This is a prospective observational phase IV study of a novel, replication-deficient smallpox vaccine that has been recently been approved by FDA. The purpose of this study is to determine if there are any abnormalities detected by electrocardiographic testing and/or blood tests within 35 days of receiving the second dose of smallpox vaccine either alone or co-administered with other vaccines that may/may not be suggestive of myopericarditis.

Start Date01 Mar 2029

Sponsor / Collaborator

Womack Army Medical Center

[+1]

NCT05745987 / Not yet recruitingPhase 4IIT

SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)

A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.

Start Date01 Sep 2024

Sponsor / Collaborator

McMaster University

NCT06366672 / RecruitingEarly Phase 1IIT

Evaluating the Durability of the Human Immune Response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) Vaccine

This study is designed to evaluate the magnitude and duration of the human adaptive immune response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in the blood, lung mucosa, skin and bone marrow.

Start Date10 Jun 2024

Sponsor / Collaborator

Washington University School of Medicine

100 Clinical Results associated with Smallpox vaccine(Bavarian Nordic A/S)

100 Translational Medicine associated with Smallpox vaccine(Bavarian Nordic A/S)

100 Patents (Medical) associated with Smallpox vaccine(Bavarian Nordic A/S)

1,419

Literatures (Medical) associated with Smallpox vaccine(Bavarian Nordic A/S)

15 Nov 2108·Psychiatria DanubinaQ4 · MEDICINE

NON-SUICIDAL SELF-INJURY AMONG UNIVERSITY STUDENTS IN TURKEY: THE EFFECT OF GENDER AND CHILDHOOD ABUSE

Q4 · MEDICINE

Article

Author: Idig-Camuroglu, Meltem ; Gölge, Z Belma

BACKGROUND:

The purpose of this study was to explore the effect of gender and childhood abuse on non-suicidal self-injurious (NSSI) behaviors among university students in Turkey.

SUBJECTS AND METHODS:

In this study convenience sampling technique was used, the sample consisted of 1000 young adults who were from the eight universities in two big cities; Istanbul and Ankara. Besides with demographic questionnaire, Inventory of Statements about Self-Injury and Childhood Trauma Questionnaire were used.

RESULTS:

The prevalence of NSSI was 28.5% and the most prevalent three self-injurious behaviors were wound picking, banging/hitting and pinching self. There was not a gender difference in NSSI behavior frequency but in the type of behavior; males had significantly higher percentages of hitting and burning behavior. Examining the intrapsychic and interpersonal functions of NSSI, "affect regulation" and "toughness" functions were the most used ones among the participants. In terms of gender differences, "revenge" function was used by females more than males. Self-injurers had higher childhood abuse scores on sexual, physical, and emotional abuse and neglect subscales than non self-injurers, and males were significantly more abused than females.

CONCLUSIONS:

Accepting childhood abuse as an important predictor of NSSI behavior, screening and assessment of abused children and adolescents can help to prevent the onset of the behavior.

31 Dec 2024·Expert review of vaccines

Immunogenicity and safety of ebolavirus vaccines in healthy adults: a systematic review and meta-analysis of randomized controlled trials

Review

Author: Miao, Mingsan ; Qin, Changjiang ; Wang, Chaoyang ; Zhang, Liang ; Yin, Juntao

BACKGROUND:

This review aimed to systematically evaluate the immunogenicity and safety of the candidate Ebola virus vaccine (EVV).

METHODS:

We searched five databases for randomized controlled trials (RCTs) evaluating the effects of EVV on healthy adults. The primary outcomes were relative risk (RR) of sero-conversion or sero-response of EVV in healthy adults between the groups that received EVV and the controls.

RESULTS:

Twenty-nine RCTs (n = 23573) were included. There was a significant difference in RR of sero-conversion of EVV (RR 13.18; 95% CI 11.28-15.41; I² = 33%; P < 0.01) between the two groups. There was a significant difference in RR of adverse events (AEs) of EVV (RR 1.49; 95% CI 1.27-1.74; I² = 88%; P < 0.01), although no difference in RR of serious AE (SAE) between the two groups. Subgroup analysis showed that there was no significant difference in RR of AEs for DNAEBO, EBOV-GP, MVA, and rVSVN4CT1 vaccines, compared with controls.

