Cyanocobalamin

New modeling shows 40 million more children will suffer from hunger's worst effects by 2050 due to climate change, but immediate action could instead boost health, spur economic growth SEATTLE, Sept. 17, 2024 /PRNewswire/ -- In its eighth annual Goalkeepers report released today, the Bill & Melinda Gates Foundation urged world leaders to increase global health spending where it is needed most in order to boost children's health and nutrition, especially in the face of the global climate crisis. The Goalkeepers report, "A Race to Nourish a Warming World," projects that without immediate global action, climate change will condemn an additional 40 million children to stunting and 28 million more to wasting between 2024 and 2050. Scaling up solutions now can avoid this outcome, while also building resilience to climate change and spurring much-needed economic growth. In 2023, the World Health Organization estimated that 148 million children experienced stunting, a condition where children don't grow to their full potential mentally or physically, and 45 million children experienced wasting, a condition where children become weak and emaciated, leaving them at much greater risk of developmental delays and death. These are the most severe and irreversible forms of chronic and acute malnutrition. At the same time, as global challenges intensify, the total share of foreign aid going to Africa has decreased. In 2010, 40% of foreign aid went to African countries. But that number is now down to just 25%—the lowest percentage in 20 years—despite more than half of all child deaths occurring in sub-Saharan Africa. This trend leaves hundreds of millions of children at serious risk of dying or suffering from preventable diseases and threatens the unprecedented progress the world made in global health across Africa between 2000 and 2020. "Today, the world is contending with more challenges than at any point in my adult life: inflation, debt, new wars. Unfortunately, aid isn't keeping pace with these needs, particularly in the places that need it the most," writes report author Bill Gates, co-chair of the Bill & Melinda Gates Foundation. "I think we can give global health a second act—even in a world where competing challenges require governments to stretch their budgets." According to Gates, malnutrition is "the world's worst child health crisis," and climate change is only making it worse. Amidst this crisis, Gates calls for maintaining global health funding; immediately addressing the growing threat of child malnutrition by supporting the Child Nutrition Fund, a new platform that coordinates donor financing for nutrition; and governments fully funding the established institutions that have proven effective at protecting millions of lives each year. These institutions include Gavi, the Vaccine Alliance, which is due to hold its next funding replenishment in 2025; and the Global Fund to Fight AIDS, Tuberculosis and Malaria, which is expected to also hold its replenishment next year. "If we do these three things, we won't just usher in a new global health boom and save millions of lives—we'll also prove that humanity can still rise to meet our greatest challenges," Gates writes. The report also shines a light on the catastrophic economic costs of malnutrition and highlights solutions that can help mitigate them. According to the World Bank, the cost of undernutrition is US$3 trillion in productivity loss every year, because malnutrition stunts people's physical and cognitive abilities. In low-income countries, that loss ranges from 3% to 16% (or more) of GDP, which amounts to a permanent 2008-level global recession every year. Proven Tools Exist Today "The best way to fight the impacts of climate change is by investing in nutrition...Malnutrition makes every forward step our species wants to take heavier and harder," Gates writes. "But the inverse is also true. If we solve malnutrition, we make it easier to solve every other problem. We solve extreme poverty. Vaccines are more effective. And deadly diseases like malaria and pneumonia become far less fatal." The report highlights proven tools that are helping solve malnutrition, building people's resilience to the worst impacts of climate change, and further driving down childhood deaths. They include: New agricultural technologies that are producing up to two to three times more milk and safer milk, which can prevent millions of cases of child stunting by 2050. Modeling shows that in India, Ethiopia, Kenya, Nigeria, and Tanzania, these technologies can prevent 109 million cases of child stunting by 2050. Efforts to scale up new ways of fortifying pantry staples, such as salt and bouillon cubes, can reduce millions of cases of anemia and prevent deaths due to neural tube defects. In Ethiopia, a new process to fortify salt with iodine and folic acid could lead to a 4% reduction in anemia and could eliminate up to 75% of all deaths and stillbirths due to neural tube defects. In Nigeria, fortifying bouillon cubes with iron, folic acid, zinc, and vitamin B12 could avert up to 16.6 million cases of anemia and up to 11,000 deaths from neural tube defects. Efforts to provide a high-quality prenatal vitamin for pregnant women could save almost half a million lives and improve birth outcomes for 25 million babies by 2040. Adopting multiple micronutrient supplements (MMS) costs as little as $2.60 for an entire pregnancy in all low- and middle-income countries. The report also highlights how promising new research