Vaccine Info

JYNNEOS Smallpox (Monkeypox) Vaccine

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October 3, 2022
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JYNNEOS® (MVA-BN) Smallpox Monkeypox Vaccine Description 2022

Bavarian Nordic JYNNEOS® smallpox monkeypox vaccine is based on a live, attenuated vaccinia virus, Modified Vaccinia Ankara (MVA), incapable of replicating in the human body yet able to elicit a potent immune response. The MVA is cultured in Chicken Embryo Fibroblast cells and a serum-free medium. It is purified and filtered from the cells using various methods, including benzonase digestion.

The two-dose MVA-BN (JYNNEOS®, USA, IMVANEX®, Europe; IMVAMUNE®, Canada) was approved by the U.S. Food and Drug Administration (FDA) on September 24, 2019, and by the European Medicines Agency EMEA/H/C/002596 in 2013 and is now indicated for preventing smallpox and monkeypox (MPXV) diseases in adults 18 years of age and older determined to be at high risk for infection. Concurrent with the approval, the FDA granted Bavarian Nordic a Priority Review Voucher under the Material Threat Medical Countermeasure PRV program, which can accelerate the FDA's review of a future human drug application and is also transferrable.

JYNNEOS is the only FDA-approved non-replicating smallpox and monkeypox vaccine for military and non-military use but is not commercially available in the USA. On August 9, 2022, the FDA announced it issued an emergency use authorization (EUA) for the JYNNEOS vaccine to allow healthcare providers to use the vaccine by intradermal injection for individuals determined to be at high risk for monkeypox infection. The FDA updated STN: 125678 and the Approval Letter STN: BL 125678/36 on September 2, 2022.

JYNNEOS vaccine was developed in partnership with the U.S. Government (BARDA, BioShield) to ensure adult populations can be protected from smallpox, including people with weakened immune systems or at high risk of adverse reactions to traditional smallpox vaccines based on replicating vaccinia virus strains. In terms of efficacy, recent research found that MVA-BN induced strong cellular activity and humoral (antibody) immune response about ten days following the second dose and has demonstrated an ability to stimulate a response even in individuals with pre-existing immunity against vaccinia.

In November 2021, the U.S. CDC's vaccine committee unanimously voted for JYNNEOS as an alternative to ACAM2000 for primary vaccination and booster doses. On June 21, 2021, the U.S. FDA updated JYNNEOS - STN: BL 125678/20. ATC code: J07BX.

The U.S. national monkeypox vaccine strategy was announced on June 28, 2022, and updated on August 22, 2022. In addition, on September 1, 2022, the CDC published: Technical Report 2: Multi-National Monkeypox Outbreak, United States, 2022. On September 28, 2022, the CDC reported most Jynneos vaccinations had been administered as post-exposure prophylaxis, and unvaccinated people had 14 times the risk of monkeypox disease compared to people who were vaccinated. The data assessed from 32 jurisdictions accounted for 54% of the U.S. population eligible for vaccination and, therefore, might not be generalizable, said the CDC.

On September 9, 2022, a non-peer-reviewed phase 2 clinical study funded by the Company's related parties found the MVA-BN booster vaccine-induced anamnestic responses to support durable immune memory; one or two primary MVA-BN vaccinations induce similar durable B cell memory responses; Anamnestic responses were observed in those immunized with MVA-BN 2 years earlier, and no safety concerns were revealed following a 2-year MVA-BN booster. The peer-review journal NEJM published a Perspective on September 29, 2022: Intradermal Vaccination for Monkeypox — Benefits for Individual and Public Health.

Bavarian Nordic is headquartered in Kvistgaard, Denmark (OTCMKTS: BVNRY) (OMX: BAVA), which focuses on developing, manufacturing, and commercializing life-saving vaccines.

JYNNEOS Monkeypox Vaccine Price

The Jynneos vaccine is not sold commercially in the USA as of October 3, 2022.

JYNNEOS Breakthrough Infections

In this small study based in Chicago, IL, published by The JAMA Network on September 30, 2022, the majority of postvaccination monkeypox infections occurred within two weeks of receiving the first dose of MVA-BN, in line with published immunogenicity data. Because the incubation period for monkeypox is 3 to 17 days, some of the cases occurring between 1 and 14 days after vaccination may not represent true vaccine failure because patients may have sought vaccination after realizing they were exposed. Of concern is that at least two breakthrough infections were observed in individuals at least three weeks after a second dose.

