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. 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.

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 US Food and Drug Administration (FDA) announced that it is slowing down Emergency Use Authorizations (EUAs) of new in vitro diagnostics for COVID-19 and Mpox. The agency will continue reviewing tests that have already been submitted for authorization and is expected to review only some additional tests from experienced developers that use innovative technological approaches, fill a gap in need, or demonstrate potential for wide public health benefits. Instead, the agency is encouraging most developers to submit their tests through different review processes. Despite the end of the national emergency declaration for the COVID-19 pandemic on May 11, the 440 EUAs already granted will remain in effect as long as a separate agency-level EUA declaration determined by FDA continues.The World Health Organization (WHO) convened an emergency meeting of the Marburg virus vaccine consortium following the confirmation of the first-ever Marburg outbreak in Equatorial Guinea. During the meeting, five vaccine developers shared updates on their vaccine candidates for the disease. WHO is taking steps toward pursuing a real-time clinical trial for some of the candidates in alignment with the already-approved WHO clinical trial protocol for Marburg vaccines (which needs to be adapted to the country context) and in consultation with country officials. Sabin Vaccine Institute and Janssen’s candidates are in phase 1 clinical trials, while IAVI, Public Health Vaccines, and Auro Vaccines’ candidates are still in the pre-clinical development stage.A new study published last week found that a drug tested in mice could potentially be used as a birth control option for men. If successful in further trials, the drug would work as an on-demand contraceptive compared to other male contraceptives in the pipeline, like daily pills and gels, that researchers say are more complicated, time-consuming, and long-lasting. The drug works by preventing a molecular action from turning sperm “on” and activating them to pursue an egg. The researchers have founded a new company to move forward development of the drug but note it will likely be years before it is ready for testing in men.

2022 has been a year of both formidable global health challenges and exciting innovations in research and development (R&D). In addition to the ongoing COVID-19 pandemic, the year saw alarming outbreaks of mpox (monkeypox) and Ebola. These crises further highlight the importance of building adequate capacity to prevent and respond to outbreaks and pandemics. Greater investment is urgently needed to ensure we have the global health technologies and R&D capacity to develop lifesaving, transformative innovations like the COVID-19 vaccines, and to address the resource and access gaps that exacerbate the worst effects of these outbreaks and diseases. With adequate investment and political will, breakthroughs are possible—and we have seen several this year.As the year comes to an end, GHTC reflects on a few of the global health innovation stories that shaped 2022.1. mRNA vaccine technology is being applied to existing and future pandemicsThe rapid development and dissemination of messenger RNA (mRNA) vaccines for COVID-19 has generated a wealth of data about the safety and efficacy of mRNA vaccine technology.   The Moderna and Pfizer/BioNTech mRNA COVID-19 vaccines have already saved millions of lives as new formulations continue to gain approval. Their success has also helped advance the clinical development of vaccines for other respiratory diseases including influenza and respiratory syncytial virus (RSV).Renewed interest and tremendous progress in the development of a universal flu vaccine can be connected to the rapid development of mRNA COVID-19 vaccines and an increased focus on pandemic preparedness. Recent results from an exciting trial investigating a universal mRNA vaccine for influenza showed that the vaccine reduced flu symptoms and deaths, although further testing in humans is needed to confirm its safety and efficacy.This year, we have seen exciting new uses of mRNA technology for a variety of infectious diseases—including those yet to surface. There has been either interest in or initiated clinical trials evaluating vaccines using mRNA technology for HIV, tuberculosis (TB), Nipah virus, malaria, and Ebola. Additionally, we have seen pandemic preparedness efforts harnessing mRNA technology take shape. This past year, Moderna announced an initiative to develop mRNA vaccines for emerging pathogens and the Coalition for Epidemic Preparedness Innovations announced an effort to build a mRNA vaccine library against Disease X (the next pathogen with epidemic or pandemic potential that has been yet to be identified).2. Africa continues to strengthen R&D capacitiesThis year has seen a series of accomplishments indicating the flourishing role of Africa in global health R&D efforts, particularly around pandemic preparedness. 2022 saw the decision to make the Africa Centres for Disease Control and Prevention a fully autonomous agency, giving it more authority to assess and respond to disease outbreaks on the continent.Additionally, in 2022, the South African Health Products Regulatory Authority was classified by the World Health Organization (WHO) as maturity level three (on the four-level scale), a step that recognizes the stability and reliability of the agency in ensuring the safety, quality, and effectiveness of vaccines. The South Africa mRNA hub, which was launched by WHO in 2021, despite challenges, has begun development of an mRNA vaccine for TB and is working on developing a local mRNA vaccine candidate for COVID-19.Universal Corporation Ltd, supported by Medicines for Malaria Venture and Unitaid, this year became the first African manufacturer to gain WHO prequalification of sulfadoxine-pyrimethamine, marketed as Wiwal, a malaria drug aimed at preventing malaria in pregnant individuals and infants.3. Urgency and awareness of antimicrobial resistance is on the riseAntimicrobial resistance (AMR) continues to grow as a global health security threat, and many new reports and studies this year have documented the alarming trend. A 2022 report from Global Research on Antimicrobial Resistance found that AMR has become a leading cause of death globally, with the most deaths directly linked to AMR in sub-Saharan Africa and South Asia. Another recent report from WHO echoed the severity and