Eluned Morgan MS, Minister for Health and Social Services
Given the global supply constraints on the availability of monkeypox vaccine and following advice given by the Joint Committee for Vaccination and Immunisation (JCVI) to the UK Health Security Agency (UKHSA), we are announcing the adoption of a fractional dosing approach to vaccinating those most at risk of contracting monkeypox. This approach, which will operate initially as a pilot, will commence shortly and we expect eligible individuals will begin to be invited for their vaccination in the coming days.
Fractional dosing is a safe and clinically-approved approach, which has been commonly used in other worldwide outbreaks when vaccine supplies are constrained. This approach will maximise the number of doses that can be administered without compromising protection, with clinical study results showing it provides a near-identical immune response in patients.
Fractional dosing has recently been authorised in the US by the Food and Drug Administration for its own monkeypox response. The European Medicines Agency Emergency Task Force has also approved the approach.
The change in dosing will mean all those eligible for pre-exposure vaccination aged 18 and over will be offered a 0.1ml dose of the Jynneos vaccine, instead of the 0.5ml dose that is generally used when vaccine is not in short supply. This will enable an up to a five-fold increase in the number of people that can be offered vaccination and will significantly increasing the number of eligible individuals able to access the vaccine in Wales and across the UK, supporting our efforts to break the chain of transmission.
In addition to a review of the available evidence by the JCVI and UKHSA, the change in approach has been considered and endorsed by clinical experts here in Wales and preparations are now underway within NHS Wales to commence the pilot.
Under this revised approach, the vaccine will be administered by intradermal vaccination technique. An intradermal vaccination is an injection given into the upper layer of the skin, rather than the more common approach of injecting either below the skin (subcutaneous) or into the muscle of the upper arm (intramuscular). It may take a few seconds longer and should produce a “bleb” (a small blister) that disappears within a minute. This method is commonly used for skin testing and vaccination against tuberculosis.
Clinical trials demonstrate the protection offered through intradermal vaccination is equivalent to other routes of administration and the vaccine takes the same length of time (around 10 days) to produce a protective immune response.
Those eligible for pre-exposure vaccination include:
- healthcare workers at risk of exposure including those working in sexual health services and High Consequence Infectious Disease (HCID) units; and
- Gay and bisexual men, specifically those receiving PrEP or that have recently contracted a STI.
The JCVI has also recommended that during periods of supply constraint, post exposure vaccination offers should be prioritised. Post exposure vaccination for contacts will be prioritised for those at greater risk of severe disease, including children under the age of five, pregnant women and people who are severely immunosuppressed. In addition, people eligible for pre-exposure vaccination, for example high risk Gay and Bisexual men, may be offered post-exposure vaccination.
We urge everyone who is eligible for the vaccine to take it up when they receive their invite.
We should all be aware of the risks and symptoms of monkeypox and be careful when attending events and situations where close contact may occur. People concerned about symptoms should contact NHS 111 or a sexual health service. Further information is available on the Public Health Wales and the Terrence Higgins Trust websites.
This statement is being issued during recess to keep Members informed. Should Members wish us to make a further statement or to answer questions on this when the Senedd returns we would be happy to do so.