A non-peer-reviewed study based in France reported on August 4, 2022, among the 276 vaccinated individuals, 12 (4%) had a confirmed MPXV breakthrough infection with no severe infection. Ten out of 12 patients developed a Monkeypox infection in the five days following vaccination, and two had a breakthrough infection at 22 and 25 days.

JYNNEOS Monkeypox Vaccine Availability

As of October 3, 2022, the MVA-BN (Jynneos, IMVANEX, MVAMUNE) vaccine was available in AustraliaBrazilCanada, CaribbeanCyprus, Democratic Republic of CongoDenmarkEuropeFrance, Germany, Iceland, IndonesiaIsreal, ItalyMexicoNigeria, Norway, PortugalScotlandSpain, and the U.K

On September 28, 2022, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) confirmed it had delivered 833,293 Jynneos vials of vaccines to jurisdictions. As of September 27, 2022, 803,596 monkeypox vaccine doses had been administered in the 39 U.S. Jurisdictions Reporting Data, such as American SamoaAnchorageAtlantaAustin, Baltimore, BirminghamBosieBoston, Chicago, ConnecticutDallasDenver, GuamHouston, LaramieLittle RockLos AngelesMiami, New OrleansNew York City, OrlandoPheonixPhiladelphia, Pittsburg, San AntonioSan Francisco, Washington DC, and Wilmington Del. And New York City announced on September 13, 2022, that it would offer Jynneos vaccine second doses to people (3,402) who received their first dose on or before July 23, 2022.

As of September 2022, the U.S. government had ordered 5.5 million vials of JYNNEOS from Bavarian Nordic to be filled, finished, and delivered from U.S. government-owned bulk vaccine stored in Denmark, bringing the U.S. government supply to approximately 7 million vials by mid-2023. Specifically, 2.5 million of those vials are to be filled and finished by a U.S.-based contract manufacturer.

Bavarian Nordic announced on September 7, 2022, that the European Health Emergency Preparedness and Response Authority ordered an additional 170,000 doses of the MVA-BN vaccine, which will be made available before the end of 2022. This brings the total number of vaccine doses directly purchased by the EU to 334,540. Separately, the U.K.'s Health Services Agency confirmed as of August 30, 2022, a total of 38,079 administered doses of the MVA vaccine have been recorded, of which 33,918 doses have been administered as pre-exposure vaccination.

The MVA-BN® vaccine is marketed under the brand names IMVANEX in the European Union and IMVAMUNE in Canada. On July 22, 2022, the European Medicines Agency (EMA) human medicines committee (CHMP) recommended extending the indication of Imvanex to include protecting adults from monkeypox disease. The use of the vaccine in either indication (monkeypox or smallpox) is based on immunogenicity data generated in humans and animals and on protection in animals challenged with the virus. The CHMP considered that the effectiveness of Imvanex in the prevention of monkeypox virus disease in humans could be inferred from these studies. The European Commission (EC) extended Imvanex's marketing authorization on July 25, 2022, to include monkeypox. And Canada extended its contracts with Bavarian Nordic on September 20, 2022, securing IMVAMUNE® deliveries in 2023 with the option to procure additional doses annually until 2032. 

JYNNEOS Vaccinations By Pharmacists

On October 3, 2022, the U.S. HHS published a Public Readiness and Emergency Preparedness Act declaration in the Federal Registry that grants pharmacists certain authorities to administer monkeypox vaccines.  

JYNNEOS U.S. FDA Approval

The approval of JYNNEOS for smallpox by the U.S. FDA in 2019 was based on a comprehensive development program comprising a total of 7,871 individuals aged 18 through 80 years who received at least one dose (7,109 smallpox vaccine-naïve and 762 smallpox vaccine-experienced individuals) in 22 clinical trials, including two Phase 3 studies, the latter of which showed non-inferiority in terms of immunogenicity measured by plaque reduction neutralization test of JYNNEOS compared to ACAM2000. The approval for monkeypox use is based on survival data obtained in lethal monkeypox virus challenge studies (FDA's Animal Rule) in non-human primates. Overall survival in various models ranged from 80% to 100% of JYNNEOS-vaccinated animals compared to 0-40% in control animals.

The U.S. FDA's emergency use authorization (EUA) for Jynneos for monkeypox was issued by Peter Marks, MD, Ph.D., in EUA Application Number: 28801, on August 9, 2022. The U.S. government believes up to five Jynneos doses could be available for intradermal vaccination per vial.

JYNNEOS Dosage

In the USA, the standard U.S. FDA regimen for Jynneos involves a subcutaneous (Subcut) route of administration with an injection volume of 0.5mL. Since August 9, 2022, the standard regimen has been authorized for people aged <18 years under an FDA-issued EUA.

