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Second Vaccine Doses To Be Offered To Those At Highest Risk From Monkeypox

25th September 2022

Clinics continue to prioritise first doses for those at highest risk.

The UK Health Security Agency (UKHSA) has announced that second doses of the smallpox (Jynneos) vaccine will be offered to people at highest risk from monkeypox, in order to maximise protection against the virus.

This targeted approach is also supported by modelling published in today's technical briefing 8 which suggests vaccinating 25% of the groups most at risk could significantly reduce the risk of transmission.

Whilst sexual health clinics will continue to prioritise offering first doses to those at highest risk, some clinics will also begin to offer eligible people a second dose to provide longer term protection.

The Joint Committee on Vaccination and Immunisation (JCVI) has endorsed UKHSA's proposal to offer second doses to those at highest risk, while continuing efforts to maximise uptake of the first dose within this group.

There are no current plans to widen the offer of vaccination beyond the existing priority cohorts, though this decision will be kept under review.

The NHS will call forward those that are eligible for vaccination. Second doses will be offered from around 2 to 3 months after the first dose to maximise protection.

As of 20 September, more than 45,000 people have received a dose of the vaccine including over 40,000 gay, bisexual and other men who have sex with men who are at highest risk of exposure.

In order to maximise the number of people that can be vaccinated, more clinics will offer the vaccine using intradermal administration in the coming weeks. This safe and clinically approved approach has been positively received by patients and staff where it has been used already.

UKHSA has confirmed delivery of 20,000 additional vaccines from Bavarian Nordic, the single global supplier of the vaccine being used in response to the current outbreak of monkeypox in the UK. The vaccines are available for NHS services to order and are being distributed now, with a further 80,000 vaccines expected to arrive later this month. The use of intradermal administration will mean that everyone at highest risk will have access to two doses of monkeypox vaccine in the coming months.

As of 16 September, there are 3,585 confirmed and highly probable cases of monkeypox in the UK. Following a clear peak of more than 60 cases per day in mid-July, the number of cases has decreased throughout August and continues to fall, with less than 15 cases per day on average in early September.

Analysis of wider infection trends suggests changes in behaviour in the groups most at risk may have contributed to the reduced case rates.

Dr Gayatri Amirthalingam, Deputy Director, Public Health Programmes at UKHSA said, "It's encouraging that we're continuing to see fewer cases of monkeypox reported in the UK and we are grateful to everyone who has followed advice about potential symptoms, isolated as part of this outbreak or come forward for a vaccination to help limit transmission.

Prioritising vaccine stock where possible for second doses for those at highest risk will help us maximise protection and interrupt transmission. When you are called forward for vaccination, please take up the offer.

Professor Sir Andrew Pollard, chair of the JCVI, said, "The JCVI has endorsed the UKHSA’s proposal that vaccination to protect against monkeypox should continue to be prioritised for those at highest risk of exposure to the virus, including offering second doses to individuals once they become eligible.

This approach will ensure the globally-limited supplies are used most effectively, continuing to break chains of transmission, as well as providing those at highest risk of exposure with longer-lasting protection.

The use of the intradermal vaccination method at some clinics also means more doses can be drawn from the vials, helping to maximise the reach of the UK’s supplies and ensure second doses for all those eligible. The JCVI will keep the offer of monkeypox vaccination under review to ensure it continues to have the maximum impact on the current outbreak.

21 June 2022
Monkeypox outbreak: vaccination strategy
Information regarding UKHSA's vaccine strategy in response to the UK monkeypox outbreak.

Monkeypox is a rare disease caused by infection with the monkeypox virus. The virus is related to but distinct from the ones that cause smallpox and cowpox. Monkeypox is a notifiable disease in England.

There are 2 genetic clades of monkeypox virus: West African and Central African. The West African clade is usually associated with milder disease than the Central African clade.

Spread of monkeypox may occur when a person comes into close contact with an infected animal or an infected human. It may also occur when a person comes into close contact with material contaminated with the virus (for example bedding).

Most individuals experience a mild illness, with spontaneous and complete recovery within 3 weeks. However, severe illness can occur and sometimes results in death. The risk of severe disease is higher in children, pregnant women and immunosuppressed individuals.

In May 2022, 3 separate incidents of the West African monkeypox clade in the UK were identified. The first was a recognised travel-associated case from Nigeria with no further spread.

The second incident was not related to travel and therefore likely to have been acquired through local transmission in the UK with spread limited to the same household.

The third incident remains under active investigation and there is ongoing transmission primarily in gay, bisexual and other men who have sex with men (GBMSM). Cases within the GBMSM population have largely been located in the London area. Illness appears to be generally mild, consistent with previous experience with the West African clade.

