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.University of Cambridge scientists have identified 200 existing drugs as possible candidates to repurpose against COVID-19 and validated two of them in early tests—the antimalarial therapy proguanil and rheumatoid arthritis medication sulfasalazine. In the study, both drugs safely inhibited the replication of SARS-CoV-2 in monkey and human cell lines. Both are well established and well tolerated for other human diseases and will likely be rapidly advanced into clinical trials to test whether they can prevent or treat COVID-19. The Cambridge research, which mapped a network of human proteins induced by SARS-CoV-2 infection, identified 476 key proteins most relevant in viral replication and screened approved drugs against those proteins, finding 200 drugs, 40 of which are already in COVID-19 clinical trials and another 30 of which have previously been proposed as potential candidates against the disease.A malaria vaccine candidate that pairs a shot of the live parasite that causes the disease with a dose of infection-fighting drugs showed promise in early clinical trials, researchers reported in Nature last week. The live parasite vaccine and drug combination showed 87.5 percent efficacy in a small group of healthy adult participants. The study, conducted at the National Institutes of Health, gave 44 healthy people in the United States three intravenous doses of the vaccine spaced about a month apart, followed by one of two antimalarial drugs—pyrimethamine or chloroquine—two or three days after the shot to weaken and eliminate the parasite. A phase 2 clinical trial of the vaccine is now underway in Mali, a malaria-endemic country.The CoronaVac COVID-19 vaccine appears to be safe and induce an antibody response among children and adolescents ages 3 to 17, according to phase 1/2 clinical trial data. The vaccine, manufactured by Sinovac, has recently been approved for emergency use in China for children over the age of 3. The trial results evaluated the vaccine among healthy children and adolescents in Zanhuang County, China, finding 96 percent of participants who received two doses of the vaccine developed antibodies against SARS-CoV-2. Most adverse reactions were mild or moderate, with pain at the injection site the most commonly reported symptom. Researchers noted that the number of participants was small and concentrated and recognized a need for larger studies in other regions, as well as for data evaluating long-term safety and immune responses.

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 first technology transfer hub for mRNA COVID-19 vaccines will be established in South Africa, the World Health Organization (WHO) announced last week. The hub will assist in scaling production of and access to doses across the African continent by providing training on mRNA technologies for manufacturers from low- and middle-income countries and licensing them for local production. The hub is still in the process of securing agreements with manufacturers of mRNA vaccines, the technology of which is potentially easier to scale than alternatives and could be faster and easier to adapt for COVID-19 variants of concern. If knowledge of the way to produce an existing mRNA COVID-19 vaccine is transferred to the new hub in South Africa, doses could be produced at the site in the next 9 to 12 months, according to WHO.Scientists at the University of Oxford will evaluate Ivermectin in a new clinical trial to prevent hospitalization among people with COVID-19 symptoms. Ivermectin, most commonly used to treat parasitic infections, has been promoted for use against COVID-19 in several regions despite a current lack of clinical data to support its use. There have been early, “promising” results from small and observational studies, but it would be “premature” to recommend Ivermectin for COVID-19, according to a researcher from the upcoming trial. The Oxford team said they selected Ivermectin to be included in the trial because it was readily available globally and known to be relatively safe.The US Food and Drug Administration granted emergency use authorization to a COVID-19 antibody test that uses mouth swabs, rather than blood samples, to detect the presence of IgA, IgG, and IgM antibodies. The rapid, saliva-based test, called CovAb, delivers a result within 15 minutes and does not require any additional hardware or instruments. The authorization allows the diagnostic to be used at the point of care among adults and children. In clinical trials, CovAb demonstrated a false-negative rate of less than 3 percent and a false-positive rate of nearly 1 percent when administered at least 15 days after the onset of symptoms, when the body’s antibody response reaches higher levels.

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 showed 90 percent efficacy in preventing laboratory-confirmed symptomatic infection among adults aged 18 and older, according to phase 3 trial results released last week. The vaccine was also 91 percent protective in high-risk populations, 93 percent protective against variants of concern and variants of interest, and completely protective against hospitalization and death due to COVID-19. The recombinant protein vaccine is given in two doses, three weeks apart, and can be stored at refrigerator temperatures. Novavax plans to file for authorization with several drug regulators, including the US Food and Drug Administration (FDA), in the third quarter and expects to be able to produce 100 million doses a month by the end of that quarter followed by 150 million per month by the end of the year. Novavax also has an agreement with Gavi, the Vaccine Alliance, to deliver 1.1 billion doses of its vaccine, once authorized, to the COVAX vaccine-sharing facility.In new data from the UK Recovery Trial, Regeneron’s antibody cocktail reduced the chance of death among hospitalized COVID-19 patients who haven't produced their own antibody responses to the disease. The study showed REGEN-COV reduced risk of death by 20 percent among seronegative participants, or those who produced no natural antibody response, while for patients who had developed antibodies, the treatment didn't work at all. Among the seronegative group, the treatment also reduced the average hospital stay by four days and decreased the chance of a patient requiring a ventilator. REGEN-COV received emergency use authorization from the FDA late last year for patients with mild to moderate COVID-19 and recently received an expanded green light for a lower dose and delivery by subcutaneous injection. Regeneron now intends to take the new data to the FDA for expansion to use in seronegative hospitalized patients.CureVac’s two-dose mRNA COVID-19 vaccine was 47 percent effective against COVID-19 disease of any severity among participants in a 40,000-person trial, interim analysis shows. The broad diversity of variants makes it challenging to demonstrate high efficacy, according to a statement from CureVac’s chief executive—13 variants were recorded in the trial, with only a single case caused by the original SARS-CoV-2 virus. More than half of the cases were infections with variants of concern. The trial, conducted in ten countries in Latin America and Europe, will continue, and final data is expected in the coming weeks. The CureVac vaccine is of most importance to the European Union, which has preordered 225 million doses, with the option to buy 180 million more.