In the context of the current national Public Health Emergency, the FDA authorized an alternative regimen that may be used for adults aged ≥18 years under a EUA beginning August 9, 2022. The authorized alternative regimen involves an intradermal route of administration with an injection volume of 0.1mL. The CDC updated its recommendations on August 22, 2022.

On August 19, 2022, the EMA's Emergency Task Force (ETF) noted that there is no information available on the maximum number of 0.1 ml doses that can be withdrawn from the authorized presentation (0.5 ml suspension) and recommended using low-dead volume syringes to optimize the number of doses that can be extracted. The UK and Spain began testing this dosing strategy on August 22, 2022.

JYNNEOS Second Dose

The U.S. FDA confirmed on August 9, 2022, the second vaccine dose of Jynneos should be given 28 days after the first dose. New York City began offering people second doses of Jynneos in September 2022. The UK Health Security Agency announced on September 23, 2022, that second doses of the Jynneos vaccine will be offered to people at the highest risk from monkeypox.

JYNNEOS (MVA) Fractional Formulation Study

A non-peer-reviewed, limited phase 1 study conducted by the Erasmus Medical Center, Rotterdam, The Netherlands, supported by European Unions Horizon 2020 Grant VEO, published on September 1, 2022, found Jynneos vaccine dose-sparing leads to lower antibody levels, whereas a third MVA vaccination further boosts antibody response.

An alternative vaccination dosage study was published on September 22, 2015, in the journal Vaccine / Science Direct (Frey SE et al, Vaccine, 2015; 33(39):5225-5234) - Comparison of lyophilized versus liquid MVA (Jynneos) formulations and subcutaneous versus intradermal routes of administration in 524 healthy vaccinia-naïve subjects who were randomized to receive either a full dose of Lyophilized-SC, a full dose of Liquid-SC or 20% (2 × 107 TCID50 in 0.1 mL) of a full dose Liquid-ID MVA on Days 0 and 28. At 180 days after the second vaccination, geometric mean neutralization titers declined to 11.7, 10.2, and 10.4, with only 54.3%, 39.2%, and 35.2% of subjects remaining seropositive for the Lyophilized-SC, Liquid-SC and Liquid-ID groups, respectively. Both the Lyophilized-SC and Liquid-ID groups were considered non-inferior (primary objective) to the Liquid-SC group.

Jynneos Coadministration With Other Vaccines

As of October 2022, the CDC says there is limited clinical trial data on administering the Jynneos vaccine simultaneously as other vaccines. However, there are additional considerations if administering a COVID-19 vaccine. (Interim Clinical Considerations for Use of COVID-19 Vaccines). People, particularly young adult males, might consider waiting four weeks after JYNNEOS or ACAM2000 vaccination before receiving a Moderna, Novavax, or Pfizer-BioNTech COVID-19 vaccine, because of the observed risk for myocarditis and/or pericarditis after receipt of ACAM2000 and mRNA (i.e., Moderna and Pfizer-BioNTech) vaccines and the unknown risk for myocarditis and/or pericarditis after Jynneos vaccination.

JYNNEOS Booster

The U.S. CDC vaccine committee stated, 'regarding booster doses, a systematic review identified one randomized controlled trial and 17 observational studies that included a total of 6,417 subjects. After considering geometric mean titer and seroconversion rate together, the Vaccine Work Group estimated with very low (level 4) certainty that a small increase in disease prevention occurs after the JYNNEOS booster versus the JYNNEOS 2-dose primary series only. The ACIP unanimously voted in favor of recommending JYNNEOS boosters as an alternative to ACAM2000 boosters in persons who received ACAM2000 as the primary vaccine.

JYNNEOS Cell Line

JYNNEOS (MVA-BN) Vaccine (IMVANEX, IMVAMUNE) utilizes Chicken Embryo Fibroblast cells to produce the vaccine. Replication-competent poxvirus strains can cause clinical infection in humans as well as produce an infectious virus that can be transmitted to others. However, replication-deficient poxvirus strains, including modified vaccinia Ankara (MVA), do not produce infectious viruses in humans and therefore do not cause clinical infection. As such, replication-deficient poxvirus strains pose a substantially lower risk of adverse events compared with replication-competent strains. 

