{"id":45180,"date":"2023-04-06T07:30:53","date_gmt":"2023-04-06T07:30:53","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=45180"},"modified":"2023-11-02T17:51:16","modified_gmt":"2023-11-02T17:51:16","slug":"uk-data-on-mpox-vaccine-efficacy-in-unadjusted-analyses","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/45180","title":{"rendered":"UK data on efficacy of mpox vaccine: caution needed in observational analyses\u00a0"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong><a href=\"https:\/\/i-base.info\/htb\/wp-content\/uploads\/2022\/06\/typical-MPV-rash-on-hand-2-colour1.png\"><img loading=\"lazy\" decoding=\"async\" class=\" wp-image-43297 alignright\" src=\"https:\/\/i-base.info\/htb\/wp-content\/uploads\/2022\/06\/typical-MPV-rash-on-hand-2-colour1-300x236.png\" alt=\"\" width=\"226\" height=\"180\" \/><\/a>New data from the UK on the efficacy of mpox MVA-BN vaccine have been published in Lancet Infectious Diseases, together with an editorial comment that highlights major limitations in this and similar studies. [1, 2]<\/strong><\/p>\n<p>Estimating efficacy of this vaccine is complicated by a lack of prospective data, that the decline in mpox cases predated widespread access to the vaccine, and the significant differences in mpox risk factors between vaccinated and unvaccinated groups.<\/p>\n<p>The new dataset is based on self-completed questionnaires from roughly one-third of the cases reported in the UK from July to October 2022.\u00a0Overall, only 508\/1545 people with confirmed cases returned the questionnaire and the final analysis only included 363\/508 cases in gay and bisexual men who provided the required information.<\/p>\n<p>Of these replies, 322\/363 (89%) were unvaccinated, 8\/363 (2.2%) occurred at least 14 days after vaccination and 32 (8.8%) occurred within 13 days after vaccination. However, by October 2023, actual vaccine coverage was only 47%, so this would have been significantly lower for much of the study period.<\/p>\n<p>Vaccine effectiveness using this case-coverage design was based on coverage at 50% of an estimated 89,000 gay and bisexual men at risk. This compared vaccine coverage among cases with coverage in the eligible population.\u00a0Rates were also calculated for higher and lower coverage.<\/p>\n<p>Based on these data, three key results were reported.<\/p>\n<ul>\n<li>The estimated effectiveness at least 14 days after a single dose of MVA-BN was 78% (95% CI: 54 to 89).<\/li>\n<li>When excluding people older than age 50 (due to likely childhood smallpox vaccination), effectiveness was 74% (95% CI: 43 to 88).<\/li>\n<li>No early protection was reported within 13 days of the vaccine: \u20134% (95%CI: \u201350 to 29).<\/li>\n<\/ul>\n<p>In sensitivity analyses, vaccine effectiveness was 85% (95% CI: 69 to 93) for high-coverage (63% coverage) and 71% (40 to 86) for low-coverage (42% coverage) scenarios.<\/p>\n<p>Breakthrough infections more than 14 days after a vaccine occurred in 8.\/363 cases, with 4\/8 in men living with HIV.<\/p>\n<p>The researchers concluded that a single dose of the MVA-BN vaccine was significantly protective of symptomatic mpox.<\/p>\n<p>The linked editorial notes that major limitations of this study include:<\/p>\n<ul>\n<li>The low questionnaire return rate.<\/li>\n<li>The inability to systematically adjust for potential confounders of vaccine effectiveness, including age, underlying clinical conditions (such as HIV), previous childhood smallpox vaccination, and behavioural practices related to mpox exposure.<\/li>\n<li>No data on\u00a0the likely duration of protection.<\/li>\n<\/ul>\n<p>Not adjusting for relevant confounders of vaccine effectiveness are significant limitations of two other frequently quoted studies looking at vaccine efficacy. [3, 4]<\/p>\n<p>This is despite numerous studies at CROI 2023 that reported significant differences in both risk and related demographics in people who accessed mpox vaccines. [5, 6, 7, 8, 9, 10]<\/p>\n<h3>comment<\/h3>\n<p><strong>Although many centres in the UK are still providing vaccine services, this will apparently only be for a short period. Anyone not yet having had a first dose will have to do this by 16 June 2023. The last day to complete the second dose is 31 July 2023.\u00a0<\/strong><\/p>\n<p><strong>This was announced by UK-HSA on 22 March 2023 in a press release that also referred to the 78% protection described above. \u00a0The second dose was only described as providing &#8216;longer term protection&#8217;. [11]<\/strong><\/p>\n<p><strong>Although in England almost 68,000 people received a first dose, only 26,600 have had a second dose.\u00a0<\/strong><strong>This does not seems like sufficient coverage for a public health response that would prevent future outbreaks, especially given unequal distribution among people at risk.\u00a0<\/strong><\/p>\n<p><em><strong>STOP PRESS: A more rigorously designed US study published in the NEJM in May reported efficacy rates of only 36% following a single vaccine dose and 66% after two shots. [12]<\/strong><\/em><\/p>\n<p>References<\/p>\n<ol>\n<li>Bertran M et al. Effectiveness of one dose of MVA-BN smallpox vaccine against mpox in England using the case- coverage method: an observational study. Lancet Infect Dis 2023. (13 March 2023).<br \/>\n<a href=\"https:\/\/doi.org\/10.1016\/S1473-3099(23)00057-9\">https:\/\/doi.org\/10.1016\/S1473-3099(23)00057-9<\/a><\/li>\n<li>Ogoina D..