Bavarian Nordic Research Articles

Decline of Mpox Antibody Responses After Modified Vaccinia Ankara–Bavarian Nordic Vaccination

Decline of Mpox Antibody Responses After Modified Vaccinia Ankara–Bavarian Nordic Vaccination

Temporary adaptations to sexual behaviour during the mpox outbreak in 23 countries in Europe and the Americas: findings from a retrospective cross-sectional online survey

After rapid epidemic growth between May and August, 2022, new mpox diagnoses declined in Europe and the Americas, with low-level transmission continuing thereafter. Characterising the extent of behavioural adaptation, mpox vaccination, and mpox prevalence across these regions could improve our understanding of the transmission dynamics of the virus. We aimed to characterise the presence and duration of adaptations to sexual behaviour related to the emergence of mpox during the first year of the outbreak among affected communities in Europe and the Americas. This retrospective, cross-sectional online survey was conducted in 23 countries in Europe and the Americas between May 19 and May 31, 2023. The survey was advertised via four geospatial dating apps used by affected communities. Eligible participants were aged 18 years or older and identified as a gay man, a bisexual man, a man who has sex with men, as transgender, or as non-binary. We described and regionally compared the mpox prevalence, mpox vaccination rates (one dose or two doses of modified vaccinia virus Bavarian Nordic), and the extent and duration of behavioural adaptation during the outbreak. For these behavioural outcomes, we used regression analyses to estimate crude prevalence ratios (PRs) and adjusted prevalence ratios (aPRs) with 95% CIs. Of 17 428 individuals who completed the survey, 16 875 (96·8%) met the eligibility criteria and were included in the study. 1086 (6·4%) participants reported having mpox during the outbreak. Vaccination with at least one dose was reported by 4987 (29·6%) participants; 3502 (20·8%) reported two doses. Vaccination rates in Latin America and eastern Europe and the western Balkans were significantly lower than in western Europe and northern America (p<0·0001). Adaptations to sexual behaviour were reported by 8583 (50·9%) of 16 875 participants and across all regions; 3045 (35·5%) of these 8583 participants said they continued adapting their sexual behaviour until May, 2023. Participants who reported concerns about mpox (9884 [58·6%] of 16 875) were more likely to adapt their behaviour than those who did not report concerns (PR 2·43 [95% CI 2·34-2·53]). In adjusted regression models, participants who reported vaccination (aPR 0·25 [95% CI 0·21-0·28] for two doses and 0·43 [0·37-0·51] for one dose) or having had mpox (0·37 [0·30-0·44]) were less likely to continue adaptations than those who did not. Participants in Latin America or northern America were significantly more likely to adapt their sexual behaviour and to continue with adaptations than those in western Europe. Adaptations to sexual behaviour due to mpox were widespread, dynamic, and responded to evolving individual risk perceptions. We propose that the decline in mpox transmission seen at the end of 2022 resulted primarily from a combination of behavioural adaptation and naturally acquired immunity. As mpox vaccination is an important preventive measure, stark vaccine inequity highlights the need to increase access to mpox vaccines. WHO Contingency Fund for Emergencies.

Equivalence of freeze-dried and liquid-frozen formulations of MVA-BN as smallpox and mpox vaccine