JYNNEOS Indication

JYNNEOS is indicated to protect people from smallpox and monkeypox viruses, including people with weakened immune systems or at high risk of adverse reactions to traditional smallpox vaccines based on replicating vaccinia virus strains. JYNNEOS involves a replication-deficient virus. The WHO says, 'Monkeypox is a sylvatic zoonosis caused by the monkeypox virus (MPXV) and belongs to the Orthopoxvirus family, including variola virus (smallpox). The WHO states, 'Vaccination against smallpox with first-generation vaccinia-virus-based smallpox vaccine was 85% effective in preventing monkeypox in the past. Therefore, persons exposed to the MPXV and who have not received the smallpox vaccine within the last three years should consider getting vaccinated. The sooner the person receives the vaccine, the more effective it will be in protecting against MPXV, says the CDC. However, JYNNEOS can be used for PEP, PEP++, or PrEP, following risk-benefit discussions and a review of any conditions that could increase the risk for serious adverse events.'

European Medicines Agency (EMA) 's human medicines committee (CHMP), and the European Commission extended the marketing authorization for the Company's smallpox vaccine, IMVANEX®, to include protection from monkeypox and disease caused by the vaccinia virus. On June 21, 2022, the UKHSA published its vaccine strategy in response to the monkeypox outbreak. As monkeypox is related to the virus which causes smallpox, vaccines developed for smallpox are considered to provide cross-protection against monkeypox.

Jynneos And HIV

The CDC stated on August 10, 2022, that it is currently unknown whether HIV infection affects a person's risk of acquiring Monkeypox virus infection and developing the disease after exposure. On August 5, 2022, the early release Morbidity and Mortality Weekly Report - Interim Guidance for Prevention and Treatment of Monkeypox in Persons with HIV Infection — United States, August 2022. Prompt diagnosis and treatment and enhanced prevention efforts might reduce the risk for severe outcomes. The safety and immunogenicity of JYNNEOS have been established in people with HIV, stated the CDC on August 5, 2022. The vaccine can be safely given to people who are living with HIV infection and those who are taking pre-exposure prophylaxis (PrEP), says the UK NHS.

On September 19, 2019, the FDA disclosed on pg. 191, 'Unlike ELISA antibody responses, HIV-infected individuals had a notably lower PRNT SCR at Peak Visit, compared to HIV-uninfected controls (58.1% HIV vs 78.9% HIV-uninfected), which suggests the possibility of a less robust functional antibody vaccine response. Seroconversion and GMTs did not differ significantly between CD4 cell count strata, though they did tend to be lower in subjects with lower CD4 counts. Mean PRNT GMTs at the time of peak immune response (2 weeks after the second MVA-BN dose) for both healthy and HIV-infected individuals were at or below the lower limit of quantitation for the assay (20) 20.8 and 13, respectively, which raises doubt about the interpretation and significance of these data.

JYNNEOS For Children

On September 15, 2022, the U.S. CDC confirmed children and adolescents with exposure to people with suspected or confirmed monkeypox infections may be eligible for post-exposure prophylaxis with vaccination. Interim Clinical guidance for Healthcare Providers was published by the CDC in September 2022.

JYNNEOS For Women

There are no clinical efficacy data regarding women who are pregnant or breastfeeding. However, the CDC stated on September 1, 2022, pre- or post-exposure prophylaxis could be offered to women who are pregnant or breastfeeding. When pre- or post-exposure prophylaxis by vaccination is chosen, JYNNEOS, a live, non-replicating viral vaccine, can be used. The virus in the vaccine does not grow and multiply in the human body, so it cannot spread to an unborn child, says the UK NHS. However, if you catch monkeypox, you could pass the infection to your baby.

JYNNEOS U.S. CDC Presentations

On September 29, 2022, the CDC published 'Technical Report 3: Multi-National Monkeypox Outbreak, United States, 2022.'

The U.S. CDC Emergency Preparedness and Response COCA call on August 11, 2022, discussed CDC and FDA Update: Interim Clinical Considerations for Monkeypox Vaccination. And Considerations for Monkeypox Vaccination on July 29, 2022. In addition, the COCA delivered a presentation on July 26, 2022: Monkeypox Outbreak: Updates on the Epidemiology, Testing, Treatment, and Vaccination. The U.S. CDC issued Health Alert Network CDCHAN-00468 on June 14, 2022 - Updated Case-finding Guidance: Monkeypox Outbreak—U.S. On May 27, 2022, the U.S. CDC's Morbidity and Mortality Weekly Report published - Use of JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) for Preexposure Vaccination of Persons at Risk for Occupational Exposure to Orthopoxviruses: Recommendations of the Advisory Committee on Immunization Practices — U.S., 2022. Potential vaccinees should weigh the risks and benefits of each vaccine when deciding which to receive. On April 8, 2022, a CDC MMWR reviewed: Monkeypox in a Traveler Returning from Nigeria — Dallas, Texas, July 2021.

