Breakthroughs Blog: Monkeypox

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.

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 Thursday, the World Health Organization (WHO) declared the end of the global health emergency for mpox following a recommendation from WHO’s emergency committee on mpox, which also recommended continued management to prevent the virus from evolving. Bavarian Nordic’s vaccine for smallpox was deployed in the United States and Europe under emergency authorizations and recommended by WHO primarily for post-exposure during the mpox emergency, although the limited available stock that was already earmarked for wealthy countries created access challenges in low- and middle-income countries. Randomized control trials planned in endemic countries will provide more essential data about the efficacy of the vaccine against mpox. Additional data is also needed to fully understand how the strain of the virus evolved to sustain prolonged transmission between humans.Last week, the US$30 million Human Pangenome project, launched in 2019 and funded by the US National Human Genome Research Institute, published the first phase of the first human pangenome, which aims to be a genome that is more representative of the diversity of DNA in humans around the world. The genome could be an important guide for researchers building genetic tests and looking for new drug targets. This initiative addresses diversity gaps in the first reference genome, released in 2001, which have undermined the ability to develop tests that work across diverse populations.A new global research consortium organized by the Centres for Antimicrobial Optimisation Network aims to fight antimicrobial resistance by improving clinical use of antimicrobials and improving practices and guidelines for prescribers, users, and policymakers. Research hubs in Kampala, Cape Town, São Paulo, Liverpool, and London—where there is a high burden of drug-resistant infections and where there are communities highly affected by the burden of infectious disease—will generate essential data on the optimal use of antibiotics. Researchers hope this will in turn lead to more effective treatment and prevention of bacterial infections in the face of rising antimicrobial resistance worldwide.

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. In June, South Sudan is expecting to begin the rollout of the preventive malaria intervention seasonal malaria chemoprevention (SMC), although there are concerns that high parasite resistance in eastern and southern African countries will limit its long-term efficacy. In June 2022, the World Health Organization (WHO) updated its recommendations that previously restricted SMC’s use to the Sahel region, where malaria transmission is highly seasonal, to encourage its use in other regions after pilot studies showed positive results in countries with high resistance, including South Sudan. Experts have emphasized the need for rigorous monitoring and evaluation to assess SMC’s efficacy in areas of high resistance and to detect any parasite resistance in the Sahel, as well as the development of alternative tools and drugs for malaria chemoprevention.Last week, the European Medicines Agency recommended authorization of GSK’s Arezvy vaccine for respiratory syncytial virus (RSV) in adults 60 years of age and older, which if approved, will be the world’s first available vaccine for RSV. Regulatory agencies in the United Kingdom and United States are expected to make decisions on GSK’s vaccine in the coming months. Pfizer and Moderna are also developing vaccines for the virus, with Pfizer’s candidate already having gained the backing of a panel of US Food and Drug Administration (FDA) advisors earlier this year.Bavarian Nordic, the maker of the Jynneos vaccine, which is approved by the FDA to protect against both smallpox and mpox, is planning to dramatically scale up production capacity for their vaccine. The company’s CEO connected the move to the rapid spread of mpox last year, which highlighted the need to be able to manufacture at a much greater scale than currently available: from tens of millions to hundreds of millions of doses. Bavarian Nordic plans to simplify its production process to facilitate partnerships with other manufacturers in order to have adequate production capacity for stockpiling and in case of a future emergency.

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.French researchers are investigating after 59 percent of individuals in a new mpox outbreak cluster claim to be vaccinated, raising fears that the virus has mutated. The investigation will look at various questions, including when the individuals were vaccinated and at what dose, as well as whether they share a common characteristic like having HIV that could impact the effectiveness of the vaccine. If other possibilities are ruled out, French health authorities will start looking at the possibility of a mutation in the virus. The vaccine, Imvanex or Jynneos, is a third-generation smallpox vaccine. There is no specific vaccine for mpox, and this investigation could yield important data about the real-life efficacy of this vaccine for the virus, which is expected to remain a public health issue.This week, German diagnostics startup Midge Medical announced a partnership with the Institut Pasteur de Dakar to offer a rapid molecular diagnostic test for Marburg virus for field testing on the African continent. The collaboration started with a request from the Institut to adapt the startup’s Minoo system, a portable, battery-operated, isothermal amplification instrument with smartphone connectivity enabling data analysis and readout of results, which was previously used for COVID-19 testing. Midge Medical said they integrated the Marburg virus test into the Minoo platform within a month and delivered a prototype assay and provided training to staff at the Institut for field testing, where it has been favorably received.German scientists have reported promising results for a nasal vaccine for COVID-19 tested in hamsters. While this vaccine is not yet close to rollout, other nasal vaccines have been in use in China and India since last fall (although studies about their effectiveness has not yet been published) and at least four other nasal vaccines for COVID-19 are in late-stage clinical trials. While strong data to back up these vaccines is still needed, the hope is that these next-generation vaccines could better prevent people from getting sick and spreading infection by blocking the virus at the point of entry in the nose and throat where it first gains a foothold.