ABSTRACT Modified Vaccinia Ankara Bavarian Nordic (MVA-BN) as a smallpox and mpox vaccine has been approved in its liquid-frozen (LF) formulation in the US, Canada, and EU. A freeze-dried (FD) formulation may offer additional benefits, such as a longer shelf life and reduced dependence on cold chain storage and transport. In a phase 2 clinical trial, 651 vaccinia-naïve participants were vaccinated with two doses of MVA-BN LF or FD, 4 weeks apart. The objectives were to compare MVA-BN FD with LF in terms of vaccine-induced immune responses, safety, and reactogenicity. Non-inferiority of the immune response was assessed by the 95% CI of the geometric mean ratios. Both formulations induced robust vaccinia-specific humoral and cellular immune responses. At peak humoral responses (Week 6), geometric means of total antibody titers were 1096 (95% CI 1013, 1186) from the FD group and 877 (95% CI 804, 956) from the LF group, achieving the primary endpoint of non-inferiority of MVA-BN FD compared to MVA-BN LF. At peak cellular responses (Week 2), geometric means of T cell spot forming units were 449 (95% CI 341, 590) from the FD group and 316 (95% CI 234, 427) from the LF group. Both formulations of MVA-BN were well tolerated, with similar unsolicited AEs and solicited systemic reactions in both groups but slightly more local reactions in the FD group. No vaccine-related serious adverse events (SAEs) or vaccine-related AE of special interest were reported. The FD formulation of MVA-BN was shown to be equivalent to MVA-BN LF.

A phase 2 study of a brachyury-targeting vaccine in combination with radiation therapy for the treatment of advanced chordoma.

This was a single-arm, phase 2 clinical trial of Bavarian Nordic (BN)-Brachyury vaccine plus radiotherapy (RT) designed to determine the objective response rate (ORR), progression-free survival (PFS), and safety of the combination in chordoma. A total of 29 adult patients with advanced chordoma were treated with two subcutaneous priming vaccine doses of modified vaccinia Ankara-Bavarian Nordic (MVA-BN)-Brachyury and one vaccine dose of fowlpox virus (FPV)-Brachyury before RT. After RT, booster vaccinations were given with FPV-Brachyury every 4 weeks for 4 doses, then every 12 weeks (week 110). A minimum RT dose of >8 Gy in one fraction for each target was required. Response was evaluated by modified Response Evaluation Criteria in Solid Tumors 1.1 (mRECIST), where only radiated lesions were considered targets, and by standard RECIST 1.1 in a subset of patients. Two of 26 evaluable patients experienced durable partial response (PR) (ORR of 7.7%; 90% confidence interval [CI], 2.6-20.8]) by mRECIST 1.1. A total of 21 patients (80.8%; 90% CI, 65.4-90.3) had stable disease, and three patients (11.5%; 90% CI, 4.7-25.6) had progressive disease as best response per mRECIST 1.1. Median PFS was not reached during the study. This trial confirms the safety of BN-Brachyury and RT. Although the study did not meet the predefined study goal of four responses in 29 patients, we did observe two PRs and a PFS of greater than 2 years. For a vaccine-based study in chordoma, an ultra-rare disease where response rates are low, a randomized study or novel trial designs may be required to confirm activity.

Predicting vaccine effectiveness for mpox

The Modified Vaccinia Ankara vaccine developed by Bavarian Nordic (MVA-BN) was widely deployed to prevent mpox during the 2022 global outbreak. This vaccine was initially approved for mpox based on its reported immunogenicity (from phase I/II trials) and effectiveness in animal models, rather than evidence of clinical efficacy. However, no validated correlate of protection after vaccination has been identified. Here we performed a systematic search and meta-analysis of the available data to test whether vaccinia-binding ELISA endpoint titer is predictive of vaccine effectiveness against mpox. We observe a significant correlation between vaccine effectiveness and vaccinia-binding antibody titers, consistent with the existing assumption that antibody levels may be a correlate of protection. Combining this data with analysis of antibody kinetics after vaccination, we predict the durability of protection after vaccination and the impact of dose spacing. We find that delaying the second dose of MVA-BN vaccination will provide more durable protection and may be optimal in an outbreak with limited vaccine stock. Although further work is required to validate this correlate, this study provides a quantitative evidence-based approach for using antibody measurements to predict the effectiveness of mpox vaccination.

Monitoring and Characteristics of Mpox Contacts, Virginia, USA, May-November 2022.