During the U.S. CDC's ACIP Meeting on September 29, 2021, Agam Rao, M.D. CAPT, U.S. Public Health Service, presented: Background information to interpret GRADE tables and Evidence to Recommendations framework about the JYNNEOS vaccine. The Demographic Subgroup Information - JYNNEOS. On November 3, 2021, Pablo Sanchez, MD Chair, ACIP Orthopoxvirus W.G., led an update discussion, followed by Brett Petersen, MD, MPH, who presented Clinical Guidance for the use of JYNNEOS. Then, Agam Rao, MD CAPT, presented a Summary of Evidence to Recommendations Frameworks for Using JYNNEOS.

JYNNEOS Side Effects

This smallpox/monkeypox vaccine is not recommended for the general public in the USA since smallpox has been eradicated. According to the U.S. CDC, routine smallpox vaccination among the American public stopped in 1972. However, health officials are prepared to use a vaccine if there were a smallpox outbreak, says the CDC. And there is no visible "take" and, as a result, no risk for spread to other parts of the body or other people. In addition, a major advantage of MVA-BN is the virus' inability to replicate in a vaccinated individual, unlike the original smallpox vaccines. 

Typical severe adverse reactions known for replicating vaccinia virus strains, such as myocarditis, encephalitis, generalized vaccinia, or eczema vaccinatum, were not observed during Jynneos's clinical 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%). And the FDA disclosed up to 2.1% of recipients had a cardiac event of special interest, compared to 0.2% of placebo subjects.

To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at the toll-free phone at 1-800-675-9596 or VAERS, a passive reporting system, meaning it relies on individuals to send in reports of their experiences. Anyone can submit a report to VAERS, including parents and patients. Healthcare providers are required by law to report to VAERS.

JYNNEOS Contraindication

JYNNEOS is contraindicated in persons with a serious allergy to any vaccine component, says the CDC.

JYNNEOS Efficacy

On September 30, 2022, the CDC MMWR reported across 32 U.S. jurisdictions, among males aged 18–49 years eligible for JYNNEOS vaccination, monkeypox incidence was 14 times as high among unvaccinated males compared with those who had received a first vaccine dose ≥14 days earlier. As of September 2022, the CDC stated the peak immunity is expected to be reached 14 days after the second dose of Jynneos; however, immunity duration is unknown. In addition, no immune correlate of protection (i.e., minimum threshold level of antibodies needed to prevent symptoms) has been established.'

The WHO stated on September 7, 2022, that it is waiting for clinical trials to confirm the Jynneos (MVA) vaccine efficacy against the current versions of the MPXV, which are expected in October 2022.

JYNNEOS / IMVANEX Production

Bavarian Nordic A/S received approvals from the U.S. and EU regulatory authorities on July 27, 2022, to manufacture JYNNEOS®/IMVANEX® smallpox and monkeypox vaccine at the Company's fill and finish facility in Denmark. On August 18, 2022, Bavarian Nordic announced today that the Company has entered into an agreement with Grand River Aseptic Manufacturing for the fill and finish of 2.5 million JYNNEOS vaccines/vials.

JYNNEOS U.S. Government Contracts

Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing, and supply of a non-replicating smallpox vaccine. The Company has supplied nearly 30 million doses of the vaccine to the U.S. SNS, with the vast majority being delivered for emergency use - and now expired - before approval of the vaccine by the FDA in 2019, which included approval for the monkeypox indication.  On August 18, 2022, Bavarian Nordic entered into a production agreement with Grand River Aseptic Manufacturing (GRAM). And on August 29, 2022, HHS announced it would provide approximately $11 million to support the manufacturing of Jynneos in Grand Rapids, Michigan.

JYNNEOS CPT Code

The AMA-issued CPT code (90611) describes the FDA-approved JYNNEOS vaccine manufactured by Bavarian Nordic for the prevention of smallpox and monkeypox disease in adults 18 years of age and older at high risk for smallpox or monkeypox infection.

Monkeypox Outbreak 2022

As of October 3, 2022, the CDC confirmed (26,049) monkeypox-infected patients in the USA and 68,874 cases and 28 related fatalities globally. Additional outbreak news is posted at MonkeypoxToday.

Bavarian Nordic Financial News

September 20, 2022 - Bavarian Nordic A/S announced a revised contract with the Public Health Agency of Canada to supply doses of IMVAMUNE® smallpox vaccine to a total value of up to USD 470 million.

