FDA Collaboration Seeks To Speed Development Of Pneumococcal Vaccines For Children In Developing Countries
The U.S. Food and Drug Administration (FDA) today announced a collaboration with PATH to advance development of a vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia. Worldwide, the bacterium also causes infections of the brain ( meningitis ), blood (sepsis), and middle ear ( otitis media ) and each year kills about 1 million children younger than 5 years of age. The collaboration aims to improve the techniques used to produce effective, safe, and affordable vaccines against pneumococcal disease for children in the developing world. PATH is an international nonprofit organization based in Seattle that creates sustainable, culturally relevant, and affordable solutions to help communities worldwide to break cycles of poor health. The collaborative project, expected to run for two years, is being conducted under the Cooperative Research and Development Agreement (CRADA) program. The program allows federal laboratories and businesses to form partnerships that help expedite research activities.
The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture, is working closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infection associated with certain salami products. The CDC reports that 202 people have been infected with a matching strain of Salmonella Montevideo in at least 42 states and the District of Columbia. Recently, the CDC and public health officials in multiple states conducted an epidemiologic study by comparing foods eaten by 41 ill and 41 well persons. Preliminary analysis of this study has suggested pepper-coated salami as a possible source of illness: see here. On Jan. 23, 2010, Daniele International Inc. recalled ready-to-eat varieties of Italian sausage products, including salami, which is regulated by the USDA: see here. The recalled meat products have an extended shelf life up to one year. Consumers are advised to check the USDA list of the recalled products to make sure they do not have any of them in their homes.
MedImmune announced that clinical results of its pivotal multinational, randomized, double-masked trial for motavizumab have been published in the current issue of the peer-reviewed publication, Pediatrics: Official Journal of the American Academy of Pediatrics. Motavizumab is an investigational monoclonal antibody (MAb) being evaluated by the FDA for its potential to prevent serious disease caused by respiratory syncytial virus (RSV) among infants at high risk. The phase 3, pivotal trial assessed the safety and RSV hospitalization in 6, 635 preterm infants aged six months or younger at enrollment or children aged 24 months or younger with chronic lung disease of prematurity who received either 15 mg/kg palivizumab or motavizumab monthly. Secondary endpoints included outpatient medically attended lower respiratory tract infections (MALRIs), RSV-specific MALRIs, otitis media, antibiotic use, development of anti-motavizumab antibodies and motavizumab serum concentrations. In this first head-to-head trial, motavizumab demonstrated non-inferiority, but not superiority, to Synagis ®
In collaboration with a multinational team, Queensland Institute of Medical Research (QIMR) scientists, Associate Professor Don Gardiner, Dr Katharine Trenholme, and team, have identified a new way to kill the parasites that cause malaria - a disease that kills over 1 million people every year. "We have examined the structure of an enzyme that allows the parasite to obtain nutrients from the blood, " said Associate Professor Gardiner. "If we can make a drug that will stop this enzyme from working properly, we can essentially starve the parasites to death." Associate Professor Gardiner and his team have been studying the structure of this enzyme, and this latest research helps us to understand how it functions, and which drugs would be likely to work on this enzyme, killing the parasite. "Using X-rays we could see the way the enzyme worked. We also added compounds to block the action of the enzyme, and showed without the enzyme, the parasites can no longer survive." Associate Professor Gardiner hopes this will lead to alternative therapies for malaria.
Oculus Innovative Sciences Introduces Microcyn R Solution For Use In Post-Surgical Wounds To U.S. Hospitals And Physicians
Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), a commercial medical technology company that designs, produces and markets safe and effective tissue care products based upon the Microcyn® Technology platform, unveiled Microcyn Solution with preservatives, at the New York Podiatric Clinical Conference & Exhibition being held in downtown Manhattan, January 29-31. The Microcyn® Solution for professional use is intended for the irrigation and management via debridement of post-surgical wounds. Available in 500 mL and 990 mL units with attached pharmasling® hangers, Microcyn Solution has no known drug/treatment interactions or contraindications; is non-foaming and safe to use around nose, mouth and eyes; does not contain antibiotics and will not facilitate bacterial resistance. With a laboratory-proven inactivation of bacteria, fungus and spores in-solution, Microcyn delivers a six-log reduction of MRSA, VRE, Pseudomonas, Acinetobacter and many other pathogens in just 30 seconds as labeled and cleared by the FDA.