During 2022, a global outbreak of mpox resulted primarily from human-to-human contact. The Virginia Department of Health (Richmond, VA, USA) implemented a contact tracing and symptom monitoring system for residents exposed to monkeypox virus, assessed their risk for infection, and offered interventions as needed. Among 991 contacts identified during May 1-November 1, 2022, import records were complete for 943 (95.2%), but 99 (10.0%) were not available for follow-up during symptom monitoring. Mpox developed in 28 (2.8%) persons; none were healthcare workers exposed at work (n = 275). Exposure risk category and likelihood of developing mpox were strongly associated. A total of 333 persons received >1 dose of JYENNOS (Bavarian Nordic, https://www.bavarian-nordic.com) vaccine, most (n = 295) administered after virus exposure. Median time from exposure to vaccination was 8 days. Those data tools provided crucial real-time information for public health responses and can be used as a framework for other emerging diseases.

Prospective monitoring of adverse events following vaccination with Modified vaccinia Ankara - Bavarian Nordic (MVA-BN) administered to a Canadian population at risk of Mpox: A Canadian Immunization Research Network study

MVA-BN is an orthopoxvirus vaccine that provides protection against both smallpox and mpox. In June 2022, Canada launched a publicly-funded vaccination campaign to offer MVA-BN to at-risk populations including men who have sex with men (MSM) and sex workers. The safety of MVA-BN has not been assessed in this context. To address this, the Canadian National Vaccine Safety Network (CANVAS) conducted prospective safety surveillance during public health vaccination campaigns in Toronto, Ontario and in Vancouver, British Columbia. Vaccinated participants received a survey 7 and 30 days after each MVA-BN dose to elicit adverse health events. Unvaccinated individuals from a concurrent vaccine safety project evaluating COVID-19 vaccine safety were used as controls. Vaccinated and unvaccinated participants that reported a medically attended visit on their 7-day survey were interviewed. Vaccinated participants and unvaccinated controls were matched 1:1 based on age group, gender, sex and provincial study site. Overall, 1,173 vaccinated participants completed a 7-day survey, of whom 75 % (n = 878) also completed a 30-day survey. Mild to moderate injection site pain was reported by 60 % of vaccinated participants. Among vaccinated participants 8.4 % were HIV positive and when compared to HIV negative vaccinated individuals, local injection sites were less frequent in those with HIV (48 % vs 61 %, p = 0.021), but health events preventing work/school or requiring medical assessment were more frequent (7.1 % vs 3.1 %, p = 0.040). Health events interfering with work/school, or requiring medical assessment were less common in the vaccinated group than controls (3.3 % vs. 7.1 %, p < 0.010). No participants were hospitalized within 7 or 30 days of vaccination. No cases of severe neurological disease, skin disease, or myocarditis were identified. Our results demonstrate that the MVA-BN vaccine appears safe when used for mpox prevention, with a low frequency of severe adverse events and no hospitalizations observed.

A Multi-pronged Approach to Addressing Global Poxviruses Vaccine Inequity: A Case of Monkeypox.

Monkeypox has been endemic in Congo and Nigeria for at least five decades. Since early May 2022, there have been numerous unprecedented outbreaks throughout the world in places without any previously reported cases. While a majority of the diagnosed cases have been within Europe and the Americas, several cases have occurred in non-endemic African countries. As of December 2022, 82,999 cases had been reported globally, prompting concern among the World Health Organization (WHO) members. While the WHO has not labeled this epidemic a Global Health Emergency, member states have begun to put forward plans to consolidate their emergency vaccine stockpiles and share the limited number of vaccines made by the single FDA-approved manufacturer, Bavarian Nordic. Many countries are concerned about how vaccines will be shared. Some of the larger donor States are positioned to be the biggest beneficiaries of vaccine sharing, while States from areas that have been suffering from the virus since the 1970s have not been allocated any. This pattern of vaccine distribution echoes that seen during the early part of the COVID-19 pandemic. Due to the similarities between Monkeypox and Smallpox, contact precautions and vaccination seem to be effective strategies to combat its rapid spread. We aim to evaluate how an eradication program model similar to that used for Smallpox can be applied to Monkeypox, and whether it can address vaccine inequity. To do this, we use a multi-pronged approach targeting disease surveillance, vaccine awareness, manufacturing, cost, and distribution strategies.

