Hannah Sachs-Wetstone

2021 was a year of significant progress in the global effort to eradicate polio, despite challenges due to the COVID-19 pandemic. Unfortunately, as we sit toward the close of 2022, the outlook is less optimistic. Recently, polio has been popping up in the news with increasing frequency as outbreaks have occurred around the world. In observance of World Polio Day on October 24, GHTC is reflecting on the biggest news about this year’s polio outbreaks and on the connection between this year’s outbreaks and polio vaccines, as well as the potential of new vaccines to contribute to eradication. The development of a vaccine against polio was one of the most important and impactful medical technological breakthroughs of the last century and since then, more than 2.5 billion children have been vaccinated through the Global Polio Eradication Initiative, a public-private partnership led by national governments, the World Health Organization (WHO), Rotary International, the US Centers for Disease Control and Prevention, UNICEF, the Bill & Melinda Gates Foundation, and Gavi, the vaccine alliance. Two types of vaccines are used for polio. The oral polio vaccine (OPV) is used in mass vaccination campaigns in low- and middle-income countries, while the inactivated polio vaccine, which is more expensive and complex to administer, is used in most high-income countries. One of the largest remaining challenges in global polio eradication efforts is that in rare cases, the use of OPV in areas of low vaccine coverage can lead to vaccine-derived polio, which partly accounts for the recent rise in cases. For a short time after OPV immunization, children have the weakened vaccine-virus in their bodies and excrete it. In areas of low immunization, if the excreted vaccine-virus circulates for an extended period of at least a year, it could change genetically to the circulating vaccine-derived poliovirus.Vaccine-derived polio has emerged due to outbreaks of the type 2 virus, which was removed from the oral vaccine by WHO in 2016 after it was declared to be eradicated. In 2020, in response to vaccine-derived outbreaks, WHO granted an emergency use authorization for a novel oral vaccine that is aimed at type 2 poliovirus (nOPV2) and is less likely to lead to vaccine-derived cases. The first-ever vaccine authorized under WHO’s Emergency Use Listing process, nOPV2 was rolled out in March 2021 and doses of the vaccine have already been delivered in over 20 countries. However, supply constraints and challenges in vaccine uptake need to be addressed for nOPV2 to be rolled out more widely. Full immunization throughout populations would prevent the spread of vaccine-derived polio, highlighting the importance of employing polio vaccines in order to prevent the outbreaks we have seen this year.Read more about this year’s spate of outbreaks:"In new setback for eradication campaign, poliovirus from Pakistan shows up in Africa" (Science, 2/17/2022)"Polio is found in the U.K. for the first time in nearly 40 years. Here's what it means" (NPR, 6/22/2022)"Wastewater monitoring identifies polioviruses in New York City" (STAT, 8/12/2022)"The Guardian view on polio: we have the tools to tackle this old enemy" (The Guardian, 8/16/2022)Read more coverage about vaccine-derived polio:"What to know about polio, a disease once again vying for attention" (STAT, 7/26/2022)“New polio cases highlight the urgency of eradication” (Think Global Health, 8/16/2022)"Polio was almost eradicated. This year it staged a comeback." (The New York Times, 8/18/2022)"Polio spread in Israel, US, UK highlights extremely rare risk of oral vaccine" (The Times of Israel, 8/21/2022)“Polio Is Exploiting a Very Human Weakness” (The Atlantic, 9/16/2022) Read more about nOPV2:"New polio vaccine against strain that threatens eradication is safe and generates immune response" (MedicalXpress, 12/10/2020)"WHO nod to first emergency use vaccine can tackle rising vaccine-derived poliovirus cases" (Down to Earth, 12/16/2020)“Independent experts advise move to next use phase for novel oral polio vaccine type 2” (GPEI press release, 10/10/2021)"The polio threat continues to grow—but a new vaccine could make a difference" (Time, 8/31/2022)“Supply issues a major challenge to polio vaccination programs” (MedPage Today, 10/4/2022)“Opinion: The US needs to prepare to introduce the novel oral polio vaccine” (The BMJ, 10/4/2022)Read more about polio funding:"Opinion: Polio eradication is in sight. Don’t stop funding it now" (STAT, 10/16/2022)“Gates Foundation pledges $1.2B to eradicate polio. Here’s why it’s been a struggle for decades” (Associated Press via PBS News Hour, 10/16/2022)“Bill & Melinda Gates Foundation pledge $1.2 billion to eradicate polio” (Reuters, 10/17/2022)“Global leaders commit $US2.6 billion at World Health Summit to end polio” (UNICEF press release, 10/18/2022)More information about World Polio Day can be found here. 

