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FDA expert: Universal flu vaccine still 5-10 years off

first_imgFeb 13, 2013 (CIDRAP News) – Top federal health officials who testified on Capitol Hill today said the nation has much better influenza defenses today than it had 10 years ago, but one of them predicted that a “universal” flu vaccine is probably still 5 to 10 years away.Officials from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) pointed to increases in flu vaccine production capacity and newly approved flu vaccines as signs of progress, but they also made clear that the goal of a vaccine offering broader, longer-lasting protection is still distant.The hearing before the House Energy and Commerce Subcommittee on Oversight and Investigations focused on the current flu season and flu preparedness generally. The panel heard from CDC Director Thomas Frieden, MD, MPH, FDA Chief Scientist Jesse Goodman, MD, MPH, and Marcia Crosse, PhD, healthcare director for the Government Accountability Office (GAO). The session was webcast.The hearing also featured some questions about the potential effects of the “sequester” budget cuts scheduled to hit in March. Frieden and Goodman vowed that their agencies will do the best they can but gave no specifics on how the cuts will be handled.A lengthy questWhen one panel member asked Goodman how close scientists are to developing a universal flu vaccine, he replied that he is more optimistic than he was a couple of years ago. If some recent developments pan out, he added, “It’s possible we could have some real leads in this direction in the next 5 to 10 years, but it’s not something that’s just on the horizon.”Later, Rep. Michael Burgess, MD, R- Tex., vice chairman of the committee, pressed Goodman further, saying that a universal vaccine was talked about in 2005. “How close are we?” he asked.”Nature is very tricky and as this is a very crafty virus, so I’d be very hesitant to predict,” Goodman replied. “I think the earliest we’d begin to see something with clinical benefit might be 5 to 10 years. . . . There’s some exciting progress, but there’s a ways to go.””This is not for lack of trying, this is because this is a hard scientific problem,” he added.Burgess asked him if a universal vaccine is still a worthwhile goal. “Absolutely,” he replied. “Can you imagine if we had a world where we didn’t have flu pandemics?”Existing flu vaccines target the head of the virus’s hemagglutinin (HA) protein, which evolves constantly, requiring reformulation of the vaccine each year to keep pace with the circulating strains. The holy grail of flu vaccine development is a product that would target a part of the virus that is the same among different strains, so that one vaccination could protect against a variety of strains, including novel strains, for several years or longer.The latest vaccinesIn recent months the FDA has approved vaccines that mark advances in flu vaccine production technology, but they still target the HA head.As Goodman noted in his written statement, Novartis’s Flucelvax, approved in November, is the first US-licensed flu vaccine grown in cell culture instead of chicken eggs. And last month the FDA approved Flublok, made by Protein Sciences Corp., the first US flu vaccine made with recombinant DNA technology. The process uses an insect virus grown in insect cells to make the target HA.Frieden, in commenting on the new vaccines and related developments in vaccine manufacturing, called them “useful tweaks but not breakthroughs in terms of a longer-lasting vaccine.”Goodman observed that Flucelvax eliminates the need for a large supply of eggs and may allow a faster startup of vaccine manufacturing, while Flublok doesn’t require use of the actual virus to start production, which could be very important in the event of a pandemic.Commenting on general flu preparedness, Goodman noted that the number of companies making flu vaccine for the United States has reached seven, versus only three a decade ago. The more than 140 million doses of vaccine produced this year represent “a dramatic improvement from a few years ago,” he said.Along the same lines, Crosse said CDC and global flu surveillance have improved in the past decade. “Across the board we are in much better shape than 10 years ago, but there’s still room for improvement,” she said.But she added that surge capacity is still a big challenge: “Emergency rooms are flooded every winter with people with flu, norovirus, other kinds of infectious diseases. That capacity has not significantly improved.”Flu season past its peakIn an update on the current busy flu season, Frieden said activity has peaked and is beginning to decline, but will continue for several weeks. He added that hospitalizations of elderly people with lab-confirmed flu are about twice as high as usual.”The flu shot is not as effective as we’d like and is less effective for the elderly,” he said. The CDC recently estimated the effectiveness of this year’s vaccine at 62% overall.Noting that A/H3N2 is the dominant flu strain in the US this year, Frieden said that for unclear reasons, such seasons are harder on the elderly. That was the case in 2003-04 and in 2007-08, he added.Goodman told the panel that this year’s vaccine is well-matched to the circulating flu strains. “The issue is the severity of the virus and the number of unvaccinated people,” he said.He didn’t mention recent suggestions that the match between the vaccine and circulating strains may be less important than generally supposed. For example, the 2009 pandemic H1N1 vaccine was very well-matched to the virus, yet its effectiveness was estimated at 56%.Frieden told the panel that overall flu vaccine coverage this season is roughly 40%. “We’d like to see at least an 80% vaccination rate, and obviously higher is better,” he said.Impending budget cutsCommittee members noted that the automatic budgets scheduled to take effect Mar 1—unless Congress agrees on an alternative approach—will be 5.2% for the FDA and CDC. They asked the health officials how the cuts would affect their agencies.Frieden said more than two thirds of the CDC’s budget goes to state and local health departments, so they are likely to be affected. “With fewer resources we’d have less capacity to detect and respond [to outbreaks] and to develop better tools in the future,” he said.Goodman said, “A substantial cut . . . would affect our science and highly interactive review processes for new technologies. It would also affect our user-fee programs.”Burgess advised the health officials that their agencies should be able to adjust to lower budgets, just as businesses routinely do. “I think if you’re not doing that in your agencies, I’d encourage you to do so. I felt obligated to make that editorial statement,” he said.Later, Rep. Kathy Castor, D-Fla., came to the agencies’ defense, saying, “It’s important to remember we’ve already cut the budget of the CDC and FDA. What you’re doing is cutting into their core missions.””We have a responsibility to the American public to get them vaccinated, to get them all the tools to ward off disease,” she added. “It’s just wishful thinking to say, ‘You can accept more budget cuts and more budget cuts.'”White House Office of Management and Budget officials have told senior federal science officials not to discuss budget cuts forced by the sequestration, according to a news story published today in Nature.On another topic, Rep. Tim Murphy, R-Pa., chair of the committee, said the panel is awaiting FDA documents concerning the recent outbreak of fungal meningitis linked to injectable steroids. He said the committee sent a letter to FDA Commissioner Margaret Hamburg 2 weeks ago requesting all the FDA’s relevant documents by Feb 25. He asked Goodman to remind Hamburg of the request.See also: House subcommittee hearing pageJan 11 CIDRAP News story “CDC’s early-season look finds flu vaccine 62% effective”Nature News story on sequesterlast_img read more

