KEMRI and NEC Announce Trials on Biometric-based Vaccination Management System for Newborn Children in Kenya JCN Newswire

KEMRI and NEC Announce Trials on Biometric-based Vaccination Management System for Newborn Children in Kenya

February 7, 2023
TOKYO, Feb 7, 2023 - (JCN Newswire via SEAPRWire.com) - Kenya Medical Research Institute (KEMRI), NEC Corporation (NEC) and Nagasaki University, Japan, have developed a digital biometric-based vaccination management system for newborn children in Kenya. Validation of this system is taking place through KEMRI with a clinical trial that began in September 2022 at the Kinango Sub-County Hospital in Kwale and initial results are very encouraging. Hospital staff member scanning a newborn's fingerprintScreenshot from the vaccination management system (fingerprint data registration page)Screenshot from the vaccination management system (vaccination data registration page)The digital system being provided by NEC, a leader in the integration of IT and network technologies, and KEMRI, one of Africa's leading research Institutions, will effectively and seamlessly manage vaccination history and scheduling using fingerprint identification for newborn children and voice recognition for caregivers.This technology marks the first time that biometric identification is being used at a hospital to identify newborn children at the time of vaccination, including those immediately after delivery(1). As of November 2022, data from more than 300 caregivers and newborns had been registered, including the vaccination histories of more than 150 newborns. The new technology combines fingerprint identification for children and voice recognition for caregivers to confirm not only their identity, but also to reliably manage vaccination histories and schedules, thereby promoting the implementation of appropriate vaccinations for newborns and children during the first 24 months of life. Going forward, demonstration tests that network among multiple hospitals will begin, aiming for full-scale introduction throughout Kenya by the end of 2023, and more international deployment in the future. "We are excited that KEMRI together with its partners, is spearheading this landmark study that identifies newborns using a biometric and a vaccination management system that is not only in real time, but is also expected to support policy and action towards the attainment of better health outcomes and Universal Health Coverage. I am happy to announce that this tool will be validated by KEMRI researchers in partnership with Kinango Sub-County Hospital in Kwale, NEC Corporation and Nagasaki University," said Prof. Sam Kariuki, Acting Director General, Kenya Medical Research Institute (KEMRI)"I expect that this vaccination management system, including newborn fingerprint biometric technology, will expand the coverage of vaccinations for children under 24 months old through accurate identification methods for mothers and children in Kenya. I also express great expectations for this research to act as a guideline for precise vaccination management featuring newborn and caregiver identification to become an important contributor to Universal Health Coverage," said Prof. Miriam Khamadi Were, Laureate, 1st Hideyo Noguchi Africa PrizeThe system utilizes voice recognition to identify caregivers, as well as fingerprint patterns to ensure that newborns are appropriately matched with the identified caregivers. Since voice recognition can be performed almost instantaneously, this system can minimize the burden placed on caregivers. Medical institutions can also introduce voice recognition with little to no change to existing procedures. Rather than using conventional fingerprint authentication methods to identify newborns, researchers developed a new method with which fingerprint pattern information is extracted from fingerprint images and a newborn child can be identified by combining fingerprint pattern data from multiple fingers.Importance of and challenges associated with vaccinationsMany children around the world continue to lose their lives at a very young age. In 2020 alone, approximately 5 million children died before reaching their fifth birthday, even without taking into account the impact of COVID-19. Furthermore, about half of these children under the age of five, or 2.4 million children, passed away within 28 days of birth, with many of these deaths considered preventable(2).Meanwhile, in some regions in the world, the use of digital technology has not advanced due to delays in the development of electricity and telecommunications infrastructure. In these regions, basic information such as who was born, when, where, and what type of medical services they have received may only be recorded by hand. In such cases, health care providers cannot easily ascertain which medical services are needed for the caregivers and children who visit their hospitals, which is one of the factors hindering efforts to ensure that children receive the vaccinations they need. Procedures for using this system in hospitals.The