Global guidelines on regulatory preparedness for pandemic influenza vaccines have been revised to strengthen the regulating of vaccines risk-based approaches to vaccine regulation in the event of a pandemic. During the 2009 H1N1 influenza pandemic, the deployment of pandemic influenza vaccines in importing countries was delayed or disrupted due to the lack of regulatory preparedness. This resulted in WHO developing guidelines for non-vaccine producing countries on the appropriate regulatory approaches to the marketing authorization and lot release of pandemic influenza vaccines in public health emergency conditions. These guidelines were developed in the context of the Pandemic Influenza Preparedness (PIP) Framework’s Partnership Contribution High Level Implementation Plan, covering regulatory capacity-building and strengthening of pandemic preparedness and response. However, subsequent public health emergencies such as the Ebola epidemic and COVID-19 pandemic further exposed gaps in regulatory preparedness for other types of pandemic vaccines. The role of national regulatory authorities was not acknowledged ...
Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform Altamira Therapeutics, a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets has announced that it has entered into a collaboration agreement with Univercells Group to evaluate the use of the Company’s proprietary SemaPhore platform for the delivery of mRNA vaccines. Univercells is a global life sciences company creating platforms for developing and manufacturing biologics, including mRNA vaccines and therapeutics, in a simple, scalable and cost-efficient way. Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform. Should the experiments prove successful, Univercells and Altamira intend to discuss and negotiate a commercial agreement for the development and manufacturing of nanoparticle-based mRNA vaccines using Univercells’ production platform. Covadonga Pañeda, PhD, Altamira’s ...
On March 27, 2024, the oral hexavalent reassortant rotavirus live attenuated rotavirus vaccine (Vero cell), jointly developed by SINOVAC’s Beijing Kexing Zhongwei Biotech Co. and Kexing (Dalian) Vaccine Technology Co. SINOVAC’s hexavalent reassortant rotavirus vaccine was approved for entry into the clinic in January 2024. This study is intended to be a single-arm, open design in adults and children, and a randomized, double-blind, placebo-controlled design in infants, to assess the safety and tolerability of the vaccine in adult and pediatric populations, as well as the immunogenicity of the vaccine in healthy infants. Rotavirus (RV) is a virus of the family Eutheroviridae, whose primary mode of transmission is fecal-oral, with the possibility of respiratory transmission also present, and which primarily infects the epithelial cells of the small intestine, thereby causing cellular damage and diarrhea. Rotavirus gastroenteritis (RVGE) is the leading cause of severe, fatal diarrhea in children under 5 years of ...
On March 25th, Jiangsu Ruike Biotechnology Co., Ltd (hereinafter referred to as “Ruike Biotechnology”, stock code: 02179.HK) and Shanghai Rongsheng Biopharmaceutical Co. (hereinafter referred to as “Rongsheng Biopharmaceuticals”) in Shanghai. At the meeting, both parties signed a strategic cooperation agreement on the new adjuvant vaccine project and discussed the details of the project. Adjuvant is an important component in the development of vaccines, and new adjuvants have become the key to the success of innovative vaccine research and development. According to the terms of the agreement, the two parties will jointly carry out the development of new adjuvant vaccines, with Ruike Biologicals providing new adjuvants independently developed based on the new adjuvant technology platform, and Rongsheng Biologicals providing viral antigens independently designed by Rongsheng Biologicals. The project will improve the immunogenicity of existing Rongsheng Bio’s vaccines under development by empowering them with novel adjuvants for the purpose of optimizing immunization ...
EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2024. Every year, EMA issues EU recommendations for the composition of seasonal influenza vaccines on the basis of observations by the World Health Organization (WHO) which are informed by regular monitoring activities on the prevalence and characteristics of different influenza viruses worldwide. Based on this data EMA’s Emergency Task Force (ETF) has issued a statement recommending a transition from quadrivalent to trivalent vaccines that do not include the B/Yamagata component. Currently, most authorised influenza vaccines are quadrivalent, which means that they are formulated to protect against the four main strains of influenza responsible for seasonal flu, A(H1N1)pdm09 and A(H3N2), B/Victoria and B/Yamagata. However, the B/Yamagata strain of the influenza B virus has not been detected in circulation since March 2020. This is thought to be due ...