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. 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 mitigating symptoms and preventing serious outcomes in 450 adults (including pregnant individuals) and children with monkeypox. SIGA Technologies, Inc.’s TPOXX is approved for the treatment of smallpox in the United States. The drug impedes the spread of virus in the body by preventing virus particles from exiting human cells. Trial participants will be randomly assigned to receive the oral pill or placebos twice daily for two weeks. The World Health Organization (WHO) has announced that a clinical trial of vaccines aimed at preventing the rare Sudan strain of Ebola could start within weeks, pending regulatory approvals from the Ugandan government. There is no vaccine for the Sudan strain, which is behind the rapidly growing outbreak in Uganda. The trial will test two vaccines in development that have shown potential to treat this strain. Details about the specific vaccine candidates were not released. While the Sudan strain is less transmissible and has had a lower fatality rate in past outbreaks, compared to the Zaire strain, the Ugandan outbreak is incredibly concerning, and vaccines are urgently needed. By raising public awareness of emerging diseases and the need for laboratory capacity to address them, COVID-19 has inspired several Asian countries, including India, to invest in advanced biosafety laboratories. These labs are needed for working on dangerous pathogens and live viruses like SARS-CoV2. Some researchers have expressed concerns about the high cost of maintaining these facilities due to extensive safety measures including extra security, self-closing doors, and filtered air, among others. Concerns have also arisen about the potential risk of these labs handling extremely dangerous pathogens, however new labs could also improve overall safety practices that would reduce this risk. These new labs could play an important role in supporting more vaccine research, including for endemic infectious diseases in the region, as well as improving working conditions for researchers. 

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. Excision BioTherapeutics is investigating whether a single Crispr infusion can effectively keep HIV at undetectable levels in the body. If effective, this innovation could eliminate the need for daily antiretroviral therapy. The Crispr therapy attempts to disrupt the replication process by targeting regions in the HIV genome that are critical in that process. While antiretroviral drugs can stop the virus from replicating, the Crispr therapy is designed to go further by ensuring that the virus cannot reactivate in the future. The trial aims to enroll nine participants and compare the efficacy of three different dosages. The Medicines Patent Pool has signed a voluntary licensing agreement with Japanese pharmaceutical company Shionogi, to allow low- and middle-income countries (LMICs) rapid access to its COVID-19 antiviral treatment pill, contingent on its regulatory approval. Under the agreement, the Medicines Patent Pool will grant sub-licenses to qualified generic manufacturers to produce the antiviral (ensitrelvir fumaric acid) in 117 LMICs. The candidate, which showed promising results in phase 2/3 trials, could make a significant difference in low-and middle-income countries with low vaccination rates.The Biomedical Advanced Research and Development Authority has granted a multi-year contract to Vir Biotechnology with US$55 million in funding to support its influenza-focused antibody drug that is expected to continue trials soon. The contract also allows for a potential billion-dollar investment for the development of candidates against emerging infectious diseases, including influenza. The funding is aimed at improving pandemic preparedness efforts through investments in technologies that target pathogens 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. The World Health Organization (WHO) has announced a clinical trial of one or possibly two experimental vaccines designed to protect against the rare Sudan strain of the Ebola virus that has been identified in the recent, rapid outbreak in Uganda. The trial could begin within weeks depending on the Ugandan government’s permission, which is expected soon, as well as regulatory and ethics review approvals. The trial was announced by the WHO’s Health Emergencies Program, which has been conferring to identify vaccines that are far enough along in their development to undergo clinical testing. There are six vaccine candidates in development that are designed to target the Sudan strain, only half of which have advanced to the stage of human clinical trials. Of those, a candidate developed by the Sabin Vaccine Institute and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases is the furthest along in its development. Dengue resurged across Asia following a period of lower transmission due to reduced mobility because of COVID-19 restrictions, but an exciting vaccine has the potential to make huge strides in reducing the burden of the disease not only in the region but around the world. In August, Indonesia became the first country in the world to approve Takeda’s Qdenga, or TAK-003, vaccine for use against dengue in 6- to 45-year-olds. Qdenga showed incredibly promising results in clinical trials and is under review by the European Medicines Agency and other regulatory agencies in dengue-endemic countries, although it is yet to receive WHO prequalification. The vaccine addresses the complexity of dengue’s four strains by using a weakened version of the DENV 2 strain as its base and including genes from the other three strains.In 2020, a clinical trial in South Africa testing PrEP as a shot delivered every few months found incredible success with results showing high efficacy compared to the daily pill. The drug used in the trial (long-acting cabotegravir or Cab-LA) made by ViiV Healthcare has only been awarded regulatory approval in the United States to date. Access to the shot in low- and middle-income countries has been hampered by the company’s decision to not grant licenses for generic makers to produce the drug at a lower cost. The company has made an agreement with the Medicines Patent Pool that permits three or fewer companies to make generic versions of the drug in 90 low- and middle-income countries, but it could take at least three years for regulatory approval. Viiv Healthcare has submitted its drug for WHO prequalification, which could speed up this approval process. 

