Breakthroughs Blog: Access

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 Assembly (WHA) convened last week and concluded with several decisions affecting the global health architecture. The Assembly adopted a decision to bolster sustainable financing at the World Health Organization (WHO) by raising “assessed contributions,” or mandatory member fees, to cover 50 percent of the organization’s base budget by 2030, alongside steps to increase the agency’s efficiency. Proposals to immediately reform the International Health Regulations—which govern countries’ obligations to report and respond to pathogens that could lead to global public health emergencies—were not adopted due to member state disagreement, but the Assembly established an extended consultation process for future reforms and set a timeline for their implementation. Member states also discussed the ongoing negotiations around a pandemic instrument, which are being driven by an intergovernmental negotiating body formed last year, but any specific decisions will likely be at next year’s WHA at the earliest.Rising cases of monkeypox—confirmed in 19 countries since early May—have driven interest in the existing range of vaccines and treatments that could be used to offer protection against the outbreak. The monkeypox 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 monkeypox, according to WHO. There are two available smallpox vaccines: Bavarian Nordic’s Jynneos, also known as Imvamune or Imvanex, which has US approval for prevention of smallpox and monkeypox and European Union approval for smallpox but ability to be prescribed off-label for monkeypox, and Emergent Biosolutions’ ACAM2000, which has US approval for people at high risk for smallpox infection and no European Union authorization. While symptoms of monkeypox often resolve on their own within two to four weeks, there are also smallpox antivirals that may be considered for use.On Wednesday, Pfizer committed to provide its patented medicines and vaccines already available in the United States and Europe at a not-for-profit price to 45 lower-income countries. The deal, announced during last week’s World Economic Forum, includes 23 medicines and vaccines for infectious diseases, some cancers, and rare and inflammatory diseases, as well as future products. The initiative also includes Paxlovid, Pfizer’s oral antiviral treatment for COVID-19. Rwanda, Ghana, Malawi, Senegal, and Uganda are the first five countries to commit to join the accord, which will help inform rollout in all 27 low-income countries and 18 lower-middle-income countries that have transitioned from low to lower-middle-income classification in the past ten years. Pfizer says the initiative will be paired with improvements in diagnostics capacity and distribution infrastructure to improve access, as well as technical assistance for health worker training and expedited regulatory processes for entry of the new medicines.

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 Pfizer-BioNTech COVID-19 vaccine’s effectiveness among children ages 5 to 11 wanes over time but continues to protect against the most severe outcomes, according to new real-world evidence released last week. Analysis from the US Centers for Disease Control and Prevention, summarizing data from ten states, suggested that while vaccine effectiveness faded during omicron and generally decreases relative to the time since vaccination, the vaccine was protective against hospitalization and death in 5-to-17-year-olds, even after omicron emerged. A preprint study by the New York State Department of Health, also published last week, showed a substantial decline in protection among the younger age group in the state, including a significant decline in protection against hospitalizations. The new data comes amid developments involving vaccines for children under 5, which the US Food and Drug Administration plans to wait to review until data on third doses is available.The Biden administration plans to share government-backed COVID-19 technology with the World Health Organization (WHO) to help bolster access to medicines in low- and middle-income countries. The technologies, developed by the National Institutes of Health (NIH), would be licensed to the WHO’s COVID-19 Technology Access Pool as well as sublicensed through the United Nations-backed Medicines Patent Pool. Details on which technologies would be made available through the deal are still being determined, but the policy is not intended to apply to vaccines and therapeutics in the US market developed by private companies. Sharing NIH-devised technologies is meant to allow other countries to replicate the manufacturing process and therefore more quickly boost the global stockpile of pandemic supplies.On Wednesday, a WHO panel backed the use of Merck & Co., Inc.’s COVID-19 antiviral pill for high-risk patients. The recommendation, based on new data from six clinical trials involving 4,796 patients, conditionally endorses the pill, molnupiravir, for use among patients with non-severe disease who are at high risk of hospitalization. This could include immunocompromised individuals, the unvaccinated, older people, and those with chronic diseases. No recommendation has been made for use of the pill among patients with severe or critical illness, as there is no trial data for the group. The WHO panel is also preparing recommendations for Pfizer’s COVID-19 antiviral pill, Paxlovid.

