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.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 Africa Centers for Disease Control and Prevention, African Union Commission, and Coalition for Epidemic Preparedness Innovations have announced a partnership to enhance vaccine research, development, and manufacturing in Africa. The agreement, announced following a two-day virtual conference on African vaccine manufacturing, will seek to strengthen the COVID-19 response and outbreak preparedness, build on key lessons from COVID-19, and leverage the successes of procurement and distribution of vaccines by COVAX and the African Vaccine Acquisition Task Team. Through the initiative, the partner institutions also intend to invest in capacity strengthening and innovations to accelerate vaccine production, strengthen African scientific institutions, and build partnerships that enable sustainable expansion of vaccine manufacturing in Africa.Regeneron plans to request an expanded emergency use authorization from the US Food and Drug Administration for its COVID-19 antibody cocktail after new data indicated it can prevent disease in healthy individuals. In a phase 3 trial run jointly with the National Institutes of Health, the antibody therapy cut the risk of developing symptomatic COVID-19 by 81 percent among healthy individuals who lived with an infected person. The antibody cocktail is currently authorized as an intravenous infusion to minimize disease progression in sick patients; the new request would allow the drug to be administered as a single-dose subcutaneous injection and used as a preventative measure. If authorized, the antibody cocktail could play a practical role in COVID-19 protection measures, including after high-risk exposures and in immunocompromised individuals who may not respond well to vaccines, according to a company statement.Amid reports of rare blood clot–related side effects among individuals who received COVID-19 vaccines developed by AstraZeneca and Johnson & Johnson, researchers are investigating whether and how the vaccines are causing this adverse reaction. Two papers published in the New England Journal of Medicine described 16 patients who experienced this cerebral venous sinus thrombosis, tied to the AstraZeneca vaccine, and offered a partial explanation for a potential link, finding blood clots were seen in conjunction with high levels of antibodies to platelet factor 4. The finding provides a first step toward explaining the extremely rare side effect but does not explain why a vaccine might cause the immune system to produce those antibodies. Researchers plan to continue investigating the reaction, assessing the data, and monitoring cases alongside regulatory authorities.

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 global vaccine initiative COVAX has delivered 38.4 million COVID-19 vaccine doses to 102 countries and economies, six weeks after it began its rollout around the world, according to a World Health Organization statement released Thursday. Among the countries reached so far, 61 received doses through the COVAX Advance Market Commitment, a donor-financed mechanism to ensure vaccine access for low- and middle-income countries. Amid this progress, reduced supply has caused delays in delivery, and the Serum Institute of India–produced AstraZeneca vaccine is no longer being shipped out of India amid COVID-19 surges in the country. COVAX plans to reach all participating countries within the first half of 2021 and intends to deliver at least 2 billion doses by the end of the year.The US Food and Drug Administration (FDA) granted emergency use authorization last week to a COVID-19 antibody test that can be taken at home and mailed to a lab for results. The COVID-19 Self-Collected Antibody Test System, developed by Symbiotica, Inc., is the first antibody test to receive FDA authorization for use at home, adding to the more than 75 antibody tests approved for use at point-of-care settings. The test can be used by individuals ages 5 and over and requires a fingerstick blood sample completed at home and sent to a Symbiotica lab to process for evidence of COVID-19 antibodies, the presence of which would indicate past infection.The Walter Reed Army Institute of Research (WRAIR) has begun a phase 1 clinical trial evaluating a new COVID-19 vaccine candidate following positive preclinical results against SARS-CoV-2, its variants, and SARS-CoV-1. The candidate, a nanoparticle vaccine based on a ferritin platform, has a multi-faced sphere design, which allows it a flexible approach to combating variants and coronaviruses and an ordered introduction of the coronavirus spike protein to the immune system. The phase 1 study will enroll 72 adult volunteers between the ages of 18 and 55, divided into vaccine and placebo groups, and will be conducted at the WRAIR Clinical Trials Center.

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.