August 29, 2022 - The U.S. Department of HHS confirmed it provided approximately $11 million to support increased Jynneos vaccine production in Michigan.

August 15, 2022 - Bloomberg Law reported 'The HHS for Strategic Preparedness and Response on Aug. 12 raised the contract ceiling “for the additional procurement of the Smallpox/Monkeypox vaccine JYNNEOS© in the amount of one billion dollars.” The previous cap was $871 million. HHS has spent $675 million so far on vaccines. 

May 9, 2022 – Bavarian Nordic A/S announced its interim financial results and business progress for the first three months of 2022. Revenue was DKK 320 million, and EBITDA was a loss of DKK 94 million.

JYNNEOS Vaccine News 2008 - 2022

October 3, 2022 - Bavarian Nordic A/S announced an agreement with a Latin American country for the supply of the Company’s monkeypox vaccine. This is the Company’s first bilateral supply agreement in Latin America, outside the scope of the agreement entered with the Pan American Health Organization in August 2022, which has enabled access to the vaccine for its member countries. 

October 1, 2022 - The Financial Times reported the UK's Health Secretary Thérèse Coffey refrained from ordering additional Jynneos doses.

September 28, 2022 - The U.S. CDC reported among 32 U.S. jurisdictions, monkeypox incidence among people who are currently recommended to receive vaccine was higher among unvaccinated people compared with those who had received their first vaccine dose 14 days or earlier.

September 14, 2022 - New York health officials expanded eligibility for the monkeypox vaccine to include people who are at risk of becoming infected. "By expanding eligibility, we are hopeful that many more New Yorkers will get immunized and prevent further transmission,” Health Commissioner Dr. Mary T. Bassett said.

September 9, 2022 - In this non-peer-reviewed study, an MVA-BN vaccine booster dose induced a robust immune response regardless of smallpox vaccination history and regardless of the use of 1 or 2 doses of MVA-BN at priming. And no safety concerns were identified in the follow-up study, for the subset of participants administered a booster dose of MVA-BN 2 years following primary vaccination.

September 7, 2022 - Paul Chaplin, President, and CEO of Bavarian Nordic, said: “European countries remain significantly affected by monkeypox, and many EU Member States depend on the availability of vaccines through HERA to be able to respond to the outbreak. We are pleased to supply additional vaccines for deployment already this year, enabling HERA to step up their efforts in the short term.”

September 3, 2022 - The journal published: Vaccinia-Virus-Based Vaccines Are Expected to Elicit Highly Cross-Reactive Immunity to the 2022 Monkeypox Virus. That concluded - clinical data is required to determine the exact efficacy of these vaccines against MPXV-2022.

September 2, 2022 - The U.S. FDA published updates to STN: 125678 and Supplemental Approval Letter BL 125678/36.

September 1, 2022 - A non-peer-reviewed phase 1 clinical study found - Low levels of monkeypox virus neutralizing antibodies after MVA-BN vaccination in healthy individuals - A primary MVA-BN immunization series in non-primed individuals yields relatively low levels of MPXV neutralizing antibodies. And no correlate of protection against MPXV infection has been identified, raising Jynneos's efficacy questions.

August 31, 2022 - The Head of Indonesia's National Agency of Drug and Food Control, Penny K. Lukito, stated: That jynneos vaccines can be used to handle the potential infection of monkeypox disease.

August 25, 2022 - The Swiss government said in a statement that it would purchase 40,000 doses of the Jynneos vaccine from Bavarian Nordic.

August 24, 2022 - Bavarian Nordic A/S and the Pan American Health Organization agreed to facilitate equitable access to Jynneos for countries in Latin America and the Caribbean, with initial deliveries in September 2022.

August 22, 2022 - The UKHSA and Spain launched alternative, fractional vaccine dosing programs.

August 18, 2022 - Bavarian Nordic A/S entered into an agreement with U.S.-based Grand River Aseptic Manufacturing to produce the JYNNEOS vaccine.

August 13, 2022 - CNN reported U.S. FDA Commissioner Dr. Robert Califf and Dr. Peter Marks, the director of the FDA's Center for Biologics and Evaluation Research, recently sent a letter to Bavarian Nordic CEO Paul Chaplin, commenting, "The results of this (2015) study demonstrated that intradermal administration produced a very similar (smallpox) immune response to subcutaneous administration."

August 11, 2022 - Reuters reported Spain asked the European Medicines Agency for permission to administer a smaller dose of the Jynneos monkeypox vaccine.

August 10, 2022 - The U.S. CDC published Interim Guidance and Revised Vaccination Schedule.

