Research Roundup: Pfizer's licensing deal, an effective preventative antibody combo, and pediatric schistosomiasis treatment

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.

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. A clinical trial is launching to evaluate a new Ebola vaccine that could protect against multiple species of the virus. While effective vaccines against Ebola have been developed in recent years, they have been approved for only one of the four species of the Ebola virus—the Zaire species, which is responsible for many outbreaks and has the highest mortality rate. Researchers at the University of Oxford are now starting human trials of a new vaccine designed to protect against the Sudan species in addition to the Zaire species, which together have caused almost all of the Ebola outbreaks and deaths. The vaccine is based on the same underlying technology used for the Oxford-AstraZeneca COVID-19 vaccine.Regeneron’s antibody cocktail reduced the risk of COVID-19 infection by 81.6 percent over a period of two to eight months, according to phase 3 trial results announced last week. Previously reported results from the trial had shown REGEN-COV to reduce risk of infection during the first month after administration; the new results demonstrate potential for the drug to provide more long-lasting preventive immunity, which could be an important tool for those who do not respond to COVID-19 vaccines, including people who are immunocompromised. The antibody cocktail is currently authorized in the United States and European Union to treat non-hospitalized patients who are already infected and at high risk of severe illness and in certain cases as a post-exposure prophylaxis.GlaxoSmithKline (GSK) and Vir Biotechnology announced on Friday that their COVID-19 antibody treatment, sotrovimab, works as well when given as a shot in the arm as when administered via standard infusion. Intramuscular injection could offer additional convenience for delivery of the treatment, as it can be performed by family doctors in non-hospital settings. Sotrovimab is authorized for emergency use in the United States to mitigate progression of mild and moderate cases of COVID-19, and the European Medicines Agency has greenlit its use by member states, though EU-wide approval is still outstanding. GSK plans to speak to global regulators, including the US Food and Drug Administration, about approval for the new method of administration.