\u00a0Can a single dose of Modified Vaccinia Ankara-Bavarian Nordic vaccine protect against mpox? (13 March 2023).<br \/>\n<a href=\"https:\/\/doi.org\/10.1016\/%20S1473-3099(23)00115-9\">https:\/\/doi.org\/10.1016\/ S1473-3099(23)00115-9<\/a><\/li>\n<li>Payne AB et al. Incidence of monkeypox among unvaccinated persons compared with persons receiving \u22651 JYNNEOS vaccine dose\u201432 US Jurisdictions July 31\u2013September 3 2022. MMWR Morb Mortal Wkly Rep 2022 71: 1278\u201382.<\/li>\n<li>Sagy YW et al. Real-world effectiveness of a single dose of mpox vaccine in males. Nature Med. DOI: 10.1038\/s41591-023-02229-3.9. (31 January 2023).<br \/>\n<a href=\"https:\/\/www.nature.com\/articles\/s41591-023-02229-3\">https:\/\/www.nature.com\/articles\/s41591-023-02229-3<\/a><\/li>\n<li class=\"HTBBODYtext\"><span lang=\"EN-US\">Vaidya A et al. <\/span><span lang=\"EN-US\">Characteristics and disparities among hospitalized persons with mpox in California. <\/span><span lang=\"EN-US\">CROI 2023, 19\u201322 February 2023, Seattle. Poster abstract 902.<br \/>\n<a href=\"https:\/\/www.croiconference.org\/abstract\/characteristics-and-disparities-among-hospitalized-persons-with-mpox-in-california\">https:\/\/www.croiconference.org\/abstract\/characteristics-and-disparities-among-hospitalized-persons-with-mpox-in-california<\/a><br \/>\n<\/span><\/li>\n<li class=\"HTBBODYtext\">Philpott DCE et al. CD4 count &lt; 350 cells\/mm<sup>3<\/sup> increases risk of hospitalization with mpox in PWH. CROI 2023, 19\u201322 February 2023, Seattle. Poster abstract 903.<br \/>\n<a href=\"https:\/\/www.croiconference.org\/abstract\/cd4-count-350-cells-mm3-increases-risk-of-hospitalization-with-mpox-in-pwh\/\">https:\/\/www.croiconference.org\/abstract\/cd4-count-350-cells-mm3-increases-risk-of-hospitalization-with-mpox-in-pwh<\/a><\/li>\n<li class=\"HTBBODYtext\">Corma-Go\u0301mez A et al. Mpox virus infection is more severe in patients with uncontrolled HIV infection. CROI 2023, 19\u201322 February 2023, Seattle. Poster abstract 904.<br \/>\n<a href=\"https:\/\/www.croiconference.org\/abstract\/mpox-virus-infection-is-more-severe-in-patients-with-uncontrolled-hiv-infection\/\">https:\/\/www.croiconference.org\/abstract\/mpox-virus-infection-is-more-severe-in-patients-with-uncontrolled-hiv-infection<\/a><\/li>\n<li class=\"HTBBODYtext\">Silva MST et al. Impact of HIV infection on mpox-related hospitalizations in Brazil. CROI 2023, 19\u201322 February 2023, Seattle. Poster abstract 905.<br \/>\n<a href=\"https:\/\/www.croiconference.org\/abstract\/impact-of-hiv-infection-on-mpox-related-hospitalizations-in-brazil\/\">https:\/\/www.croiconference.org\/abstract\/impact-of-hiv-infection-on-mpox-related-hospitalizations-in-brazil<\/a><\/li>\n<li class=\"HTBBODYtext\">Garneau WM et al. Clinical outcomes among in- and outpatients with\u00a0 mpox in an urban health system. CROI 2023, 19\u201322 February 2023, Seattle. Poster abstract 907.<br \/>\n<a href=\"https:\/\/www.croiconference.org\/abstract\/clinical-outcomes-among-in-and-outpatients-with-mpox-in-an-urban-health-system\">https:\/\/www.croiconference.org\/abstract\/clinical-outcomes-among-in-and-outpatients-with-mpox-in-an-urban-health-system<\/a><\/li>\n<li class=\"HTBBODYtext\">Cholli PA et al. Characteristics of patients hospitalized with mpox during the 2022 us outbreak. CROI 2023, 19\u201322 February 2023, Seattle. Poster abstract 912.<br \/>\n<a href=\"https:\/\/www.croiconference.org\/abstract\/characteristics-of-patients-hospitalized-with-mpox-during-the-2022-us-outbreak\/\">https:\/\/www.croiconference.org\/abstract\/characteristics-of-patients-hospitalized-with-mpox-during-the-2022-us-outbreak<\/a><\/li>\n<li>UKHSA press release. People still eligible for mpox vaccine urged to come forward. (22 March 2023).<br \/>\n<a href=\"https:\/\/www.gov.uk\/government\/news\/people-still-eligible-for-mpox-vaccine-urged-to-come-forward\">https:\/\/www.gov.uk\/government\/news\/people-still-eligible-for-mpox-vaccine-urged-to-come-forward<\/a><\/li>\n<li>Collins S. US study reports efficaacy of single- vs double-dose mpox vaccine as 36% vs 66%. HTB (18 May 2023).<br \/>\n<a href=\"https:\/\/i-base.info\/htb\/45502\">https:\/\/i-base.info\/htb\/45502<\/a><\/li>\n<\/ol>\n<div>\n<div id=\"AppleMailSignature\">\n<div>\n<div><\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base New data from the UK on the efficacy of mpox MVA-BN vaccine have been published in Lancet Infectious Diseases, together with an editorial comment that highlights major limitations in this and similar studies. [1, 2] Estimating &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[323],"tags":[],"class_list":["post-45180","post","type-post","status-publish","format-standard","hentry","category-mpox"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/45180","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=45180"}],"version-history":[{"count":34,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/45180\/revisions"}],"predecessor-version":[{"id":46591,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/45180\/revisions\/46591"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=45180"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=45180"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=45180"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}