Considerations for monkeypox vaccination

Ian Allen, Pharmacy Quality Assurance Regional Specialist (NW), North West Pharmaceutical Quality AssurancePublished Last updated See all updates

Considerations for giving vaccine pre or post exposure during a monkeypox incident.

Currently available stock

Bavarian Nordic has a licensed vaccine containing Live Modified Vaccinia Virus Ankara (MVA-BN). This is named Imvanex® in GB and Europe, and Jynneos® in the USA.

No stock of the UK-licensed product is immediately available. Therefore, the US Jynneos® brand and the EU version of Imvanex® are currently being imported into the UK.

Licence status

Overview

EU Imvanex® is unlicensed in the UK, but is licensed in the EU so pharmaceutical quality is assured. Product information, including the SmPC and PIL in English, can be found on the European Medicines Agency website.

Jynneos® is licensed in the US. A Batch-Specific Variation (BSV) was granted by MHRA to allow importation of initial stock of Jynneos® into the UK. The BSV applies to specific batch numbers which are considered to be licensed in GB, for further information see the direct healthcare professional communication (DHPC) letter.

Subsequent stocks of Jynneos® are being imported into the UK without a MHRA BSV and are unlicensed in the UK. This stock is physically identical to the Jynneos® stock approved under BSV, therefore pharmaceutical quality is assured. However, because it is an unlicensed medicine there are restrictions to the legal mechanisms by which it may be administered (see legal mechanisms for administration section below).

Summary of imported stock

Current Stock     Licence status      Batch no.      Expiry (at -20°C)

Imvanex                   Unlicensed                 FDP00007        30/09/22

Jynneos                   BSV- licensed            FDP00012         31/08/24

Jynneos                   Unlicensed                 FDP00059         31/05/25

A prescription is the only legal mechanism that can be used to administer an unlicensed medicine, and must be used for unlicensed stock.

Where vaccine is licensed under a BSV this product can also be administered under a PGD. The UK Health Security Agency has developed a smallpox vaccine PGD template.

Organisations providing immunisations to staff under an occupational health scheme can use a Written Instruction or PSD for licensed products, including those licensed under a BSV.

Handling of products

Although the vaccines are identical, there are different handling requirements owing to differences in regulatory approval in the USA and the EU.

Expiry dates for frozen vaccine

  • For Imvanex® , the expiry date on the carton relates to storage at -50OC (5 years from manufacture). However, the vaccine will be supplied at -20°C with an expiry date 2 years from manufacture. As the expiry date at -20°C is not printed on the label it must be manually calculated at the point of receipt to check the vaccine has not expired.
  • For Jynneos® the -20°C expiry is printed on the outer carton and no calculation is needed.

Expiry dates for thawed vaccine

  • Imvanex® has a shelf-life of 8 weeks starting from the time of thawing and transfer from –20°C storage to the refrigerator at 2-8°C.
  • The US (FDA) approval of Jynneos® only allows a holding time of 12 hours at 2-8°C. However he MHRA has approved a shelf-life of 8 weeks starting from the time of thawing and transfer from –20°C storage to the refrigerator at 2-8°C in line with the UK/EU approval.

SPS example procedures are available to support sites in managing the thawing of the vaccine in a refrigerator and assigning a subsequent post thaw expiry.

Mutual aid

The flexibility afforded by mutual aid for the movement of COVID-19 vaccines does not apply to monkeypox vaccines.

Clinical information

The UK Health Security Agency has issued guidance on the use of pre and post exposure vaccination during a monkeypox incident, along with a chapter in the Green Book.

Information for individuals receiving the vaccine

The UK Health Security Agency has several monkeypox vaccination resources aimed at recipients of the vaccine.

The package insert for Jynneos® is available on the US Food & Drug Administration (FDA) website.

Information about Imvanex® smallpox vaccine can be found on the European Medicines Agency website.

Change history

  1. Update to include details on unlicensed Jynneos stock
  1. Advice added on legal mechanisms for occupational health.
  1. Clarification around mutual aid included.
  1. Separate procedures issued for Imvanex and Jyneos brand as confirmed Jynneos brand has -20C expiry printed on the carton. There is therefore no requirement to calculate -20C expiry for Jynneos
  1. Section on information for individuals receiving the vaccine added
  1. Link to smallpox vaccine PGD template added. Thawing SOP updated
  1. Changed to reflect BSV product (Jynneos®) availability.
  1. Example SOP for thawing Imvanex in a refrigerator added.
  1. Link to Green Book chapter added.
  1. Labelling language confirmed.
  1. Updated to reflect current understanding of labelling language.
  2. Published