This is the first time that chains of transmission have been reported in Europe without known epidemiological links to West or Central Africa.

There has been a rapid response from the UK Health Security Agency (UKHSA) in testing and confirming suspected cases, tracing contacts and issuing urgent advice in the clinical management of cases and contacts. In addition, UKHSA has been working closely with the Joint Committee on Vaccination and Immunisation (JCVI) on the role of vaccine to prevent further cases and limit ongoing spread.

On 25 May 2022, the JCVI met to discuss and provide their advice on vaccination against monkeypox in the context of the ongoing outbreak.

Vaccine
There is currently no vaccine licensed in the UK or Europe for immunisation against monkeypox. As monkeypox is related to the virus which causes smallpox, vaccines developed for smallpox are considered to provide cross-protection against monkeypox.

Smallpox Modified Vaccinia Ankara - Bavarian Nordic (MVA-BN) is currently distributed under 2 brand names, although it is the same vaccine.

The brand names are:

Imvanex - approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK (and the European Medicines Agency in the EU) for the prevention of smallpox. Although this vaccine is not specifically licensed for the prevention of monkeypox in Europe, it has been used in the UK in response to the current and previous incidents
Jynneos – approved by the Food and Drug Administration (FDA) in the US for the prevention of monkeypox as well as smallpox
There is very limited evidence on whether MVA-BN can prevent or modify disease when given to contacts after possible exposure to the monkeypox virus.

As some immunological response to the first dose of vaccine can be seen within the first 2 weeks, it is considered that rapid vaccination may modify disease severity for cases that may have longer incubation periods.

Prior to this ongoing outbreak, it was recommended that the MVA-BN vaccine should be offered to laboratory workers routinely handling material potentially infected with orthopox viruses, and to healthcare staff expected to provide care to monkeypox cases or who may be exposed to materials contaminated with virus.

Pre-exposure vaccination
Targeted pre-exposure vaccination
JCVI proposed that vaccination should be offered as soon as feasible to GBMSM at highest risk due to a large number of contacts.

The committee agreed that GBMSM at highest risk could be identified amongst those who attend sexual health services, using markers of high-risk behaviour similar to those used to assess eligibility for HIV pre-exposure prophylaxis (PrEP), but applied regardless of HIV status. These risk criteria would include a recent history of multiple partners, participating in group sex, attending sex on premises venues or a proxy marker such as recent bacterial STI (in the past year).

In view of the current epidemiology and vaccine supply available, wider vaccination in low risk GBMSM individuals or the general population is not advised at this time.

Occupational vaccination
Pre-exposure vaccination should also be prioritised for the following workers at high risk of exposure:

staff expected to provide care to monkeypox cases in high consequence infectious disease (HCID) units
staff in sexual health clinics designated to assess suspected cases
staff in additional hospitals outside HCID units designated to care for monkeypox patients
workers in laboratories where pox viruses (such as monkeypox or genetically modified vaccinia) are handled, and others whose work in specialist and reference laboratories
staff regularly undertaking environmental decontamination around cases of monkeypox
Other healthcare staff should be able to avoid inadvertent exposure by ensuring suspected monkeypox cases are assessed by designated staff, or by wearing appropriate personal protective equipment.

First doses should be prioritised during this outbreak, with the offer of a second dose for those who continue to be at an increased risk of exposure.

Post-exposure vaccination
There is very limited evidence on the effectiveness of post-exposure vaccination using MVA-BN, and therefore vaccine should be prioritised for those most likely to benefit. This would be based on timeliness of vaccination following exposure and for individuals at higher risk of severe disease following infection.

It is recommended that post-exposure vaccination of high-risk community or occupational contacts is offered ideally within 4 days of exposure, although may be offered up to 14 days in those at ongoing risk, or those who are at higher risk of the complications of monkeypox.

Those at higher risk of complications include:

children under the age of 10 to 11 (school year 6 in England and Wales, year 7 in Northern Ireland and year P6 In Scotland)
people who are pregnant
individuals with immunosuppression (as defined in the Green Book)
This advice is given within the context of the current epidemiological situation in the UK, where disease is typically mild and transmission is predominately occurring within the GBMSM population. It is also given with the consideration that vaccine supply is limited.

The UKHSA advice and guidance will be kept under review as the outbreak develops, with JCVI consulted where appropriate. UKHSA will also evaluate the impact of vaccination on the outbreak.

Conclusions and advice
Based on the currently available vaccine supply and advice from JCVI, UKHSA recommends that the available doses of MVA-BN vaccine should be used as a selective vaccine strategy with the aim of interrupting transmission in the subset of individuals at increased risk.

The JCVI concluded that this would be the best way to bring the current outbreak under control.