PATH Commends The Bill Melinda Gates Foundation For Their Outstanding New Commitment To Fund Vaccine Innovation And Delivery
Vaccination may be the most effective public health intervention of all time - especially in low-income countries, where many families can't access or afford health care when they are sick. On Friday, January 29, speaking at the World Economic Forum in Davos, Switzerland, Bill and Melinda Gates announced a new ten-year Gates Foundation commitment to funding vaccine development and delivery. "The commitment announced by Bill and Melinda Gates today will have a tremendous impact on children and families in the poorest areas of the world, " said Dr. Christopher Elias, president and CEO of PATH. "PATH is committed, as is the Bill & Melinda Gates Foundation, to letting no child die from a preventable disease, and we are heartened by their continued efforts to move us one step closer toward a world where health is within reach for everyone." As one example of the power and promise of vaccines, the New England Journal of Medicine published research results from Mexico that demonstrate a reduction in diarrheal disease deaths following rotavirus vaccine introduction.
Bill and Melinda Gates announced Friday during the World Economic Forum in Davos, Switzerland, that their foundation would commit $10 billion over the next decade to research, develop and deliver vaccines for the world's poorest countries, the New York Times reports (McNeil, 1/29). The Gateses "said they hope the commitment would spur support by governments, corporations, and other donors for vaccinations efforts, " the Chronicle of Philanthropy writes (Wilhelm, 1/29). The Bill & Melinda Gates Foundation's commitment is in addition to $4.5 billion the foundation has already allocated to vaccines and "comes amid growing worries at the World Health Organization and other health groups that funding shortfalls will stifle the distribution of promising new vaccines and allow diseases like polio to spread in new areas, " the Wall Street Journal reports (Guth, 1/28). Bloomberg writes that the foundation used a model developed by a consortium lead by "the Johns Hopkins Bloomberg School of Public Health to project the impact of vaccines on childhood deaths over the next decade.
Medical equipment used for diagnosis of patients with heart disease and cancer could be a key weapon in stopping nuclear waste seeping into the environment, according to new research. A team of scientists from the Universities of Manchester and Leeds have joined forces with experts in nuclear medicine at Manchester Royal Infirmary, using medical gamma-ray cameras to track radioactive isotopes in soil samples from a US civil nuclear site. This is the first time the technique, which is used in hospitals for heart, bone and kidney scanning, has been used to study the environmental behaviour of nuclear waste - and its success could help scientists find new ways of using bacteria to control the spread of radioactivity. Radioactive isotopes of the element technetium (Tc) are produced in bulk by nuclear facilities, while a specific isotope of Tc with a very short life is routinely used as a medical tracer in human bodies. Nuclear fission of Uranium has released tonnes of Tc from nuclear facilities over the past decades, with the element remaining radioactive for thousands of years.
Vaccine Research: Gates Foundation Announcement Commended By IVAC Executive Director Dr. Orin Levine Commends
The Bill & Melinda Gates Foundation hasvannounced that it will dedicate $10 billion over the next ten years to support vaccine research, development and delivery throughout the developing world. This commitment is unprecedented. Preventable diseases such as pneumonia, diarrhea and malaria take the lives of 5 million children worldwide every year, mostly in low-income countries, simply because life-saving vaccines don't reach those who need them most. Today's commitment from the Gates Foundation promises to take the biggest step yet toward addressing this global inequity. "Today's announcement is a major boost for global health and vaccines. The Bill & Melinda Gates Foundation has once again set the bar for results-driven aid. By aiming at pneumonia, diarrhea, and malaria, the funding will save millions of lives, " said Orin Levine, executive director of IVAC. "But the Gates Foundation cannot achieve the full promise of vaccines on its own. Manufacturers must increase their investments in vaccine research and development, donor countries must mobilize to help fund new vaccines, and developing countries must make the investments and take the steps necessary for delivering life-saving vaccines to their children.
Senate Foreign Relations Committee Hearing Examines Aid To Haiti, Rebuilding; Senators Introduce Legislation
At a Senate Committee on Foreign Relations hearing on Thursday and in a "separate teleconference by relief organizations, " officials said international aid to Haiti has been delayed by the "island nation's inept government, a lack of coordination by aid organizations and the legacy of past U.S. policy failures, " McClatchy/Miami Herald reports. At the hearing, Paul Farmer, the U.N. deputy special envoy to Haiti pointed to disconnect between relief efforts and the country's ability to take in the aid, according to McClatchy. Farmer also said, "Where we are creating 4, 000 jobs in cleaning rubble, we must create 40, 000 jobs." He added, "We must hasten our efforts to get tents, tarpaulins and latrines or composting toilets to Haiti." If the poor sanitation situation continues, cholera and other diseases could spread, according to Farmer, the news service reports (Sahoo, 1/29). "Asked by the panel's chairman Senator John Kerry how much of the city needed rebuilding, Farmer replied: 'The majority of it.