Adverse Reactions After Intradermal Vaccination With JYNNEOS for Mpox in Korea.

In response to the Mpox domestic epidemic, South Korea initiated a nationwide vaccination program in May 2023, administering a 0.1 mL intradermal dose of JYNNEOS (Modified Vaccinia Ankara vaccine, Bavarian Nordic) to a high-risk group. To investigate the adverse reactions after intradermal JYNNEOS vaccination, an anonymous online survey was conducted at the National Medical Center from May 22 to July 31, 2023. Overall, 142 individuals responded. Over 80% of the respondents reported local reactions of predominantly mild severity. The predominant local reactions were pruritus, redness, and swelling; their incidence rates after the first dose were 66.2%, 48.1%, and 49.4%, respectively; the corresponding rates after the second dose were 69.2%, 60.6%, and 53.8%. Fewer respondents reported systemic symptoms. The most common systemic symptom was fatigue, the incidence rates of which after the first and second doses were 37.7% and 24.6%, respectively. Overall, the intradermally administered JYNNEOS vaccine appeared well tolerated.

Pan-pox-specific T-cell responses in HIV-1-infected individuals after JYNNEOS vaccination.

People living with human immunodeficiency virus (HIV) are the individuals most affected by the current Monkeypox virus outbreak that was first announced in May 2022. Here we report Pan-pox-specific T-cell responses in a cohort of HIV-1-infected individuals after receiving the nonreplicative, attenuated smallpox vaccine JYNNEOS from Bavarian Nordic. Intradermal (i.d.) and subcutaneous (s.c.) vaccination was safe without major side effects. Dose-sparing i.d. vaccination was superior to s.c. vaccination and promoted T-cell polyfunctionality, and the expression of the gut-homing marker α4β7 integrin on lymphocytes. HIV-1-infected individuals with CD4 T-cell counts ≤500/mm3 blood required at least a booster vaccination to exhibit efficient virus-specific T-cell responses. The magnitude of the Th1 response after this booster directly correlated with the CD4 T-cell count of the vaccinees. Further studies with a larger number of participants are warranted to confirm and expand our observations.

2888. Safety and Immunogenicity of an Adjuvanted Chikungunya Virus (CHIKV) Virus-like Particle (VLP) Based Vaccine in Two Pivotal Phase 3 Trials, ≥12 Years of Age

