Safe transport of COVID-19 vaccines on commercial aircraft

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 (57^th 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:

the vaccine component itself;
data loggers and cargo tracking devices powered by lithium batteries, and that emit electromagnetic radiation that have the potential to interfere with aircraft systems; and
dry ice.
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).

Data loggers and cargo tracking devices (batteries & quantities)

a) hazards associated with the properties of the items to be transported;
Hazard Description	Information to support hazard assessment
Increased quantities of data loggers and cargo tracking devices containing lithium batteries.	Operator may not know the contents of the package – most vaccine packages will contain a data logger even if not marked as such For transport of COVID-19 pharmaceutical packaging for use or re-use, prior arrangements with the operator are required which should include the nature and quantity of lithium battery powered devices, even when not marked as such. Examples of prior arrangements with the operator include: Example 1 Information provided by the shipper that the cargo will contain lithium battery-powered data loggers / cargo tracking devices when making the booking for the cargo, that these devices have been approved by the operator and that this information will be sent to the operator if the booking is not made with the operator; Example 2 The shipper is using a data logger / cargo tracking device that is a type approved by the operator for carriage on their aircraft. The transport document such as an air waybill or other similar document contains a statement that approved devices are present. Lithium batteries can enter a thermal runaway and become a potential ignition source as a result of failure due to damage or internal quality issues. Lithium batteries generally contain an electrolyte that can become a fuel source for a fire. Capabilities of the aircraft fire suppression systems - see section d) could be exceeded Specific considerations: Manufacturer testing (38.3 of UN manual of tests and criteria) still applies. The number of lithium battery devices within the package should be taken into consideration.
b) capabilities of the operator
	Identification by the operator of the contents of the package may not be possible with an inspection – there is a need to ensure the operator has full knowledge of contents regardless of the marking or labelling that may or may not be displayed on the package. Prior arrangement should have been made for the transport of COVID-19 pharmaceutical packaging for use or re-use, to ensure the operator has this information. Acceptance for transport should be only by operators with specific approval for carrying dangerous goods as cargo and with suitable training. Training and procedures are required to ensure damaged items are not accepted for transport, regardless of whether the label indicates lithium battery contents or not
c) operational considerations;
	Operators need to ensure they are provided with the information regarding the content of the packaging and can take measures to ensure the type and quantity is consistent with the capabilities of the aircraft cargo compartment (see section d) and the procedures of the operator. Loading of packages must not exceed maximum quantities identified by the operator for the carriage of lithium batteries in the cargo compartment. Where packaging without COVID pharmaceuticals is being transported for re-use, the operator needs assurance that such packaging will still protect against damage to lithium battery-powered devices.
d) capabilities of the aircraft and its systems;
	Size, type and quantities of batteries need to be assessed to ensure the capabilities of the cargo compartment, and in particular of its fire protection or suppression system, are not exceeded
e) containment characteristics of unit load devices;
	None
f) packing and packaging;
	Compliance with packing requirements detailed in the Technical Instructions is still essential even where marking of the contents (lithium batteries) may not be mandated Design of the package and/or the data loggers and cargo tracking devices should minimize the risk of damage to the contained lithium cells or batteries.
g) safety of the supply chain for items to be transported;
	None
h) quantity and distribution of dangerous goods items to be transported
	Operators should consider the risks of loading these shipments with other flammable dangerous goods.

Data loggers and cargo tracking devices (EMI)

a) hazards associated with the properties of the items to be transported;
Hazard Description	Information to support hazard assessment
Data loggers and cargo tracking devices used in monitoring the transport of the vaccine	Operator may not know the contents of the package Specific details regarding acceptable transmissions not known by the operator Potential for the electromagnetic radiation from such devices to interfere with the aircraft systems
b) capabilities of the operator
	Identification by the operator of the contents of the package may not be possible from inspection – there is a need to ensure operator has full knowledge of contents regardless of marking or labelling Operator approves the carriage of data loggers and cargo tracking devices based on information from the device manufacturer confirming compliance with applicable standards and airframe manufacturer regarding the Portable Electronic Device (PED) tolerance of the aircraft.
c) operational considerations;
	Portable Electronic Devices that have a transmitting function should meet the requirements of the State of Design such FAA AC 91.21-1D and EASA AMC1 CAT.GEN.MPA.140. EASA published Guidelines for Use of Cargo Tracking Devices in relation to the COVID-19 pandemic
d) capabilities of the aircraft and its systems;
	aircraft systems susceptibility to electromagnetic interference; the relevant information and documents from the aircraft OEM and/or Operator should be considered; Additional guidance specific to each aircraft type and model (if any), should be obtained from the aircraft manufacturer.
e) containment characteristics of unit load devices;
	None
f) packing and packaging;
	None
g) safety of the supply chain for items to be transported;
	None
h) quantity and distribution of dangerous goods items to be transported
	See c) & d) Type and quantity of data loggers and cargo tracking devices may be limited Loading on the aircraft may be subject to specific restrictions in terms of location

Requirement for carriage of quantities of dry ice in excess of that previously specified by operator for the aircraft type

a) hazards associated with the properties of the items to be transported;
Hazard Description	Information to support hazard assessment
Data loggers and cargo tracking devices used in monitoring the transport of the vaccine	Operator may not know the contents of the package Specific details regarding acceptable transmissions not known by the operator Potential for the electromagnetic radiation from such devices to interfere with the aircraft systems
b) capabilities of the operator
	Identification by the operator of the contents of the package may not be possible from inspection – there is a need to ensure operator has full knowledge of contents regardless of marking or labelling Operator approves the carriage of data loggers and cargo tracking devices based on information from the device manufacturer confirming compliance with applicable standards and airframe manufacturer regarding the Portable Electronic Device (PED) tolerance of the aircraft.
c) operational considerations;
	Portable Electronic Devices that have a transmitting function should meet the requirements of the State of Design such FAA AC 91.21-1D and EASA AMC1 CAT.GEN.MPA.140. EASA published Guidelines for Use of Cargo Tracking Devices in relation to the COVID-19 pandemic
d) capabilities of the aircraft and its systems;
	aircraft systems susceptibility to electromagnetic interference; the relevant information and documents from the aircraft OEM and/or Operator should be considered; Additional guidance specific to each aircraft type and model (if any), should be obtained from the aircraft manufacturer.
e) containment characteristics of unit load devices;
	None
f) packing and packaging;
	None
g) safety of the supply chain for items to be transported;
	None
h) quantity and distribution of dangerous goods items to be transported
	See c) & d) Type and quantity of data loggers and cargo tracking devices may be limited Loading on the aircraft may be subject to specific restrictions in terms of location