growing threat of AMR around the world.Two 2022 WHO reports aim to contribute to overall understanding of AMR and the need for investment in R&D of new tools to strengthen the global response to it. The first identifies, in the context of AMR, 61 bacterial vaccines in clinical development and 94 candidates in preclinical development, and the second, more recent report identifies priority fungal pathogens including critical pathogens like Cryptococcus neoformans, Candida auris, Aspergillus fumigatus and Candida albicans. Hopefully, the focus on and investment in new tools to address AMR continue into the next year.4. Beating back malaria with the rollout of RTS,S vaccine and additional malaria technologiesAfter last year’s approval of the RTS,S malaria vaccine, 2022 saw the beginning of the rollout of this groundbreaking technology. Malawi, Ghana, and Kenya initiated routine immunization programs that will hopefully play an important role in the global effort to eliminate malaria. This year, a University of Oxford research team also published promising results for a new malaria vaccine, R21. The developers say the vaccine can be produced for just a few dollars and that they expect it to be rolled out next year through a manufacturing deal for more than 100 million doses a year, in partnership with the Serum Institute of India.  A new “mosquito-grounding” insecticide, Chlorfenapyr, that causes mosquitos’ wings to spasm and wither could also bolster the fight against malaria, according to trial results published earlier this year. Insecticide-treated bednets have been central in efforts to reduce the spread of malaria, but rising insecticide resistance among mosquitos has hampered progress, and Chlorfenapyr is the first new insecticide to be deemed safe and effective in about 40 years.Finally, this year, Australian regulators approved a simple drug combination as an effective cure for children ages 2 to 16 with Plasmodium vivax malaria, adding a new tool in the battle against the disease and opening the door to approval in other countries. The drug—tafenoquine, developed by GlaxoSmithKline and the Medicines for Malaria Venture—is a single-dose treatment administered alongside traditional chloroquine treatment.Due in part to previous innovations in antimalaria tools, progress against malaria has largely held in recent years, despite disruption from the COVID-19 pandemic. These next generation tools will be key to accelerating progress over the coming years.5. Outbreaks of mpox trigger innovation in developing treatments and vaccinesRising cases of mpox in the first half of 2022 drove interest in an existing range of vaccines and treatments with the potential to offer protection against the outbreak. The mpox virus, which causes a usually mild infection, is closely related to the smallpox virus—and smallpox vaccines appear up to 85 percent effective in preventing mpox, according to WHO. The National Institute of Allergy and Infectious Diseases and the Democratic Republic of the Congo’s National Institute for Biomedical Research are co-leading a clinical trial evaluating the safety and efficacy of the antiviral drug, tecovirimat (TPOXX) in adults with monkeypox. SIGA Technologies, Inc.’s TPOXX is approved for the treatment of smallpox in the United States.Facing low supply of Jynneos, the only vaccine approved for use against monkeypox in the United States, the US National Institutes of Health launched a clinical trial to test an alternative vaccine administration method to stretch the limited supply. The dose-sparing method involves giving two doses, each one-fifth of a full dose and administered intradermally.While monkeypox cases have diminished, these trials will provide essential data about the safety and efficacy of tools to address the disease that has long been neglected before this year’s outbreaks in high-income countries like the United States and the United Kingdom.6. Sudan Ebola outbreak prompts clinical trial and calls attention to gaps in outbreak preparednessOne of the most distressing developments of 2022 was the outbreak of the rare Sudan strain of the ebolavirus in Uganda. The response, however, advanced innovative approaches and highlighted the need for increased preparedness in the future.Following the identification of the outbreak, WHO announced a clinical trial of three experimental vaccine candidates to address the outbreak. The vaccines tested in the trial include one produced by IAVI, one developed by the Sabin Vaccine Institute, and a third developed by the Jenner institute at the University of Oxford. While the trial is expected to begin shortly, the spread of the Sudan ebolavirus in Uganda has slowed dramatically, raising questions whether the trial could continue. It is clear that despite the incredible amount of effort from various cross-sector global partners to secure the vaccines, permissions, and funding for the trial, responses to such outbreaks need to occur even quicker, which can be accomplished by developing stockpiles of experimental vaccines and pre-agreed trial protocols.7. Pretomanid and the BPaL regimen honored at GHTC’s annual awardsGHTC presented the 2022 Innovating for Impact Partnership Award to TB Alliance for the development of pretomanid and the BPaL regimen—an innovative treatment for drug-resistant DR-TB. Pretomanid, the first TB drug developed by a nonprofit organization, is part of the three-drug “BPaL” regimen. This innovative new therapy reduces the time needed to treat DR-TB from as long as 18 months or longer to 6 months and the number of pills comprising treatment by nearly 95 percent, all while significantly improving cure rates and toxicity profiles compared to the previous standards of care.This year, WHO updated guidelines for the treatment of drug-resistant TB to include pretomanid-containing regimens. Additionally, a study published in the New England Journal of Medicine showed that BPaL maintained efficacy with reduced dosage of linezolid, one of the drugs in the regimen. This is just one of the key tools that are essential to strengthen efforts against TB, especially as the recent 2022 Global TB Report reported that the number of TB and drug-resistant TB cases have risen for the first time in many years.For other fascinating global health news delivered to your inbox weekly and to stay abreast of developments in 2023 and beyond, sign-up now to receive GHTC’s R&D News Roundup newsletter.Image credits: PATH/Rocky Prajapati, PATH/Eric Becker, PATH/Christopher Nelson, PATH/Georgina Goodwin, PATH/Rocky Prajapati, PATH/Matthew Dakin