JYNNEOS® Mpox Smallpox Vaccine Clinical Trials, Dosage, Efficacy, Side Effects, Usage
Bavarian Nordic A/S JYNNEOS® (MVA-BN®, IMVAMUNE®, IMVANEX®) two-dose vaccine is based on a live, attenuated vaccinia virus, Modified Vaccinia Ankara (MVA). The MVA is cultured in chicken embryo fibroblast cells and maintained in a serum-free medium. It cannot replicate in the human body but can elicit a potent immune response. It is purified and filtered from the cells using various methods, including benzonase digestion.
Since 2003, Bavarian Nordic (BN) has codeveloped JYNNEOS with the U.S. Government (BARDA) to ensure adult populations can be protected from smallpox and mpox, including people with weakened immune systems or at high risk of adverse reactions to traditional smallpox vaccines based on replicating vaccinia virus strains. Approved by the U.S. FDA in 2019, JYNNEOS was the first smallpox vaccine successfully developed under Project BioShield. BARDA has supported the development of a freeze-dried formulation of the vaccine to replenish the stockpile, and in 2017, it awarded BN a ten-year contract. BN has supplied a liquid-frozen formulation of JYNNEOS to the U.S. government for stockpiling since 2010 and in response to the mpox outbreak in 2022-2023. The U.S. government recommends two doses to provide more robust protection, and routine immunization against mpox is not recommended for the general public. Booster doses (3rd) are not endorsed. On February 14, 2025, Interim Clinical Considerations for Use of Vaccine for Mpox Prevention in the United States stated, 'Two vaccines can be used to prevent mpox: JYNNEOS® and ACAM2000®, but only JYNNEOS has been used in the ongoing clade II (mpox) outbreak.'
On July 26, 2024, Bavarian Nordic announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) had recommended approval of a Type II variation for the IMVANEX smallpox and mpox vaccine. BN confirmed that in real-world studies, vaccine effectiveness (VE) against mpox (clade 2) disease was demonstrated at least 14 days after vaccination, with adjusted VE estimates ranging from 35% (95% CI, -2-59) to 89% (95% CI, 76-95) after one MVA-BN dose and from 66% (95% CI, 47-78) to 90% (95% CI, 86-92) after two MVA-BN doses.
The Lancet Infectious Diseases published results from an observational study conducted at Charité – Universitätsmedizin Berlin on March 18, 2025, that found one dose of the JYNNEOS was 58% effective against mpox infection overall and 84% in people without HIV, and Breakthrough infections were associated with reduced symptoms, compared with infections in unvaccinated individuals. A meta-analysis of 16 studies published on April 26, 2024, revealed that the VE for one preexposure prophylactic JYNNEOS vaccination ranged from 35% to 86%, and the VE for two doses ranged from 66% to 90%.
Since September 13, 2024, JYNNEOS has been commercially available in the U.S. and added to the World Health Organization (WHO) prequalification (PQ) list. The WHO PQ and Emergency Use Listing are mechanisms for evaluating medical products' quality, safety, and efficacy, including vaccines. According to estimates from the U.S. CDC, two million U.S. individuals are eligible for mpox vaccination. Recent data shows that 15% of eligible people have received only one dose of the JYNNEOS vaccine.
On November 11, 2024, the WHO confirmed that the Mpox Vaccines Access and Allocation Mechanism endorsed an independent Technical Review Committee to allocate 899,000 MVA-BN vaccine doses to nine countries across the African region. For 2025, the Company has secured revenue from mpox/smallpox vaccine orders of approximately DKK 2,400 million, including previously announced deferred revenue. On December 16, 2024, Bavarian Nordic announced a license and manufacturing agreement for its MVA-BN® mpox vaccine with Serum Institute of India Pvt. Ltd.
Bavarian Nordic A/S, headquartered in Kvistgaard, Denmark (OTCMKTS: BVNRY) (OMX: BAVA), focuses on developing, manufacturing, and commercializing life-saving vaccines. The MVA-BN® vaccine is marketed under the brand names IMVANEX® in the European Union and IMVAMUNE® in Canada. This is the only mpox vaccine that the WHO has prequalified.