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Commissioner Garcia Richard: Holtec International Misrepresentations Raise Serious Safety Concerns For Proposed Nuclear Storage Facility In New Mexico

first_imgHoltec has falsely claimed to have secured agreements from oil and gas operators at or around the site to restrict these activities, specifically assuring the NRC that oil and gas drilling will only occur at depths greater than 5,000 feet. However, there are no such agreements containing these restrictions in place with oil and gas lessees at the site or the State Land Office. One agreement has been made with Intrepid Mining, LLC, a potash mining company, but that agreement has not been approved, as required by lease terms, by the State Land Office. SANTA FE ― Commissioner of Public Lands Stephanie Garcia Richard sent the attached letter Wednesday to Holtec International President and CEO Krishna Singh. STATE News: Commissioner Garcia Richard released the following statement regarding the letter and the Holtec proposal: “This is not the right site for high-level nuclear storage. Holtec has only provided bits and pieces of information, and what they have provided has been incomplete and at times misleading. We are talking about storing over 120,000 metric tons of nuclear waste in an extremely active oil field without a clear picture of the potential hazards of that combination. For example, I’m not aware of any studies demonstrating the safety of fracking beneath a nuclear storage site. There is no guarantee that high-level nuclear waste can be safely transported to and through New Mexico. There is no guarantee that there won’t be a hazardous interaction between the storage site and nearby oil, gas, and mining activities. There is no guarantee that this site will truly be ‘interim’ and won’t become the permanent dumping ground for our nation’s nuclear waste. I understand that we need to find a storage solution, but not in the middle of an active oil field, not from a company that is misrepresenting facts and unwilling to answer questions, not on our state trust lands.”center_img Given the State Land Office’s mineral ownership of the land and the lack of restrictions on mineral development at the site, any claim that activities at the site have been restricted is incorrect. Holtec’s submissions to the NRC, including the company’s Facility Environmental Report and Safety Analysis Report, include statements that have the potential, intended or not, to mislead federal regulators as they consider the safety implications of the proposal. The letter outlines a number of concerns regarding Holtec’s proposal for a nuclear storage facility in Lea County – specifically safety concerns that have not been addressed and misrepresentations made by the company in its filings with the Nuclear Regulatory Commission (NRC). The surface and mineral estate are split in ownership at the proposed location, with the Eddy-Lea Energy Alliance, LLC owning the surface land and the State Land Office owning the mineral estate. The proposed nuclear storage site is located in the middle of the Permian Basin, one of the world’s most productive oil and gas regions. Nearly 2,500 oil, gas, and mineral wells or sites are operated by 54 different businesses or entities within a 10 mile radius of the proposed site. Locating an interim nuclear storage site above active oil, gas, and mining operations raises serious safety concerns.last_img read more

