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. A clinical trial of a new, all-oral treatment regimen for multidrug-resistant tuberculosis (TB) has stopped enrolling patients, on an earlier-than-expected timeline, after initial data showed positive results. The phase 2/3 trial, TB-PRACTECAL, is evaluating a six-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin, which an independent data safety and monitoring board found has already shown itself, through interim data, to be superior to current standard TB care. TB-PRACTECAL will be the first multi-country, randomized controlled clinical trial to report on the safety and efficacy of such a treatment, which has the potential to save thousands of lives and improve quality of life. Médecins Sans Frontières, which is sponsoring the trial, announced the findings last Wednesday on World TB Day and said it would share the trial data with the World Health Organization and submit full results to a peer-reviewed journal in the coming months.On Wednesday, AstraZeneca announced that its COVID-19 vaccine has 76 percent efficacy at reducing the risk of symptomatic COVID-19 infection and 100 percent efficacy against severe disease, in an updated analysis of its phase 3 US-based clinical trial. The new findings came two days after an earlier analysis was flagged by the trial’s data and safety monitoring board as potentially based on incomplete information; updated results ultimately reduced the overall efficacy estimate by just three percentage points and did not impact the reported efficacy against severe disease. AstraZeneca has said it will publish the results in a peer-reviewed medical journal and submit for emergency use authorization in the United States.Pfizer is beginning a clinical trial for an oral pill to treat COVID-19, building on antiviral technology that has been used against a range of infections including HIV and hepatitis C. The early-stage US trial will evaluate the drug, known as PF-07321332, which will be administered to patients as soon as they see signs of infection. The treatment, a protease inhibitor, is intended to dampen the virus’s ability to cause severe disease and death. As an oral pill, PF-07321332 would be able to be prescribed and taken outside of a secondary care setting, rather than infusion clinics or hospitals that have been necessary for several existing COVID-19 antibody treatments.

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 has launched a phase 2/3 trial of its two-dose, mRNA-based COVID-19 vaccine in children ages 6 months to less than 12 years, the company announced last week. The KidCOVE trial, conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, will enroll about 6,750 children in the United States and Canada. The first stage of the trial will test how participants respond to different dosing levels, followed by an interim analysis to determine appropriate dose levels, and the second stage of the trial will test the selected dose against placebo shots. In a separate, ongoing trial launched in December, Moderna is testing its vaccine in 3,000 children aged 12 to 17.The COVID-19 vaccine developed by AstraZeneca and the University of Oxford reduces mild and serious forms of the disease, according to results from an interim analysis of a phase 3 trial in the United States, Chile, and Peru released Monday. The two-dose vaccine decreased symptomatic disease by 79 percent and severe disease and hospitalization by 100 percent. In its press release, AstraZeneca said the vaccine study identified no new safety concerns, and a specific review found no risk of blood clots—reports of which had led several European countries to halt rollout last week. Last Thursday, the European Medicines Agency announced the vaccine is “safe and effective,” noting its benefits outweigh the risk of potential adverse side effects, which appear to be extremely rare. AstraZeneca plans to request emergency use authorization from the US Food and Drug Administration in the coming weeks.Researchers from Cleveland Clinic's Florida Research and Innovation Center (FRIC) have identified a potential new target for COVID-19 treatments, according to findings published in Nature Microbiology. The research shows that the coronavirus enzyme PLpro blocks the body’s immune response, suggesting that therapeutics inhibiting the enzyme could help treat COVID-19 infection. In a follow-up phase of the study, the FRIC research team will investigate whether blocking PLpro’s enzymatic function, or its interaction with receptor proteins that help govern immune defenses, would strengthen human immune response against the virus. If successful, PLpro could be a new target for future COVID-19 therapeutics.