trial at this hospital is being conducted in accordance with the following procedures.1. Register the caregiver's voice and the newborn's fingerprint patterns on the day of birth (four fingers in total: left thumb, right thumb, left index finger, right index finger).2. Hospital staff encourage caregivers to return to the hospital according to the prescribed vaccination schedule.3. Caregivers are identified using voice recognition when they state their names at the time of their hospital visits, and their children are identified based on database information.4. Scan fingerprints from four fingers using a special scanner. Verify the child's identity by matching the data from the previous step with the pattern extracted from the scanned fingerprints.5. Administer the prescribed vaccination(s) and register the vaccination history in the system.Overview of the trial- Implementation period: September 2022 to March 2023- Hospital: Kinango Sub-County Hospital in Kwale- Participants: Approximately 1,000 caregivers and newborns who elect to participate in this trial (data has been registered for approximately 300 individuals as of the end of November 2022)- Description of trial: Using the vaccination management system, the hospital records information on the physical characteristics of newborns at the time of birth as well as the history of and schedule for administration of eight different vaccines and one vitamin supplement up to 24 months after birth to verify the effectiveness of and issues related to the system. The voice and fingerprint pattern data acquired will be used only for the current purpose of this trial and will be deleted after its completion.Identification using fingerprint patternsThis system uses NEC technology to classify fingerprint images collected from multiple fingers of a newborn (a total of four fingers: left thumb, right thumb, left index finger, right index finger) into five categories according to the shape of each whorl(3) and then registers the fingerprint pattern data. The system also combines pattern-based classification with NEC's voice recognition to improve accuracy when verifying the identity of caregivers and newborns. These efforts to increase vaccination coverage support Sustainable Development Goals (SDG) 3.2, "By 2030, end preventable deaths of newborns and children under 5 years of age, with all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births." The efforts also contribute to the realization of SDG 16.9, "By 2030, provide legal identity for all, including birth registration," by providing all newborns with a record of parent-child relationships and birth location information, as well as a means of identification.(1) NEC research as of February 7, 2023(2) Source: Levels and trends in child mortality, Report 2021, UN-IGMEnew windowhttps://data.unicef.org/resources/levels-and-trends-in-child-mortality/(3) The number of categories is under verification and may be changed in the future About NEC CorporationNEC Corporation has established itself as a leader in the integration of IT and network technologies while promoting the brand statement of "Orchestrating a brighter world." NEC enables businesses and communities to adapt to rapid changes taking place in both society and the market as it provides for the social values of safety, security, fairness and efficiency to promote a more sustainable world where everyone has the chance to reach their full potential. For more information, visit NEC at https://www.nec.com. Copyright 2023 JCN Newswire. All rights reserved. (via SEAPRWire)
More
Zhaoke Ophthalmology Completed Patient Enrollments for the Phase III Clinical Trials of the Myopia Progression Treatment Drug NVK002 ACN Newswire

Zhaoke Ophthalmology Completed Patient Enrollments for the Phase III Clinical Trials of the Myopia Progression Treatment Drug NVK002

August 3, 2022
HONG KONG, Aug 3, 2022 - (ACN Newswire via SEAPRWire.com) - Zhaoke Ophthalmology Limited ("Zhaoke Ophthalmology" or "the Company", SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of treatments that address significant unmet medical needs, is excited to announce that the patient enrollments for the two-year Phase III clinical trial ("China CHAMP") and the concurrent one-year Phase III bridging clinical trial ("Mini-CHAMP") of one of the Company's core products, NVK002, were completed on 21 July 2022 and 28 July 2022 respectively significantly ahead of schedule. The primary objective of the China CHAMP and Mini-CHAMP trials is to evaluate the efficacy and safety of NVK002 for the treatment of myopia progression in children and adolescents. -- China CHAMPLed by Principal Investigator Professor Wang Ning Li from Beijing Tongren Hospital , the China CHAMP trial involves 19 centers. Enrolment of 777 patients has been completed in less than four months, two months ahead of schedule. -- Mini-CHAMPCo-led by Principal Investigators Professor Qu Xiao Mei from the Eye and ENT Hospital of Fudan University and Professor Yang Xiao from Zhongshan Ophthalmic Center, Sun Yat-Sen University , the