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 is currently being imported into the UK. Initially the Imvanex® brand was also imported, however, all of this stock has now expired.

Licence status

Overview

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  (Expired)

Jynneos                   BSV- licensed            FDP00012         31/08/24

Jynneos                   BSV- licensed            FDP00072         31/07/25

Jynneos                   Unlicensed                 FDP00059         31/05/25

Legal mechanisms for administration

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 Jynneos®

Expiry dates for frozen vaccine

The -20°C expiry is printed on the outer carton

Expiry dates for thawed vaccine

The US (FDA) approval of Jynneos® only allows a holding time of 12 hours at 2-8°C. However the 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.

Sample procedure

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

• IMH-2-Unpacking-of-frozen Jynneos-and-transfer-to-fridges-to-thaw-v-1.0 11.08.22 · Word · 69 KB

Mutual aid

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

Clinical information

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

Information for individuals receiving the vaccine

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

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

Update history