Abstract Background CHIKV remains a significant public health concern globally. We report the results of two phase 3 trials evaluating an aluminum hydroxide adjuvanted CHIKV VLP vaccine. Methods Two multicenter, randomized, double-blind, placebo-controlled, parallel-group trials were conducted: an adult/adolescent trial (NCT05072080) in ages 12-64 years and an older adult trial in ages ≥ 65 years (NCT05349617). Participants received CHIKV VLP vaccine or placebo as a single intramuscular dose. Immunogenicity objectives assessed anti-CHIKV NT80 serum neutralizing antibody (SNA) titers at selected timepoints. Seroresponse rate (SRR) was the percentage of participants who achieved NT80 SNA titer ≥ 100 (FDA/EMA agreed threshold). Safety outcomes were evaluated through monitoring adverse events (AEs) through Day 183. Study overview. Results Adult/adolescent trial: 3254 participants (2790 CHIKV VLP vaccine, 464 placebo) were enrolled. Primary endpoints were met with a Day 22 SRR of 98% (2503/2559) for vaccine and 1% for placebo (5/424; p&amp;lt; 0.0001), as well as lot consistency, and superiority to placebo in geometric mean titer (GMT). A rapid antibody response was observed in the CHIKV VLP vaccine group with Day 8 SRR=47% (1169/2510) and Day 15 SRR=97% (2355/2434); responses were durable through Day 183 with SRR=86% (1967/2301). Older adult trial: 413 participants (206 CHIKV VLP vaccine, 207 placebo) were enrolled. Primary endpoints were met with a Day 22 SRR of 87% (167/191) for vaccine and 1% for placebo (2/183; p&amp;lt; 0.0001), as well as by GMT. At Day 15 a rapid antibody response was observed in the CHIKV VLP vaccine group with SRR=82% (150/182). CHIKV VLP vaccine demonstrated a favorable safety profile, and most AEs were mild to moderate in severity. The most common AEs were myalgia, fatigue, and headache. Conclusion CHIKV VLP vaccine is the only VLP-based vaccine in clinical development for active immunization against CHIKV disease. Results demonstrate that CHIKV VLP vaccine induces a rapid and robust immune response in most people by Day 15 and through Day 183. These findings support the potential of this VLP-based vaccine to help protect individuals 12 years and older from CHIKV. Disclosures Jason S. Richardson, PhD, Bavarian Nordic Canada Inc: Stocks/Bonds Debbie Anderson, MS, Bavarian Nordic: Employee|Emergent BioSolutions: Stocks/Bonds Sufia Muhammad, MD, Bavarian Nordic: Employee|Emergent BioSolutions: Stocks/Bonds Lauren Tindale, PhD, Bavarian Nordic: Employee Tobi Loreth, n/a, Emergent BioSolutions: Stocks/Bonds Sarah Royalty Tredo, MBA, Emergent Biosolutions: Employee|Emergent Biosolutions: Stocks/Bonds Victoria Jenkins, PhD, Bavarian Nordic: Employee Patrick Ajiboye, MD, Bavarian Nordic: Employee|Emergent BioSolutions: Stocks/Bonds Lisa Bedell, Director Biostatistic, Bavarian-Nordic: Advisor/Consultant|Emergent BioSolutions: Employee|Emergent BioSolutions: Stocks/Bonds

Reduced Odds of Mpox-Associated Hospitalization Among Persons Who Received JYNNEOS Vaccine - California, May 2022-May 2023.

The effectiveness of 1 dose of JYNNEOS vaccine (modified vaccinia Ankara vaccine, Bavarian Nordic) against hospitalization for mpox (caused by Monkeypox virus), has been demonstrated; however, the impact of 2 doses on hospitalization risk, especially among persons infected with HIV, who are at higher risk for severe disease, is an important factor in evaluating vaccine effectiveness against mpox disease severity and Monkeypox virus infection. Surveillance data collected by the California Department of Public Health were used to evaluate whether receipt of 2 doses of JYNNEOS vaccine reduced the odds of hospitalization among persons with mpox. The odds of hospitalization among persons with mpox who had received 1 or 2 JYNNEOS doses were 0.27 (95% CI=0.08-0.65) and 0.20 (95% CI=0.01-0.90), respectively, compared with unvaccinated mpox patients. In mpox patients with HIV infection, the odds of hospitalization among those who had received 1 JYNNEOS vaccine dose was 0.28 (95% CI=0.05-0.91) times that of those who were unvaccinated. No mpox-associated hospitalizations were identified among persons infected with HIV who had received 2 JYNNEOS vaccine doses. To optimize durable immunity, all eligible persons at risk for mpox, especially those infected with HIV, should complete the 2-dose JYNNEOS series.

Modified vaccinia Ankara–Bavarian Nordic vaccine against mpox in children

Modified vaccinia Ankara–Bavarian Nordic vaccine against mpox in children

Effectiveness of JYNNEOS Vaccine Against Diagnosed Mpox Infection - New York, 2022.