CONCLUSIONS:

The DNAEBO, EBOV-GP, MVA, and rVSVN4CT1 vaccines are likely to be safe and immunogenic, tending to support the vaccination against Ebola disease. These findings should provide much-needed evidence for public health policy makers to develop preventive measures based on disease prevalence features and socio-economic conditions.

01 Feb 2024·EClinicalMedicine

Immunogenicity and reactogenicity of modified vaccinia Ankara pre-exposure vaccination against mpox according to previous smallpox vaccine exposure and HIV infection: prospective cohort study

Article

Author: Rosati, Silvia ; Corso, Rita ; Giancola, Maria Letizia ; Cannone, Fabio ; Camici, Marta ; Nappo, Alessandra ; Sarmati, Loredana ; Mazzotta, Stefania ; Scanzano, Pietro ; Caterini, Luciano ; Matusali, Giulia ; Siddu, Andrea ; Lapa, Daniele ; Plazzi, Maria Maddalena ; Cimaglia, Claudia ; Junea, Angela ; Notari, Stefania ; Grassi, Germana ; Preziosi, Gianni ; Faccendini, Paolo ; D'Ettorre, Gabriella ; Gagliardini, Roberta ; Pinnetti, Carmela ; Tartaglia, Eleonora ; Possi, Adriano ; Lepri, Alessandro Cozzi ; Natalini, Giorgia ; Maggi, Fabrizio ; Girardi, Enrico ; Nicastri, Emanuele ; Bettini, Aurora ; Lamonaca, Alessandra ; Agrati, Chiara ; Cruciani, Stefania ; Fontana, Carla ; Gili, Simona ; Passacantilli, Sara ; Rubino, Marika ; Caputi, Priscilla ; Del Duca, Giulia ; Faraglia, Francesca ; De Ponte, Chiara ; Meschi, Silvia ; Vescovo, Maurizio ; Mondillo, Vanessa ; Masone, Erminia ; Lanini, Simone ; Mazzotta, Valentina ; Vaia, Francesco ; Piselli, Pierluca ; Cimini, Eleonora ; Di Giambenedetto, Simona ; Stingone, Christof ; Latini, Alessandra ; Montagnari, Giulia ; Paulicelli, Jessica ; Coppola, Luigi ; Antinori, Andrea ; Barca, Alessandra ; Faticoni, Augusto ; Marocco, Raffaella ; Tamburrini, Enrica ; Marchili, Mauro ; Vita, Serena ; Aguglia, Camilla ; Mondi, Annalisa ; Marani, Alessandra ; Vergori, Alessandra ; Fusto, Marisa ; Kontogiannis, Dimitra ; Farinacci, Damiano ; Anzalone, Enza ; Lichtner, Miriam ; Iannella, Maria Rosaria ; Giannico, Giuseppina ; Scorzolini, Laura ; De Marco, Nicola ; Cristofanelli, Flavia ; Oliva, Alessandra ; Colavita, Francesca ; Gallì, Paola ; Tomassi, Virginia ; Gebremeskel, Saba ; Parisi, Alfredo ; Mastrorosa, Ilaria ; Casetti, Rita ; Ridolfi, Marco ; Mastroianni, Claudio

Background:

Pre-exposure vaccination with MVA-BN has been widely used against mpox to contain the 2022 outbreak. Many countries have defined prioritized strategies, administering a single dose to those historically vaccinated for smallpox, to achieve quickly adequate coverage in front of low supplies. Using epidemiological models, real-life effectiveness was estimated at approximately 36%-86%, but no clinical trials were performed. Few data on MVA-BN immunogenicity are currently available, and there are no established correlates of protection. Immunological response in PLWH in the context of the 2022 outbreak was also poorly described.

Methods:

