Breakthroughs Blog: COVID-19

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. New study results show that combining antimalarial drugs with a vaccine, given just before peak transmission period of rainy season, could reduce malaria deaths in children by more than 70 percent. The trial—conducted over three years among 6,000 young children in Burkina Faso and Mali—tested the RTS,S malaria vaccine, the world’s first-developed shot for the disease, along with seasonal malaria chemoprevention (SMC), an existing preventative drug regimen. Results indicated the RTS,S vaccine was as effective as SMC when administered to children ahead of rainy season in countries with seasonal transmission—and that combining the two methods reduced cases by around 60 percent, hospitalizations by around 70 percent, and deaths by around 73 percent, when compared to SMC alone. The World Health Organization (WHO) is set to review evidence from the study in October.The International Vaccine Institute (IVI) and Bharat Biotech have launched a phase 2/3 trial for their chikungunya vaccine candidate. The two-dose vaccine, BBV87, is an inactivated whole virion vaccine, which showed “optimum immune response” in phase 1 studies in India. The phase 2/3 trial, led by IVI through the Global Chikungunya vaccine Clinical Development Program (GCCDP) in partnership with Bharat Biotech and supported by the Coalition for Epidemic Preparedness Innovations and the government of India’s epidemic preparedness initiative, Ind-CEPI, will test BBV87 for safety and immunogenicity in healthy adults. GCCDP aims to develop and manufacture an affordable chikungunya vaccine with the goal of achieving WHO prequalification to enable distribution in low- and middle-income countries. The trial has begun in Costa Rica and is set to expand to Panama, Colombia, Thailand, and Guatemala in the coming months.On Tuesday, the US Food and Drug Administration granted its first emergency use authorization for an at-home COVID-19 diagnostic that delivers results through the user’s smartphone. The Veritor rapid antigen test, developed by BD and Scanwell Health, involves swishing a nasal swab in a tube of liquid reagents, after which drops on a testing strip trigger colored lines, which are then read and interpreted by the smartphone. The diagnostic is designed for use by individuals ages 14 and up and can be used for children as young as two with samples collected by an adult. The digital test, which does not require a prescription, will initially be made available to employers, schools, and public health organizations looking to support routine screening programs.

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. Moderna is launching human trials for two new HIV vaccines based on the mRNA technology used in its COVID-19 vaccine, the company announced last week. The phase 1 trial will recruit 56 participants between the ages of 18 and 50 to assess the vaccines’ safety and ability to generate a broad range of neutralizing antibodies against HIV. The two vaccine candidates, mRNA-1644 and mRNA-1574, are designed to combat HIV by inducing broadly neutralizing antibodies to levels not previously obtained by other shots. The antibodies can then target multiple variants of HIV and neutralize stable parts of the virus that won’t change as much as it mutates. The study, expected to run until May 2023, is a first step in a long, complex process, according to researchers.Researchers have discovered a series of drug compounds that are highly effective against the three main species of parasitic worms that cause human schistosomiasis, according to new research published in PLOS Neglected Tropical Diseases. Currently, the only treatment for schistosomiasis is praziquantel, which is effective at a high dose against adult worms, but less so against juvenile worms, requiring repeat treatment. The new research involved screening more than 300,000 compounds to evaluate their ability to kill the worms, compared against praziquantel. The researchers identified a series of promising new drug candidates that appeared safe and highly effective against adult and juvenile worms—in a single dose around 10 times smaller than required for praziquantel. The drugs are now being explored by Merck Global Health Institute as a potential treatment for schistosomiasis.In phase 3 trial results, AstraZeneca’s COVID-19 antibody treatment, AZD7442, significantly reduced the risk of developing COVID-19 symptoms. The drug, a combination of two long-acting antibodies, reduced the risk of developing symptoms by 77 percent when given to patients who had not been exposed to COVID-19. No participants who were given the treatment developed a severe form of the disease. The monoclonal antibodies used in AZD7442, which mimic the body's natural immune response, were modified to be more long-lasting, potentially affording up to 12 months of protection. The drug could be particularly useful as a preventative treatment in patients for whom vaccines might be less effective, including immunocompromised individuals, AstraZeneca said in its statement. The company plans to submit the phase 3 results to a peer-reviewed journal and file for regulatory approval of the drug.