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Nel ASA launches updated website

first_imgSubscribe Get instant access to must-read content today!To access hundreds of features, subscribe today! At a time when the world is forced to go digital more than ever before just to stay connected, discover the in-depth content our subscribers receive every month by subscribing to gasworld.Don’t just stay connected, stay at the forefront – join gasworld and become a subscriber to access all of our must-read content online from just $270.last_img

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Why government is taking wrong approach to cutting lawyers’ jobs

first_img Government Legal Service facing deep cuts As the Gazette reported this week, the government’s spending review, to report next month, will lead to substantial cuts in the ranks of the 2,000-strong Government Legal Service.The way these cuts are to be made points to future problems in maintaining the effectiveness of the GLS, and highlights problems in the way the GLS is structured and serves government. First, there is a real issue around retaining the most skilled professionals. As is happening across the civil service, there will be many opportunities offered for voluntary redundancy. Those first in the queue tend to be the professionals who can most easily get another position elsewhere. Voluntary redundancy is the politically easy option (in both business and policy terms). But it takes away legal department heads’ ability to design the shape of team they need. That lack of control plays in to a second point. Treasury Solicitor Paul Jenkins has said in the past that his ambition is to outsource the simpler instructions that can be commoditised, retaining in-house more strategic and demanding work. The logic is compelling, and matches the plan of many of the best general counsel in the private sector. But that would point to proportionately more cuts at the bottom of the GLS pyramid than the top – and this won’t happen. For example, on the evidence so far, SCS Grade 5 (deputy directors) will be cut before lower grades, and cut in proportion. The third and most important issue surrounding indiscriminate cuts is a public interest one. A legal department focused on risk management starts not with a shopping list of the lawyers it wants, or the number it needs to lose, but the risks it needs to cover. Inadequate ‘coverage’ increases the risk of litigation, fraud, contracts that fail and so on – whereas adequate coverage can show a return on investment. These points are not special pleading for government lawyers – GLS members don’t expect exemption from public spending cuts. But it’s worrying that no one in government or Whitehall has focused on what sort of reduced GLS would be fit for purpose. As the Gazette reported yesterday, the attorney general, notional head of the GLS, is taking no lead here. And though Tsol is seen as the senior player among the legal departments serving government, it has no role here either. Related articleslast_img read more

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Silvasti completes loco-motion

first_imgThe locomotive, called Ukko-Pekka, was manufactured in 1955 by Lokomo and was gifted to the municipality of Oulainen by the Haapamäki Museum Locomotive Association.The 83-ton (75.3-tonne) locomotive measured 22.25 m in length and had a maximum width of 4 m. The locomotive’s 35-ton (31.75-tonne) coal wagon was moved separately.The machine was towed along railway tracks to Oulainen, before Silvasti lifted it onto a trailer for the last leg of its journey.Silvasti is a member of the Cargo Equipment Experts (CEE) Network in Finland. www.silvasti.com www.cargoequipmentexperts.comlast_img read more

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Barnhart plans Days Machinery Movers acquisition

first_imgThe Days Corporation subsidiary provides rigging services, including machine installation and levelling; equipment setting such as anchoring, alignment and grouting; millwright work, including fabrication and ironworking; and plant reorganisation and relocation. Equipment includes flatbed, stepdeck and double-drop trailers; a 450-ton (408-tonne) lifting capacity gantry system; forklifts; and Versa-Lift and TriLifter units.The acquisition will further enhance Barnhart’s presence in the Midwest, where it already operates several branches in Indiana, Illinois, Iowa, Nebraska, Michigan and Ohio. www.barnhartcrane.comdaysmachinerymovers.comlast_img read more

