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. On Wednesday, the US Food and Drug Administration (FDA) announced the Pfizer/BioNTech COVID-19 vaccine can be safely stored at refrigerator temperatures for up to a month, an expansion from the previous five-day limit. The authorization followed Pfizer’s submission of data to the agency supporting extended refrigerator storage of undiluted, thawed vials. The European Medicines Agency also authorized the change last week. The relaxed storage requirement should lead to more widespread availability of the vaccine by facilitating the ability of vaccine providers, such as community doctors’ offices, to receive, store, and administer the vaccine, according to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. The Sanofi/GlaxoSmithKline (GSK) COVID-19 vaccine candidate generated strong levels of neutralizing antibodies in recipients across all ages studied, according to phase 2 trial results announced by the companies last week. No safety or tolerability concerns arose in the trial. The two-dose vaccine is a recombinant protein vaccine and does not require an elaborate cold chain for storage and distribution. Sanofi and GSK also noted that high neutralizing antibody levels were generated after a single dose in participants with evidence of prior SARS-CoV-2 infection, which could suggest its value also as a booster used after an initial vaccination series. A large, international phase 3 trial is set to begin in the coming weeks, and the companies also plan to conduct studies targeting various variants of concern.The United States committed to sending an additional 20 million COVID-19 vaccine doses to other countries last week, following an initial announcement that it would share 60 million doses of the AstraZeneca vaccine, which has not yet been authorized by the FDA. In Monday’s announcement, the Biden administration committed to sharing surplus supplies of the FDA-authorized Pfizer, Moderna, and Johnson & Johnson vaccines, in addition to the AstraZeneca vaccine doses, for a total of 80 million doses sent overseas in the next six weeks. Currently, only 0.3 percent of all COVID-19 vaccine doses administered worldwide have been given in low-income 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. Last week, an advisory committee to the US Centers for Disease Control and Prevention (CDC) recommended that Pfizer’s COVID-19 vaccine be offered to adolescents between the ages of 12 and 15, following the vaccine’s authorization for this age group by the US Food and Drug Administration earlier in the week. CDC Director Rochelle Walensky adopted the recommendation later Wednesday, clearing the way for vaccine clinics to begin to vaccinate 12-to-15-year-olds. The recommendation was based on data indicating the vaccine was protective for this age group; in a trial of 2,260 adolescents, there were 18 confirmed cases of COVID-19 among those who received a placebo and no confirmed cases among those who received the vaccine.A newly established COVAX Supply Chain and Manufacturing Task Force will seek to jump-start global vaccine manufacturing capacity with a three-stage plan to enhance existing production capacity, as well as develop a new vaccine manufacturing group to bolster production in the long term. The plan seeks to address immediate manufacturing bottlenecks by identifying and matching “fill and finish” manufacturers with producers of active ingredient, accelerating approvals of export permits and customs clearances, and facilitating partnerships for the supply of vital vaccine inputs. The longer-term goals will include developing a manufacturing workforce to maximize more production using existing systems and expanding production capacity in low- and middle-income countries.Adults over 50 who received mixed types of COVID-19 vaccines for their first and second doses were more likely to report mild and moderate side effects, according to early results from a trial in the United Kingdom. The trial is evaluating whether mixing doses of the AstraZeneca and Pfizer vaccines might provide longer-lasting immunity or better protection against new variants. The findings showed more reports of chills, fatigue, headache, joint pain, malaise, and muscle aches among participants who received two different vaccines than those receiving two doses of the same vaccine, but no other safety issues were identified. Further data, including on whether and how the immune response is affected, could be released in the coming months as the studies continue.

