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New tools support RSV disease prevention decision-making
Respiratory syncytial virus (RSV) is the world’s top cause of severe respiratory disease and hospitalization in infants and young children. Groundbreaking products for preventing RSV in early life have recently achieved or are on the pathway to licensure, including long-acting monoclonal antibodies (mAbs) and maternal vaccines. In a special issue of BMC Medicine, new research from South Africa, Kenya, and Vietnam, conducted by a consortium of investigators including PATH,
provides insights into the impact and value of these products. Results show a large burden of disease outside of hospitals and that most RSV disease occurs in young infants, more than previously recognized. The studies estimate that new prevention products could have a large health impact and be cost-effective. As a way to share this and other key information, the World Health Organization (WHO), PATH, and other partners are building a suite of communications resources that public health stakeholders and advocates can use to raise awareness about RSV, forthcoming disease prevention products, and delivery considerations. Overall, these studies and resources are part of larger efforts to support decision-making around RSV disease prevention, policy, and
implementation preparedness.
Novel type 1 oral polio vaccine candidate advances to Phase 2 study
PATH and partners are advancing novel oral polio vaccines (nOPV) to provide immunity and interrupt transmission, protection already offered by the existing Sabin-strain OPV, but with a reduced risk of seeding new paralytic outbreaks. The reversion of OPV strains back to virulence is a rare occurrence, but these vaccine-associated cases now outnumber wild-type cases, and regions with low vaccine coverage are especially at risk. Because of this, since 2021, hundreds of millions of doses of nOPV against type 2 have been successfully delivered under WHO’s Emergency Use Listing (EUL) approval.
In March, in partnership with icddr,b, PATH launched a Phase 2 trial of nOPV against type 1 (nOPV1) to assess its performance in pediatric populations, ultimately aiming to advance the candidate to EUL and to WHO prequalification if the data continue to be supportive. Generating this evidence will help ensure stockpiles for outbreak response are composed of safe and immunogenic vaccines with reduced risk of causing vaccine-associated paralytic polio outbreaks.
New panel of antibodies to support affordable pneumococcal vaccine development
PATH, in collaboration with the Medicines and Healthcare Products Regulatory Agency (MHRA), recently announced the availability of a new panel of 46 high-quality and affordable pneumococcal serotype-specific mAbs. Each mAb is reactive to a specific pneumococcal polysaccharide commonly integrated into licensed polyvalent pneumococcal conjugate vaccines (PCVs) and many candidates under development. The mAbs are specific to 29 serotypes that have been associated with pneumococcal pneumonia, and one mAb is specific to the conserved cell wall polysaccharide. To facilitate ease of access, the antibodies are available in
0.5 milligram aliquots, accompanied by a certificate of analysis.
In regions like Africa and Asia, where most pneumococcal deaths occur, vaccine price and availability pose significant barriers to access. Additionally, many existing vaccines do not address all pneumococcal serotypes prevalent in these areas. These mAbs can be used to simultaneously analyze up to 25 polysaccharide serotypes in an affordable way, which will support testing for the identity, quantity, and stability of drug substance and product in a multiplex assay platform. Providing the mAbs to vaccine developers and the research community is a crucial step toward ensuring the successful development of polyvalent PCVs with additional serotypes and accelerating their availability to children in low- and middle-income countries (LMICs). The mAbs are now available through the MHRA via the National Institute of Biological Standards and Control online catalog of biological reference materials. For additional information, contact This email address is being protected from spambots. You need JavaScript enabled to view it..
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