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 US Food and Drug Administration (FDA) on Thursday approved Cabenuva as the first long-acting injectable HIV treatment for patients in stable condition. Cabenuva—a combination of cabotegravir and rilpivirine, injected separately—was shown in clinical trials to suppress HIV to undetectable levels for two years when administered once a month. The monthly injectable medication regimen, developed by ViiV Healthcare, will pose an alternative to existing HIV treatment methods that require daily pills. However, the Cabenuva approval covers only stable HIV patients—those who took daily pills and had undetectable HIV levels before entering the trial—while an ongoing trial is evaluating its efficacy in people unable to take regular oral medications. The list price of the newly approved treatment is roughly $6,000 for the initial dose, followed by around $4,000 per month.Newly inaugurated President Joe Biden last week reversed the former administration’s request to withdraw the United States from the World Health Organization (WHO) and indicated the country will support the WHO-led Access to COVID-19 Tools (ACT) Accelerator, including its global vaccine initiative known as COVAX. The ACT Accelerator aims to ensure all countries have access to COVID-19 treatments, diagnostics, and vaccines, with COVAX intending to secure and distribute 2 billion vaccine doses by the end of 2021—a goal for which fundraising targets remain unmet. The United States has historically been the largest donor to WHO, providing financial support for a wide range of program areas, including pandemic preparedness. In remarks during the WHO Executive Board meeting Thursday, Dr. Anthony Fauci announced the United States’ commitment to WHO and the global COVID-19 response, and WHO Director-General Tedros Adhanom Ghebreyesus welcomed the renewed partnership.On Thursday, Eli Lilly announced its monoclonal antibody prevented COVID-19 infections in a clinical trial among nursing home residents and facility staff. The trial results, released in a press release from the company and currently not published or peer reviewed, showed symptomatic COVID-19 infections were reduced by 57 percent among all participants and by 80 percent among just nursing home residents. Eli Lilly’s chief scientific officer emphasized that the antibody should not be seen as competition to vaccines, but that it could be useful during COVID-19 outbreaks in places vaccines have not reached. The antibody, bamlanivimab, was authorized by the FDA in November to treat COVID-19 patients at risk of severe disease, and Eli Lilly plans to discuss with the FDA whether a new emergency authorization is needed for use in COVID-19 prevention.

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. Interim data from the phase 1/2a clinical trial of Johnson & Johnson’s (J&J) COVID-19 vaccine candidate indicates the single-dose shot induced an immune response and was generally well-tolerated among trial participants aged 18 to 55. Neutralizing antibodies against COVID-19 were observed in more than 90 percent of volunteers 29 days post-vaccination and in 100 percent of volunteers 57 days post-vaccination. The vaccine—the furthest along candidate that only requires one dose—was developed by Janssen Pharmaceutical Companies of J&J using its AdVac vaccine platform, which was also used to develop Janssen’s Ebola vaccine as well as investigational Zika, RSV, and HIV vaccine candidates. The company expects to release data on participants over the age of 65 as well as results from its phase 3 trial later this month, after which it would submit applications for authorization from the US Food and Drug Administration and regulatory bodies globally.The African Union (AU) has secured provisional commitments to procure around 270 million COVID-19 vaccine doses, 50 million of which would be available before April 2021. The doses—to be supplied by Pfizer, AstraZeneca, and J&J—will be distributed among the AU’s 55 member states in pursuit of achieving herd immunity across the content. The new agreements are independent from doses secured through the COVAX Facility, a global mechanism to speed up development, manufacturing, and equitable distribution of COVID-19 vaccines, which has pledged to procure and supply vaccines for about 20 percent of each participating country’s population. The continent’s vaccine strategic plan entails vaccinating at least 60 percent of its 1.2 billion individuals, according to the director of the Africa Centers for Disease Control and Prevention.As the first COVID-19 vaccines—from Pfizer, Moderna, and AstraZeneca—are manufactured and distributed around the world, experts say there will still be plenty of need for follow-up products in the fight against the pandemic. While current vaccine launches provide hope for an end to the “acute phase of the pandemic,” longer-term management of the disease will require a larger arsenal of technologies. The next generation of vaccines could also offer advantages to the fight that the first round could not, including potential for single doses, easier mass manufacturing ability, or less rigid temperate requirements. There are currently at least 20 COVID-19 vaccine candidates in the final phase of clinical trials and dozens more in preclinical and early clinical stages.

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. On Friday, the US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Moderna’s mRNA-based COVID-19 vaccine candidate, making it the second shot to receive a greenlight in the United States after Pfizer and BioNTech’s candidate obtained EUA one week prior. The authorization follows a recommendation from an independent advisory panel to FDA, which met last Thursday to review evidence and subsequently voted to endorse the vaccine for use in people 18 years of age and older. Data released in late November indicated that the Moderna vaccine showed 94 percent efficacy in its phase 3 clinical trial, leading the company to seek regulatory clearances in the United States and Europe. The Moderna vaccine does not require the same ultra-cold temperature storage as the Pfizer/BioNTech vaccine, allowing it to be delivered more widely in upcoming distribution efforts.The US National Institutes of Health (NIH) is sponsoring two phase 3 clinical trials investigating monoclonal antibodies as treatment for hospitalized COVID-19 patients with moderate illness. The trials are sub-studies of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-3 program, an adaptive trial designed to investigate new therapeutics as they become available. One of the treatments, developed by GlaxoSmithKline and Vir Biotechnology, is a fully human anti-SARS-CoV-2 investigational monoclonal antibody with potential to neutralize the virus and kill infected cells. The second treatment, developed by Brii Biosciences, is a combination of two neutralizing monoclonal antibodies. Both trials hope to show treatment efficacy in hospitalized patients, a subset of patients for which monoclonal antibody treatments have so far not shown an impact.The FDA granted EUA last week to the first-of-its-kind rapid COVID-19 test that can be conducted fully at home without need for a prescription. The diagnostic, which was developed by Ellume, detects SARS-CoV-2 virus fragments from a nasal swab sample using an analyzer that connects with a smartphone app, providing results in as little as 20 minutes. While less accurate than typical molecular diagnostics, the test has shown a sensitivity of 96 percent and specificity of 100 percent and, in asymptomatic individuals, a sensitivity of 91 percent and specificity of 96 percent. Ellume intends to produce around 3 million tests by next month and 20 million by the second half of 2021 to be accessible in drug stores for over-the-counter use.