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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 Pfizer/BioNTech COVID-19 vaccine prevented symptomatic disease and was well-tolerated in a phase 3 trial of adolescents aged 12 to 15, the companies said Wednesday. The trial enrolled 2,260 adolescents, and efficacy was primarily measured through antibody levels in comparison to levels seen in older adolescents and adults. The vaccine prevented symptomatic COVID-19 infection, with no cases of COVID-19 among those who received the vaccine, and was well-tolerated, with participants experiencing symptoms similar to those aged 16 to 25. Pfizer and BioNTech plan to submit the data to the US Food and Drug Administration (FDA) to expand the vaccine’s emergency use authorization, which currently extends to those ages 16 and up. They hope to begin vaccinating adolescents aged 12 to 15 by the beginning of the next school year, according to the press release.Last week, the FDA issued emergency use authorizations to three COVID-19 rapid antigen diagnostic tests, including two tests that will be available over the counter for at-home use. The over-the-counter tests include Quidel’s QuickVue test and multiple versions of Abbott’s BinaxNOW test, which can be used at home and are designed to check an individual twice over two to three days. The FDA also reauthorized a BD hand-held antigen test for point-of-care use without a prescription. The National Institutes of Health (NIH) and Centers for Disease Control and Prevention plan to use the Quidel diagnostic in a community self-testing program, for which they will provide up to 160,000 residents of two counties in North Carolina and Tennessee access to the diagnostic for free in an effort to understand how best to use at-home tests to reduce viral transmission in communities.NIH has begun a clinical trial evaluating a version of Moderna’s COVID-19 vaccine modified to target the B.1.351 variant, first identified in South Africa. The trial will test the modified vaccine, mRNA-1273.351, in 210 adults and is expected to be fully enrolled by the end of April. The modified vaccine will be evaluated in both unvaccinated adults and adults who already received Moderna’s original mRNA-1273 vaccine as part of a clinical trial last year. The vaccinated group will be randomly assigned to receive either a single vaccination of 50 µg of mRNA-1273.351 or a single vaccination containing one 25 µg dose of mRNA-1273 and one 25 µg dose of mRNA-1273.351. A separate clinical trial will assess a booster shot of the original vaccine in the remaining vaccinated participants of the 2020 trial.

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.

At this week’s G20 Health Working Group meeting, G20 nations will be setting priorities that will have enormous implications for our ability to bring an end to the COVID-19 pandemic and address other emerging and enduring health crises. This pandemic has shown with devastating clarity how vital the research and development (R&D) of health technologies is to confront global health challenges. But it has also laid bare the inadequacies of our current international structures and systems for supporting R&D and ensuring affordable, equitable global access to resulting tools. As G20 health leaders meet this Thursday and Friday, GHTC urges them to prioritize the following actions to bolster R&D to defeat COVID-19, mitigate its impacts, and combat other long-standing and emerging threats: Ensure the Access to COVID-19 Tools Accelerator (ACT-A) and Coalition for Epidemic Preparedness Innovations (CEPI) are fully funded. ACT-A is facing a US$22.1 billion shortfall in funding for 2021 to realize its mission to develop and equitably deliver COVID-19 vaccines, treatments, tests, and other tools worldwide. Alongside its ACT-A work, CEPI is pursuing a boldly transformative initiative to speed vaccine development for epidemic-risk diseases to just 100 days and bolster manufacturing, for which it requires $3.5 billion in replenishment funding. Unlock sustainable financing for global health innovation by making R&D investments eligible for financing from the World Bank and other international financial institutions and creating new financial mechanisms for pandemic preparedness. Unlocking this capital would support low- and middle-income countries in securing new resources to strengthen their research, laboratory, surveillance, and manufacturing capabilities. Incorporate R&D into existing multilateral policy frameworks to help countries assess and strengthen their R&D capabilities. G20 members should push for the inclusion of R&D capacity indicators within the implementation of the International Health Regulations and support integration of R&D into the Global Health Security Agenda framework. Prioritize investments in R&D to fight the silent pandemic of antimicrobial resistance (AMR). To address the precariously thinning pipeline of antimicrobial innovations, G20 nations must directly invest in R&D for new tools to combat priority AMR threats including hospital-acquired infections and drug-resistant tuberculosis (TB), malaria, and HIV, as well as support collaborative international research efforts like the Global Antibiotic Research and Development Partnership, the AMR Action Fund, and the Global AMR R&D Hub. Sustain robust investments in R&D for long-standing global health challenges. The pandemic has eroded global progress against HIV/AIDS, TB, malaria, and other poverty-related and neglected diseases and disrupted research efforts. To regain lost ground, G20 nations must recommit to making strong sustained R&D investments and incentivize public-private partnerships to advance end-to-end product development for affordable, accessible tools. It is GHTC’s hope that G20 leaders will seize this moment to radically reimagine a future where health R&D and health equity are enshrined as top political priorities for the world.  To view more details on GHTC’s recommendations for G20 leaders, click here.