August 9, 2022 - U.S. FDA Commissioner Robert M. Califf, M.D., stated in a press release, "The FDA quickly explored other scientifically appropriate (dosing) options to facilitate (greater) access to the vaccine for all impacted individuals. By increasing the number of available (reduced) doses, more individuals who want to be vaccinated against MPX will have the opportunity to do so." And Dr. Marks issued a review of EUA Application Number: 28801.

August 9, 2022 - Bavarian Nordic CEO Paul Chaplin wrote to HHS Secretary Xavier Becerra and FDA Commissioner Robert Califf, expressing his company's concerns about splitting Jynneos vaccine doses.

August 5, 2022 - Italy's government published: Interim indications on the (Jynneos) vaccination strategy against monkeypox

July 30, 2022 - The us. CDC issued CDCHAN-00472 - alerting clinicians to clinical considerations for preventing, diagnosing, and managing monkeypox in people with HIV, children, adolescents, and people who are pregnant or breastfeeding.

July 27, 2022 - Bavarian Nordic A/S announced it received approvals from U.S. and EU authorities to manufacture JYNNEOS®/IMVANEX® smallpox and monkeypox vaccine at the Company's fill and finish facility in Denmark.

July 25, 2022 - Paul Chaplin, President, and CEO of Bavarian Nordic, commented in a press release: "We are pleased to receive the approval from the European Commission."

July 22, 2022 - The EMA's Committee for Medicinal Products for Human Use reviewed relevant data to extend the vaccine's authorization to include use against monkeypox.

July 19, 2022 - Bavarian Nordic A/S announced a non-disclosed country had ordered an additional 1.5 million doses of IMVANEX® vaccines. The majority of the doses will be delivered during 2023.

July 8, 2022 - The ECDC reported: Modelling the efficient use of vaccines indicates that PrEP vaccination would be the most efficient strategy when there is less effective tracing.

June 30, 2022 - The U.S. CDC published 'Vaccine Strategies to Prevent Monkeypox; What You Need to Know.

June 28, 2022 - The European Commission's Health Emergency Preparedness and Response Authority delivered 5,300 vaccine doses in Spain.

June 27, 2022 - DC Health announced it would offer Jynneos vaccines for free to eligible adult residents. Washington DC residents are encouraged to follow updates on monkeypox vaccine availability at PreventMonkeypox.dc.gov.

June 23, 2022 - New York City's health department announced 'that (Jynneos) vaccination is available for people who may have been recently exposed to monkeypox.'

June 21, 2022 - A strategy published by the UKHSA recommends that men at higher risk of monkeypox exposure should be offered vaccines to help control the recent outbreak.

June 14, 2022 - Bavarian Nordic A/S announced the European Health Emergency Preparedness and Response Authority (HERA) had ordered 110,000 MVA-BN vaccine doses, which will be made available to the E.U. Member States, and Norway and Iceland, during the following months.

June 9, 2022 - Germany's Standing Committee on Vaccination recommended Imvanex vaccine become available to people exposed to the MPXV in the last 14 days.

June 7, 2022 - Bavarian Nordic A/S announced that the Public Health Agency of Canada would purchase the IMVAMUNE® smallpox vaccine at approximately USD 56 million. Deliveries under this new five-year contract are expected to occur from 2023.

June 1, 2022 - Healthcare workers in the UK will be offered MPXV vaccines as the government buys 20,000 doses.

May 27, 2022 - The U.K. purchased over 20,000 doses of Imvanex (Jynneos).

May 26, 2022 - Denmark confirmed about 200 monkeypox vaccines arrived from the Netherlands and intends to purchase thousands.

May 25, 2022 - Bavarian Nordic A/S announced the signing of a supply contract with an undisclosed country for the smallpox vaccine.

May 24, 2022 - The Canadian government announced it had deployed the Imvamune vaccine in Quebec.

May 24, 2022 - Reuters reported Germany's health minister confirmed an order for 40,000 smallpox/monkeypox vaccine doses from Bavarian Nordic.

May 23, 2022 - The UKHSA confirmed vaccinations of high-risk contacts of monkeypox cases are ongoing. Over 1,000 doses of Imvanex have been issued to NHS Trusts.

May 18, 2022 - The WHO confirmed monkeypox vaccinations (MVA-BN, Jynneos) are being offered to higher-risk contacts in England.

May 18, 2022 - Paul Chaplin, President, and CEO of Bavarian Nordic, stated, "We are pleased to announce the exercise of the first options under our contract with the U.S. government to deliver a freeze-dried version of the smallpox vaccine with an improved shelf-life, which will be manufactured at our new fill and finish facility."