Blood samples were collected from participants eligible for pre-exposure MVA-BN vaccination before (T1) receiving a full course of vaccine (single-dose for vaccine-experienced or smallpox-primed and two-dose for smallpox vaccine-naïve or smallpox non-primed) and one month after the last dose (T2 and T3, respectively). MPXV-specific IgGs were measured by in-house immunofluorescence assay, using 1:20 as screening dilution, MPXV-specific nAbs by 50% plaque reduction neutralization test (PRNT₅₀, starting dilution 1:10), and IFN-γ-producing specific T cells to MVA-BN vaccine, by ELISpot assay. Paired or unpaired t-test and Wilcoxon or Mann-Whitney test were used to analyse IgG and nAbs, and T-cell response, as appropriate. The probability of IgG and nAb response in vaccine-experienced vs. vaccine-naïve was estimated in participants not reactive at T1. The McNemar test was used to evaluate vaccination's effect on humoral response both overall and by smallpox vaccination history. In participants who were not reactive at T1, the proportion of becoming responders one month after full-cycle completion by exposure groups was compared by logistic regression and then analysed by HIV status strata (interaction test). The response was also examined in continuous, and the Average Treatment Effect (ATE) of the difference from baseline to schedule completion according to previous smallpox vaccination was estimated after weighting for HIV using a linear regression model. Self-reports of adverse effects following immunization (AEFIs) were prospectively collected after the first MVA-BN dose (T1). Systemic (S-AEFIs: fatigue, myalgia, headache, GI effects, chills) and local (L-AEFIs: redness, swelling, pain) AEFIs were graded as absent (grade 0), mild (1), moderate (2), or severe (3). The maximum level of severity for S-AEFIs and L-AEFIs ever experienced over the 30 days post-dose by vaccination exposure groups were analysed using a univariable multinomial logistic regression model and after adjusting for HIV status; for each of the symptoms, we also compared the mean duration by exposure group using an unpaired t-test.

Findings:

Among the 164 participants included, 90 (54.8%) were smallpox vaccine-experienced. Median age was 49 years (IQR 41-55). Among the 76 (46%) PLWH, 76% had a CD4 count >500 cells/μL. There was evidence that both the IgG and nAbs titers increased after administration of the MVA-BN vaccine. However, there was no evidence for a difference in the potential mean change in humoral response from baseline to the completion of a full cycle when comparing primed vs. non-primed participants. Similarly, there was no evidence for a difference in the seroconversion rate after full cycle vaccination in the subset of participants not reactive for nAbs at T1 (p = 1.00 by Fisher's exact test). In this same analysis and for the nAbs outcome, there was some evidence of negative effect modification by HIV (interaction p-value = 0.17) as primed people living with HIV (PLWH) showed a lower probability of seroconversion vs. non-primed, and the opposite was seen in PLWoH. When evaluating the response in continuous, we observed an increase in T-cell response after MVA-BN vaccination in both primed and non-primed. There was evidence for a larger increase when using the 2-dose vs. one-dose strategy with a mean difference of -2.01 log₂ (p ≤ 0.0001), after controlling for HIV. No evidence for a difference in the risk of developing any AEFIs of any grade were observed by exposure group, except for the lower risk of grade 2 (moderate) fatigue, induration and local pain which was lower in primed vs. non-primed [OR 0.26 (0.08-0.92), p = 0.037; OR 0.30 (0.10-0.88), p = 0.029 and OR 0.19 (0.05-0.73), p = 0.015, respectively]. No evidence for a difference in symptom duration was also detected between the groups.

Interpretation:

The evaluation of the humoral and cellular response one month after the completion of the vaccination cycle suggested that MVA-BN is immunogenic and that the administration of a two-dose schedule is preferable regardless of the previous smallpox vaccination history, especially in PLWH, to maximize nAbs response. MVA-BN was safe as well tolerated, with grade 2 reactogenicity higher after the first administration in vaccine-naïve than in vaccine-experienced individuals, but with no evidence for a difference in the duration of these adverse effects. Further studies are needed to evaluate the long-term duration of immunity and to establish specific correlates of protection.

Funding:

The study was supported by the National Institute for Infectious Disease Lazzaro Spallanzani IRCCS "Advanced grant 5 × 1000, 2021" and by the Italian Ministry of Health "Ricerca Corrente Linea 2".

200

News (Medical) associated with Smallpox vaccine(Bavarian Nordic A/S)

