Understanding COVID-19 vaccines
COVID-19 vaccines were first introduced under the Regulation 174 exemption from the Medicines Act, before they had full UK Marketing Authorisations.
Their use in the mass vaccination programme meant that they were prepared and administered by staff with limited experience in dilution of vaccines and using multi-dose vials. SPS responded by providing a comprehensive set of articles and Standard Operational Procedures (SOPs) to assist the rapid establishment of vaccination centres.
The COVID-19 vaccines in use in the UK now all have Marketing Authorisations, so these detailed articles and SOPs have been retired following the Autumn 2024 vaccination campaign.
This article provides information that may be useful to sites involved in the ongoing COVID-19 vaccination programme.
Information about the vaccines
Summaries of Product Characteristics (SmPC) are available for all the COVID vaccines on the Electronic Medicines Compendium and Patient Information Leaflets (PIL) can be found in every pack.
These leaflets provide detailed information about all aspects of handling, preparing and using the vaccines. For vaccines in multi-dose containers this includes assigning a post-puncture expiry time.
Summary information including a ‘which vaccine’ poster can be found on the UK Health Security Agency (UKHSA) web pages.
Further information for healthcare professionals is available from UKHSA, and NHSE has published a Site Campaign Guide for Spring 2025.
Packaging and labels
Although the vaccines have full Marketing Authorisations (MA), denoted by the PLGB number on their SmPCs, sometimes vaccines packaged for a non-UK market are supplied with a different MA (licence) number on the carton or vial. These vaccines are still considered licensed in the UK.
Movement of vaccines
When COVID-19 vaccines were first introduced, great caution was needed because the effects of movement and vibration were not well understood. Now, the vaccines are known to be more robust; any restrictions are stated in the SmPC and PIL.
Movement of punctured vials (all multi-dose vaccines)
COVID-19 vaccines contain no preservative and the method of puncture cannot preclude the risk of microbial contamination, so SPS advises that transport of punctured vials should not be routine.
The decision to move punctured vaccine vials between locations within the same legal entity must include an assessment of the risk of microbial contamination and proliferation versus risk of wastage and loss of opportunities to administer vaccines at alternative locations.
Any decision to move punctured vials must be made locally under the direction of the Chief Pharmacist or site lead pharmacist, taking the specific circumstances into account, and using appropriate risk control measures such as temperature control, infection prevention and control, and a means to identify that the vial has been punctured.
If it is essential to transport a vial of any vaccine after first puncture, it should be in a cool box at 2 to 8°C and the vial must be used within 6 hours of first puncture. If a vaccinator has punctured and unpunctured vials in their possession, it is essential they are stored and transported separately to avoid the risk of confusion.
Governance
When they were introduced, COVID-19 vaccines were novel, and the mass vaccination programme meant that they were prepared and administered by staff with limited experience. COVID-19 vaccines are now all licensed medicines and the vaccination programme no longer requires any additional information.
Several different vaccines may be stored and used within a single vaccination site. It is vital that all vaccines are stored, selected, handled and administered correctly, and that staff are trained in and practise safe preparation and administration of the vaccine, to ensure that every patient receives the right dose of the right product at the right time. The Green Book provides additional information to support good vaccine governance.
For information about removing small numbers of vials from their original container and “packing down” for use elsewhere in the same legal entity see our guidance on Repacking and over-labelling small batches of medicines.
For information about legal mechanisms for administering the vaccines, see our article Legal mechanisms and their application to give COVID-19 vaccines.
Report and learn from incidents
Notify all errors and near misses to the designated clinical lead and report using local governance processes. This will ensure that learning can be shared more widely and the content of national guidance adjusted if appropriate.
The UKHSA vaccine incident guidance gives further information on actions required.