Bavarian Nordic JYNNEOS Revenues 2025
Revenue from sales of JYNNEOS/IMVANEX/IMVAMUNE in the first quarter of 2025 was DKK 629 million (DKK 344 million) and includes revenue from ongoing contracts with the U.S. government, other governments, and organizations, and private markets (the U.S. and Germany). For 2025, DKK 3,000-4,000 million is still expected in revenue from JYNNEOS/IMVANEX/IMVAMUNE, of which contracts have secured DKK 2,650 million as of May 2025. The ongoing, global mpox clade 1 and 2 outbreak continues to drive a surge in demand, resulting in the guided annual revenue exceeding the communicated base level of DKK 1,500-2,000 million.
Bavarian Nordic JYNNEOS (MVA-BN) Production
Since 2022, Bavarian Nordic has created a vaccine inventory to provide a surge capacity for potential outbreaks. Bavarian Nordic has identified 50 million doses that could be supplied during the next 12-18 months, pending regulatory approvals and demand. The Company has informed the African CDC that it can manufacture an additional 10 million doses by the end of 2025, which aligns with current orders. On December 16, 2024, Adar Poonawalla, CEO of Serum Institute of India, said, "Partnering with Bavarian Nordic on the MVA-BN mpox vaccine reflects our shared commitment to protect millions at risk. Leveraging our manufacturing strength and rapid response capabilities, we aim to enhance epidemic preparedness and expand access to life-saving vaccines, safeguarding vulnerable populations and easing the global burden of mpox."
Bavarian Nordic - Biomedical Advanced Research and Development Authority Agreements
Bavarian Nordic has collaborated with the U.S. government on developing, manufacturing, and supplying the smallpox vaccine. On May 6, 2025, Bavarian Nordic announced that BARDA had exercised additional options valued at $143.6 million under the existing contract to supply a freeze-dried formulation of JYNNEOS® smallpox vaccine. On September 24, 2024, Bavarian Nordic announced that it had received an additional order valued at $63 million from BARDA to manufacture additional bulk products and final freeze-dried doses of the JYNNEOS® smallpox/mpox vaccine. On August 8, 2024, Bavarian Nordic announced a new order valued at $156.8 million from the BARDA to manufacture additional bulk products for JYNNEOS®. On August 3, 2023, Bavarian Nordic announced it would manufacture and supply additional liquid-frozen doses of JYNNEOS to the U.S. government in 2023, valued at $3 million. Additionally, on August 3, 2023, Bavarian Nordic announced that BARDA had placed a new order valued at $120 million, primarily for manufacturing a new bulk product for the JYNNEOS smallpox/mpox vaccine.
JYNNEOS Vaccine U.S. FDA
The U.S. Food and Drug Administration (FDA ) initially approved JYNNEOS for smallpox prevention in September 2019, based on a comprehensive development program comprising 22 clinical trials, including two Phase 3 studies. The FDA granted Bavarian Nordic a Priority Review Voucher (PRV) under the Material Threat Medical Countermeasure program, thereby accelerating the FDA's review of the application. The FDA's emergency use authorization (EUA) for JYNNEOS for mpox was issued by Peter Marks, MD, Ph.D., in Application Number 28801 on August 9, 2022. JYNNEOS' or mpox use was based on survival data from lethal mpox virus challenge studies (FDA's Rule) on human primates. The FDA granted an Emergency Use Authorization for use in adolescents in 2022. On March 15, 2023, the U.S. FDA updated JYNNEOS - STN: BL 125678/20. As of 2025, JYNNEOS is the only FDA-approved smallpox and mpox vaccine for military and non-military use. On March 31, 2025, the FDA approved the freeze-dried formulation of JYNNEOS.
