Breakthroughs Blog: Pandemic preparedness

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last week, the World Health Organization (WHO) prequalified the first conjugate vaccine to protect against the five dominant causes of meningococcal meningitis in Africa. The vaccine, MenFive, which was developed through a collaboration between the Serum Institute of India Private Limited and PATH, with financial support from the UK’s Foreign, Commonwealth, and Development Office, demonstrated a high level of safety and immunogenicity in extensive clinical studies in The Gambia, India, and Mali. WHO’s prequalification will allow MenFive to be procured by United Nations agencies and Gavi, offering a promising tool that could avert the annual outbreaks and epidemics in the African countries with the most meningitis cases and deaths.A multisite phase 1 HIV vaccine clinical trial carried out by the Globally Relevant AIDS Vaccine Europe-Africa Trials Partnership concluded with preliminary analysis demonstrating strong results. The novel mosaic HIV vaccine candidate, HIVconsvX, demonstrated the ability to trigger a strong and specific immune response that targets a broad range of HIV-1 variants, making it potentially applicable for HIV strains around the world. Researchers say it also represents an innovative approach within a pipeline of vaccine candidates that needs to be diverse to maximize the chances of success. The full reporting of the primary findings from the trial is expected later this year followed by further in-depth analysis.Last week, a joint statement from the United Nations Food and Agriculture Organization, WHO, and the World Organization for Animal Health warned that the H5N1 avian flu virus could adapt to more easily infect humans and urged multisector, international partnership and cooperation to protect both animal and human populations. The current H5N1 clade 2.3.4.4b has been circulating since 2020, causing unprecedented deaths around the world across different animal populations, especially in wild birds and increasingly, mammals. Although human cases have been only sporadic, maintaining and strengthening surveillance capability to be able to detect viral changes and human cases, as well as testing the currently circulating viruses for resistance to available antiviral drugs, will be essential to avoid further devastation.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Gavi, the World Health Organization (WHO), and UNICEF have announced that an initial 18 million doses of the world’s first malaria vaccine, RTS,S/AS01, will be rolled out in 12 African countries, where the risk of child illness and deaths from malaria is highest. The vaccine, which will be produced by GlaxoSmithKline and Bharat Biotech, is expected to arrive in the initial countries in late 2023. A further 16 countries have also asked for access and are expected to receive it once production has scaled up. Another malaria vaccine, R21, developed by Oxford University is currently awaiting WHO prequalification. In the coming years, both vaccines are expected to play a key role in the fight against malaria alongside other tools.A study published last week found that injections of broadly neutralizing antibodies in children living with HIV can improve the protective effects of antiretroviral drugs, marking the first time broadly neutralizing antibodies have been tested in combination with antiretroviral drugs in a pediatric population. The treatment suppressed cells that contained the virus and were capable of reactivating, paving the path to further research that could confirm the use of this method as a supplemental or alternative treatment for HIV in children. The publication of these findings follows recent research, which has focused on testing broadly neutralizing antibodies as a treatment for adults with HIV. Worldwide, about 1.7 million infants and children are living with HIV.Last week, Gavi confirmed that some of the $2.6 billion remaining in COVAX, the COVID-19 vaccine delivery initiative, could be redirected towards furthering investigational vaccine candidates for Marburg and Ebola Sudan, as well as a hexavalent vaccine that would offer protection against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and the inactivated polio vaccine. The investments for Marburg and Ebola Sudan will hopefully contribute to ensuring clinical trials in future outbreaks, especially after the scrapped trials during the recent Marburg and Ebola Sudan outbreaks.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last week, the Bill & Melinda Gates Foundation and Wellcome Trust announced that they will jointly invest more than $500 million in phase 3 trials for the GSK-developed M72/AS01E tuberculosis (TB) vaccine, which could become the first new tuberculosis vaccine in 100 years. 2018 phase 2b trials showed that the vaccine was 50 percent effective, but after GSK pulled out because they did not see a commercial market for the vaccine, the company passed the license to the Bill & Melinda Gates Medical Research Institute in 2020. The phase 3 trials will involve 26,000 people in Africa and Southeast Asia, hopefully confirming the vaccine’s viability as TB cases and deaths rise around the world.A new initiative led by Gavi, the World Health Organization, and the Coalition for Epidemic Preparedness Innovations will work to stockpile experimental vaccines for infectious diseases with epidemic potential to improve preparedness for future outbreaks. This global virtual pooled inventory will initially focus on Marburg and the Sudan strain of Ebola, for which there are no existing vaccines or proven treatments. Last year’s outbreaks in Africa of these two hemorrhagic fevers saw aborted attempts to move forward clinical trials for vaccines, losing crucial opportunities to gather essential data on potential tools and highlighting the need for this kind of stockpiling, preparation, and partnership.The Medicines Patent Pool recently announced sublicensing agreements with seven manufacturers to produce and distribute generic versions of Shionogi’s COVID-19 antiviral treatment in low- and middle-income countries, improving availability and equitable access in these countries, even after the end of the Public Health Emergency of International Concern. The oral antiviral, Ensitrelvir, is currently only approved in Japan, although it is being considered in the United States and all 117 countries in the agreements. Medicines Patent Pool previously signed sublicensing agreements with Pfizer in 2021 to manufacture and distribute its treatment, Paxlovid, in 95 low- and middle-income countries.

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last week, a US Food and Drug Administration (FDA) advisory committee voted to recommend a monoclonal antibody product to protect children one year and under, as well as high-risk children between one and two years old, from respiratory syncytial virus, or RSV. Nirsevimab, which will be marketed as Beyfortus, was developed by AstraZeneca and will be marketed in the United States by Sanofi. The product is intended to be administered to babies via a single injection during RSV season or at birth depending on birth timing. RSV is a major challenge in children, particularly in very young children, causing up to 80,000 hospitalizations and 300 deaths a year in the United States. Pfizer’s RSV vaccine for pregnant people, which is also aimed at protecting babies, is currently being considered by regulators as well.Moderna will launch a phase 1/2 trial of their mpox vaccine this summer with the goal of generating data to inform dose selection and eventually licensure. The company announced the start of preclinical work on an mpox vaccine back in May of last year, with the vaccine being swiftly developed using the company’s mRNA platform. After the immediate mpox outbreak waned in the United States, the vaccine was deprioritized by Moderna, but ahead of this summer, when mpox is expected to re-emerge, Moderna has announced the trial and has been meeting with the US mpox response team.The Coalition for Epidemic Preparedness Innovations (CEPI) last week announced £1.5 million in funding for Germany’s Leipzig University, where researchers have created artificial intelligence technology that will be used to build a vaccine library aimed at streamlining the development of a new generation of vaccines against a future pathogen with pandemic potential, or Disease X. The technology will analyze the genetic structures of pathogens from ten high-risk viral families, starting with those families that include Nipah and Lassa viruses; model protein sites in the viruses that are crucial targets for generating immune responses in human; and then use those viral protein targets to develop vaccine blueprints. Future scientists will hopefully be able use the library to develop vaccine candidates within 100 days of identifying a pathogen with pandemic potential.