team engages external stakeholders to share ideas, successes and challenges, as well as to gather information related to the transportation by air of the COVID-19 vaccines being developed around the world. As potential issues emerge, the Team uses existing FAA policies and procedures to explore and address potential issues and outcomes in the following key areas.
The amount of dry ice that can be safely carried on an aircraft is a function of dry ice sublimation rates, aircraft system capabilities, airline procedures and risk mitigation controls. Packaging advancements can also result in a decrease in the sublimation rate of dry ice and enable an increase in the amount of dry ice that can be safely carried on an aircraft. Air carriers, working closely with the FAA, are using their Safety Management Systems (SMS) to evaluate their ability to safely increase the amounts of dry ice they carry, and determine any necessary safety mitigations.
The FAA reviews the air carrier's risk assessment and mitigation plan before accepting the air carrier's safety approach. This includes reviewing the air carrier's identified hazards, risk controls and mitigation strategies to ensure the aircraft can be safely operated under the specific conditions presented by carrying increased amounts of dry ice.
The FAA also recommends that operators without an FAA-approved SMS conduct safety analyses and determine risk mitigations when planning to transport increased quantities of dry ice. On Dec. 10, the FAA issued a Safety Alert for Operators that identifies specific considerations related to the air transport of dry ice (PDF).
The FAA tested a sample of vaccine packaging containing dry ice to better understand potential changes in dry ice sublimation rates in the air carrier operational environment (i.e., at altitude and during ground operations). The testing also considered whether the size of the dry ice pellets used would affect the dry ice sublimation rate. The intent was to ensure that air carriers understand the potential risks when considering dry ice limits, conducting safety risk assessments and identifying corresponding mitigations. The FAA plans to publish the test results once the agency's analysis is complete and it has summarized its initial findings in a Safety Alert for Operators (SAFO 20017). The FAA's testing is not intended to replace testing that packaging manufacturers perform, or the safety risk assessments of air carriers. Packaging manufacturers have the ultimate responsibility to ensure that stated sublimation rates and testing parameters are captured and communicated to entities that use their packaging.
The FAA engages with air carriers and operators to identify issues, actions and potential needs for regulatory authorizations, approvals and permits to enable safe flight operations and provide guidance and information to operators and inspectors to promote a consistent approach to aviation safety.
- Advisory Circular 91-76A – Hazard Associated with Sublimation of Solid Carbon Dioxide (Dry Ice) Aboard Aircraft
- Transportation of COVID-19 Vaccines Requiring Large Quantities of Dry
- Preliminary Results of Dry Ice Tests to Support Safe Shipment of COVID-19 Vaccines (PDF)
The FAA is evaluating the use of each vaccine by medical certificate and medical clearance holders as soon as the U.S. Food and Drug Administration (FDA) issues an emergency use authorization (EUA). On Dec. 12, 2020, the day after the FDA issued the EUA for the first COVID-19 vaccine in the U.S., the FAA issued a policy statement approving pilots and air traffic controllers to receive the two-dose vaccine subject to a 48-hour waiting period after each dose before resuming sensitive-safety functions. Following the FDA's issuance of a second EUA, the FAA issued a similar policy statement for that vaccine.
- Use of Moderna, Pfizer and Johnson & Johnson COVID-19 Vaccines by Pilots and Air Traffic Controllers
Air Traffic Control/Airspace Management
The FAA tracks, prioritizes and coordinates vaccine flights throughout U.S. airspace, as necessary, and has established supporting processes to monitor and report information about the transportation of vaccines by air.
On Dec. 11, 2020, the FAA provided guidance to U.S. airports on operational considerations during vaccine transportation by air. This included coordination with local, state, and federal government agencies on security and inspections; airport capacity and design capabilities; evaluation of current Airport Rescue and Fire Fighting coverage at primary and divert airports; and vehicle and pedestrian operations.
Carriage of Dangerous Goods/Hazardous Materials
Air carriers and other operators must continue to follow existing requirements for transporting dry ice in packages by air, as well as for lithium-battery-powered data loggers/trackers that may accompany vaccine shipments. FAA regulations at 14 CFR § 25.831 state that carbon dioxide concentration during flight must be shown not to exceed 0.5 percent (5000 ppm) by volume (sea level equivalent) in compartments normally occupied by passengers or crew. The FAA has addressed issues related to lithium-battery-powered data loggers/trackers in Advisory Circular 91.21-1D — Use of Portable Electronic Devices Aboard Aircraft. In addition, air carriers that want to transport dangerous goods, such as dry ice or lithium batteries, must state on their operating certificate that they will carry dangerous goods, and have the appropriate procedures for doing so. Advisory Circular 121-40 – 14 CFR Part 121 and Part 135 Dangerous Goods Transportation Operations provides air carriers and other operators with recommended contents for a dangerous-goods training program and manual designed to guide and manage dangerous-goods operations.
The Vaccine Team also recognizes that effective communication and timely information sharing are critical to the success of the overall vaccine distribution effort. Of particular importance is developing processes to communicate information about flights carrying vaccines to U.S. and foreign government authorities, as well as information sharing about potential barriers to the efficient and safe air transportation of the vaccines around the world. The FAA is working closely with external stakeholders to explore and address all potential safety issues using Safety Management System principles in a risk-management framework. In addition, the FAA is working closely with the Department of Transportation, Department of Homeland Security, Department of Health and Human Services, and Operation Warp Speed to support a consistent and well-informed U.S. government approach to this effort.
The global aviation community will play an integral role in achieving the safe, efficient, timely and secure distribution of COVID-19 vaccines. The delivery of these vaccines will also aid in the recovery of the air transportation industry. The FAA will continue to share best practices and actively engage with the aviation community to address the current and evolving challenges posed by the scope, volume and time constraints of transporting these vaccines by air.
- FAA's Information Paper on: Managing Safe and Efficient COVID-19 Vaccine Transportation by Air in the United States (PDF)
- EASA's Guidelines for Use of Cargo Tracking Devices (in relation to the COVID-19 pandemic)
- EASA issues guidance on use of dry ice in COVID-19 vaccine transportation
- Safe transport of COVID-19 vaccines on commercial aircraft (International Civil Aviation Organization)
- ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air (PDF)