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. Last week, the US government announced it would support a proposal to temporarily waive intellectual property rights for COVID-19 vaccines. The proposal, first introduced to the World Trade Organization (WTO) last fall by South Africa and India, would cover patents, industrial designs, copyrights, and protection of trade secrets, ultimately making it easier for countries that permit compulsory licensing to allow a manufacturer to export vaccines. In order to pass, the proposal would need support from all WTO members, and the measure is still opposed by a number of high-income countries. Following the US statement, however, several countries announced they are open to discussing the proposal. A decision on whether to grant the waiver is expected next month.An existing, cheap therapy could have potential as a long-acting injectable treatment for COVID-19, according to a recent preclinical study by researchers at the University of Liverpool. The data showed niclosamide, a therapy used to treat tapeworm infestations, to be highly effective against the SARS-CoV-2 virus in multiple laboratory studies. The researchers formed dispersible solid drug nanoparticle formulations of niclosamide that can be stored as solids, reconstituted with water, and then utilized as a long-acting injectable. The research team is looking to move the therapy into human trials and is working with a contract manufacturing organization toward scale up and clinical manufacturing.The Moderna COVID-19 vaccine was 96 percent effective in preventing illness in adolescents aged 12 to 17, according to early data released by the company Thursday. The vaccine was also generally well tolerated, and the majority of adverse events were mild or moderate, according to the statement. The analysis, which came from a study of the vaccine among 3,235 participants in the United States, identified no serious safety concerns. Moderna said it is in discussions with regulators about a potential amendment to expand its regulatory authorization to this younger age group. It is currently authorized for people aged 18 and over in countries where it has been approved.

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 is studying a new version of its COVID-19 vaccine that could be kept refrigerated for up to three months, according to a statement released Thursday. Currently, the vaccine can be stored at refrigerator temperatures for one month after being thawed from its frozen storage temperature, which requires ultra cold-chain equipment that is not widely available globally. If authorized, the refrigerator-stable vaccine could increase the number of locations able to vaccinate using Moderna’s shot. The company also announced plans to invest in manufacturing facilities in Switzerland, Spain, and the United States, which would boost its capacity to produce up to 3 billion doses of the mRNA-based vaccine in 2022.The ANTICOV clinical trial has begun recruitment for a new arm of its study that will test a combination of nitazoxanide and ciclesonide to treat patients with mild-to-moderate COVID-19 infection. ANTICOV, coordinated by the Drugs for Neglected Diseases initiative, is the largest trial in Africa seeking to identify early COVID-19 treatments to prevent progression to severe disease and potentially limit transmission. The study began in September with an adaptive platform design, allowing treatments to be added or removed as new evidence emerges. Nitazoxanide, an antiparasitic, and ciclesonide, an inhaled corticosteroid, are both already commercially available, and if shown to be effective against COVID-19, the treatment combination could be affordable and easy to access and administer.Adults in the United States over the age of 65 who have been fully vaccinated with either the Pfizer/BioNTech or Moderna COVID-19 vaccine are 94 percent less likely to be hospitalized with the disease than those not vaccinated, according to new data released by the US Centers for Disease Control and Prevention (CDC) on Wednesday. The findings also showed partial vaccination reduced the risk of hospitalization by 64 percent. Based on hospitalization data from two surveillance networks originally established to monitor serious influenza disease, the new evidence represents a real-world evaluation of the two mRNA-based vaccines in the United States. CDC says it is planning additional ongoing efforts to measure COVID-19 vaccine effectiveness to inform future vaccine policy.