Recently, CanSinoBio’s Quadrivalent Conjugate Vaccine (QCV) initiated a Phase III clinical trial in Indonesia and completed the enrollment of the first subject. The clinical trial aims to evaluate the safety and immunogenicity of the vaccine in people aged 18-55 years. Currently, rheumatic encephalitis remains a serious challenge in global public health, and vaccination is the most cost-effective and efficient way to prevent it.2022 In June, CanSinoBio’s self-developed Mannhexin®, Asia’s first tetravalent rheumatic encephalitis conjugate vaccine, was officially approved for marketing, which fills the gap of China’s lack of high-end rheumatic encephalitis vaccines in this field. This clinical trial will expand the applicability of the quadrivalent conjugate vaccine to adults. According to the statistics, the incidence of epidemic epidemic is found in all age groups, among which the incidence rate is higher in children under 5 years old. Usually, the incidence rate of epidemic encephalitis decreases with age, but the incidence ...
The centre will deliver free training, outreach materials and programmes The University of Birmingham is set to lead UK-wide virtual reality (VR)-assisted training in medicines manufacturing to address critical skills demand in life sciences. Set to benefit future medicine and vaccine makers, the new RESILIENCE Centre for Excellence for UK Medicines Manufacturing Skills Centre aims to deliver free training, outreach materials and programmes. Supported by £4.5m of funding from Innovate UK and the Office for Life Sciences, the centre will be led by an academic consortium of UK universities, including University College London, Teesside University and Heriot-Watt University. The training centre aims to work with healthcare and pharmaceutical organisations to provide a single-entry point for training and career input, which includes a pipeline of continuing professional development courses. Hundreds of students across the UK are set to benefit from the training developed by the RESILIENCE Centre, including VR and mixed ...
Rowe, N.J., March 13, 2024 – Merck Sharp & Dohme (Merck is the corporate trading name of Merck & Co. of Rowe, N.J., U.S.A.) announced at the European Organization for the Study of Genital Infections and Neoplasms (EUROGIN) Congress 2024 plans to initiate a novel multivalent human papillomavirus (HPV) vaccine clinical trial designed to provide broader protection against HPV types. At the same time, Merck Sharp & Dohme also plans to conduct additional clinical trials to evaluate the protective efficacy and safety of Gardasil®9 [nine-valent human papillomavirus vaccine (brewer’s yeast)] single-dose regimen1 compared to the already approved three-dose regimen. Within China, Gardasil®9 is indicated for the prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical intraepithelial neoplasia (CIN grades 1/2/3) and adenocarcinoma in situ (AIS) of the uterine cervix caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and ...
More than 3,700 cases of mpox have been identified in the UK since May 2022 The National Institute for Health and Care Research (NIHR) has announced a new phase 1/2 trial, delivered by the NIHR Clinical Research Network and sponsored by Moderna, to test the effectiveness of an investigational mRNA vaccine for mpox. The mPower trial will evaluate the safety and immune response to mRNA-1769, which aims to protect against illness caused by the mpox virus. Currently a global public health threat, mpox is an infectious disease caused by the monkeypox virus, which is spread through physical contact with someone who is infected, leading to symptoms including painful rashes, enlarged lymph nodes and fever. Since May 2022, over 3,700 cases of mpox have been identified in the UK, the majority of which have been from the Clade II B.1 lineage, predominantly in gay, bisexual and other men who have sex ...
The NHS has announced it is targeting young adults to catch up on their missed measles, mumps and rubella (MMR) vaccines as part of the NHS catch-up campaign. In England, more than 900,000 adults aged 19 to 25 years will be invited to book an appointment for their missed vaccine. Following on from the national health service’s recent reminder for 200,000 16- to 19-year-olds to receive the MMR vaccine, the NHS campaign will target young adults in areas more at risk: the West Midlands, Greater Manchester and London. MMR are highly infectious illnesses that can lead to blindness, deafness and swelling of the brain. Currently one of the most infectious diseases globally, with no medical treatment available, one adult or child infected with measles can pass the disease on to around 15 other unvaccinated individuals. According to the UK Health Security Agency (UKHSA), between October 2023 and March 2024, approximately ...
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