Worldwide demand for COVID-19 vaccines will result in a significant increase in the volume of vaccines offered for air transport. The purpose of this guidance is to identify the specific areas related to the air transport of vaccines that may require action by the operator and regulator to facilitate the safe air transport of vaccines.
It is understood that by complying with the requirements of Annexes 6, 18, 19 and the Technical Instructions for the Safe Transport of Dangerous Goods by Air (Doc 9284, Technical Instructions) operators will be able to safely accept, handle and transport these vaccines.
The transport of vaccines must comply with the detailed provisions of the Technical Instructions where the vaccines are classified as dangerous goods, or the vaccines are shipped with dry ice as a refrigerant, or data loggers and cargo tracking devices are included in packages or attached to packages or overpacks.
The UN Sub-Committee of Experts of the Transport of Dangerous Goods (57th session) confirmed that genetically modified micro-organisms based vaccines authorized for use (including clinical trials) are not subject to the UN model regulations for transport. As a result, ICAO is currently reviewing the applicability of the Technical Instructions to genetically modified vaccines and will be issuing advice through a State letter shortly. As such this issue has not been addressed in the following guidance.
Changes to the Technical Instructions (TIs) to remove some of the normal marking requirements for packages containing vaccines and lithium batteries contained in equipment are being considered by ICAO. If and when these changes are approved in ICAO, any hazards and risks associated with the change may need to be mitigated by other means. Further information will be provided below in the event of this change being approved.
Chapter 15 to Annex 6, Part I (applicable Nov 2020) requires a risk-based assessment, in addition to the prescriptive requirements in the Technical Instructions, for operators transporting items in the cargo compartment. The elements of the safety risk assessment set out in Chapter 15 to Annex 6, Part I have been used as the basis for reviewing the changes proposed to the existing requirements to determine what additional risk mitigations may need to be implemented.
The following key issues have been identified in relation to the carriage of COVID-19 vaccines
1. Data loggers and cargo tracking devices (batteries & quantities)
Data loggers and cargo tracking devices may be required to monitor the temperature and location of vaccines during transport. Most such devices are powered by lithium batteries and the packages need to be properly identified as such. The following table identifies the hazards associated with the data loggers and trackers transported, and the considerations for the operators risk assessments.
2. Data loggers and cargo tracking devices (EMI)
Inclusion of transmitting/receiving devices in packages for the purposes of tracking and data logging (e.g. of temperature) has the potential for electromagnetic interference with aircraft systems. The potential risk to the operations needs to be assessed.
3. Requirement for carriage of quantities of dry ice in excess of that previously specified by operator for the aircraft type
At present, many of the vaccines need to be transported in temperature controlled conditions. These conditions are specific to the vaccine itself. For example, some of the vaccines need to be kept at temperatures that require dry ice (carbon dioxide, solid) for cooling purposes. The volume of vaccine to be transported means that the quantity of dry ice proposed for carriage exceeds that previously specified for the aircraft type in the operator's manuals. A review of the risk assessment based on the considerations provided may be needed.
Guidance to support the operators risk assessment process
The following tables provide guidance for both the air operator and the regulator to facilitate a common understanding of the requirements. It is structured around each element the operator is required to consider as part of its specific safety risk assessment and based on Guidance for Safe Operations Involving Aeroplane Cargo Compartments (Doc 10102). However, where the vaccine supply chain requires use of smaller aircraft without cargo compartments, this material can still be used as some guidance to develop the associated risk assessments for these types of operations. Different mitigation strategies may need to be developed depending upon the type of aircraft and operation considered.
Packages of vaccines may contain multiple elements such as:
For each identified element in the package, the following considerations will need to be addressed, to maintain safe operations.
The tables should not be considered as an exhaustive or limiting list and each operator is expected to tailor the tables as necessary for the individual case and context.
Specific guidance to conduct risk assessments with respect to operations that involve the transport of items in the cargo compartments of an aeroplane can be found in Doc. 10122. Further guidance on safety risk management can be found in Chapter 2.5 of the Safety Management Manual (4th edition).