Becoming a mother can be one of the most rewarding experiences of a woman’s life—but unfortunately, it can also be one of the most dangerous. More than 290,000 women die each year in pregnancy and childbirth, with the vast majority of those deaths occurring in low-income countries.  For decades, the US Agency for International Development (USAID) has been supporting problem solvers to create simple, affordable solutions to protect mothers and their babies during birth. Here are ten amazing USAID-supported innovations to make motherhood safer:  Preeclampsia is a dangerous condition that impacts 1 in 20 pregnancies. Yet its symptoms, headaches and swelling, can be difficult to spot since they mimic those of routine pregnancy. To detect this condition early before it turns deadly, researchers at Ohio State University created the Congo Red Dot test. This inexpensive, easy-to-use test uses a specific red dye in paper that reacts to unique proteins in the urine of pregnant women with preeclampsia, delivering results in just three minutes. Postpartum hemorrhage (PPH), or excessive bleeding post birth, affects millions of women every year and can cause death within hours if left untreated. Too often, lifesaving deliveries of blood and emergency supplies are limited by inadequate transportation, communication, and supply chain infrastructure. To facilitate easy, affordable, and rapid delivery of essential health supplies, several global initiatives, including from Zipline and Matternet, are using unmanned aerial vehicles—or drones—to carry blood and other urgent medicines to rural health facilities.  Argentine car mechanic Jorge Odón was watching a YouTube video about how to remove a cork from inside a wine bottle, when he had an inspiring realization: the same technique could be used to help extract a baby’s head during obstructed labor. This idea led him to create the Odon Device, which uses a plastic sleeve, pumped with air, to safely cushion a baby’s head while it is sucked out. In partnership with BD, Odón is working to advance and test this simple, low-cost innovation that could make it safer and easier to deliver complicated births without the use of forceps or a vacuum extractor.  A uterine balloon tamponade (UBT) is a standard device used in high-income countries to stop postpartum bleeding by putting pressure on the walls of the uterus. But at a cost of hundreds of dollars for a single use, these devices were unaffordable in many low-resource settings. This led health workers to improvise their own devices made from a condom and rubber tubing. Inspired by this ingenuity, PATH and Sinapi created an optimized, quality-assured version of this “condom catheter” called the Ellavi UBT, which at $7.50 per unit is putting this lifesaving device within reach for women around the world.  Blood pressure (BP) disorders like preeclampsia are a leading cause of maternal death. BP cuffs have been used to monitor BP since the early 1900s, but they can be hard to maintain and read by less-skilled health workers. A startup named Biospectal is reinventing this approach with their OptiBP cuff-less smartphone app. By simply placing a finger on a smartphone camera and using the software, anyone anywhere in the world can transform their phone into an instant, medical-grade blood pressure monitoring device.  Blood donation shortages in low-resource communities can leave health workers with few options if a woman is hemorrhaging blood during childbirth. Attendants often resort to using improvised tools like a soup ladle and gauze to try to salvage and recycle a patient’s own blood. The Hemafuse pump, developed by Sisu Global Health, is a cost-effective, hygienic alternative. This innovative tool sucks up blood, filters it, and transfers it to a bag for transfusion back to the patient.  Healthy timing and spacing of pregnancies are critical to the health of mothers and their babies. To expand family planning options, the Population Council developed the long-acting Annovera contraceptive ring—the first and only contraceptive to provide a year of protection while fully under a woman’s control. The soft, reusable silicone ring can be inserted and removed by its user, providing women with the ease of a long-term method and control of a short-term method. The ring does not require refrigeration, making it particularly effective for distribution and use in low-resource settings.  Poor water and sanitation in low-resource health facilities can expose moms and their babies to dangerous infections at birth. Chlorine is a commonly used disinfectant, but supply chain issues make it hard for facilities to ensure a steady, reliable supply. To help address this problem, PATH and MSR Global Health created a portable, low-cost tool—the SafiStation Chlorine Generator—that can produce chlorine on site using just water, salt, and electricity.  In high-income countries, an infusion pump is a common technology used to intravenously deliver medications or fluids. But it requires electricity—a luxury not always present in maternity clinics worldwide. To solve for this challenge, PATH innovators sought to create a low-cost, rugged infusion pump that could function without electricity or batteries. After testing different tactics, they settled on a simple approach to power the device: a hand-powered bicycle pump. Called the RELI Delivery System—short for reusable, electricity-free, low-cost, infusion delivery—this innovative device can power a consistent fluid delivery rate, over the equivalent of one clinic shift, with just a few pumps.  PPH, the world’s leading cause of maternal mortality, overwhelmingly affects mothers in low- and middle-income countries. The gold standard therapy for prevention and treatment of PPH, oxytocin, currently exists only as an injection—requiring refrigeration and skilled health care workers for administration. The Monash Institute of Pharmaceutical Sciences, in partnership with Janssen Pharmaceutica NV and GlaxoSmithKline, is developing a heat-stable, inhaled form of oxytocin to improve access to this lifesaving therapy to women in low-resource settings.  Photos, from top: Ohio State University Wexner Medical Center, Paul Kagame, Ministerio de Ciencia, Sinapi Biomedical, Biospectal, Sisu Global Health, Bedsider Providers, PATH/Adam Drolet, PATH/Tom Furtwangler, Monash Institute of Pharmaceutical Sciences 

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.