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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.This morning, Moderna announced 94 percent efficacy of its mRNA-based COVID-19 vaccine candidate in the main analysis of its late-stage trial, and the company is now seeking emergency use regulatory clearances in the United States and Europe. The updated results from Moderna’s 30,000-volunteer phase 3 study show a total of 196 symptomatic cases of COVID-19, of which 185 received a placebo injection and 11 received the vaccine. The news follows similarly strong results from Pfizer and BioNTech’s vaccine candidate, which the companies submitted for US Food and Drug Administration (FDA) emergency use authorization on November 20. The FDA committee will convene December 10 to review Pfizer’s vaccine candidate and December 17 to review Moderna’s candidate.Thirteen African countries and an international network of research institutions are launching a multi-country clinical trial of COVID-19 treatments in patients with mild to moderate illness. Led by the Drugs for Neglected Diseases initiative, the ANTICOV trial aims to identify drugs that can be used for early treatment of COVID-19. The ANTICOV consortium will carry out the trial at 19 sites across 13 countries and will begin by examining repurposed drugs that have previously been used for HIV, malaria, and other infectious diseases before expanding to additional treatments and adapting over time. The trial is part of the Access to COVID-19 Tools (ACT) Accelerator therapeutics pillar, launched in April to ensure equitable global access to COVID-19 innovations.As several COVID-19 vaccine candidates await regulatory clearance by health authorities around the world, the question of global distribution efforts is becoming more relevant. While the United States and European countries have signed direct agreements with vaccine developers to secure enough doses to cover their populations if the vaccine candidates are approved, many low- and middle-income countries (LMICs) will be reliant on the ACT Accelerator’s vaccines pillar, a mechanism aiming to accelerate development and equitable distribution of COVID-19 vaccines. The effort plans to distribute 1 billion vaccine doses to LMICs based on a “fair allocation program” by the end of 2021, which will cover about 20 percent of their populations, but it will likely face distribution and storage challenges due to funding gaps, manufacturing facility locations, and cold-storage requirements.  

The Global Health Technologies Coalition (GHTC) strongly endorses yesterday’s declaration from G20 health ministers elevating the importance of investments in new tools and technologies to fight infectious diseases—work that has provided a strong foundation for combatting the COVID-19 pandemic and can be broadly beneficial in confronting a wide range of other threats.There is now a growing understanding of what GHTC members have long understood: infectious diseases are formidable foes that easily traverse national borders with the potential to inflict substantial damage on people and economies. The G20 statement affirms that our best defense is to support international collaborations to produce new drugs, vaccines, and diagnostic tests and make them affordable and accessible everywhere. GHTC welcomes the support expressed by G20 leaders for the Access to COVID-19 Tools Accelerator (ACT-A), highlighting the importance of this landmark cooperation to accelerate the development, manufacturing, distribution of, and equitable access to new health technologies in the fight against COVID-19. It is now imperative that G20 members match their rhetoric with action and make concrete funding commitments to close the US$28 billion funding gap for ACT-A, including the $4.6 billion in urgent investment that it needs in the coming months to fulfill its mandate. G20 leaders should also continue to work collaboratively with the Independent Panel for Pandemic Preparedness and Response and the International Health Regulations Review Committee on evaluating the global health response to the COVID-19 pandemic and ensure that the recommendations and lessons outlined by these review processes lead to concrete reforms. Now is the time to take important steps to strengthen global mechanisms and infrastructure and build back better to ensure that we develop the preparedness and response capacities needed for the next pandemic.The ministers also rightly noted that even as we fight COVID-19, we must continue supporting research and development (R&D) that addresses other emerging threats. They point to the need for new tools to fight antimicrobial resistance (AMR), including drug-resistant strains of tuberculosis. The ministers called on G20 member states to pursue international collaborations to develop better antimicrobials, vaccines, and diagnostics and noted the importance of the Global AMR R&D Hub to facilitate this work. As the world grapples with COVID-19, it is critical for the G20 health ministers to take a lead role in highlighting the importance of health R&D, both to respond to the current pandemic and answer the call of many other health challenges. The forceful statement from the ministers is a timely reminder that subduing global health threats requires rallying a global community around an effective strategy, one that includes a strong emphasis on innovation and equitable access.  

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. Pfizer and BioNTech filed on Friday for emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for their COVID-19 vaccine candidate, after data indicated 95 percent efficacy of the vaccine in phase 3 trials. A first look at early phase 3 data had showed the mRNA-based vaccine was more than 90 percent effective at preventing COVID-19 infection; follow-up numbers released after the trial collected sufficient safety data then showed a 95 percent efficacy rate. The vaccine could receive authorization by the end of the year—allowing distribution to begin in 2020—depending on the speed of the review, according to the CEO of BioNTech. The vaccine developers expect to produce up to 50 million doses of the two-shot regimen in 2020 and up to 1.3 billion doses in 2021.New data from AstraZeneca and the University of Oxford’s phase 3 COVID-19 vaccine trial signaled that the candidate has an average efficacy of 70 percent, with a range of 62 to 90 percent in different dosing schemes. Late last week, AstraZeneca and Oxford released results from their phase 2 trial, which showed that the candidate was safe and produced a strong immune response in younger adults and older participants. The developers plan to file for emergency use from regulatory bodies in the United Kingdom and other countries and expect about 3 billion doses to be ready in 2021. The results from Oxford/AstraZeneca’s trial followed announcements by two US-based vaccine efforts—Pfizer/BioNTech and Moderna/National Institute of Allergy and Infectious Diseases—indicating more than 90 percent efficacy of their COVID-19 vaccine candidates in phase 3 trials.FDA has granted EUA to the first rapid COVID-19 diagnostic able to be performed entirely at home. The test, developed by Lucira Health, requires the user to self-conduct a nasal swab, which is then swirled in a vial of laboratory solution that plugs into a portable device. The rapid result—which is delivered within 30 minutes—is then displayed as a light, labeled positive or negative. Initial use of the single-use test kit will require a prescription, but the company has said it expects the test to be widely available by next spring at a cost of US$50. FDA has authorized emergency use of nearly 300 COVID-19 diagnostics to date, but this will be the first conducted entirely at home, which experts hope will allow quicker quarantining and contact-tracing to combat spread of the virus.