In 2022, an international Monkeypox virus outbreak, characterized by transmission primarily through sexual contact among gay, bisexual, and other men who have sex with men (MSM), resulted in 375 monkeypox (mpox) cases in the state of New York outside of New York City (NYC).*,† The JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic), licensed by the U.S. Food and Drug Administration (FDA) against mpox as a 2-dose series, with doses administered 4 weeks apart,§ was deployed in a national vaccination campaign.¶ Before this outbreak, evidence to support vaccine effectiveness (VE) against mpox was based on human immunologic and animal challenge studies (1-3). New York State Department of Health (NYSDOH) conducted a case-control study to estimate JYNNEOS VE against diagnosed mpox in New York residents outside of NYC, using data from systematic surveillance reporting. A case-patient was defined as a man aged ≥18 years who received a diagnosis of mpox during July 24-October 31, 2022. Contemporaneous control patients were men aged ≥18 years with diagnosed rectal gonorrhea or primary syphilis and a history of male-to-male sexual contact, without mpox. Case-patients and control patients were matched to records in state immunization systems. JYNNEOS VE was estimated as 1 - odds ratio (OR) x 100, and JYNNEOS vaccination status (vaccinated versus unvaccinated) at the time of diagnosis was compared, using conditional logistic regression models that adjusted for week of diagnosis, region, patient age, and patient race and ethnicity. Among 252 eligible mpox case-patients and 255 control patients, the adjusted VE of 1 dose (received ≥14 days earlier) or 2 doses combined was 75.7% (95% CI = 48.5%-88.5%); the VE for 1 dose was 68.1% (95% CI = 24.9%-86.5%) and for 2 doses was 88.5% (95% CI = 44.1%-97.6%). These findings support recommended 2-dose JYNNEOS vaccination consistent with CDC and NYSDOH guidance.

Estimated Effectiveness of JYNNEOS Vaccine in Preventing Mpox: A Multijurisdictional Case-Control Study — United States, August 19, 2022–March 31, 2023

As of March 31, 2023, more than 30,000 monkeypox (mpox) cases had been reported in the United States in an outbreak that has disproportionately affected gay, bisexual, and other men who have sex with men (MSM) and transgender persons (1). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic) was approved by the Food and Drug Administration (FDA) in 2019 for the prevention of smallpox and mpox via subcutaneous injection as a 2-dose series (0.5 mL per dose, administered 4 weeks apart) (2). To expand vaccine access, an Emergency Use Authorization was issued by FDA on August 9, 2022, for dose-sparing intradermal injection of JYNNEOS as a 2-dose series (0.1 mL per dose, administered 4 weeks apart) (3). Vaccination was available to persons with known or presumed exposure to a person with mpox (postexposure prophylaxis [PEP]), as well as persons at increased risk for mpox or who might benefit from vaccination (preexposure mpox prophylaxis [PrEP]) (4). Because information on JYNNEOS vaccine effectiveness (VE) is limited, a matched case-control study was conducted in 12 U.S. jurisdictions,† including nine Emerging Infections Program sites and three Epidemiology and Laboratory Capacity sites,§ to evaluate VE against mpox among MSM and transgender adults aged 18-49 years. During August 19, 2022-March 31, 2023, a total of 309 case-patients were matched to 608 control patients. Adjusted VE was 75.2% (95% CI = 61.2% to 84.2%) for partial vaccination (1 dose) and 85.9% (95% CI = 73.8% to 92.4%) for full vaccination (2 doses). Adjusted VE for full vaccination by subcutaneous, intradermal, and heterologous routes of administration was 88.9% (95% CI = 56.0% to 97.2%), 80.3% (95% CI = 22.9% to 95.0%), and 86.9% (95% CI = 69.1% to 94.5%), respectively. Adjusted VE for full vaccination among immunocompromised participants was 70.2% (95% CI = -37.9% to 93.6%) and among immunocompetent participants was 87.8% (95% CI = 57.5% to 96.5%). JYNNEOS is effective at reducing the risk for mpox. Because duration of protection of 1 versus 2 doses remains unknown, persons at increased risk for mpox exposure should receive the 2-dose series as recommended by the Advisory Committee on Immunization Practices (ACIP),¶ regardless of administration route or immunocompromise status.

Maintaining Warp Speed: Policy Requirements for a Just-in-Time, Capability-Based, Scalable Medical Countermeasure Research and Development Enterprise.

Maintaining Warp Speed: Policy Requirements for a Just-in-Time, Capability-Based, Scalable Medical Countermeasure Research and Development Enterprise.