28 Jun 2024

·www.globenewswire.com

Bavarian Nordic Joins Global Efforts to Fight Mpox Outbreak in Africa

Bavarian Nordic is committed to support global efforts to address the mpox situation in Africa through a donation of 15,000 doses of mpox vaccineEmergency Use Authorization for the MVA-BN vaccine has been issued in the DR Congo COPENHAGEN, Denmark, June 28, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced an extended commitment to help fight the current mpox outbreak in Africa. The Company’s MVA-BN vaccine, the only FDA and EMA-approved mpox vaccine, which served as an important tool during the 2022-2023 mpox outbreak, could soon also become available in the DR Congo (DRC) and other countries in Africa. Mpox is on the rise in African countries with increasing incidence of the more severe clade I. So far in 2024, more than 9,000 mpox cases and over 400 deaths have been reported across seven African countries of which the vast majority (96%) having occurred in the DRC1. Earlier this week, the regulatory authorities in the DRC, ACOREP (Autorité Congolaise de Réglementation Pharmaceutique), issued an Emergency Use Authorization allowing for the use of the MVA-BN vaccine for individuals at risk of mpox. Locally, in the DRC, clinical studies are also planned to support a full regulatory approval of the MVA-BN vaccine, as recently announced by Bavarian Nordic. To further strengthen the response in the DRC and throughout the African region, Bavarian Nordic will collaborate with global health partners, including WHO, UNICEF and Gavi. Bavarian Nordic applauds Gavi’s Board decision to approve a new Vaccine Investment Strategy which includes the establishment of a global mpox vaccine stockpile. In the near term, Bavarian Nordic is committed to work in partnership with Gavi, WHO and UNICEF to coordinate dose donations in response to the ongoing outbreak in the DRC and other African countries. To support these efforts, Bavarian Nordic has committed to donating 15,000 doses of its MVA-BN mpox vaccine to the African response. “The spread of mpox in the Democratic Republic of the Congo and elsewhere is highly concerning and could pose a global threat if it is not urgently contained,” said Dr Sania Nishtar, CEO of Gavi, the Vaccine Alliance. “Gavi and its partners welcome Bavarian Nordic’s resolve to help fight this outbreak and its contribution in doses. Our Alliance welcomes the availability of new vaccines for countries and is committed to working with Bavarian Nordic and the relevant authorities to facilitate their arrival and timely administration in line with country plans.” “Mpox has been a public health threat in several African countries for more than 50 years and is now spreading across the continent with higher incidence and severity. Global partners are uniting to build a stronger public health response throughout the affected region. and we are proud to contribute through a donation of our mpox vaccine,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. About mpox in the DRC and other African countriesAfrica is currently tackling one of the largest and deadliest known mpox outbreak to date. Over 8,700 mpox cases and 408 deaths have been reported in the DRC this year alone, with children accounting for the majority of infections and deaths. Cases have also been confirmed in the Republic of Congo, Cameroon, Central African Republic, Ghana, Liberia and South Africa. Mpox was first identified in the DR Congo in 1970. In most cases, mpox symptoms - typically fever and headache, followed by painful lesions - resolve within a few weeks. However, for some, mpox can lead to medical complications, such as bronchopneumonia, sepsis, encephalitis, loss of vision, or death. The mpox virus strain behind the current outbreak, known as clade I, is estimated to be fatal in up to 10% of cases. About the smallpox/mpox vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and the only mpox vaccine approved in the U.S. and Switzerland (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), and the EU/EEA and United Kingdom (marketed as IMVANEX®). Originally developed in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN has been indicated for use in the general adult population (18 years and older) in individuals considered at risk for smallpox or mpox. During the 2022-2023 mpox outbreak, the vaccine was granted an Emergency Use Authorization by the U.S. FDA for both pre- and post-exposure use in adolescents. Bavarian Nordic has been a long-term supplier of the vaccine to the U.S. and Canada as well as several other countries as part of their national biological preparedness. During the 2022-2023 mpox outbreak, Bavarian Nordic has furthermore supported governments and supranational organizations by expanding access to the vaccine to more than 70 countries worldwide. About Bavarian NordicBavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. For more information visit www.bavarian-nordic.com. Forward-looking statements This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance, and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. ContactsEurope: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600 1 https://africacdc.org/download/africa-cdc-weekly-event-based-surveillance-report-june-2024/ Attachment 2024-06-28-en

Drug ApprovalVaccineAccelerated Approval

25 Jun 2024

·www.biospace.com

Tonix Pharmaceuticals Presents Vaccine Platform Data in Keynote Talk at the Vaccine Congress 2024