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. Novavax’s COVID-19 vaccine has an overall efficacy of 89.7 percent, with 100 percent efficacy against severe disease, according to final results of its phase 3 trial in the United Kingdom. The results, released Thursday and not yet published in a peer-reviewed journal, showed 96.4 efficacy against the original strain of the COVID-19 virus and 86.3 percent against the B.1.17 variant, first identified in the United Kingdom. The company also announced results from a phase 2b trial in South Africa, which showed 48.6 percent efficacy overall but maintained 100 percent efficacy against severe disease. Phase 3 trials in the United States and Mexico are ongoing. Novavax plans to apply for regulatory approvals around the world, including for use by the global vaccine initiative COVAX, to which Novavax pledged to provide 1.1 billion doses.An antibody cocktail developed by Eli Lilly decreased risk of hospitalization and death due to COVID-19 by 87 percent when compared to a placebo, the company said Wednesday. The antibody duo, a lower-dose combination of bamlanivimab and etesevimab, received emergency use authorization from the US Food and Drug Administration (FDA) in February based on previous trial data indicating a 70 percent reduction in hospitalizations and deaths using higher doses. The treatment showed complete protection against death in both phase 3 cohorts. Eli Lilly has a supply deal with United States for 100,000 doses of the treatment, set to be delivered by the end of the month, and the company has now partnered with Amgen to help produce up to 1 million doses of the cocktail by the end of the year. On Thursday, results from a long-term study in South Africa showed almost all patients who received a new treatment for highly drug-resistant tuberculosis remained clear of the disease two years after the trial. The six-month, all-oral regimen of bedaquiline, pretomanid, and linezolid (BPaL) treats highly drug-resistant strains of tuberculosis and shortens the treatment period from two years, with limited side effects. The new findings come from analysis of the Nix-TB trial, conducted by the TB Alliance of South Africa, which tested the BPaL regimen on 109 patients at three sites in the country. Preliminary trial results showed a 90 percent success rate after six months of treatment and six months of post-treatment follow-up, and according to the new data, only two patients had challenges by two years after the treatment.

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 Tuesday, leaders of the global vaccine platform COVAX announced the initiative’s plans to distribute 237 million doses of the AstraZeneca/University of Oxford COVID-19 vaccine to 142 countries by the end of May 2021. COVAX’s rollout began with deliveries to India, Ghana, and Cote D’Ivoire two weeks ago, followed by 11 million doses distributed between Angola, Cambodia, the Democratic Republic of the Congo (DRC), and Nigeria last week. Around 1.2 million doses of the Pfizer/BioNTech vaccine will also be delivered in the first quarter of 2021, in supplement to the new allocation plan. COVAX, led by the World Health Organization; Gavi, the Vaccine Alliance; and the Coalition for Epidemic Preparedness Innovations, with UNICEF as the implementing partner, intends to deliver 2 billion doses to 190 countries by the end of the year.Pharmaceutical company Merck will partner with Johnson & Johnson (J&J) to help produce J&J’s single-dose COVID-19 vaccine, which was authorized for emergency use in the United States on February 27. The United States has purchased 100 million doses of the vaccine, with 94 million anticipated by the end of May and the full amount by the end of June. The Merck collaboration, announced by President Joe Biden last week, is intended to boost manufacturing capacity of the vaccine but is not expected to significantly impact supply within the next three months. The deal is geared toward the second half of the year, according to an administration official, when the threat of variants could require manufacturing of booster shots and when the United States may turn attention to sending vaccine doses abroad.Up to 4.3 percent of people with HIV in the DRC were able to naturally suppress the virus without medication, according to a study published last Tuesday in EBioMedicine, a journal published by The Lancet. Typically, so-called “elite controllers” make up less than 1 percent of people with HIV. The new study, among HIV-positive individuals in the DRC tested from 2017 and 2019, found the prevalence of elite controllers to be between 2.7 and 4.3 percent, the largest group detected in a single country. While it remains unknown how elite controllers are able to suppress infection, scientists hope further research could serve as a basis for the development of a vaccine or new treatments to combat the virus. The research team included scientists from Abbott Diagnostics, Université Protestante au Congo, Johns Hopkins School of Medicine, the US National Institute of Allergy and Infectious Diseases, and University of Missouri—Kansas City