Short-term Adverse Events Following Immunization With Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine for Mpox

This study uses data collected by Australia’s vaccine safety surveillance system to examine the adverse event profile of the modified vaccinia Ankara–Bavarian Nordic vaccine.

Sustained antibody persistence for at least 15years after a booster vaccination against tick-borne encephalitis following different primary vaccination schedules: Third 5-year follow-up.

Vaccination is the best mode of protection against tick-borne encephalitis (TBE) and its sequelae. The duration of protection and the optimal interval of repeat booster doses are still debated. The current study evaluated the persistence of the antibody response 11-15years after a first booster vaccination following different primary vaccination schedules with a TBE vaccine (Encepur Adults, manufactured by Bavarian Nordic, previously by GSK). This phase IV, open-label, mono-centric extension study enrolled adults who had received (at≥12years of age) primary vaccination with one of three randomly assigned TBE vaccine schedules (rapid [group R], conventional [group C], or accelerated conventional schedule [group A]) followed by a booster dose 3years later. The antibody response was measured annually from 11 to 15years post-booster using a TBE virus neutralization test (NT). An NT titer of≥10 was considered as a clinically meaningful threshold and surrogate for protection. In total, 194 participants were enrolled and included in the per-protocol set; 188 completed the study. The percentage of participants with an NT titer≥10 was 100% in group R and 99.0% in group A at all visits and ranged from 100% (year 11) to 95.8% (year 15) in group C. NT geometric mean titers were similar in the three study groups (181-267 in group R, 142-227 in group C, 141-209 in group A). NT geometric mean titers also remained high among participants≥50years old (98-206) and≥60years old (91-191) across study groups and time points. This study showed neutralizing antibody persistence for at least 15years after a first booster dose of the Encepur Adults TBE vaccine in all age groups evaluated, regardless of which primary vaccination schedule was given to adolescents or adults. Trialregistry: ClinicalTrials.gov: NCT03294135.

JYNNEOS Vaccination Coverage Among Persons at Risk for Mpox — United States, May 22, 2022–January 31, 2023

From May 2022 through the end of January 2023, approximately 30,000 cases of monkeypox (mpox) have been reported in the United States and >86,000 cases reported internationally.* JYNNEOS (Modified Vaccinia Ankara vaccine, Bavarian Nordic) is recommended for subcutaneous administration to persons at increased risk for mpox (1,2) and has been demonstrated to provide protection against infection (3-5). To increase the total number of vaccine doses available, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on August 9, 2022, recommending administration of the vaccine intradermally (0.1 mL per dose) for persons aged ≥18 years who are recommended to receive it (6); intradermal administration can generate an equivalent immune response to that achieved through subcutaneous injection using approximately one fifth the subcutaneous dose (7). CDC analyzed JYNNEOS vaccine administration data submitted to CDC from jurisdictional immunization information systems (IIS)† to assess the impact of the EUA and to estimate vaccination coverage among the population at risk for mpox. During May 22, 2022-January 31, 2023, a total of 1,189,651 JYNNEOS doses (734,510 first doses and 452,884 second doses)§ were administered. Through the week of August 20, 2022, the predominant route of administration was subcutaneous, after which intradermal administration became predominant, in accordance with FDA guidance. As of January 31, 2023, 1-dose and 2-dose (full vaccination) coverage among persons at risk for mpox is estimated to have reached 36.7% and 22.7%, respectively. Despite a steady decline in mpox cases from a 7-day daily average of more than 400 cases on August 1, 2022, to five cases on January 31, 2023, vaccination for persons at risk for mpox continues to be recommended (1). Targeted outreach and continued access to and availability of mpox vaccines to persons at risk are important to help prevent and minimize the impact of a resurgence of mpox.

Use of tecovirimat for mpox infection followed by JYNNEOS vaccination postinfection in a liver transplant recipient.

Use of tecovirimat for mpox infection followed by JYNNEOS vaccination postinfection in a liver transplant recipient.