Mini-CHAMP trial involves 18 centers and the enrolment of 526 patients has been completed in less than three months, three months ahead of schedule. These early completions of patient recruitment across both trials, gives the company a strong headstart in moving towards its goal to lead the market in launching a myopia progression treatment drug.In the United States and Europe, the Company's partner, Vyluma Inc., has been conducting a parallel Phase III clinical trial "CHAMP", with three years of NVK002 treatment, and the trial is expected to complete in 2022. Following this, a New Drug Application ("NDA") submission to the US Food and Drug Administration (the "FDA") is expected in 2023. NVK002 is currently thought to be the most likely first clinically-proven and approved pharmaceutical product for treating the progression of myopia in the world.Dr. Li Xiaoyi (Benjamin), Chairman of the Board of Directors, Executive Director and CEO of Zhaoke Ophthalmology, said, "The early completion of the patient recruitment of NVK002's Phase III clinical trials marks another huge and exciting milestone for Zhaoke Ophthalmology. Both China CHAMP and Mini-CHAMP trials completed the recruitment significantly ahead of schedule. I would like to express my sincere gratitude to all members of our clinical operation team, who continue to demonstrate superb clinical operations capability and expertise in the ophthalmology area. Our early completion of recruitment also clearly shows the immense demand and need for a safe and efficacious treatment for myopia progression control in China. Thanks to this achievement, Zhaoke Ophthalmology is hoping to commercialize NVK002 as the one of the first low-dose atropine treatments for myopia progression in China, in order to meeting this huge unmet need in the country, as well as in South Korea and parts of Southeast Asia."About NVK002NVK002 is an investigational novel topical ophthalmic solution to treat myopia progression in children and adolescents. The drug has a proprietary formulation that successfully addresses the instability of low concentration atropine and has a technology that has intellectual property protection globally. It is preservative-free with an expected shelf life of over 24 months. According to China Insights Consultancy ("CIC"), NVK002 is currently one of the most advanced atropine drug candidates globally for myopia progression control, and targets the broadest patient group, covering children and adolescents aged from three to 17 years old. The clinical development of NVK002 involves two different concentrations of atropine to allow flexibility in achieving maximal efficacy and minimal adverse effects for tailoring to the needs of individual patients. About myopia progression controlMyopia has become a major social issue that plagues the growth of children and adolescents in China. In the "14th Five-Year National Health Plan" issued by the State Council of the Chinese government, clear instructions have been made for the prevention and treatment of myopia in children and adolescents, and strive to reduce the overall myopia rate among children and adolescents nationwide by more than 0.5% per year. The Ministry of Education also issued the "Proposal for Parents of Comprehensive Prevention and Control of Myopia in Children and Adolescents", calling on parents to pay attention to their children's eye health.According to data from the World Health Organization ("WHO") and CIC, there are currently approximately 700 million myopia patients in China, 163 million of those are children and adolescents, who may be able to benefit from NVK002. Zhaoke Ophthalmology believes the potential commercialization of NVK002 will allow the Company to establish a leading position in meeting these huge unmet needs in China.About the partnershipIn October 2020, the Company entered into a license agreement, the NVK002 License Agreement, with Nevakar, which later transferred the agreement to its wholly-owned subsidiary, Vyluma, for an exclusive license to develop, manufacture, register, import, and commercialize NVK002 in Greater China, South Korea and certain countries in Southeast Asia (including Brunei, Burma, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore Thailand and Vietnam). For details of the license agreement in relation to NVK002, please refer to "Business - Collaborations and License Agreements - License of NKV-002" of the Company prospectus dated April 16, 2021. For further information about myopia in children, please feel free to listen to Episode 1 of our In Conversation with Zhaoke Podcast here. https://tinyurl.com/wut8fjzmAbout Zhaoke OphthalmologyFounded in 2017, Zhaoke Ophthalmology (SEHK: 6622) is a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs in the world. The company was listed in the Main Board of the Hong Kong Stock Exchange on 29 April 2021. Zhaoke Ophthalmology has a comprehensive drug portfolio of innovative and generic treatments covering six major eye diseases across both the front and back of the eye. Many of the drugs are being