Anna Kovacevich

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.

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. 

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.

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) last week issued an emergency use listing for the Covaxin COVID-19 vaccine, developed by Indian pharmaceutical company Bharat Biotech, making it the eighth vaccine to receive WHO authorization. Covaxin, which is formulated from an inactivated SARS-CoV-2 antigen, was found to be 78 percent effective against COVID-19 of any severity 14 or more days after the second dose. WHO review groups determined the vaccine meets standards for protection against COVID-19, with benefits far outweighing the risks, and recommended it be used in two doses with a dose interval of four weeks for people 18 and above. The WHO approval makes Covaxin eligible for distribution through the COVAX vaccine-sharing facility, and the vaccine’s easy storage requirements make it especially suited for global distribution.Merck’s oral COVID-19 treatment, molnupiravir, received approval from its first regulatory body Thursday when the UK Medicines and Healthcare products Regulatory Agency authorized its use for individuals with mild to moderate COVID-19 and at least one risk factor for developing severe illness. The treatment—the first antiviral medication for COVID-19 that can be taken as a pill rather than injected or given intravenously—cut the risk of hospitalization or death by about half in clinical trials. Given twice a day, starting within five days of symptoms developing to be most effective, the pill targets an enzyme that the virus uses to replicate, preventing it from multiplying—an approach that should make the treatment equally effective against new variants of the virus as it evolves, according to Merck.On Friday, Pfizer released results from a late-stage clinical trial of its antiviral pill to combat COVID-19 showing it to be highly effective at preventing severe illness among at-risk individuals who receive the drug shortly after the onset of symptoms. The pill cut the risk of hospitalization or death by 89 percent when given within three days of exhibiting symptoms, according to data from the trial, which an independent board of experts recommended be stopped early because the drug’s benefit to patients had proved so convincing. Pfizer plans to submit the data as soon as possible to the US Food and Drug Administration to seek authorization for the pill to be used in the United States.