into the microbiome can improve people's health. Studies indicate that better gut health can help children absorb nutrients, develop strong immune systems, and grow as they should to thrive. A deeper understanding of gut health, Gates writes, has the potential to change not just how the world treats malnutrition but also overnutrition, which impacts wealthy countries. This year's report also features essays from farmers and experts on the frontlines of the malnutrition crisis, who explain the impacts these tools are making in their communities, including Sushama Das, a dairy farmer in Astaranga, India; Coletta Kemboi, a dairy farmer in Maili Nne, Kenya; Ladidi Bako-Aiyegbusi, director of nutrition at the Nigerian Ministry of Health and Social Welfare and leader of a large-scale effort to fortify bouillon cubes; Dr. Sabin Nsanzimana, Rwandan minister of health and leader of efforts to ensure all Rwandan women have access to MMS; and Dr. Víctor Aguayo, director of child nutrition and development at UNICEF. Read their comments and the full press release here: . About the Bill & Melinda Gates Foundation Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people's health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Mark Suzman, under the direction of Co-Chairs Bill Gates and Melinda French Gates and the board of trustees. About Goalkeepers Goalkeepers is the foundation's campaign to accelerate progress towards the Sustainable Development Goals (Global Goals). By sharing stories and data behind the Global Goals through an annual report, the Gates Foundation hopes to inspire a new generation of leaders—Goalkeepers who raise awareness of progress, hold their leaders accountable, and drive action to achieve the Global Goals. About the Global Goals On September 25, 2015, at the United Nations headquarters in New York, 193 world leaders committed to the 17 Sustainable Development Goals (Global Goals). These are a series of ambitious objectives and targets to achieve three extraordinary things by 2030: end poverty, fight inequality and injustice, and fix climate change. Media contact: [email protected] Photos from the report WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The FDA specifically chided Zydus for failing to suss out the cause of cross contamination incidents—including with glass particulates—as well as poor safeguards against microbial contamination and subpar production and process controls. Last week, Zydus Lifesciences confirmed the receipt of an FDA warning letter at its Waghodia plant in Gujarat, India, marking the latest in a string of production reprimands for the Indian drugmaker.Now, more details about what FDA investigators uncovered have come to light.The warning letter, which was posted to the FDA’s website on Tuesday, outlines three major manufacturing slights turned up during an inspection in April of this year. Zydus received the Warning Letter after previously being slapped with an FDA Form 483, which the company responded to in mid-May.The FDA specifically chided Zydus for failing to suss out the cause of cross-contamination incidents—including with glass particulates—as well as poor safeguards against microbial contamination and subpar production and process controls.On the first observation, FDA inspectors noted that Zydus failed to sufficiently investigate glass particulate contamination in multiple batches of its cyanocobalamin injection, which is used to treat and prevent a lack of vitamin B12.Zydus relied on visual inspections of the drug vials in question and ultimately released batches of the product without identifying the root cause of the issue, “even though there was potential for glass contamination,” the FDA said.To make matters worse, Zydus’ operators that carried out the visual inspections on the cyanocobalamin vials “were not adequately qualified for their ability to identify these defects,” the FDA continued.Zydus informed the FDA that it stopped manufacturing the vitamin deficiency injection in August of 2022, adding that it had not received any complaints about glass found in the product.Still, the FDA viewed Zydus’ response as inadequate, arguing that a “lack of customer complaints alone is neither a verification of a robust quality system nor indication that you have appropriate process controls in place.” Zydus also failed to tie up other cross-contamination concerns beyond the glass snafu, according to the FDA.For instance, Zydus suffered "multiple cross-contamination events” largely tied to products manufactured with shared equipment that wasn’t adequately cleaned, the regulator said. The agency specifically flagged a July 2024 recall tied to cross-contamination at the drugmaker.As for Zydus’ microbial contamination oversights, the FDA dinged the drugmaker for “poor aseptic behavior,” with investigators flagging “multiple instances” of poor aseptic techniques during the start-up and filling of certain injectable drug batches.Given the nature of Zydus’ production shortfalls, the FDA has recommended the company enlist a consultant to help bring its manufacturing standards up to par.Zydus’ warning letter marks the latest writeup in a string of manufacturing wrist-slaps for the company. In early May, the FDA hit Zydus’ site in Gujarat with a Form 483, citing 10 observations around poor production protocols.Three weeks prior to that rebuke, Zydus’ facility in Matoda, India, received a separate Form 483 that yielded four observations, including the company’s failure to clean and maintain equipment.