JYNNEOS Vaccine U.S. CDC
In November 2021, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) vaccine committee unanimously recommended JYNNEOS as an alternative to ACAM2000 for primary and booster doses of smallpox vaccine. The ACIP group leader, Pablo Sanchez, MD, led the presentations on the mpox vaccine on October 20, 2022, and February 22, 2023. The CDC announced Interim Clinical Considerations on February 22, 2023: Mpox vaccination should continue to be offered to people with the highest potential for exposure to mpox. An updated U.S. National Mpox Vaccination Strategy was published on February 6, 2023.
On June 23, 2023, Agam Rao, MD, CAPT, U.S. Public Health Service, presented: Considerations for Long-term Protection against Mpox - No CDC Recommendation for a Third JYNNEOS Dose, Including Persons with Advanced HIV or Other Severe Immunocompromised Immune Systems. On August 18, 2023, the CDC stated that all adults at risk for mpox should receive the JYNNEOS vaccine, regardless of childhood smallpox vaccination status. On October 25, 2023, the CDC recommended the routine use of JYNNEOS for individuals at risk of smallpox or mpox infection. Survey results published in the U.S. CDC's Volume 30, Number 5 May 2024, showed that among vaccine-eligible GBMSM, uptake was 69% (95% CI 65%–72%; 601/875) and 92% (95% CI 89%–94%; 601/655) among those offered the JYNNEOS vaccine.
As of May 2025, the CDC published updated Clinical Considerations for Mpox in Children and Adolescents in the U.S.
JYNNEOS Vaccine Availability in the United States
As of May 2025, healthcare providers in the United States can order JYNNEOS through their preferred wholesalers and distribution partners to make it available to at-risk individuals at pharmacies, physician offices, and public health clinics. This HHS operational planning guide is provided to aid state, tribal, local, and territorial health officials in their planning and response efforts. JYNNEOS became commercially available at pharmacies in the U.S. in 2024. As of April 2024, Morris & Dickson became the first U.S. commercial distributor of JYNNEOS. Cities such as Austin, Texas, offer free JYNNEOS vaccination services.
IMVAMUNE® Vaccine Europe
The European Commission issued marketing authorization for smallpox prevention for MVA-BN (Imvanex) in 2013. It extended it to include mpox for adults in 2022, based on efficacy data in non-human primates and immunogenicity data from numerous studies involving more than 4,000 healthy and immune-compromised individuals. On September 19, 2024, the European Medicines Agency (EMA) recommended extending the indication of the smallpox and monkeypox vaccine Imvanex to adolescents aged 12 to 17. It is inferred that the vaccine will provide similar protection in adolescents to that expected in adults.
MVA-BN® Vaccine
As of May 1, 2025, the Democratic Republic of the Congo (DRC) has administered more than half a million mpox vaccine doses since October 2024, receiving more than 950,000 doses from various sources. The European Commission delivered 10,000 doses of the MVA-BN® vaccine to Uganda in January 2025. On September 26, 2024, Bavarian Nordic announced an agreement with UNICEF to supply 1 million doses of the MVA-BN® mpox vaccine for African countries. In the agreement, UNICEF has negotiated a price of up to $65 per vaccine dose, the lowest price in the market. On August 20, 2024, USAID confirmed donating 50,000 Jynneos vaccines to the Democratic Republic of the Congo (DRC). On August 13, 2024, Bavarian Nordic announced a new order from the European Health Emergency Preparedness and Response Authority (HERA) for the MVA-BN® vaccine. HERA will procure 175,420 vaccine doses for donation to the Africa Centres for Disease Control and Prevention.
Additionally, Bavarian Nordic will donate 40,000 doses to HERA. This more significant donation follows a recent pledge from the Company for 15,000 doses as part of a coordinated response in the African region by Gavi, WHO, and UNICEF. Bavarian Nordic was awarded a contract on September 13, 2023, to supply its MVA-BN smallpox vaccine to rescEU, a strategic reserve within the European Union.