Tonix’s live virus vaccine TNX-801 is designed to provide long-term protection from mpox and smallpox with one dose TNX-801 vaccination demonstrated efficacy in protecting animals from lethal challenge with intratracheal monkeypox Clade II mpox is now endemic in the U.S. with >30,000 cases reported since May 20221 and Clade I mpox is endemic in the Democratic Republic of the Congo2 Tonix’s vaccine platform has been selected by NIH’s Project NextGen for clinical testing CHATHAM, N.J., June 25, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals, Inc. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced data presented at an oral Keynote Talk at the Vaccine Congress 2024 held June 24-25, 2024 in Prague, Czech Republic. A copy of the Company’s presentation is available under the Scientific Presentations tab of the Tonix website at . The presentation titled, “A New Live Virus, One Dose Vaccine Platform for Mpox, Smallpox and COVID-19”, detailed the Company’s vaccine platform, including TNX-801 (horsepox, live virus) vaccine for preventing mpox (formerly known as monkeypox) and smallpox and TNX-1800 (horsepox expressing SARS-CoV-2 spike protein) for protecting against COVID-19. TNX-801 and TNX-1800 are live replicating attenuated vaccines based on horsepox that are believed to provide immune protection with better tolerability than modern vaccinia viruses. In the presentation, Tonix highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected non-human primates against lethal challenge with intratracheal Clade 1 monkeypox virus3. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of non-human primates. These findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccinia vaccine, which eradicated smallpox and kept mpox out of the human population. “We are excited for the prospects of our live virus vaccine platform and look forward to advancing development for our vaccine candidates to prevent mpox, smallpox, COVID and other infectious diseases,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “TNX-801 combines immune protection with improved tolerability compared to other vaccines based on orthopoxviruses. TNX-801 is administered with a single dose which has advantages over two-dose regimens. We believe TNX-801 can be rapidly scaled up for manufacturing and can be distributed and stored without a costly and cumbersome ultra-cold supply chain. TNX-801 also has the potential to be used as a viral vector platform, for which recombinant versions can be developed to protect against other infectious diseases. Tonix developed TNX-1800 as a vaccine to protect against COVID-19. We are excited that TNX-1800 was selected for the U.S. National Institute of Health’s (NIH’s) Project NextGen and we look forward to providing updates on the program.” The presentation noted that the global mpox outbreak, which commenced in 2022, has affected over 90,000 persons in countries where mpox had previously not been endemic, including Europe and the US. The spread of Clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Unlike Clade IIb mpox, the Clade I strain of mpox remains restricted to several Central African countries, including the Democratic Republic of the Congo, where it is currently endemic. Clade I mpox is typically associated with higher case fatality rates than Clade IIb mpox. According to the U.S. Centers for Disease Control and Prevention (CDC), and other experts, there is a significant risk that the deadlier Clade I strain may appear in the U.S.1,4. Further, the presentation noted that the Bipartisan Commission on Biodefense recently highlighted the renewed dual threats of both a more virulent mpox epidemic as well as smallpox re-introduction from lab accidents or bad actors, while the National Academies of Science, in its review of smallpox preparedness, highlighted the need for new single dose vaccines against smallpox5,6. The keynote presentation also included preclinical data for TNX-1800, demonstrating immunity and tolerability7,8. TNX-1800 was selected by the NIH’s Project NextGen for inclusion in clinical trials as part of a select group of next generation COVID-19 vaccine candidates with the intent to identify promising vaccine platforms. NIH plans to conduct a Phase 1 trial and cover the full cost, while Tonix provides the vaccine candidate. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya**, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. *Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication. **Tonmya™ is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication. 1McQuiston JH, et al. U.S. Preparedness and Response to Increasing Clade I Mpox Cases in the Democratic Republic of the Congo. 2024, MMWR Morb Mortal Wkly Rep: United States. p. 435-440 2CDC. 2022-2023 Mpox: US Map and Case Count. 3Noyce RS, et al. Viruses. 2023 Jan 26;15(2):356. doi: 10.3390/v15020356. PMID: 36851570; PMCID: PMC9965234 4World Health OrganizationSAGE meeting highlights on updated mpox vaccine recommendations. 2024, March 5Bipartisan Commission on Biofence. Box the Pox: Redicing the risk of Smallpox and Other Orthopoxviruses, Washington:2024 6U.S. National Academies of Science. Future State of Smallpox Medical Countermeasures. Washington:2024 7Awasthi M, et al. Viruses. 2023 Oct 21;15(10):2131. doi: 10.3390/v15102131. PMID: 37896908; PMCID: PMC10612059. 8Awashti AM et al Vaccines (Basel). 2023 Nov 2;11(11):1682. doi:10.3390/vaccines11111682.PMID: 38006014 Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at . Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor Contact Jessica Morris Tonix Pharmaceuticals investor.relations@tonixpharma.com (862) 904-8182 Peter Vozzo ICR Westwicke peter.vozzo@westwicke.com (443) 213-0505 Media Contact Katie Dodge LaVoieHealthScience kdodge@lavoiehealthscience.com (978) 360-3151

