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.The United Kingdom’s Medicines Healthcare products Regulatory Authority on Wednesday authorized Pfizer and BioNTech’s COVID-19 vaccine for emergency use across the country. The United Kingdom has a supply deal for 40 million doses of the vaccine, enough for 20 million people, which it will begin to distribute in the upcoming days to priority groups including care home residents, health and care staff, the elderly, and populations that are clinically extremely vulnerable. The mRNA-based vaccine, which was shown to have 95 percent efficacy in phase 3 trials, requires a strict cold chain and will be delivered through a network of 50 hospitals, as well as specialist vaccination centers, and any general practitioners and pharmacists that have cold storage capacity. The US Food and Drug Administration (FDA) and the European Medicines Agency are expected to finalize their reviews of the vaccine candidate within the next few weeks.A major federal advisory committee in the United States voted Tuesday that health care personnel and people who live in long-term care facilities should receive priority in COVID-19 vaccine distribution. However, the Advisory Committee on Immunization Practices (ACIP) also acknowledged that pregnant health care workers, who make up about 330,000 members of the workforce, are at heightened risk of COVID-19 mortality and that none of the initial vaccine products have been specifically tested in pregnant people, leaving their inclusion in early vaccine rollout an open question. The unclear implications of the guidance likely means that if the ACIP recommendation is accepted by the Centers for Disease Control and Prevention, the decision will fall to individual states and health care systems to determine whether to offer pregnant health care workers the vaccine alongside their non-pregnant colleagues. FDA emergency use authorization applications for Pfizer’s and Moderna’s COVID-19 vaccine candidates are currently pending, which could lead to approval and rollout later this month.Biotech company Roche received FDA emergency use authorization for its COVID-19 antibody blood test capable of measuring the levels of specific antibodies that target the virus’ cell-unlocking spike protein. The quantitative antibody test provides a result in about 18 minutes and was shown to be very accurate in the 15 days after screening and diagnosis of an active infection with a molecular test. Studies also showed that patients’ antibody concentrations did not fall below a detectable range for at least 100 days following infection. The company has said tests of this kind will play a critical role in measuring vaccine-induced immune responses, and hopes it will help track the success of vaccines as well as identify people who have recovered from an infection and could serve as convalescent plasma donors or assist in the development of new therapies.

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.  

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.

On November 19, the Global Health Technologies Coalition (GHTC) convened its first virtual Hill event of the COVID-19 pandemic, connecting a group of congressional staff with representatives from four organizations advancing COVID-19 innovations to meet global needs. Twelve staffers representing members serving on key committees participated in the virtual dialogue. GHTC hosted the conversation to continue educating allies on the Hill about the need for COVID-19 innovations designed for use in low-resource settings, and how the US Agency for International Development (USAID) could support that effort—if Congress appropriates sufficient emergency funding in the next COVID-19 relief bill. The organizations who participated have strong records of advancing innovations for health emergencies with USAID support and are poised to play an important role in the global response to COVID-19. The event began with a presentation by Dr. Rebecca Richards-Kortum, director of the Rice 360° Institute for Global Health, on the institute’s COVID-19 diagnostic tool. The simple-to-use, rapid point-of-care diagnostic offers results in 30 minutes or less, using a platform that is expected to cost less than US$5,000 per instrument and less than $2 per test. With USAID support, Rice is validating the test and plans to pursue emergency use authorization from the US Food and Drug Administration (FDA). The team hopes to scale the test quickly to countries in sub-Saharan Africa where they have research partners and infrastructure in order to make an impact in communities where trained laboratory personnel, basic hardware, and reagents are not readily available to support widespread testing using currently available COVID-19 diagnostics. Shift Labs' DripAssist device. Photo: Shift Labs Next, Dr. Beth Kolko, co-founder and CEO of Shift Labs gave an overview of its DripAssist IV device. This ingenious device, designed to be durable, portable, easy to assemble, and operable with minimal training, can help a clinician anywhere in the world give IV medication safely and effectively without the use of costly infusion pumps. DripAssist, which was developed with support from USAID through the Fighting Ebola and Saving Lives at Birth Grand Challenges, was widely used during the recent Ebola outbreak in the Democratic Republic of the Congo—and even more recently was deployed in health care facilities in the United States facing a shortage of infusion pumps to address a surge in COVID-19 patients. “Designing for global needs gives engineers like our team a set of constraints that requires them to be more inventive,” Dr. Kolko noted, “And on the back end, you end up with a device that is more widely deployable,” including right here at home. Dr. Devin Sok, senior director of antibody discovery and development at GHTC member IAVI, followed with a presentation on IAVI’s COVID-19 antibody research efforts and how emerging antibody therapies could be a key tool to defeat COVID-19 globally. IAVI is focused on developing COVID-19 monoclonal antibodies both to treat individuals just exposed to the virus to stop progression to the severe form of the disease and also to prevent infection in individuals who might be at risk of exposure, like a temporary vaccine. While antibody therapies are typically expensive, Dr. Sok referenced the example of a low-cost monoclonal antibody product already on the market for rabies and noted that IAVI is proactively taking several steps in developing its product to drive down costs and ensure that it will be accessible and deployable in low-resource settings worldwide, even though this might delay product introduction. “We were aware from the beginning that we were not going to be first to market, but the priority was to be first to access,” he said. OraSure Technologies' rapid HIV self-test. Photo: World Health OrganizationFinally, Dr. Stephen Tang, president and CEO of OraSure Technologies, shared more about his company’s progress on developing a rapid antigen self-test for COVID-19, a tool with potential to dramatically simplify and expand access to COVID-19 testing in the United States and globally. Described by Dr. Tang as a “lab on a swab,” the test uses a self-collected nasal sample and delivers easy-to-read results at point of care without the need for additional instruments or laboratory analysis. OraSure’s history of designing diagnostics for global health needs has positioned the company well to support global access to COVID-19 diagnostic tools. It created the first rapid oral HIV self-test prequalified by the World Health Organization and the first FDA-approved rapid diagnostic test for Ebola, and it is now leveraging the same lateral flow platform these tests are built on for its COVID-19 diagnostic. Subject to receipt of an emergency use authorization by FDA, OraSure’s rapid self-test for COVID-19—developed with funding from the Biomedical Advanced Research and Development Authority—could be deployed worldwide.  Reflecting on the lessons OraSure has drawn from its experience developing HIV diagnostics and what’s required to ramp up COVID-19 diagnostic testing to the massive scale the world requires, Dr. Tang emphasized several interrelated factors: instrument-free self-tests are ideal for countries with limited laboratory infrastructure; ease of use is key, particularly in countries with low literacy rates; experience counts when it comes to working with regulators, particularly during health emergencies; and the ability to scale manufacturing to meet demand is paramount for impact.  After the presentations, the congressional staff participants posed a range of thoughtful questions about the innovations as well as the innovators’ perspectives on what the United States can do support the global response to COVID-19—from how US military research capabilities can be leveraged to design COVID-19 products suited for austere settings, to how members of Congress who represent researchers and research institutions can better advocate for resources needed to support science, to the specific measures that must be taken to scale up COVID-19 diagnostic capacity in the United States and around the world. As we consider the challenges of delivering certain COVID-19 products—including the leading vaccine candidates—everywhere they are needed worldwide, GHTC will continue to connect policymakers and their teams with innovators working to design tools with global access in mind. We hope this dialogue creates the foundation for an enduring partnership between congressional champions for global health innovation and the researchers whose work is fueling progress against COVID-19 and other global health threats.