MVA-BN® Vaccine For Adolescents
On April 15, 2025, Dr. Buddy Creech presented the immunogenicity and safety of JYNNEOS in 12- to 17-year-olds to the U.S. CDC's ACIP. The Evidence to Recommendations Framework: Vaccination with Jynneos for Adolescents at Risk of Mpox During Outbreaks was presented by Faisal Syed Minhaj, PharmD, MPH; and Routine Vaccination with Jynneos for Adolescents at Risk of Mpox.
A National Institutes of Health-funded Phase 2 clinical trial of JYNNEOS in 229 adolescents found it to be. It generated an antibody response equivalent to that seen in adults—a peer-reviewed study funded by the U.K. Health Security Agency, published on June 15, 2023, concluded that a single dose of MVA–BN for post-exposure prophylaxis was well-tolerated in children and induced robust antibody and cellular responses up to 15 weeks after vaccination. On September 15, 2022, the U.S. CDC confirmed that children and adolescents exposed to people with suspected or confirmed mpox infections might be eligible for post-exposure prophylaxis with vaccination. In addition, the CDC published interim Clinical guidance for Healthcare Providers in September 2022.
Bavarian Nordic announced on October 29, 2024, the initiation of a Phase 2 clinical study (NCT06549530) of the MVA-BN mpox/smallpox vaccine in children aged 2 to 11 years in the Democratic Republic of the Congo (DRC), with plans also to include sites in Uganda. The study is partially funded by the Coalition for Epidemic Preparedness Innovations, which announced on May 30, 2024, that it awarded BN $6.5 million to support phase 2 clinical trials.
JYNNEOS Vaccine Efficacy
The JAMA Network published results from a study on October 3, 2024, which concluded that two doses provided 66% effectiveness and one dose provided 36% effectiveness in achieving peak immunity during the 2022 mpox outbreak. The findings of a study conducted in the context of a targeted vaccination program in Canada, published on September 11, 2024, suggested that one dose of MVA-BN is moderately effective (58% [95% CI 31% to 75%]) in preventing clade 2 mpox infection. The study showed that the MVA-BN vaccine generated mpox serum antibody responses that largely waned after 6 to 12 months. High titers of mpox NAbs (median titer 965) were detected at three months. MVA-BN provided 66% efficacy as a 2-dose regimen and 36% as a 1-dose regimen at peak immunity during the 2022 mpox outbreak in the U.S.
U.S. CDC research, published in the journal Emerging Infectious Diseases, Volume 30, Number 10—October 2024, concluded that the estimated effectiveness of the 2-dose JYNNEOS vaccine was approximately 80%. Results from a study announced in March 2024 showed mpox antibodies waned within a year of JYNNEOS vaccination. Among individuals with childhood smallpox vaccination, most people had detectable IgG after one year, and the GMT reduction between 4 weeks after the last vaccine dose in 2022 and the one-year follow-up visit was 2.5-fold for those vaccinated with two doses of JYNNEOS, and 1.9-fold for those vaccinated with one dose of JYNNEOS.
On March 14, 2024, the U.S. CDC staff stated, 'JYNNEOS vaccination is expected to be effective regardless of mpox clade. Mpox virus Clade I is divided into lineages 1–5, while Clade II is divided into subclades IIa and IIb. Clade IIb is responsible for the global mpox outbreak that began in May 2022. On December 7, 2023, the CDC published a Health Alert Network Health Advisory stating that mpox vaccines are expected to be effective for both Clade I and Clade II MPXV infections. However, the ECDC reported in 2023 that real-world data regarding JYNNEOS' effectiveness against clade 1 is lacking.
The Lancet Infectious Diseases reported on December 7, 2023, that 12% of vaccinated individuals were non-antibody responders, whereas all people with mpox infection developed a neutralizing antibody response. A case-series (67) study published by The Lancet Infectious Diseases on September 4, 2023, confirmed that natural and vaccine-induced immunity are not fully protective against mpox infection. Demographic subgroup information is available in Section 1.1 of the Clinical Review Memo, which details participation in the clinical trials and notable analyses of demographic subgroup outcomes. And Section 6.2 (Postmarketing Experience) to the Package Insert.
