Rotavirus vaccine(The Wistar Institute)

Antibody rise observed in lactating mothers and in their breast milk Long-term goal is to provide protection to infants through passive antibody transfer SOUTH SAN FRANCISCO, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it has completed the topline analysis for the Phase 1 clinical trial evaluating Vaxart’s oral pill bivalent norovirus vaccine candidate. The trial was focused on lactating mothers. Antibodies to norovirus rose on average 4.0 fold for the G1.1 virus strain and 6.0 fold for the GII.4 virus strain in the breast milk of lactating mothers who received the Vaxart vaccine candidate in the high dose group. There were no vaccine-related serious adverse events (SAEs) and no dose-limiting pharmacotoxicity. “This is an important step forward as we drive toward a vaccine candidate that may make it possible for mothers to protect their children against this highly contagious – and potentially lethal – virus. It can be difficult to immunize the youngest of children mucosally because the immune system is still developing. Passive transfer of antibodies from mothers to infants via breast milk is an innovative approach to potentially improve infection resistance in infants,” said Dr. James F. Cummings, Vaxart’s Chief Medical Officer. “We would like to thank the study subjects for their participation in this novel and important clinical trial.” There is no approved vaccine against norovirus, which sickens approximately 21 million people in the United States each year, including the 15% of children under age 5 who contract norovirus annually. Approximately 3 million sets of parents are forced by this virus to miss work – approximately 2.2 days on average – to care for their children. The annual disease burden from norovirus is $10.6 billion in the United States alone. Globally, norovirus has become the leading cause of pediatric gastroenteritis in health care settings in countries that have adopted a rotavirus vaccine program.1 Pediatric deaths in the United States due to norovirus are rare, but they are much more common in the developing world. This Phase I trial was conducted in South Africa (trial #20230307), and partially funded by the Bill & Melinda Gates Foundation. More complete results, including other immunogenicity measures, will be reported in a future scientific manuscript. About the VXA-NVV-108 Clinical Trial This Phase 1, multicenter, randomized, double-blind, placebo-controlled single dose, dose-ranging study is designed to evaluate the safety, tolerability, and immunogenicity of orally administered bivalent GI.1/GII.4 norovirus vaccine in healthy lactating females 18-43 years of age. The study enrolled 76 subjects at five sites in South Africa. Subjects were randomized into high- or medium-dose vaccine (N=30 for each arm) or placebo (N=16). The primary endpoint results were: Serum VP1-specific IgA rose an average of 5.6 fold in response to GI.1 and 4.4 fold in response to GII.4 in the high dose group, similar to the response observed in a previous Vaxart bivalent study conducted in adults 18-55 years of age in the United States. Breastmilk VP1-specific IgA rose on average 4.0 fold in response to G1.1 and 6.0 fold in response to GII.4 in the high dose group. The vaccine was well tolerated, with no SAEs, no adverse events of special interest (AESIs) and no new onset of chronic illness (NOCIs) observed through the active period. Further information, including information about study funding, can be found in Vaxart’s press release of December 1, 2022, as well as Vaxart’s latest annual filing with the Securities and Exchange Commission. 1 Shah and Hall, Infect Dis Clin North Am. 2018 Mar; 32(1): 103-118. About Vaxart Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus, and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists. Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, results from preclinical and clinical trials and the timing of such results, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," “anticipate,” "plan," and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart's ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart's expectations regarding clinical results and trial data, and the timing of receiving and reporting such clinical results and trial data; and Vaxart's expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law. Contacts Vaxart Media Relations: Mark Herr Vaxart, Inc. mherr@vaxart.com (203) 517-8957 Investor Relations: Andrew Blazier FINN Partners IR@vaxart.com (646) 871-8486

WASHINGTON, April 19, 2024 (GLOBE NEWSWIRE) -- The Sabin Vaccine Institute yesterday presented the Albert B. Sabin Gold Medal to physician-researchers Keith Paul Klugman and Shabir Ahmed Madhi, and its Rising Star award to infectious diseases epidemiologist Nicole Elaine Basta at a ceremony in the National Academy of Sciences building in Washington D.C. Klugman and Madhi received the Sabin Gold Medal, one of the highest recognitions for vaccinologists globally, for their seminal combined contributions to the development of vaccines against pneumonia and diarrheal disease – major causes of death in children in low- and middle-income countries (LMICs). Klugman first met his then-graduate student Madhi at South Africa’s University of the Witwatersrand (also known as Wits University), where Klugman established, and Madhi expanded, a now globally renowned infectious diseases research institute. Apart from pneumonia, their work focused on maternal and children’s vaccines including influenza, respiratory syncytial virus (RSV), typhoid, and Group B streptococcus (GBS). The evidence produced by these two awardees has and continues to inform the World Health Organization’s recommendations for vaccines. Klugman and Madhi’s research has helped pave the way for the introduction of lifesaving vaccines in public immunization programs – including the pneumococcal conjugate vaccine where their findings were pivotal in influencing vaccination policy in many LMICs. “I am honored to award the Sabin Gold Medal to Dr. Klugman and Dr. Madhi for their extraordinary work on vaccines that have saved lives in communities most in need of these interventions,” says Amy Finan, Sabin’s chief executive officer. “Their pneumonia research has been particularly transformative in shaping our understanding of the disease and strengthening global health strategies to protect children from this vaccine-preventable disease.” Fueled by an early interest in science as a child in South Africa -- in part due to a physician father – Klugman holds both a medical as well as a science doctorate degree from Wits University and was the first student in the school’s history to obtain them simultaneously. He began his research career nearly five decades ago investigating the typhoid vaccine and has since distinguished himself as a formidable infectious diseases’ scientist. Klugman is widely known for his work on pneumonia, which still kills a child under five every 43 seconds, many in the world’s poorest countries. As the director of the pneumonia program at the Seattle-based Bill and Melinda Gates Foundation, Klugman orchestrates strategic initiatives aimed at reducing deaths from pneumonia, RSV, neonatal sepsis, and meningitis. He has authored hundreds of publications that have been cited over 50,000 times to date and has been elected to the National Academy of Medicine in the United States. Klugman is also a professor emeritus of global health at Atlanta’s Emory University. His scientific achievements aside, Klugman has long championed the need for the world’s poorest children to have equitable access to vaccines. While in South Africa he joined in Wits University’s struggle to allow access to the institution for all students. “It is absolutely wonderful to be receiving this award, especially together with Shabir,” he says. “When I look down the list of previous awardees, I recognize the great majority of them, and it is extraordinary to now be numbered among them.” With a career spanning more than 25 years, Madhi, also from South Africa, is a trained pediatrician whose research continues to be instrumental in prioritizing the rollout of vital vaccines and guiding global public health policies. At Wits University, he led clinical trials focused on respiratory and meningeal pathogens, including vaccines targeted at pregnant women and their unborn babies. Madhi led the first study showing that a rotavirus vaccine could significantly prevent severe diarrhea during the first year of life in African infants. That research served as a key piece of evidence for the WHO’s recommendation of universal rotavirus vaccination. In addition, he also led the first two COVID-19 vaccine trials in Africa, and a number of COVID-19 epidemiology studies which led to the first evidence suggesting that infection-induced immunity and vaccinations played a role in reducing severity of disease. Madhi heads South Africa’s widely respected South African Medical Research Council (SAMRC) Vaccines and Infectious Diseases Analytics Research Unit (Wits VIDA) and is a professor of vaccinology at Wits. He too has co-authored hundreds of publications which have been cited over 59,000 times. Madhi is a recipient of numerous lifetime achievement awards in South Africa, as well being bestowed an Honorary Commander of the Order of the British Empire (CBE) from the British Government for his services to science and public health in a global pandemic. “It is really humbling for me to be acknowledged for my contributions in the field of vaccinology along with those who have received the Gold Medal award,” says Madhi. “It makes me realize that the work my team and I have done is acknowledged by my peers as being of substance. Most significantly, we contributed to protecting lives in those settings where a majority of death and suffering occurs, and that is in LMICs.” Sabin’s 2024 Rising Star Nicole Basta, an associate professor at Canada’s McGill University and Canada Research Chair in Infectious Disease Prevention, has led numerous studies to evaluate the impact of vaccines and vaccination programs for a number of globally challenging viral and bacterial diseases, including COVID-19, meningococcal disease, influenza, and HPV. Inspired by her parents’ emphasis on the importance of education, Basta is a first-generation college graduate who earned an undergraduate degree at Princeton University and graduate degrees at the University of Cambridge and the University of Washington. She has distinguished herself as a prolific researcher with a focus on assessing the impact of vaccination programs and increasing vaccine awareness, acceptance, and uptake. She designed and led studies to evaluate the impact of the meningococcal A vaccine MenAfriVac in Mali and the meningococcal B vaccine Bexsero in the US, both of which contributed to better understanding about how to best implement vaccination programs. In 2020, she and a colleague developed an interactive online COVID-19 vaccine tracker, providing real-time updates to millions of users around the world on the pandemic vaccine development progress. “Prof. Basta’s impactful and policy-shaping epidemiological research benefits from her ability to make it accessible and useful to the global health community. The COVID-19 vaccine tool is one such instance,” says Finan. “Those achievements alone would make her deserving of the Rising Star but there’s more: she also demonstrates a deep commitment to mentoring the next generation of public health researchers through her research group which is exactly the kind of emerging leader we need.” Once an infectious diseases outbreak investigator with the Florida Department of Health, Basta has first-hand knowledge that scientific research needs to be understood and adopted beyond the confines of academia. She works with policy makers and public health agencies and organizations to translate research findings into actionable strategies for disease prevention and control. “It’s truly an honor to receive the 2024 Rising Star Award from the Sabin Vaccine Institute, especially since I am deeply committed to ensuring that we have the evidence we need to demonstrate the importance of vaccination and increase access and uptake,” says Basta. “This recognition is also a testament to the outstanding collaborators and trainees I have had the privilege to work with and it motivates us to continue to make a difference in the years ahead.” The Gold Medal is Sabin’s highest scientific honor. It has been given annually for more than three decades to a distinguished member of the global health community who has made exceptional contributions to vaccinology or a complementary field. Past award recipients include leaders of vaccinology and vaccine advocacy such as Drs. Barney Graham, Carol Baker, Bill Foege, Anne Gershon, Stanley Plotkin, and Kathrin Jansen. Sabin’s Rising Star award was created in 2020 to encourage and recognize the next generation of vaccine and immunization leaders. About the Sabin Vaccine Institute The Sabin Vaccine Institute is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non-profit with three decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit and follow us on Twitter, @SabinVaccine. Media Contact: Monika Guttman Senior Media Relations Specialist Sabin Vaccine Institute +1 (202) 662-1841 press@sabin.org A photo accompanying this announcement is available at 2024 Albert B. Sabin Gold Medal and 2024 Sabin Rising Star Award Presentations Dr. Keith Klugman (left) and Dr. Shabir Madhi (right) were presented the 2024 Albert B. Sabin Gold Medal and Prof. Nicole Basta (center) received the 2024 Sabin Rising Star Award from the Sabin Vaccine Institute at the National Academy of Sciences in Washington, D.C.