Research Roundup: A non-exclusive COVID-19 license, Pfizer's shot in kids, and a vaccine testing network

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. Pfizer signed a voluntary license agreement last week to share the patents and knowledge to manufacture its COVID-19 antiviral pill, Paxlovid, with the Medicines Patent Pool (MPP). The agreement will allow MPP to grant sublicenses to qualified generic medicine manufacturers to supply the treatment to 95 countries once regulatory authorization or approval is granted. Paxlovid, a five-day oral treatment regimen, was shown to reduce the risk of COVID-19-related hospitalization and death by 89 percent in phase 2/3 clinical trial results. The new licensing agreement will allow the rapid scale-up of manufacturing of the treatment, which is particularly well-suited for low- and middle-income countries and would contribute to global efforts to combat COVID-19, according to the executive director of MPP. AstraZeneca’s antibody cocktail is more than 80 percent effective at preventing symptomatic COVID-19, according to results released by the company Thursday. The study—in which more than 75 percent of participants had comorbidities that put them at risk of developing severe COVID-19—showed the long-acting antibody combination reduced the risk of symptomatic COVID-19 by 83 percent over a period of six months. There were also no cases of severe disease or death among those who received the antibody cocktail, which is administered as a one-time 300-mg dose in two separate, sequential shots. The preventative treatment is intended to help at-risk individuals, particularly those who do not develop an adequate immune response to the COVID-19 vaccine, to prevent serious illness from the virus. Merck KGaA (EMD Group) and the Pediatric Praziquantel Consortium have announced pivotal phase 3 trial results for schistosomiasis treatment arpraziquantel, indicating the drug has met the primary endpoint of clinical cure among children ages three months to six years. Arpraziquantel—an orally dispersible tablet derived from praziquantel, the formulation used for older children and adults—is tailored to the needs of the estimated 50 million preschool-aged children suffering from schistosomiasis, who currently have no treatment option. Merck KGaA intends to apply for a scientific opinion from the European Medicines Agency under a high-priority procedure for medicines intended for markets outside the European Union, which would facilitate prequalification by the World Health Organization as well as regulatory approvals in endemic countries.