The CDC reported in October 2023 that the JYNNEOS Vaccine Effectiveness (VE) against mpox ranges from 36% to 75% for a single-dose vaccination and 66% to 89% for a two-dose vaccination. VE trended higher for immunocompetent participants compared to those who self-reported as immunocompromised. The Lancet Infectious Diseases reported that the JYNNEOS vaccine showed an effectiveness of 66–78%, and second episodes of mpox and cases of breakthrough infections among fully vaccinated individuals have been reported. On June 29, 2023, Orginal Research estimated adjusted vaccine effectiveness was 66% (95% confidence interval [CI], 47.4 to 78.1), and 146 case patients and 1000 control patients received one dose, among whom the estimated adjusted vaccine effectiveness was 35.8% (95% CI, 22.1 to 47.1).
On May 18, 2023, the New England Journal of Medicine (NEJM) published data from Cosmos, a nationwide Epic Electronic Health Record (EHR) database, to assess the effectiveness of JYNNEOS vaccination in preventing mpox disease among adults who received two doses of the vaccine. The estimated adjusted vaccine effectiveness was 66% (95% confidence interval [CI], 47.4 to 78.1), and those who received one dose, among whom the estimated adjusted VE was 35.8% (95% CI, 22.1 to 47.1).
JYNNEOS Breakthrough Mpox Infections
The CDC published a Morbidity and Mortality Weekly Report (MMWR, 73(20);460–466) in May 2024 that highlighted that among 32,819 U.S. mpox cases reported from May 2022 to May 2024, only 0.8% occurred among people who had received two doses of JYNNEOS. Between May 2022 and May 2024, 271 mpox cases occurred among fully vaccinated individuals from 27 U.S. jurisdictions. The CDC issued an MMWR on June 23, 2023, and the Clinician Outreach and Communication Activity (COCA) call on May 18, 2023, confirmed a cluster of mpox cases in Chicago, Illinois. During March 18–June 12, 2023, 40 laboratory-confirmed mpox cases were identified in Chicago, including 22 (55%), five (13%), and 13 (33%), respectively, among patients who had received two doses of JYNNEOS or one dose of ACAM2000 vaccine, those who had received one vaccine dose of JYNNEOS vaccine, and those who had not received any vaccines for mpox.
JYNNEOS Vaccine Coadministration
As of 2025, the CDC says limited clinical trial data have been presented on administering the JYNNEOS vaccine simultaneously with other vaccines.
JYNNEOS Vaccine Dosage
In the U.S., the standard U.S. FDA regimen for JYNNEOS involves subcutaneous administration with two injections of 0.5 mL four weeks apart.
JYNNEOS Vaccine Booster
On October 3, 2024, JAMA published a Research Letter concluding that data suggest protective immunity may be waning in individuals vaccinated with MVA-BN in 2022, and that booster doses may be required to maintain robust levels of protective immunity. The U.S. CDC wrote on September 12, 2024, that JYNNEOS booster doses are not recommended.
JYNNEOS Pre and Post-Exposure Vaccination
On July 29, 2024, a Phase 4 clinical study was launched to assess whether an mpox vaccine can protect people against the disease after exposure to the potentially deadly infection. A study published in January 2024 concluded that the time to PEP and the observed incubation period resulted in overestimating PEP effectiveness using a conventional method. On October 10, 2022, the WHO confirmed that post-exposure vaccination (PEPV) is recommended for close contacts with MPX cases, ideally within four days of first exposure and up to 14 days after exposure without symptoms.
JYNNEOS Cell Line
JYNNEOS (MVA-BN) vaccine utilizes Chicken Embryo Fibroblast cells to produce the vaccine. Replication-competent poxvirus strains can cause clinical infections in humans and contain infectious viruses that can be transmitted to others. However, replication-deficient poxvirus strains, including MVA, do not produce contagious viruses in humans and, therefore, do not cause infection. As such, replication-deficient poxvirus strains pose a substantially lower risk of adverse events than replication-competent strains.