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Transmash and Bombardier sign partnership

first_imgBOMBARDIER Transportation’s Chief Operating Officer Wolfgang Tölsner and Transmash Holding President Dmitri A Komissarov have signed a €12·5m agreement establishing two equally-owned joint ventures in Russia. Signed in the Black Sea resort of Sochi on May 25 during the Strategic Partnership 1520 conference, the agreement covers the creation of an engineering joint venture in Moscow this autumn which will develop advanced propulsion technology and rolling stock components. ‘For the first time in Russian railway manufacturing, a technologically-independent engineering centre will be created,’ Komissarov told delegates including RZD President Vladimir Yakunin. ‘Together with our foreign partners, it will develop new advanced products based on mutual experience, knowledge and technologies, not only for the Russian market, but also for other countries.’A manufacturing joint venture will be established at Transmash Holding’s plant in Novocherkassk, manufacturing traction converters based on Bombardier’s Mitrac technology. Production will begin with advanced converters required for a new generation of RZD locomotives with asynchronous traction, and an output of least 600 converters is planned for 2012. Bombardier will support the start-up of production to ensure that work is undertaken to the latest European standards, and provide training in western Europe for Russian staff.Law firm Hogan & Harston advised Transmash on the corporate, tax and intellectual property aspects of the ventures.Yakunin and Komissarov signed a contract in Sochi for the development and delivery of 806 EP20, EP2, EP3 and EP4 locos with asynchronous traction by 2015. RZD Vice-President Valentin Gapanovich said the €4m multi-system EP20 locos would make possible a saving of 16 million kWh per year at a time when RZD is seeking to lower its energy costs. RZD is currently responsible for around 5% of total electric power consumption in Russia, with its usage expected to grow 10% by 2010. Traction power and fuel make up 16% of RZD’s total operational expenditure.last_img read more

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Call to end migration of trained Caribbean nurses

first_imgThe Chair of the Regional Nursing Body (RNB), Nester Edwards, has called for urgent action to address the migration of nurses and midwives from the Caribbean.Addressing the RNB’s 45th annual general meeting in Georgetown, Guyana, the Grenada Chief Nursing Officer, said  “Experienced nurses are leaving in large numbers.Renewed active migration“Chief Nursing Officers (CNOs) can testify to a certain renewed active migration taking place where international agencies are coming in a secretive manner and recruiting our personnel”, she told the gathering of CNOs, representatives of Nursing Councils, universities and international development partners. We need to bring this issue back to the table and talk about implementing those strategies”, she added.Among the recommendations to deal with the situation include the need for strong advocacy for the implementation of the 2001 Migration Strategy and for a statement to be issued by the RNB to the leadership of the Caribbean Community (CARICOM) highest decision-making body.Need comprehensive HR strategyGuyana’s Minister for Public Health, Volda Lawrence, in her address underscored the urgent need for a comprehensive human resource strategy that will boost the present workforce and prioritize the improvement of nursing education in keeping with current trends and best practices in the field.  “We cannot achieve the goal of our citizens being the healthiest in the Caribbean and the Americas, if we do not have at our disposal a core of highly qualified and professional dedicated health workers.”The meeting which ends on Friday, will provide an opportunity for reviewing progress and challenges in the sector, including an update on the collaboration with the Caribbean Examinations Council (CXC) with respect to the CXC-Managed Regional Examination for Nurse Registration (RENR).The organizers said that it is hoped the meeting here will also agree on a number of initiatives including the ratification of the definition, regulation and Scope of Practice of Assistive Nursing Personnel and, in partnership with the Pan American Health Organization (PAHO), the Regional Strategic Framework updated and finalized.last_img read more

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Digicel customer wins Samsung Galaxy Tablet

first_img Tweet 31 Views   no discussions Sharing is caring! Share LocalNews Digicel customer wins Samsung Galaxy Tablet by: – October 8, 2012center_img Share Share Lucky winner Rebecca Edwards receives prize from Digicel’s representatives Nathalie Walsh Walsh (left) and Lorna Charles (right)Monday October 8, 2012 Digicel continues on its commitment to deliver the very best prepaid and postpaid service to its many customers. The company is known for raising the bar through its affordable and easy postpaid plans and attractive rates, making it more economical for its valued customers on its network.During the month of September Digicel postpaid customers who settled their bills by the 28th of the month were eligible for a chance to win a brand new state of the art Samsung 10” Galaxy Tablet.From the many customers who qualified, the lucky winner who walked away with the Samsung Galaxy Tablet prize for the month of September is Rebecca Edwards of Canefield.“It feels good to be a Digicel postpaid customer, I am happy with the service. I always pay my Digicel postpaid bills on time. I feel so happy to have won this lovely gift from Digicel”, said Mrs Rebecca Edwards.“Digicel congratulates Rebecca on her winning. Our postpaid customers continue to enjoy real value for their money with flexible plans from Digicel and great benefits such as, 5% discount every month, free local talk every weekend, free regional talk every time, per second billing and roll over minutes”, said Nathalie Walsh, Digicel Dominica Sales and Marketing Manager. There are a lot more prizes to be won from The Bigger, Better Network – Digicel. Customers are encouraged to settle their postpaid bills by the 28th of October to qualify for a chance to win a BlackBerry Playbook. Press releaselast_img read more