produced in its state-of-the-art and fully functional development and production facility in Nansha, Guangzhou.Zhaoke Ophthalmology is focusing on advancing towards the goal of product commercialisation, and achieve the objective of improving visual health in China through scientific research as soon as possible.Through its ambitious growth strategy, including partnering with domestic and international pharmaceutical companies, Zhaoke Ophthalmology's goal is to become a leader in ophthalmology in the world.For more information, please visit: www.zkoph.com About Vyluma, Inc.Vyluma is a development-stage biopharmaceutical company with a focus on pharmaceutical treatments for refractive errors of the eye. Vyluma's pipeline of therapies is led by NVK002, an investigational, preservative-free, low-dose atropine eye drop to treat myopia progression in children. NVK002 is currently in late Phase III clinical development in the United States, Europe, and Asia.Vyluma has a robust pipeline of other assets in various stages of development which address important unmet treatment needs of patients with refractive errors or eye pain.Vyluma itself is a subsidiary of Nevakar Inc., a holding company whose subsidiaries are engaged in developing products for the ophthalmic and injectable markets. For additional information please visit www.vyluma.com.Media Contact:Artemis Associates Diana Footitt, CEOM: +852 9183 0667E: diana.footitt@artemisassociates.com Bowen Chui, DirectorM: +852 9783 0643E: bowen.chui@artemisassociates.comIris Pei, DirectorM: +86 15000 465 016E: iris.pei@artemisassociates.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
More
Therapeutic Goods Administration Grants Provisional Approval for Moderna’s COVID-19 Vaccine in Children Aged Six Months to Five Years ACN Newswire

Therapeutic Goods Administration Grants Provisional Approval for Moderna’s COVID-19 Vaccine in Children Aged Six Months to Five Years

July 19, 2022
Cambridge, MA, Jul 19, 2022 - (ACN Newswire via SEAPRWire.com) - Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna's mRNA COVID-19 vaccine, Spikevax, in a two-dose series of 25 ug per dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to 5 years. Until now, children under six were the only age group not eligible for vaccination against COVID-19 in Australia."We are pleased that our vaccine for children under six years of age has received provisional approval by the TGA," said Michael Azrak, General Manager of Moderna for Australia and New Zealand. "The continued evolution of COVID-19 represents an emergent threat to global public health, including young children. Since the onset of the pandemic, we have worked with a deep sense of responsibility to deliver on the promise of mRNA science to all Australians. The approval from TGA helps extend an opportunity to all parents and caregivers in Australia to protect their young children against SARS-COV-2."Positive interim results from the Phase 2/3 KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6-month to 5 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile. The antibody titers in the pre-specified 6 month to 23 month and 2 years to 5 years of age sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study. Preliminary efficacy analysis on PCR-confirmed cases collected during the Omicron wave showed similar efficacy estimates against Omicron in the 6-month to 5 years of age group to those in adults after two doses of mRNA-1273.The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The ClinicalTrials.gov identifier is NCT04796896.Moderna is committed to supporting the Australian Government on the COVID-19 program implementation in children aged 6 months to five years upon receiving a recommendation from the Australian Technical Advisory Group on Immunisation (ATAGI).The TGA previously approved the use of Moderna's mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged six years or over.Authorized UseTherapeutic Goods Administration has provisionally approved the use of Moderna's mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.About ModernaIn 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both ground-breaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic.Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.Forward Looking StatementsThis post contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the development of the Company's COVID-19 Vaccine (mRNA-1273, or Spikevax); the approval of the vaccine in children ages 6 months to 5 years by the Therapeutic Goods Administration; and the safety, efficacy, and tolerability of the vaccine in children ages 6 months to 5 years of age. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this post in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.Moderna ContactsMedia:Luke Mircea-WillatsDirector, Media Relations & CommunicationsLuke.mirceawillats@modernatx.comInvestors:Lavina TalukdarSenior Vice President & Head of Investor Relations617-209-5834Lavina.Talukdar@modernatx.comSOURCE: Moderna, Inc. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
More