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 a new report, the US Department of Health and Human Services’ (HHS’) Office of the Inspector General (OIG) analyzed the US Food and Drug Administration’s (FDA’s) policies during the COVID-19 pandemic response and made recommendations for improving responses to future health emergencies. The report recognized several strong practices including the creation of templates for emergency use authorization (EUA) submissions and communication forums for the agency and developers. However, continual policy shifts and the decision to ease EUA requirements, possibly leading to the authorization of substandard assays, to increase the availability of COVID-19 tests were among the challenges identified. The report’s six recommendations include a revised device-tracking platform to facilitate the EUA submission process, formal communication channels with the lab community, and a national testing strategy.The messenger RNA (mRNA) hub, established last year in South Africa with support from the World Health Organization (WHO), began development of an mRNA vaccine for tuberculosis. The hub’s objective is to develop inoculations to address high-burden diseases in low- and middle-income countries. It is also working on developing a local mRNA vaccine candidate for COVID-19 (which will enter human trials in the coming months) after low- and middle-income countries faced major challenges accessing COVID-19 vaccines during the pandemic. The first approved mRNA vaccines were developed for the COVID-19 pandemic, but the technology has potential to accelerate vaccine development for other diseases as well, including tuberculosis.Last week, the government of Uganda declared an outbreak of a relatively rare strain of Ebola. The Sudan strain has not been reported globally in a decade and there is no approved vaccine to use against it. The rVSV-ZEBOV vaccine, or Ervebo, is currently used across Africa to limit the spread of Ebola outbreaks but it is only approved for the Zaire strain, which is responsible for the majority of outbreaks. However, WHO has pointed to a different Johnson & Johnson vaccine that has potential in targeting the Sudan strain, which could be confirmed through testing.

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.President Biden signed an executive order establishing a new national biomanufacturing initiative and pledging more than US$2 billion to fund building or expanding drug manufacturing facilities and ensuring an adequate supply of raw materials. The Biden administration’s goal is to strengthen the biotech supply chain and maintain US competitiveness with foreign manufacturers in the wake of major supply chain challenges and shortages during the COVID-19 pandemic. $40 million of the pledge will go toward expanding the production of antibiotics and the base materials needed to produce products for future pandemic responses.A new study looking at antimicrobial resistance (AMR) records from laboratories in 14 African countries found that the basic requirements for testing for drug-resistant pathogens are unmet in most areas despite plans to tackle antimicrobial resistance on the continent. The researchers found that only 1.3 percent of the 50,000 medical laboratories included in the study were conducting bacteriology testing. Of those laboratories that were, even fewer were equipped to test for AMR and among those who were testing for AMR, only a third of the high-priority antibiotic-resistant pathogens designated by the World Health Organizations were being tested consistently. The study highlights larger challenges in Africa including limited access to antibiotics, imperfect use of antibiotics, and a lack of information about the impact of AMR because of incomplete and fragmented data.The smallpox treatment tecovirimat, or TPOXX, is undergoing a phase 3 clinical trial to test efficacy in treating monkeypox after preliminary data from the Centers for Disease Control and Prevention showed some alleviation of symptoms in patients. The trial is being run by the AIDS Clinical Trial Group in locations nationwide and will enroll more than 500 people who test positive for monkeypox. The intent is to provide stronger data that federal officials and agencies can use to inform decisions about the use of TPOXX in the national response to monkeypox.