JYNNEOS For Pregnant Women
The U.S. FDA says available human data on JYNNEOS administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Four developmental toxicity studies conducted in female rats and rabbits evaluated the effect of JYNNEOS on embryo-fetal and postnatal development. As of October 27, 2022, the CDC confirmed no clinical efficacy data regarding pregnant or breastfeeding women.
JYNNEOS Vaccine HIV
The European AIDS Clinical Society also recommends the vaccine for adults infected with HIV or on preexposure prophylaxis treatment, and it may support additional national recommendations for the vaccine in the future. On August 5, 2022, the early release of the CDC Report - Interim Guidance - confirmed the JYNNEOS vaccine can be safely given to people who are living with HIV infection and those who are taking preexposure prophylaxis (PrEP).
JYNNEOS Vaccine Myocarditis Risk
According to the U.S. CDC, myocarditis and pericarditis have occurred following either primary vaccination or revaccination with live vaccinia virus smallpox vaccines, and are a known health risk for military forces (2003). The CDC reported on October 25, 2023, that VAERS and VSD data suggest an increased risk for myocarditis or pericarditis following JYNNEOS. Similar to smallpox vaccination, the possibility of a negligible risk cannot be excluded.
JYNNEOS Side Effects
A study funded by the European Medicines Agency (EMA) concluded in March 2025 that the MVA-BN vaccination was safe and well-tolerated. The risk of a severe allergic reaction should be weighed against the risk of disease due to smallpox or mpox. A Research Letter Published on May 5, 2023, reviewed a Phase 4 clinical study of adverse events following Jynneos vaccination and found that local adverse event rates were highest following intradermal administration. The adverse event rate was highest following dose 1 of intradermal vaccination (53%) and low immunization dose 2 of subcutaneous vaccination (31%). The adverse effects of immunization included local redness, itching, and swelling following intradermal vaccination and local pain, swelling, and redness following subcutaneous immunization.
Jonathan Dufimmunization, Immunization Safety Office, CDC Advisory Committee on Immunization Practices, presented JYNNEOS Vaccine Safety Monitoring During the 2022 Mpox Outbreak on February 22, 2023. According to VAERS, the number of serious adverse events reported after JYNNEOS was 26. The CDC announced on December 8, 2022, that the vaccine's safety profile was consistent with the results of pre-licensure studies. The most common adverse health events reported were nonserious, including injection site reactions. Serious adverse events were rare among adults.
Severe adverse reactions, such as those associated with replicating vaccinia virus strains, including myocarditis, encephalitis, generalized vaccinia, or eczema vaccinatum, were not observed during the Jynneos development program. The U.S. FDA reports in smallpox vaccine-naïve healthy adults, the most common (> 10%) solicited injection site reactions were pain (84.9%), redness (60.8%), swelling (51.6%), induration (45.4%), and itching (43.1%); the most common solicited systemic adverse reactions were muscle pain (42.8%), headache (34.8%), fatigue (30.4%), nausea (17.3%) and chills (10.4%).
JYNNEOS Contraindication
According to the CDC, JYNNEOS is contraindicated in persons with allergies to any vaccine component.
JYNNEOS Immunocompromised
Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to JYNNEOS.
JYNNEOS Storage Requirement
JYNNEOS must be safely stored at 20 degrees Celsius (20°C).
JYNNEOS MVA-BN® Vaccine News
May 15, 2025 - The WHO published the 52nd situation report for the multi-country outbreak of mpox, with data as of May 2025. The African Region has more than 668,000 doses of MVA-BN vaccines administered in seven countries.
May 9, 2025 – Bavarian Nordic A/S announced that Public Preparedness (mpox, smallpox) revenue increased by 83% to DKK 629 million compared to the first quarter of 2024.
