Breakthroughs Blog: Medicines

Neglected tropical diseases (NTDs) are a group of infectious diseases that exert a crushing burden in vulnerable communities around the world. These diseases blind, disable, and disfigure people, robbing them of health and opportunity and trapping them in poverty. While breakthroughs in recent years have brought new resources to the fight against NTDs, significant gaps remain in the arsenal of tools needed to control and eliminate these diseases. In recognition of World NTD Day on January 30, GHTC is testing our readers’ knowledge with nine questions about NTD innovation. See if you can beat our quiz below and join the fight to #BeatNTDs and #EndTheNeglect. Loading...(function(i,s,o,g,r,a,m){var ql=document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if(ql){if(ql.length){for(var k=0;k

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 National Institute of Allergy and Infectious Diseases’ (NIAID) ACTIV-2 clinical trial has begun testing two monoclonal antibody therapies for treatment of mild to moderate cases of COVID-19. ACTIV-2, part of NIAID’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, was established in August to test investigational COVID-19 therapeutics, including Eli Lilly’s monoclonal antibody treatment LY-CoV555, which was subsequently granted emergency use authorization by the US Food and Drug Administration for a subset of mild to moderate COVID-19 patients. The recently begun trials will test BRII-196 and BRII-198, both monoclonal antibody therapies developed by Brii Biosciences that use synthetic versions of naturally produced antibodies to bind to viruses and prevent them from infecting cells. The study will begin with 220 participants, half of which will receive the treatment through intravenous infusions while the other half receive placebos.Convalescent plasma from patients previously infected with COVID-19 may delay or stop progression of illness in mildly ill older adults, according to a new study published in the New England Journal of Medicine. The data comes from a small randomized, controlled, and double-blind trial conducted by Fundacion INFANT in Buenos Aires, Argentina, which tested the effects of infusing convalescent plasma in older adults. Among 80 patients given convalescent plasma, 16 percent developed severe COVID-19, compared with 31 percent of the population given a placebo. In a modified analysis, results showed a larger effect after excluding a subset of patients who developed severe illness before plasma or placebo infusion. Authors of the study hope the treatment—which they say is relatively easy to access and administer at low costs—can be used to reduce demands on health care systems.Pfizer and BioNTech’s COVID-19 vaccine appears effective against a key mutation found in new variants of the virus discovered in the United Kingdom and South Africa, according to a not yet peer-reviewed laboratory study conducted by Pfizer and the University of Texas Medical Branch. The study tested the vaccine against the N501Y spike protein mutation found in both new variants of COVID-19, which could be responsible for greater virus transmissibility. Blood samples from individuals who have received the vaccine indicated it is effective against the mutation—along with 15 other mutations the company has previously tested the vaccine against—but the findings remain limited, as the study has yet to address the full set of mutations found in either of the new variants. Researchers plan to continue running tests against other mutations found in both variants and hope to have more data in upcoming weeks.

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.Last Wednesday, the United Kingdom authorized AstraZeneca and the University of Oxford’s COVID-19 vaccine, giving the candidate its first regulatory greenlight and providing the country with its second vaccination option. The two-dose AstraZeneca/Oxford vaccine—of which a two-dose, full-strength regimen showed 62 percent efficacy in clinical trials—is low cost and easy to handle, as it can be stored in refrigerators rather than ultra-cold or freezer temperatures that other vaccines require. The United Kingdom has also updated its distribution strategy and will allocate the first vaccine dose of both vaccines to as many people as possible before circling back within 12 weeks, rather than 3, to provide the second dose, instead of holding large amounts in reserve for the second shot. By providing more people with quicker access to the first dose, the hope is to enable the greatest number of eligible people to receive some level of protection in the shortest time possible. Rollout of the AstraZeneca/Oxford vaccine in the United Kingdom begins today.The World Health Organization (WHO) on Thursday issued an emergency use validation for Pfizer and BioNTech’s COVID-19 vaccine, the first COVID-19 vaccine authorization the agency has made. The emergency validation allows some countries to expedite their own regulatory approval processes for the candidate, as well as allows UNICEF and the Pan-American Health Organization to acquire and deliver the vaccine to countries in need. In its statement, WHO also emphasized the need for equitable global access to COVID-19 vaccines and urged a global effort to ensure enough vaccine supply for priority populations around the world. The two-dose Pfizer/BioNTech vaccine, which was shown to have 95 percent efficacy in clinical trials, requires a strict cold chain that could pose a challenge to distribution in many countries.The US Food and Drug Administration (FDA) has approved Ridgeback Biotherapeutics’ Ebanga drug to treat Ebola. The endorsement makes Ebanga the second FDA-approved Ebola therapeutic, following approval of Regeneron’s Inmazeb in October. The two treatments, both antibody therapies, were tested in a trial conducted during the 2018-19 Ebola outbreak in Democratic Republic of the Congo against standard-of-care therapies Zmapp and remdesivir for the control arm. Trial data indicated patients who received Ebanga were more likely to survive than those in the control group. Among those receiving the treatment, 35.1 percent died compared to 49.4 percent in the control group. The 11th and most recent Ebola outbreak in the Democratic Republic of the Congo was identified in June and declared over in mid-November.

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. Last week, Pfizer and BioNTech released preliminary data from their ongoing phase 3 COVID-19 vaccine trial, indicating up to 90 percent efficacy of their mRNA-based vaccine candidate. The companies hope to have enough data to file for emergency use authorization (EUA) within the next few weeks. If the vaccine candidate does receive approval, Pfizer and BioNTech will launch their extensive distribution plan—which requires the vaccine to be kept at -94°F, a strict cold chain that has led to feasibility concerns from many countries—to fulfil hundreds of millions of doses ordered through advanced purchase commitments. These commitments include a 300-million dose deal with the European Union, a 120-million dose deal with Japan, a 100-million dose deal with the United States, and a 30-million dose deal with the United Kingdom. Pfizer and BioNTech plan to roll out a total of 100 million doses of the vaccine by the end of 2020, followed by an additional 1.3 billion doses in 2021.The US Food and Drug Administration (FDA) last week granted EUA to Eli Lilly’s COVID-19 antibody treatment for use among people age 12 or older with mild or moderate COVID-19 infection. The drug, bamlanivimab, continues to be tested in a clinical trial to establish additional safety and efficacy data, after early results suggested it may help clear COVID-19 infection sooner and cut hospitalization rates in patients with mild or moderate cases. A study of the treatment in hospitalized patients was stopped in late October due to lack of efficacy, upon recommendation from independent monitors of the trial. The US government has signed an agreement with Eli Lilly to purchase 300,000 700-mg vials of the drug, though it is unclear how many doses that will provide, as early results indicated at least 2,800 mg is necessary to provide any effect. Eli Lilly’s therapeutic is the first antibody drug to receive EUA to treat COVID-19.The Senegal-based Pasteur Institute is developing an affordable, handheld COVID-19 diagnostic kit able to provide results in minutes. The rapid test kit contains a simple test strip housed in a plastic unit and requires a small blood sample, collected by finger prick. No electricity or laboratory analysis is required, and the center hopes the kits will cost as little as US$1. Developers plan to start manufacturing and distribution after regulatory checks are complete, making the kits first available to countries in Africa through governments and health organizations like the Africa Centers for Disease Control and Prevention, with a goal of issuing 10 to 15 million kits by February 2021.