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Flexible Device to Convert Energy from Wi-Fi Signals into Electricity

first_imgImagine a world where smartphones, laptops, wearables, and other electronics are powered without batteries. Researchers from MIT have taken a step in that direction, with the first fully flexible device that can convert energy from Wi-Fi signals into electricity that could power electronics.Devices that convert AC electromagnetic waves into DC electricity are known as “rectennas.” The researchers demonstrate a new kind of rectenna, described in a study appearing in Nature today, that uses a flexible radio-frequency (RF) antenna that captures electromagnetic waves – including those carrying Wi-Fi – as AC waveforms.The antenna is then connected to a novel device made out of a two-dimensional semiconductor just a few atoms thick. The AC signal travels into the semiconductor, which converts it into a DC voltage that could be used to power electronic circuits or recharge batteries.In this way, the battery-free device passively captures and transforms ubiquitous Wi-Fi signals into useful DC power. Moreover, the device is flexible and can be fabricated in a roll-to-roll process to cover very large areas.Promising early applications for the proposed rectenna include powering flexible and wearable electronics, medical devices, and sensors for the “internet of things.” Flexible smartphones, for instance, are a hot new market for major tech firms. In experiments, the researchers’ device can produce about 40 microwatts of power when exposed to the typical power levels of Wi-Fi signals (around 150 microwatts). That’s more than enough power to light up an LED or drive silicon chips.Another possible application is powering the data communications of implantable medical devices, says co-author Jesús Grajal, a researcher at the Technical University of Madrid. For example, researchers are beginning to develop pills that can be swallowed by patients and stream health data back to a computer for diagnostics.All rectennas rely on a component known as a “rectifier,” which converts the AC input signal into DC power. Traditional rectennas use either silicon or gallium arsenide for the rectifier. These materials can cover the Wi-Fi band, but they are rigid. And, although using these materials to fabricate small devices is relatively inexpensive, using them to cover vast areas, such as the surfaces of buildings and walls, would be cost-prohibitive. Researchers have been trying to fix these problems for a long time. But the few flexible rectennas reported so far operate at low frequencies and can’t capture and convert signals in gigahertz frequencies, where most of the relevant cell phone and Wi-Fi signals are.To build their rectifier, the researchers used a novel 2-D material called molybdenum disulfide (MoS2), which at three atoms thick is one of the thinnest semiconductors in the world. In doing so, the team leveraged a singular behavior of MoS2: When exposed to certain chemicals, the material’s atoms rearrange in a way that acts like a switch, forcing a phase transition from a semiconductor to a metallic material. The resulting structure is known as a Schottky diode, which is the junction of a semiconductor with a metal.Parasitic capacitance is an unavoidable situation in electronics where certain materials store a little electrical charge, which slows down the circuit. Lower capacitance, therefore, means increased rectifier speeds and higher operating frequencies. The parasitic capacitance of the researchers’ Schottky diode is an order of magnitude smaller than today’s state-of-the-art flexible rectifiers, so it is much faster at signal conversion and allows it to capture and convert up to 10 gigahertz of wireless signals.The reported work provides blueprints for other flexible Wi-Fi-to-electricity devices with substantial output and efficiency. The maximum output efficiency for the current device stands at 40 percent, depending on the input power of the Wi-Fi input. At the typical Wi-Fi power level, the power efficiency of the MoS2 rectifier is about 30 percent. For reference, today’s rectennas made from rigid, more expensive silicon or gallium arsenide achieve around 50 to 60 percent.The team is now planning to build more complex systems and improve efficiency. The work was made possible, in part, by a collaboration with the Technical University of Madrid through the MIT International Science and Technology Initiatives (MISTI).last_img read more

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