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Moving COVID-19 vaccines legally within the NHS

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Topics: COVID-19 vaccineSupply

Moving vaccines within and between NHS organisations is subject to regulatory constraints. Senior pharmacists need to be able to advise on appropriate practice

This article forms part of a series
  1. Managing COVID-19 Vaccines: Guidance and SOPs
    1. Ordering, receiving and storing COVID-19 vaccines
    2. Transporting COVID-19 vaccines
    3. Safe and secure handling, spillage and disposal of COVID-19 vaccines
    4. Moving COVID-19 vaccines legally within the NHS
    5. Preparing Comirnaty 30 micrograms (XBB.1.5) vaccine
    6. Preparing Comirnaty 10 (XBB.1.5) ready to use vaccine
    7. Preparing Comirnaty 3 (THREE) (XBB.1.5) concentrate vaccine
    8. Preparing Spikevax (XBB.1.5) vaccine
Contents
  1. Supply across legal boundaries
    1. Mutual aid
    2. Repacking
  2. Supply within the same organisation
    1. Repacking on a hospital site
    2. Packing vials on a vaccination site
    3. Moving punctured vials
  3. Further information
  4. Update history

Supply of medicines across a legal boundary i.e. from one legal entity to another, is subject to regulatory control.

An MHRA Wholesale Dealer’s Licence (WDL), also termed a Wholesale Distribution Authorisation (WDA), is usually required. Supply must also be in accordance with NHSE guidance.

Mutual aid

Mutual Aid allows for vaccines to be moved from one organisation providing NHS COVID-19 vaccination services to another in exceptional circumstances. Use of the mechanism may be considered when there is a significant risk that patients would go unvaccinated. For further information see the Transfer of COVID-19 vaccines between NHS vaccination sites NHSE guidance

Repacking

Repacking, or ”packing down”, of medicines in bulk for supply to another legal entity is classed as manufacturing (assembly). This is subject to regulatory control and must be performed under a Manufacturing Licence (MIA) or a Manufacturing (Specials) Licence (MS).

Supply within the same organisation

Supply of vaccines from one part of an organisation to another part of the same organisation is not regulated but is subject to organisational controls. It must still comply fully with the principles of MHRA Good Distribution Practice and the vaccine manufacturer’s requirements for safe transport and storage. Supply must also be in accordance with NHSE guidance.

Repacking on a hospital site

The activity of repacking, or “packing down” must be performed under the direct Supervision of a Pharmacist (Section 10 of the Medicines Act).

The MHRA is clear that if this provision is to be used, they expect compliance with principles of Good Manufacturing Practice “in more than name only”. This requires the use of controlled worksheets and labelling systems, SOPs and a pharmaceutical quality management system. Many pharmacy teams will not necessarily have the expertise to meet this requirement.

Packing vials on a vaccination site

It should be noted that packing a number of individual vials into a cool box isn’t a licensable activity in regulatory terms, but business-as-usual medicines distribution when performed in response to daily orders or requisitions from another site within the same legal entity, or from a roving vaccination team who then collect and take the vaccine to a care home or school for administration that day.

Packing a specified number of vials for supply from a vaccination site to a temporary site must be carried out under Regulation 3A(1) of Human Medicines (Coronavirus) (Further Amendments) Regulations 2022 under the supervision of a doctor, registered nurse or pharmacist. Supply must also be in accordance with NHSE guidance.

Moving punctured vials

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.

Further information

The following resources are available for vaccine specific advice on transportation and general advice about transportation while maintaining the cold chain:

Update history

  1. Removed relabelling of frozen vaccine. Added additional detail on moving punctured vials. Text relating to moving with care removed. Added section on mutual aid
  1. Page reviewed and up to date for Autumn 2023 campaign
  1. Content rationalised and reformatted. Page title and para headings x 4 shortened. Paras 1 and 2 of "packing on a vaccination site" inverted.
  1. Heading changed: Relabelling for supply to another legal entity must be carried out under an MIA or MS
  1. Amendment: The WDA(H) requirement is waived under Regulation 19(4A) if supply is under mutual aid..... OR AT THE DIRECTION OF NHSEI..... to a user at the end of the supply chain.
  1. Link to NHSEI Mutual Aid Policy updated
  1. major revision to clarify MHRA licence requirements for packing and labelling for supply across legal boundaries, to add brand names, reflect provision to allow Moderna to be moved at 2-8C, and to clarify that opened packs of AZ ONLY may be moved under MA.
  1. minor typo corrected
  1. Typo corrected
  1. Updated to correct typos, rearrange paragraphs and reflect the imminent arrival of Comirnaty and Spikevax branded products
  1. "Re-labeling" changed to "re-labelling" throughout, in response to user feedback !
  2. typo correction x 1. Addition of "for 15-vials packs" to para on WDAH supply of Pfizer vaccine.
  1. Published