VaccinePhase 3Breakthrough TherapyImmunotherapy

06 Jun 2024

·www.drugs.com

Mpox Is Still Circulating Among U.S. Gay Men

THURSDAY, June 6, 2024 -- Though not at numbers seen in the 2022 outbreak, mpox cases are still circulating in the United States, largely among gay and bisexual men, new government data shows. According to the U.S. Centers for Disease Control and Prevention , the outbreak of mpox (formerly known as monkeypox ) viral illness in the United States during 2022 sickened more than 32,000 people and killed 58. The outbreak ebbed after education campaigns and vaccinations among high-risk groups were initiated. However, mpox remains a global threat, with a major outbreak unfolding in central Africa. And now a new report finds sporadic U.S. cases of mpox are still occurring among men who have sex with men. The study involved 196 people treated at 13 U.S. hospital emergency departments between June and December of 2023. The patients were selected because they showed up with rashes that were compatible with the rash seen with mpox disease. Forty-five percent were female and 20% were children. Of the total cohort, only three people (1.5%) turned out to have mpox. All three were gay or bisexual men who hadn't been vaccinated for mpox and said they'd had multiple sexual partners they'd met via dating apps. Mpox is spread through close personal contact. This typically involves skin-to-skin contact, so sex can often be a means of transmission. Initial symptoms include fever, chills, exhaustion, headache and muscle weakness, often followed by a rash with lesions that scab over and slowly heal over a period of weeks. Although anyone can get mpox, men who have sex with men are particularly at risk, and those who have HIV are more vulnerable to severe disease. Luckily, there is an mpox vaccine, manufactured under the brand name Jynneos . It's a two-dose regimen, with shots given about a month apart. Study co-leader Dr. David Talan , a professor of emergency medicine/infectious diseases at the David Geffen School of Medicine at UCLA, said keeping track of mpox is crucial. “Clinicians should remain vigilant for mpox infections, particularly in gay and bisexual men who have sex with men, and educate patients on risk reduction, including the importance of vaccination,” Berdahl said. The study was published June 6 in the CDC journal Morbidity and Mortality Weekly Report . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

VaccineClinical ResultClinical Study

100 Deals associated with Smallpox vaccine(Bavarian Nordic A/S)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Smallpox vaccine(Bavarian Nordic A/S)	J07BX	DB15483