Awaiting a chance to prove themselves, key technological advances that enabled swift development of vaccines against SARS-CoV-2 stood by for years before the pandemic struck. Chief among these were mRNA-based vaccines, which stalled in early-stage development. Research funders questioned the scientific merit of novel immunological approaches; major vaccine producers doubted their profit potential. Nevertheless, a handful of innovation-seeking public-private development partnerships, fueled by hard-won support, drove novel vaccine platforms forward just as SARS-CoV-2 gripped the world.As with much else, the COVID-19 pandemic upended vaccine research and development (R&D), leaving the world’s largest vaccine makers to play catch-up with smaller companies focused on vaccine innovation. Biotech start-ups capitalizing on cutting-edge technologies increasingly are driving vaccine development, which in turn is shedding its image as an investment backwater. Maintaining this momentum through ongoing investment in technological innovation can drive breakthroughs to thwart future pandemic threats, as well as endemic diseases that kill millions each year.During the early months of the historic rollout of vaccines to fight COVID-19, the Sabin Vaccine Institute’s Influenzer Initiative asked experts and innovators specifically to reflect on the past, present, and game-changing future of mRNA vaccine protection against a range of viral threats, including influenza. Exciting insights from these conversations are featured in the initiative’s latest video episode. As several of those interviewed attest, mRNA vaccines exemplify how basic discovery research coupled with targeted translational investments remain the engine of transformative innovations that save uncountable lives and immeasurably improve their quality. Eric Topol, founder of Scripps Research Translational Institute, observes that investments in immunology, virology, and molecular and structural biology provided the foundation for the rapid development of successful vaccines against SARS-CoV-2. David Topham, the founding director of the Translational Immunology and Infectious Diseases Institute at the University of Rochester, notes that vaccine platforms that have delivered us out of the current pandemic were enabled by targeted investments in nanoparticle technology.  Innovations like the COVID-19 vaccines provide benefits that extend far beyond their initial targets, such that every dollar spent on R&D yields five in return, notes economist Benjamin Jones of Northwestern University. In the case of mRNA vaccines, that beneficial ripple effect may include disarming the next pandemic threat. “Today we need methodologies that we can rapidly adapt so that when a new pathogen arises, we can make a vaccine against it,” says Teresa Lambe of Oxford University. That’s a key advantage of the mRNA platform, according to Topol. “mRNA does appear to have the ultimate flexibility,” he observes. “You go from sequence to template in a matter of hours.” SARS-CoV-2 demonstrates the value of this nimble technology, as the triumphant achievement of astonishingly effective vaccines remains threatened by the rise of potentially evasive variants—a long-standing challenge in building defenses against the next influenza pandemic.The challenges and consequences of inequitable access to vaccines has never been more sharply evidenced than by the current pandemic. The relative simplicity of mRNA vaccine manufacturing, as compared with that of traditional vaccine approaches, offers the potential to make vaccines when and where viral threats emerge and more readily available to the people who most need them. Vaccine manufacturing processes should be designed to be globally adaptable, Lambe argues. “All low- to middle-income countries, in fact all countries, should have the ability to make vaccines for themselves and to supply worldwide,” she says. Rajeev Venkayya, of Takeda Pharmaceutical Company, adds that decentralized vaccine production offers benefits beyond those provided by vaccines themselves. He describes how countries new to vaccine manufacturing could “leapfrog” into cutting-edge technology via mRNA vaccine production and build a new ecosystem for vaccine research, development, and distribution. The full potential of mRNA vaccines thus extends far beyond quashing pandemics. Developed and produced according to national or regional needs, mRNA vaccines can create innovative opportunity and healthier futures for people everywhere.Decades will be spent taking the measure of the COVID-19 pandemic: calculating its toll in multiple metrics, defining its vast and diverse lessons, and recognizing the changes it catalyzed. During that time, viruses with potential to cause even greater destruction will emerge. As the recent declaration of G7 leaders emphasizes, we must act now to develop transformative, adaptable, and affordable technologies to meet these threats—a declaration that George Gao, director of the Chinese Center for Disease Control and Prevention, insists must produce action. Among the pursuits he advocates is the exploitation of recently proven vaccine technologies to prevent another pandemic. “mRNA plus nanoparticle vaccines are two important routes for the development of novel influenza vaccines,” he says. Novel vaccines that enable robust, globally accessible disease prevention are within reach, according to Amesh Adalja of Johns Hopkins University. “I don’t think we’re going to be left in such a position with future emerging infectious disease emergencies,” he concludes. We take courage from these words, and those of Venkayya, who expressed his hope “that people will seize this moment to recognize that we could potentially avert the next pandemic.”