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 Medicines Patent Pool (MPP) has signed agreements with 27 generic manufacturing companies to produce and supply the oral COVID-19 antiviral molnupiravir for 105 low- and middle-income countries. The sublicense agreements follow a voluntary licensing agreement signed by MPP and Merck, Sharp & Dohme—which developed the drug—in October to facilitate global access of the COVID-19 treatment. The nonexclusive licenses allow generic manufacturers to produce the raw ingredients and finished drug itself: five companies will focus on producing the raw ingredients, thirteen companies will produce both raw ingredients and the finished drug, and nine companies will produce only the finished drug. Molnupiravir has not yet been approved by the World Health Organization (WHO), a step often regarded as a precursor to the negotiation of manufacturing licenses by a United Nations-supported group like MPP.Antimicrobial resistance (AMR) poses a significant threat to humanity, as it has become a leading cause of death worldwide killing about 3,500 people every day, according to a new study published in The Lancet last week. More than 1.2 million people—and potentially millions more—died in 2019 as a direct result of antibiotic-resistant bacterial infections. The analysis, which covered more than 200 countries and territories, is the most comprehensive estimate to date of the global impact of AMR, which has caused common infections to become untreatable. The report highlights an urgent need to scale up action to combat AMR and outlines immediate actions policymakers can take to help save lives and protect health systems, including optimizing the use of existing antibiotics, taking greater action to monitor and control infections, and providing more funding to develop new antibiotics and treatments.The COVAX vaccine-sharing facility has delivered 1 billion COVID-19 vaccine doses, across 144 countries, as of last weekend. The program, which was initiated in 2020 with the goal of delivering 2 billion doses by the end of 2021, began delivering vaccines in February 2021 but hit several setbacks throughout the year, including vaccine hoarding by high-income countries and export restrictions which limited vaccine supply. Shipments increased exponentially in the last quarter of 2021, but vaccine inequity remains high, according to the latest WHO data showing 67 percent of the population in richer nations have been fully vaccinated, compared with only 5 percent in poorer nations. More than 40 percent of the world's population has yet to receive a first dose. Gavi, the Vaccine Alliance, has launched a renewed call for COVAX funding to help reach WHO's goal of vaccinating 70 percent of the populations in poorer countries by July.

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.Novavax has completed submission of the final data package for its COVID-19 vaccine to fulfill the prerequisites for an emergency use authorization (EUA) request from the US Food and Drug Administration. The company plans to complete an official EUA application by the end of the month. The vaccine, NVX-CoV2373, received emergency use listing from the World Health Organization last month for its formulations manufactured in Europe and India, allowing Novavax and partner Serum Institute of India to ship doses to the COVAX initiative, which aims to supply vaccines to low- and middle-income countries. NVX-CoV2373 was also granted conditional marketing authorization in December by the European Medicines Agency to be produced in Europe. Novavax expects its global supply chain to exceed 2 billion doses in 2022.A new COVID-19 vaccine developed by researchers from the Texas Children’s Hospital and Baylor College of Medicine is being offered patent-free to vaccine manufacturers around the world. The CORBEVAX vaccine—originally developed to combat SARS, which is caused by a strain of coronavirus—employs a long-established protein subunit technology that uses proteins from a virus or bacterium to induce an immune response but not cause disease. Clinical trials conducted in India found the vaccine to be 90 percent effective in preventing disease caused by the original COVID-19 virus strain and 80 percent effective against the delta variant, leading India’s regulatory agency to grant emergency use authorization in December. Indian vaccine manufacturer Biological E Limited has sold 300 million doses to the Indian government and plans to produce 100 million doses per month.Dolutegravir-based antiretroviral therapy (ART) is more effective than standard treatments for HIV-positive children, reducing treatment failure by 40 percent, according to a new study published in The New England Journal of Medicine. The clinical trial, conducted at 29 clinical centers across Africa, Europe, and Asia, evaluated the safety and efficacy of dolutegravir-based ART as a first- or second-line treatment in children living with HIV in comparison to non-dolutegravir-based, standard-care ART. Results showed the dolutegravir-based ART reduced treatment failure by 40 percent in HIV-positive children 3 to 18 years old, indicating dolutegravir-based ART is superior to current standard-care treatment in children and adolescents living with HIV, according to researchers.