Breakthroughs Blog: NIH

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. An experimental oral antiviral drug showed promise as a potential treatment for COVID-19 after demonstrating an ability to prevent the virus from replicating, according to study results from the National Institutes of Health (NIH). The drug, TEMPOL, was tested in an experiment of cell cultures with live viruses and was able to impair an enzyme the virus needs to make copies of itself inside human cells, which could limit the severity of the disease. An oral drug to prevent virus replication would be an important tool, as additional effective and accessible COVID-19 treatments are still needed, according to the NIH statement. NIH researchers said they plan to conduct additional preliminary studies and will seek opportunities to evaluate the drug in a clinical study.The World Health Organization (WHO) approved the Sinovac-CoronaVac COVID-19 vaccine for emergency use on Tuesday after evaluating its safety, efficacy, and quality. Other COVID-19 vaccines that have been authorized by WHO include those developed by Sinopharm, Pfizer, Moderna, Johnson & Johnson, and AstraZeneca. The emergency use paves the way for countries around the world to approve and import the vaccine for distribution quickly, according to the WHO press release, in addition to being a prerequisite for use by the COVAX global vaccine-sharing facility. WHO also noted that the easy storage requirements of the vaccine make it suitable for use in low-resource settings.The COVAX advance market commitment (AMC) initiative raised US$2.4 billion to fund COVID-19 vaccines for low- and middle-income countries, in addition to 54 million vaccine donations, during a COVAX AMC virtual summit on Wednesday. This brings the total pledged to the COVAX AMC to $9.6 billion. The summit, hosted by the government of Japan and Gavi, the Vaccine Alliance, brought in donations from nearly 40 governments, the private sector, and foundations that will be used to secure 1.8 billion doses of COVID-19 vaccines for AMC-participating countries. The vaccines will be delivered in 2021 and early 2022 and will cover close to 30 percent of the adult population against COVID-19 in the 91 participating countries. 

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 malaria vaccine candidate showed up to 77 percent efficacy in a phase 2b trial among children in Burkina Faso, according to results published by researchers at the University of Oxford’s Jenner Institute. The vaccine is the first to meet the World Health Organization goal of 75 percent efficacy. Developers have begun recruitment for a large-scale phase 3 trial to test the vaccine for safety and efficacy in 4,800 children across four countries. Following final trial results, Oxford would apply for regulatory authorizations, with a best-case scenario of approval by the end of 2022, according to the director of the Jenner Institute. The researchers have made a deal with the Serum Institute of India to manufacture the vaccine at large scale and low cost. It has pledged to deliver 200 million doses a year if the vaccine is licensed.The National Institutes of Health (NIH) is launching three new clinical trials to evaluate COVID-19 therapeutics, including one trial for severely ill, hospitalized patients; one for a polyclonal antibody treatment; and one to assess repurposed drugs for COVID-19 symptoms. The trial for hospitalized patients will test a combination of NeuroRx’s Zyesami, which is a formulation of aviptadil acetate, and Gilead’s Veklury, which is the antiviral remdesivir. The antibody trial will test SAB Biotherapeutics’ investigative polyclonal antibody in mild to moderate cases of COVID-19, and the study on repurposed drugs will evaluate existing over-the-counter drugs to be used at home. All three trials are part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines public-private partnership.Preliminary data on Pfizer’s and Moderna’s COVID-19 vaccines bolsters evidence that the mRNA shots are safe during pregnancy, based on reports from more than 35,000 women in the United States who received the doses while pregnant. The new evidence, published in the New England Journal of Medicine last week, showed rates of miscarriage, premature births, and other complications were comparable to those observed in pre-COVID-19 data on pregnancy. The study was led by US Centers for Disease Control and Prevention researchers, who noted continued monitoring and evidence is still needed, including on women who get COVID-19 vaccinations in the early stages of pregnancy.

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.