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.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.

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 remains unprepared to respond to future pandemics, warns the Global Health Security (GHS) Index report released last week assessing the efforts of 195 countries. The index, based on public information, measured each country’s ability to prevent, detect, and respond to health emergencies in 2021 along with other factors, like public confidence in government. The average country score for 2021 was 38.9 out of a possible 100, similar to that of the first GHS Index in 2019, and no country scored above 75.9. The report outlines key findings—most notably that all countries remain dangerously unprepared for meeting future epidemic and pandemic threats, despite many countries being able to quickly develop capacities to address COVID-19—and offers recommendations to use this opportunity to make new capacities more durable for further long-term gains in preparedness.The US Agency for International Development on Monday announced the creation of the Initiative for Global Vaccine Access, or Global VAX, a new initiative to accelerate COVID-19 vaccination efforts around the world. Global VAX will aim to get COVID-19 shots into arms as well as enhance international coordination to identify and rapidly overcome access barriers, particularly in sub-Saharan Africa. These efforts will include bolstering cold chain supply and logistics, service delivery, vaccine confidence and demand, human resources, data and analytics, local planning, and vaccine safety and effectiveness. The US government will supply $400 million in American Rescue Plan Act funds to support this work, adding to the $1.3 billion that has been previously committed for vaccine readiness.An experimental mRNA-based HIV vaccine showed promise in early animal studies, according to study results published Thursday. The research, conducted by the National Institute of Allergy and Infectious Diseases (NIAID), Moderna, and other institutions, showed the vaccine was safe and prompted antibody and cellular immune responses against an HIV-like virus in mice and monkeys. Rhesus macaques that received a priming shot followed by multiple boosters had a 79 percent lower per-exposure risk of infection by simian-human immunodeficiency virus compared to unvaccinated animals. The mRNA vaccine, which uses the same technology deployed in two effective COVID-19 vaccines, combines several features that could help overcome shortcomings of other experimental HIV vaccines, according to NIAID.

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. On Wednesday, global leaders agreed to start negotiations to create an international agreement to prevent and deal with future pandemics. The consensus decision, made during a special session of the World Health Assembly and reached after three days of talks, commits member states to begin work on an agreement, which would aim to bolster global action plans toward preventing, preparing, and responding to future pandemics. This could include creating a global structure to identify threats earlier, better share data or genome sequences of emerging viruses, and ensure the equitable distribution of vaccines and other tools. An intergovernmental negotiating body will draft and negotiate the final convention, which would then need to be adopted by member states.Aspen Pharmacare is finalizing an agreement to license the Johnson & Johnson (J&J) COVID-19 vaccine in Africa, the company announced last week after signing a non-binding agreement with two J&J subsidiaries. Aspen, which already packages J&J’s vaccine at its factory in South Africa, would be the first company with African rights to distribution, pricing, and branding of the vaccine. The licensing agreement would allow Aspen to launch the vaccine under the name Aspenovax and supply the shot to public-sector markets on the continent through deals with designated multilateral organizations and with governments of African Union member states. Aspen currently has capacity to manufacture up to 300 million doses of the shot, with plans to significantly increase that number to support vaccination across the African continent.Gavi, the Vaccine Alliance, will finance the rollout of the RTS,S/AS01 malaria vaccine—the world’s first approved malaria vaccine and the first vaccine approved for a human parasitic disease—in sub-Saharan Africa. The funding commitment, announced Thursday, will support procurement, technical assistance for vaccine introduction, and other associated costs to enable countries to add the vaccine to immunization programs as an additional tool to combat malaria. The vaccine, developed by GlaxoSmithKline in partnership with PATH and with support from the Bill & Melinda Gates Foundation, was recommended by the World Health Organization in October for broad use among children at risk in sub-Saharan Africa and other regions that experience significant levels of malaria transmission.

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’s COVID-19 Technology Access Pool and the Medicines Patent Pool last week finalized a licensing agreement with the Spanish National Research Council (CSIC) for its serological antibody test, marking the first non-exclusive license for a COVID-19 health tool. The CSIC test—a serological antibody test that evaluates for the presence of anti-SARS-CoV-2 antibodies developed either in response to a COVID-19 infection or to a vaccine—is relatively simple and suitable for basic laboratory infrastructure. The new license will allow the test to be offered royalty-free to low- and middle-income countries in order to promote equitable access to COVID-19 tools and facilitate rapid manufacturing and commercialization of the tool worldwide. Last Monday, Pfizer and BioNTech announced their COVID-19 vaccine was 100 percent efficacious in preventing infection among 12- to 15-year-olds from seven days to four months after administration of the second dose. The new results come from a longer-term analysis of a phase 3 trial—so far the only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 to 15 years of age. The vaccine has been authorized by the US Food and Drug Administration (FDA) for this age group since May and is fully licensed for individuals 16 years of age and older. The companies plan to submit the data to the FDA for an extension of their COVID-19 vaccine approval to cover the younger age group. The Coalition for Epidemic Preparedness Innovations (CEPI) plans to expand its centralized vaccine testing capabilities employed for COVID-19 to the development of vaccines for other epidemic and pandemic diseases. CEPI’s network, the world’s largest for assessing COVID-19 vaccines, comprises a global collection of labs, which more than 30 COVID-19 vaccine developers have used to access more than 15,000 clinical trial samples. The system will now be used to support vaccine development for other priority diseases, including chikungunya, Lassa fever, MERS, Nipah, Rift Valley fever, and Disease X. The testing network is intended to help quickly and accurately identify the most promising candidates with the best potential for late-stage clinical trial advancement and regulatory review, which also supports CEPI’s overarching goal of reducing the vaccine development timeline to just 100 days.