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Monkeypox	EU	Bavarian Nordic A/S	31 Jul 2013
Monkeypox	IS	Bavarian Nordic A/S	31 Jul 2013
Monkeypox	LI	Bavarian Nordic A/S	31 Jul 2013
Monkeypox	NO	Bavarian Nordic A/S	31 Jul 2013
Smallpox	EU	Bavarian Nordic A/S	31 Jul 2013
Smallpox	IS	Bavarian Nordic A/S	31 Jul 2013
Smallpox	LI	Bavarian Nordic A/S	31 Jul 2013
Smallpox	NO	Bavarian Nordic A/S	31 Jul 2013
Vaccinia	EU	Bavarian Nordic A/S	31 Jul 2013
Vaccinia	IS	Bavarian Nordic A/S	31 Jul 2013
Vaccinia	LI	Bavarian Nordic A/S	31 Jul 2013
Vaccinia	NO	Bavarian Nordic A/S	31 Jul 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 2	US	Bavarian Nordic A/S	01 Jul 2006
Dermatitis, Atopic	Phase 2	MX	Bavarian Nordic A/S	01 Jul 2006
HIV Infections	Phase 2	US	Bavarian Nordic A/S	01 Jun 2006
HIV Infections	Phase 2	PR	Bavarian Nordic A/S	01 Jun 2006
Rhinitis, Allergic, Seasonal	Phase 1	DE	Bavarian Nordic A/S	01 Apr 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05512949 (CTgov)	Phase 2	Monkeypox	229	MVA-BN (2 x 10^7 ID MVA-BN)	vgzxidrtoo(ahzkmifoav) = xcumbmtowd adxfqbegba (pytqsfuehw, rmuhyeqake - eogsjzymlu) View more	-	09 Jan 2024
				MVA-BN (1 x 10^7 ID MVA-BN)	vgzxidrtoo(ahzkmifoav) = cfcwrbrwfc adxfqbegba (pytqsfuehw, ozitovirby - zsynksqead) View more
NCT03699124 (Pubmed) Manual	Phase 3	-	1,129	MVA-BN	kvsxbfwybk(movllvolut) = uwjhguzdpt chkoqpaaff (mufzpyadpr ) View more	Positive	29 Nov 2022
NCT01668537 (CTgov)	Phase 2	Smallpox	651	LF (LF Formulation)	vnlzxdrasi(hfbkjstmna) = ufyplcepdt ekrinleyvy (ldvypmwuni, ltdhgvxpcg - bscirjkyqk) View more	-	12 Oct 2020
				MVA-BN (FD Formulation)	vnlzxdrasi(hfbkjstmna) = ctjrmfkxjc ekrinleyvy (ldvypmwuni, lxclounfgs - ioklwlwddo) View more
NCT03472014 (CTgov)	Phase 4	-	22	MVA-BN	snflhyqsxx(llexzobydg) = ukezurmcpb szrxlxbwqz (kaembcaewl, nqbsnrexzm - wekqlbmnxf) View more	-	19 Aug 2020
NCT01913353 (Pubmed \| Br Dent J) Manual	Phase 3	Smallpox	433	modified vaccinia Ankara+ACAM2000	knvsszwlbr(sizxnzsxfe): RO = 97.9 (95% CI, 96.6 - 98.3) View more	Superior	14 Nov 2019
				ACAM2000
NCT00686582 (CTgov)	Phase 2	Smallpox	304	IMVAMUNE (Initially Vaccinia Naive, 2 Dose Primed, 1 Booster Dose)	zggeqadknx(hxkkslunkt) = itybblrteo goazuugtsl (fwrtokmung, epdavapvuf - iydzucjmec) View more	-	18 Feb 2019
				IMVAMUNE (Initially Vaccinia Naive, 1 Dose Primed, 1 Booster Dose)	zggeqadknx(hxkkslunkt) = khyqbhnrbf goazuugtsl (fwrtokmung, mfjczgirww - puolsfgzfh) View more
NCT00857493 (CTgov)	Phase 2	Smallpox	120	IMVAMUNE (Group 1)	ruebylptqr(ypbzzxjpcu) = jmtaiymkwa aebyzrdzkz (uaiimvfelm, hczpdcrmhc - rdgynsfvpv) View more	-	10 Jan 2019
				IMVAMUNE (Group 2)	ruebylptqr(ypbzzxjpcu) = zctrxuvmct aebyzrdzkz (uaiimvfelm, klxgvdxwnm - xrlbngwptg) View more
NCT00316602 (CTgov)	Phase 2	Dermatitis, Atopic	632	IMVAMUNE (Healthy Participants)	barmwiodqm(tjdrjbfakq) = oimejinbeh sqghfmjpou (chctdeevzt, ovagnbluth - nyaxtotekv) View more	-	09 Jan 2019
				IMVAMUNE (Atopic Dermatitis Participants)	barmwiodqm(tjdrjbfakq) = ilemmtlnyo sqghfmjpou (chctdeevzt, birdoohulm - yrczwjkvdr) View more
NCT01144637 (CTgov)	Phase 3	Smallpox	4,005	IMVAMUNE® (Group 1)	ojojpypgcl(ppvphkmdzu) = jvendxhnyl sfquouoqgp (zufuitoxed, xolqukqand - qbaxyyrpcf) View more	-	03 Jan 2019
				IMVAMUNE® (Group 2)	ojojpypgcl(ppvphkmdzu) = pqzhzqzbka sfquouoqgp (zufuitoxed, xjjdfzqcvf - dqgtacbmex) View more
NCT00189956 (Pubmed \| Vaccine)	Phase 2	Smallpox	164	1 x 10(8)TCID(50) IMVAMUNE dose	aqacflhjdb(gedqqrufqw) = cwzhpwtzpg obqoraxyex (yzmytdqxfn ) View more	-	03 Feb 2010

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