Conference report: WHO meeting summary on mRNA-based tuberculosis vaccine development.

Tuberculosis (TB) is a global health emergency. Across the globe, approximately 2 billion people are currently infected with Mycobacterium tuberculosis (Mtb), and of those, 5-10% may progress to become ill and potentially transmit the bacterium. In 2021, nearly 10.6 million people developed TB disease and 1.6 million died. There is an urgent need for accelerated development of new TB-focused interventions, in particular, improved TB vaccines. However, progress in developing highly effective TB vaccines has been slow and is chronically under-resourced. The mRNA vaccine platform may offer an opportunity to accelerate development of new TB vaccines. In April 2023, the World Health Organization convened global experts to discuss the feasibility and potential value of mRNA-based vaccines for TB. Here we report on meeting deliberations related to the current TB vaccine pipeline and potential novel antigens, the status of efforts to identify correlates of protection, potential clinical development strategies and considerations for community acceptance of new TB vaccines based on this relatively new platform. The role of industry collaborations, ethics, social science, and responsibility to the global community regarding transparency and manufacturing capacity building were discussed through expert presentations and panel sessions. The overall conclusion of the meeting is that mRNA-based vaccines constitute a potentially powerful new tool for reducing the global burden of TB.

Immune responses against group B Streptococcus monovalent and pentavalent capsular polysaccharide tetanus toxoid conjugate vaccines in Balb/c mice.

Immunization of pregnant women with Group B Streptococcus (GBS) capsular polysaccharide (CPS) conjugate vaccine (CV) could protect young infants against invasive GBS disease. We evaluated the immunogenicity of investigational five GBS monovalent (serotypes Ia, Ib, II, III, and V) CPS-tetanus toxoid (TT)-CV with adjuvant and GBS pentavalent CPS-TT-CV with adjuvant (GBS5-CV-adj) and without adjuvant (GBS5-CV-no-adj), in Balb/c mice. Aluminum phosphate was the adjuvant in the formulations, where included. The homotypic immunoglobulin G (IgG) geometric mean concentration (GMC) and opsonophagocytic activity (OPA) geometric mean titer (GMT) did not differ after the third dose of the GBS5-CV-adj vaccine compared with the monovalent counterparts for all five serotypes. The GBS5-CV-adj induced higher post-vaccination serotype-specific IgG GMCs and OPA GMTs compared to GBS5-CV-no_adj. The GBS5-CV with and without adjuvant should be considered for further development as a potential vaccine for pregnant women to protect their infants against invasive GBS disease.

Vaccines: New challenges, new paradigms, new opportunities: Report of the 22nd DCVMN Annual General Meeting.

The Developing Countries Vaccine Manufacturers Network held its 22nd Annual General Meeting in October 2021. Vaccine manufacturing experts, leaders from global public health organizations and dignitaries from governments and multilateral organizations discussed the challenges and opportunities emerging from the COVID-19 pandemic. Over 350 delegates from 33 countries, representing over 70 organizations partook in the meetings deliberations. The development and scaled-up production of several safe and effective vaccines against COVID-19 resulted in over 12 billion doses being produced by the end of 2021. Unfortunately, this scientific achievement and outstanding industry effort has been overshadowed by the striking inequity in access to COVID-19 vaccines. High and upper middle-income countries have received 75% of the vaccines, while in Africa, less than 5% of the people are fully vaccinated. The inequitable access to vaccines is an issue of national health security, which has stressed the need to establish local vaccine manufacturing capacity in Africa. Key partnerships, initiatives and the deliberate strategies required to achieve sustainable manufacturing on the continent were discussed. The ability to acquire technology, access markets and financing mechanisms, and workforce development were reported as key enablers to achieving a healthy ecosystem. Innovative vaccine technologies, new regulatory approaches, and the importance of voluntary technology transfers in increasing the global supply capacity of both COVID-19 vaccines and traditional vaccines were highlighted. In reviewing the lessons learned from the pandemic, speakers shared a consensus that innovation and partnerships will be central to any solution proposed to mitigate the current pandemic and prepare for future ones.

Better vaccines for healthier life. Part II. Conference report of the DCVMN International 14th Annual General Meeting Hanoi, Vietnam.

New vaccines are required to meet the public health challenges of the next generation and many unmet global health needs can be addressed by developing countries vaccine manufacturers such as lower-cost vaccines based on single-dose, thermostable formulations, efficacious in children with compromised gastrointestinal tracts. GMP compliance is also a challenge, as sometimes innovation and clinical development focus is not accompanied by command of scale-up and quality assurance for large volume manufacturing and supply. Identifying and addressing such challenges, beyond cost and cold-chain space, including safety considerations and health worker behavior, regulatory alliances and harmonization to foster access to vaccines, will help countries to ensure sustainable immunization. There needs to be continuous and close management of the global vaccine supply both at national and international levels, requiring careful risk management, coordination and cooperation with manufacturers. Successful partnership models based on sharing a common goal, mutual respect and good communication were discussed among stakeholders.