Anna Kovacevich

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.

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 clinical trial of a new, all-oral treatment regimen for multidrug-resistant tuberculosis (TB) has stopped enrolling patients, on an earlier-than-expected timeline, after initial data showed positive results. The phase 2/3 trial, TB-PRACTECAL, is evaluating a six-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin, which an independent data safety and monitoring board found has already shown itself, through interim data, to be superior to current standard TB care. TB-PRACTECAL will be the first multi-country, randomized controlled clinical trial to report on the safety and efficacy of such a treatment, which has the potential to save thousands of lives and improve quality of life. Médecins Sans Frontières, which is sponsoring the trial, announced the findings last Wednesday on World TB Day and said it would share the trial data with the World Health Organization and submit full results to a peer-reviewed journal in the coming months.On Wednesday, AstraZeneca announced that its COVID-19 vaccine has 76 percent efficacy at reducing the risk of symptomatic COVID-19 infection and 100 percent efficacy against severe disease, in an updated analysis of its phase 3 US-based clinical trial. The new findings came two days after an earlier analysis was flagged by the trial’s data and safety monitoring board as potentially based on incomplete information; updated results ultimately reduced the overall efficacy estimate by just three percentage points and did not impact the reported efficacy against severe disease. AstraZeneca has said it will publish the results in a peer-reviewed medical journal and submit for emergency use authorization in the United States.Pfizer is beginning a clinical trial for an oral pill to treat COVID-19, building on antiviral technology that has been used against a range of infections including HIV and hepatitis C. The early-stage US trial will evaluate the drug, known as PF-07321332, which will be administered to patients as soon as they see signs of infection. The treatment, a protease inhibitor, is intended to dampen the virus’s ability to cause severe disease and death. As an oral pill, PF-07321332 would be able to be prescribed and taken outside of a secondary care setting, rather than infusion clinics or hospitals that have been necessary for several existing COVID-19 antibody treatments.

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. Moderna has launched a phase 2/3 trial of its two-dose, mRNA-based COVID-19 vaccine in children ages 6 months to less than 12 years, the company announced last week. The KidCOVE trial, conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, will enroll about 6,750 children in the United States and Canada. The first stage of the trial will test how participants respond to different dosing levels, followed by an interim analysis to determine appropriate dose levels, and the second stage of the trial will test the selected dose against placebo shots. In a separate, ongoing trial launched in December, Moderna is testing its vaccine in 3,000 children aged 12 to 17.The COVID-19 vaccine developed by AstraZeneca and the University of Oxford reduces mild and serious forms of the disease, according to results from an interim analysis of a phase 3 trial in the United States, Chile, and Peru released Monday. The two-dose vaccine decreased symptomatic disease by 79 percent and severe disease and hospitalization by 100 percent. In its press release, AstraZeneca said the vaccine study identified no new safety concerns, and a specific review found no risk of blood clots—reports of which had led several European countries to halt rollout last week. Last Thursday, the European Medicines Agency announced the vaccine is “safe and effective,” noting its benefits outweigh the risk of potential adverse side effects, which appear to be extremely rare. AstraZeneca plans to request emergency use authorization from the US Food and Drug Administration in the coming weeks.Researchers from Cleveland Clinic's Florida Research and Innovation Center (FRIC) have identified a potential new target for COVID-19 treatments, according to findings published in Nature Microbiology. The research shows that the coronavirus enzyme PLpro blocks the body’s immune response, suggesting that therapeutics inhibiting the enzyme could help treat COVID-19 infection. In a follow-up phase of the study, the FRIC research team will investigate whether blocking PLpro’s enzymatic function, or its interaction with receptor proteins that help govern immune defenses, would strengthen human immune response against the virus. If successful, PLpro could be a new target for future COVID-19 therapeutics.

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 has an overall efficacy of 89.7 percent, with 100 percent efficacy against severe disease, according to final results of its phase 3 trial in the United Kingdom. The results, released Thursday and not yet published in a peer-reviewed journal, showed 96.4 efficacy against the original strain of the COVID-19 virus and 86.3 percent against the B.1.17 variant, first identified in the United Kingdom. The company also announced results from a phase 2b trial in South Africa, which showed 48.6 percent efficacy overall but maintained 100 percent efficacy against severe disease. Phase 3 trials in the United States and Mexico are ongoing. Novavax plans to apply for regulatory approvals around the world, including for use by the global vaccine initiative COVAX, to which Novavax pledged to provide 1.1 billion doses.An antibody cocktail developed by Eli Lilly decreased risk of hospitalization and death due to COVID-19 by 87 percent when compared to a placebo, the company said Wednesday. The antibody duo, a lower-dose combination of bamlanivimab and etesevimab, received emergency use authorization from the US Food and Drug Administration (FDA) in February based on previous trial data indicating a 70 percent reduction in hospitalizations and deaths using higher doses. The treatment showed complete protection against death in both phase 3 cohorts. Eli Lilly has a supply deal with United States for 100,000 doses of the treatment, set to be delivered by the end of the month, and the company has now partnered with Amgen to help produce up to 1 million doses of the cocktail by the end of the year. On Thursday, results from a long-term study in South Africa showed almost all patients who received a new treatment for highly drug-resistant tuberculosis remained clear of the disease two years after the trial. The six-month, all-oral regimen of bedaquiline, pretomanid, and linezolid (BPaL) treats highly drug-resistant strains of tuberculosis and shortens the treatment period from two years, with limited side effects. The new findings come from analysis of the Nix-TB trial, conducted by the TB Alliance of South Africa, which tested the BPaL regimen on 109 patients at three sites in the country. Preliminary trial results showed a 90 percent success rate after six months of treatment and six months of post-treatment follow-up, and according to the new data, only two patients had challenges by two years after the treatment.