Breakthroughs Blog: Pneumonia

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 US Food and Drug administration (FDA) last week approved the first-ever vaccine for respiratory syncytial virus (RSV). GSK’s Arexvy vaccine is a single shot intended for use in adults aged 60 and older and could be available as soon as fall of this year, as long as the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices provides further approval. RSV, which has an annual global death toll of 160,000 people, has challenged vaccine researchers for six decades. Building on those years of efforts, GSK’s Arexvy showed strong results in an ongoing trial of nearly 25,000 adults. Further FDA approvals for RSVP vaccines developed by Pfizer, Moderna, and Bavarian Nordic could follow soon, with the decision on Pfizer’s candidate expected as soon as this month.Last week at the 2nd Global Forum on Childhood Pneumonia in Madrid, Spain, the Bill & Melinda Gates Foundation announced a nearly US$200 million commitment, to be awarded over the next year and a half, to support the development and delivery of affordable vaccines for some of the leading causes of childhood mortality, including pneumonia, meningitis, neonatal sepsis, and RSV. This includes supporting a more affordable next-generation pneumococcal conjugate vaccine, Pneumosil, developed by the Serum Institute of India and PATH and advancing a Group B streptococcus vaccine entering phase III trials later this year. The foundation is partnering with the companies developing these vaccines to ensure they are available and affordable to Gavi and low- and middle-income countries, therefore narrowing the gap between the rollout of vaccines in high-income and Gavi-supported countries.A new gold-standard clinical trial in Kenya showed that a single dose of the human papillomavirus (HPV) vaccine may be as effective as two or three doses over at least three years. Deploying a single-dose strategy could dramatically lower the rates of cervical cancer and other associated diseases, as well as extend vaccine supplies, lower costs, and simplify distribution, especially in low- and middle-income countries. At least 24 countries have already shifted to a one-dose approach, and this trial could make it a more widely adopted strategy, which the World Health Organization estimates could prevent 60 million cervical cancer cases and 45 million deaths worldwide over the next 100 years.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week A tech nonprofit, WeRobotics, is seeking to deploy drones to deliver hundreds of thousands of sterile mosquitoes into Zika hotspots across Latin America to assist with mosquito population control. Existing research suggests releasing sterile mosquitoes into the wild may eventually reduce populations by as much as 90 percent, though actual mosquito introduction has proven challenging. To solve this, WeRobotics developed small, temperature-controlled drones designed to deploy mosquitoes in rural and hard-to-reach locations, ensuring all affected areas receive the sterile mosquitoes. The drone’s cool temperature leaves the mosquitoes in a deep sleep state, protecting them during the journey, and the drone then releases the mosquitoes from a controlled height to ensure they do not die from impact. WeRobotics plans to deploy these drones soon and will educate local communities about the project. The World Health Organization (WHO) recently announced that about 11 percent of all medicines circulating in low- and middle- income countries are substandard or counterfeit. WHO estimates between 72,000—169,000 children may die from pneumonia and 116,000 may die from malaria every year after receiving falsified or substandard products, suggesting this is a widespread and alarming problem in the world’s poorest countries. Experts believe majority of these cases remain unreported, compounding existing issues with counterfeit or substandard medicine monitoring across affected countries. This is the first time WHO has assessed in-depth the global scope of the problem. In 2013, the agency set up a voluntary global monitoring system for substandard and fake drugs, which has helped bring to light the extent of the issue. An estimated 50 million doses of antibiotics are prescribed for typhoid every year, with overuse or misuse of these drugs contributing to the global rise of antibiotic-resistant bacteria. In the city of Karachi, Pakistan—a typhoid-endemic country—antibiotic resistance is rising by 30 percent per year, and 100 percent of typhoid cases are expected to be multi-drug resistant by 2020. A new typhoid vaccine may be the solution to this growing problem. The typhoid conjugate vaccine (TCV) is more effective in preventing typhoid than its predecessor and may protect individuals for up to five years—longer than the previous vaccine. Most importantly, TCV may be given to children under the age of two, expanding the level of coverage to infants who are in critical need of a vaccine. With rising levels of antibiotic-resistant bacteria, having an effective and inclusive typhoid vaccine may save thousands of lives.