May 6, 2025 - Paul Chaplin, President & CEO of Bavarian Nordic, stated, "Following the recent FDA approval of the freeze-dried formulation of our smallpox/mpox vaccine, we applaud the U.S. government's steadfast commitment to improving national health security through the exercise of these options. The freeze-dried vaccine, with its improved shelf life, significantly contributes to securing the long-term availability of countermeasures to protect U.S citizens against life-threatening diseases."
March 19, 2025 - Prof. Leif Erik Sander, Director of the Department of Infectious Diseases and Critical Care Medicine at Charité and a research group leader at the Berlin Institute of Health at Charité, commented, "Our results confirm that a single dose of the vaccine provides good protection against Mpox, at least for a short time. Unfortunately, we found that people with HIV – even those taking adequate medication – are not sufficiently protected by a single dose."
December 20, 2024 - Gavi CEO Dr. Sania Nishtar: "We thank the U.S. for these donations, which substantially strengthen the global mpox response. In addition to the 500,000 doses that Gavi procured directly in September through our First Response Fund, working with our donors, we now have legal frameworks in place to facilitate a substantial volume of additional pledged doses, which we will work with our partners to ensure are rolled out as quickly as possible."
November 22, 2024 - The WHO Director-General, agreeing with the advice of the IHR Emergency Committee, has determined that the upsurge of mpox continues to constitute a public health emergency of international concern.
November 15, 2024 - Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, said: "We have had a busy but highly purposeful and rewarding third quarter, during which we have worked intensively to support efforts to curb the ongoing mpox outbreak in Africa."
October 23, 2024 - A study reported a distinct clade I sequence from Sudan, suggesting local circulation of Monkeypox virus (MPXV) in Eastern Africa over the past four decades.
October 14, 2024 - The WHO approved JYNNEOS for people aged 12 to 17.
September 26, 2024 - Bavarian Nordic A/S announced an agreement with UNICEF to supply 1 million doses of the MVA-BN® mpox vaccine for African countries.
August 27, 2024 - Germany intends to donate 100,000 mpox vaccine doses to African countries.
August 16, 2024 - "Children and adolescents are disproportionately affected by mpox in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden access to vaccines and therapies for this vulnerable population. We applaud the NIH for their work on this study and are pleased to report data that support the use of our vaccine in adolescents, adding to the growing pool of evidence that MVA-BN is well tolerated and able to generate a relevant immune response in adolescents and adult populations," said Paul Chapel, President, and Chief Executive Officer of Bavarian Nordic.
April 2, 2024 - Brian Hujdich, Executive Director of the National Coalition for LGBTQ Health, commented: "JYNNEOS is a vital step toward ensuring equitable access to healthcare for the LGBTQ+ community and marks a significant stride in preventing the spread of mpox."
JYNNEOS Vaccine Clinical Trial
The results of a Phase 2 study, posted as a preprint on September 9, 2022, concluded that priming with either 1 or 2 doses of MVA-BN induced a durable immune memory, similar to the generation of replicating smallpox vaccines. When the MVA-BN vaccine was administered as a booster to individuals who had been primed two years earlier with MVA-BN or an older generation replicating smallpox vaccine in the distant past, it elicited a similarly rapid and durable immune response, which was generally safe and well-tolerated. One-dose priming with MVA induced a long-term B-cell memory, resulting in robust anamnestic responses following an MVA booster two years later. This suggests that a single dose may offer protection against future exposure.
The FDA approval of JYNNEOS for smallpox is based on a development program comprising 22 clinical trials, including two Phase III trials. The program enrolled 7,871 individuals aged between 18 and 80 years who received at least one dose of the vaccine. Approval for the monkeypox indication is based on survival data from studies conducted in non-human primates. The survival rate ranged from 80% to 100% in animals vaccinated with JYNNEOS, compared to 0% to 40% in the control group.
Upon successful completion of the current study, expected in 2021, the Company plans to submit a supplement to the BLA to extend the approval for both formulations of MVA-BN, anticipated in 2022.