May 7, 2022 - The UKHSA confirmed an individual had been diagnosed with monkeypox in England following travel to Nigeria.

February 11, 2022 - PLOS published an Original Research study: The changing epidemiology of human monkeypox—A potential threat? A systematic review. 'Overall, monkeypox is gradually evolving to become of global relevance. Surveillance and detection programs are essential tools for understanding the continuously changing epidemiology of this resurging disease.'

November 16, 2021 - The Maryland Department of Health, in collaboration with the U.S. CDC, confirmed a single case of monkeypox virus infection in a Maryland resident who recently returned from Nigeria.

July 16, 2021 - The U.S. CDC and the Texas Department of State Health Services confirmed a case of human monkeypox in a U.S. resident who recently traveled from Nigeria to Texas.

June 11, 2021 - Bavarian Nordic A/S announced the Company was recently engaged by Public Health England and the Medicines and Health Products Regulatory Agency to supply its IMVANEX® smallpox vaccine in response to new cases of monkeypox in the U.K.

May 25, 2021 - The United Kingdom and Northern Ireland notified the WHO of one laboratory-confirmed case of monkeypox. The patient arrived in the UK on May 8, 2021. The patient had lived and worked in Delta State, Nigeria.

May 7, 2021 - Bavarian Nordic A/S announced today that the U.S. BARDA exercised the final $12 million option under the $202 million order for JYNNEOS awarded in April 2020.

March 22, 2021 - Bavarian Nordic A/S announced that the Public Health Agency of Canada had ordered the IMVAMUNE® smallpox vaccine to the national stockpile at a total value of $31.2 million. Deliveries of the vaccines are expected to occur from the first quarter of 2022, with anticipated completion in 2023.   

December 16, 2020 - Bavarian Nordic A/S announced the U.S. BARDA exercised an option covering the majority of the second year of performance under the USD 200 million order for JYNNEOS awarded in April 2020.

November 12, 2020 - Bavarian Nordic A/S announced that Health Canada had expanded the approval of the Company's non-replicating smallpox vaccine, IMVAMUNE®, to include additional indications – specifically, monkeypox and related orthopoxvirus infections and disease in certain adults.

April 30, 2020 - Bavarian Nordic A/S announced that the U.S. Biomedical Advanced Research and Development Authority had placed a new order under the contract, awarded in 2017, for the manufacturing and supply of JYNNEOS® at a total value of U.S. $202 million. This new order is also the option to manufacture approximately 13 million freeze-dried doses worth USD 299 million. The Company expects to start manufacturing in 2022, and revenue is recognized following approval by the U.S. FDA of this vaccine formulation.

November 14, 2019 - The NEJM published an Original Article that concluded that 14 days after a single MVA vaccination, antibody levels peaked similarly to the ACAM2000 vaccination.

September 24, 2019 - The U.S. FDA announced the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, to prevent smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection, based on the Animal Rule. This is the only currently FDA-approved vaccine for the prevention of monkeypox disease. Summary Basis for Regulatory Action.

May 22, 2008 - A peer-reviewed study found that a single inoculation of MVA induces rapid protection in the monkeypox model, suggesting that it might be used effectively to vaccinate unimmunized individuals in an emergency situation caused by a sudden outbreak of smallpox. Analysis of historical records suggests that primary vaccination within four days after exposure is usually protective against serious illness.

JYNNEOS Smallpox Vaccine Clinical Trial

A phase 2 study results posted as a preprint on September 9, 2022, concluded priming with either 1 or 2 doses of MVA-BN induced a durable immune memory, similar to that of older generation replicating smallpox vaccines. When the MVA-BN vaccine was administered as a booster to individuals either primed 2 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 that was generally safe and well-tolerated. And one-dose priming with MVA induced a long-term B-cell memory that resulted in robust anamnestic responses following an MVA booster 2 years later, suggesting that a single dose may offer protection against future exposure.

The National Institute of Allergy and Infectious Diseases (NIAID) Tweeted on August 22, 2022, that it was launching a clinical trial for Jynneos in September 2022. 

The FDA approval of JYNNEOS for smallpox comes from a development program comprising 22 clinical trials, including two phase III trials. The program enrolled a total of 7,871 individuals aged between 18 and 80 years who received at least one dose of the vaccine. Approval for monkeypox indication comes from survival data gathered from studies conducted in non-human primates. The survival rate ranged from 80%-100% in animals vaccinated with JYNNEOS, compared to 0%-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.