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. GAVI, the Vaccine Alliance has partnered with the wearable tech company Kushi Baby to bridge the immunization gap for infants in low-income communities. About 1.5 million children die every year from vaccine-preventable illnesses, and one in three do not receive the immunizations they need simply because health professionals "do not know they exist." This partnership will provide children with a wearable necklace technology that remotely tracks and updates their immunization history. The technology allows health professionals to more accurately provide the supplies needed when traveling to rural communities and reach children in need of immunization. This year 1,500 infants in Northern India received the necklaces. The partnership has a goal of increasing distribution to 5,000 necklaces by the end of the year. A new vaccine under development may lower pneumonia incidence and mortality rates by targeting additional strains of the bacteria, according to a new study published in Science Advances. Current pneumonia vaccines only target the most common strains of the illness, but this vaccine candidate targets dozens of additional strains. The candidate may also help maintain the body’s microbiome—a collection of healthy bacteria often killed during the immunization process—by “attack[ing] [bacteria] only if it breaks away from the colony to cause an illness.” The World Health Organization Strategic Advisory Group of Experts on Immunization (SAGE) has recommended a new typhoid fever vaccine that has demonstrated up to 87 percent effectiveness during a clinical study. This typhoid vaccine is the first of its kind licensed for use in children under two years of age. SAGE recommended the vaccine be given to children 6 months old and that catch-up campaigns be administered to immunize children between the ages of 6 months and 15 years of age. With drug-resistant typhoid growing in typhoid-endemic communities, the vaccine will also be a valuable tool in combatting antimicrobial resistance.  

A woman's hands holding a SILCS diaphragm. (Photo: PATH/Patrick McKern) Last week, GHTC member PATH launched the Caya® contoured diaphragm in the United States, after developing and testing nearly 200 prototypes to ensure the product was safe, effective, and user friendly. PATH collected input from women and health care providers across the globe throughout the research and development (R&D) process, ultimately creating an innovative contraceptive that protects against sexually transmitted infections, has no side effects, and is discreet, comfortable, easy to use, and “one-size fits-most." The Caya® diaphragm, which is now available in 25 countries, is an important addition to existing contraceptive options, as it is the first diaphragm introduced in the United States in 50 years. In 2014, the World Health Organization (WHO) recognized the Chinese Food and Drug Administration as a functioning regulator; China has now developed two vaccines—for Japanese encephalitis and influenza—that have received WHO prequalification, a sign that a product is safe and effective. A representative of the Bill & Melinda Gates Foundation, which has worked with the Chinese government to enhance its vaccine R&D capacity, said that the second prequalification “may be the start of China truly becoming a player in global health.” China recently established a system that regulates manufacturing for pharmaceutical products based on the European Medicines Agency’s (EMA) and US Food and Drug Administration’s (FDA) standards. However, China’s regulatory system still has some barriers to overcome, as the regulatory approval process takes much longer than the EMA’s or FDA’s. Additionally, the Chinese government requires vaccines and drugs to be packaged individually—which is not conducive to international shipping—and there are currently no guidelines on how a manufacturer can obtain a license in China if clinical trials are conducted abroad. A vaccine candidate for the Middle East Respiratory Syndrome (MERS) has been successfully tested in mice and will progress to Phase I clinical trials shortly. The vaccine uses a weakened strand of a poxvirus—known as Modified Vaccinia virus Ankara—that has been altered to display a certain protein unique to the MERS virus. The immune system recognizes the protein as foreign, and develops antibodies and T cells to combat MERS. In the lab, the MERS virus was not able to reproduce in vaccinated mice despite exposure to “high levels” of the virus. The vaccine was developed by the Ludwig Maximilian University of Munich’s Institute for Infectious Diseases and Zoonoses, and the German Center for Infection Research has already committed 1.5 million euros for the Phase I clinical trials. The results of a massive trial for a new pneumonia vaccine were announced last week, demonstrating a major reduction in cases of the disease responsible for fifteen percent of deaths in children under five years of age. The vaccine, known as PCV-10, protects against ten different bacteria that can cause pneumonia. The trial lasted seven years, during which time the vaccine was given to 35,000 children in the Kenyan town of Kilifi. Eighty percent of vaccinated children demonstrated greater resistance to pneumonia. The town saw a 42.7 percent reduction in cases overall, and a 95 to 100 percent reduction in invasive pneumococcal disease—the most deadly form of pneumonia.