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. In a small study, nine people who received lab-made monoclonal antibodies were deliberately exposed to mosquitoes carrying the parasite that causes malaria—and did not become infected. In comparison, five of six people in the untreated control group developed the disease. The monoclonal antibody works by binding to a small portion of the circumsporozoite protein that studs the surface of the sporelike stage of the Plasmodium falciparum organism. While the trial was too small to confirm efficacy of the antibodies as a preventive method, the study will act as a proof of principle and open a new avenue for malaria prevention. The research team is now developing a new monoclonal antibody that is two to three times as potent, which it intends to test next year in a clinical trial in Mali. A single injection of pre-exposure prophylaxis—or PrEP, used as an HIV prevention method—once every two months lowered HIV risk by 66 percent more than a daily pill, according to results from a three-year, real-world study. The study tested a single 600 milligram shot of cabotegravir, a long-acting antiretroviral cocktail, against Truvada, a daily oral antiretroviral drug regimen, among more than 4,500 patients. The difference in effectiveness was primarily a result of adherence, according to the research team—the PrEP shot guaranteed two months of protective medicine, while the pill regimen relies on maintaining a strict daily schedule. The bimonthly cabotegravir injection is currently under review by the US Food and Drug Administration, with a decision expected in late 2021 or early 2022.On Friday, Bharat Biotech’s intranasal COVID-19 vaccine received regulatory approval in India to begin phase 2/3 trials after the nasal spray was well-tolerated in a phase 1 trial of volunteers aged 18 to 60. The adenoviral intranasal vaccine was safe, immunogenic, and well-tolerated in the preclinical toxicity studies and was able to elicit high levels of neutralizing antibodies in animal studies. The vaccine, known as BBV154, is the first nasal spray COVID-19 vaccine to undergo human trials in India. Bharat Biotech’s injectable COVID-19 vaccine, Covaxin, is already authorized for emergency use in India after demonstrating 77.8 percent efficacy against symptomatic COVID-19 and 93.4 percent efficacy against severe illness during its phase 3 clinical trials.

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.Solidarity, a global clinical trial led by the World Health Organization, will resume its efforts, testing three new treatments among hospitalized COVID-19 patients: artesunate, an antimalaria; infliximab, an antibody used to treat autoimmune disease; and imatinib, a cancer drug. The original Solidarity trial, which took place across dozens of countries simultaneously in 2020, found that none of the four treatments it tested showed benefit. While the original trial included antivirals, this new phase will focus on drugs that target the body’s immune response, rather than the virus itself, given the two drugs that have shown success in reducing mortality in hospitalized patients, dexamethasone and tocilizumbab, work by dampening patients’ immune reactions. Medicines have shipped to Finland as the first country to begin the trial with 40 more countries in the process of seeking ethical and regulatory approvals to join.Use of the monoclonal antibody therapy REGEN-COV reduced the risk of developing symptomatic COVID-19 infection by 81 percent in those exposed to an infected patient, according to a study published last week in the New England Journal of Medicine. The study, which included individuals over 12 who had a household member test positive within the prior 96 hours, found that by day 28, 1.5 percent of participants who received the therapy developed symptomatic infection compared to 7.8 percent who received the placebo. When including asymptomatic infections, risk reduction from the treatment was 66.4 percent. The study also found that patients who did become infected after receiving the therapy were more likely to have milder disease. These findings were used to support a decision late last month by the US Food and Drug Administration (FDA) to expand emergency use authorization for REGEN-COV to be used as a post-exposure prophylaxis among high-risk populations.Valneva shared positive results last week from the phase 3 trial of its single-dose vaccine against chikungunya, which found that 98.5 percent of participants saw protective antibody concentrations 28 days after receiving the shot. This protection rate exceeds the 70 percent threshold set by the FDA. The trial also found that the VLA1553 vaccine was generally well-tolerated and induced a high immune response among elderly trial participants. The trial will continue with outcomes evaluated until month six. VLA153 is currently the only chikungunya vaccine in phase 3 trials that targets long-term protection from a single-dose, according to its developer. The company signed an agreement earlier this year with the Instituto Butantan in Brazil for development, manufacturing, and marketing, with the goal of making the product more accessible in low- and middle-income countries.