Experts: Regulatory issues are main reason for keeping smallpox virus

first_img US urges keeping stockpilesIn recent months experts have published a number of articles arguing for and against destroying the virus stocks. But the US and Russian officials who hold the real power to keep or destroy them have signaled that they’re not ready to get rid of them. The virus samples are held at the US Centers for Disease Control and Prevention (CDC) in Atlanta and Russia’s State Research Center for Virology and Biotechnology in Novosibirsk. May 17 prepared remarks by HHS Secretary Sebelius The conventional smallpox vaccine, consisting of live vaccinia virus, a relative of variola, carries serious risks for some people, such as those who have eczema or weak immunity. Researchers, the report notes, have developed vaccines using attenuated vaccinia virus: modified vaccinia virus Ankara (MVA) and LC16m8. The US government has ordered 20 million doses of MVA (Imvamune) from Bavarian Nordic for the Strategic National Stockpile. In other judgments, the AGIES said live variola virus is not needed for further development of diagnostic tests and there is no public health need to sequence any more virus isolates. The group also said research on safer smallpox vaccines should continue. The WHA, composed of delegates from all WHO member countries, agreed in 1996 that the virus stocks should be destroyed. But the assembly has postponed calling for that step four times in response to the argument that more countermeasures research was needed. The delegates are scheduled to take up the issue on May 20. “We’re concerned that the smallpox virus may still exist outside the official repositories and could be released unintentionally or used as a bioweapon,” Sebelius said. “The WHO’s own review of the smallpox research program concluded definitively that additional research is needed to protect public health should this occur.” Sebelius told reporters that the virus stocks would be kept for at least another 5 years, according to an Associated Press report on her press conference yesterday. Other recent reports have said that Russian officials likewise favor keeping the virus samples. The expert panel, called the Advisory Group of Independent Experts (AGIES), made the recommendation after studying a lengthy report by a WHO committee on progress in smallpox research and development. Says the WHO should seek updated reports from all countries on their stocks of variola virus DNA WHO ACVVR report “Scientific Review of Variola Virus Research, 1999-2010” Countermeasures progressThe ACVVR report, which was released with the AGIES review in December, notes that progress has been made on two safer smallpox vaccines and three smallpox antiviral drugs. SIGA Technologies, maker of ST-246, announced last week that it was awarded a $433 million contract to provide 2 million doses for the US stockpile. The experts expressed doubts about the value of using variola virus to try to duplicate human smallpox in monkeys, saying this has led to “highly artificial models and outcomes that do not resemble human disease” and is also impractical, given the stringent regulations governing such research. Recommends that US and Russian authorities report to the WHO on which segments of variola DNA have been distributed to which laboratories The ACVVR report also notes that three antiviral drugs look promising for smallpox. The drugs—cidofovir, ST-246, and CMX001—inhibit variola replication in cell culture and multiple animal models. CMX001 is a cidofovir “prodrug” that can be given orally. On security issues, the AGIES report: That review, by the WHO’s Advisory Committee on Variola Virus Research (ACVVR), said researchers made significant progress in developing vaccines and antivirals from 1999 to 2010, and it suggested that the continued use of variola virus in testing of these products would permit greater confidence in their efficacy. At the same time, the committee noted that it’s now technically possible to recreate the virus from scratch, since its genome has been sequenced. AGIES takes different viewThe AGIES report does not call for immediate destruction of the virus stocks, but the independent experts clearly saw much less of a case for keeping them. The 10 experts were from India, Oman, Brazil, China, Thailand, South Africa, Kenya, Australia, Germany, and Canada. Keeping samples to enhance researchThe ACVVR’s review of smallpox research says that smallpox vaccines can be tested against other orthopoxviruses in animals but that tests against the smallpox virus itself would provide better assurance of their effectiveness. The report was prepared by leading variola researchers. AGIES report “Comments on the Scientific Review of Variola Research, 1999-2010” “Since smallpox has been eradicated, the efficacy of new generation vaccines will need to be tested using poxviruses related to variola virus in animal protection studies, and safety and immunogenicity studies in humans,” the report states. “However, confidence in the ability of these vaccines to protect against smallpox would be increased by use of live variola virus for in vitro neutralization tests and non-human primate studies.”center_img The report takes a stronger stance on using variola virus in testing of antivirals: “Because smallpox . . . was eradicated by mass vaccination, the effectiveness of these drugs can only be demonstrated using variola virus-infected animal models in non-human primates.” Sebelius said keeping the virus samples is necessary to continue the research, whose results she vowed the United States would share widely. She added, “Let me be clear: We are committed to the eventual destruction of the virus stocks.” “It is now technically possible to synthesize the entire variola virus genome from scratch, using only publicly available sequence information, and to reconstitute infectious virus using currently available techniques of molecular biology,” it adds. The report goes on to suggest identifying a “limited number of strains of variola virus for such testing, and to retain only these for this limited use.” The experts, who were commissioned by the World Health Organization (WHO), recommended in a report released quietly last December that researchers and regulatory authorities should work together to find new ways to test smallpox vaccines and antivirals so that the remaining stocks of variola (smallpox) virus can be destroyed. Calls for new strategies to address the potential for making of the variola virus from scratch, including adoption of national policies It adds that the only reason for trying to develop animal models of smallpox is “to meet the current stringent regulatory requirements.” The experts believe that “a more productive approach would be for the regulatory requirements for vaccine and drug approval for variola virus infection to be reconsidered, given that human infection with the virus no longer occurs.” On the other hand, the report says that the ACVVR’s argument that variola virus may be indispensable for testing antiviral drugs “appears reasonable, at least for in vitro testing.” The report summary states, “Assuming that regulatory issues around vaccine and drug testing are resolved, the only indication for use of live VARV [variola virus] is to test the efficacy of drugs in vitro.” Smallpox as a disease was eradicated in the 1970s, but supplies of the virus have been kept by the United States and Russia since then. Research on vaccines and antivirals has continued out of concern that terrorists might have secret supplies of the virus and try to use it in biological attacks. The panel “noted with concern that the only compelling scientific and public health reason to keep live variola stocks is to meet current restrictive regulatory requirements for vaccine and drug development,” the report states. “It, therefore, recommends that researchers and regulatory authorities meet and jointly define future alternative models for testing vaccines and drugs against variola virus, in preparation for destruction of variola stocks.” May 18, 2011 (CIDRAP News) – When the World Health Assembly (WHA) considers the fate of the remaining stocks of smallpox virus this week, the debate is likely to be framed in part by a report from a group of independent experts that says the only strong reason for keeping the virus is to satisfy strict regulatory requirements for new vaccines and antivirals. While suggesting that keeping the virus stockpiles would enhance countermeasures research, the report also points out that it’s now possible to synthesize the virus. Nearly complete genome information is now available for 48 geographically distinct variola isolates, it says. The ACVVR was less certain about the need to use variola virus to validate new diagnostic tests for smallpox. The report says many diagnostic assays, most of the using nucleic acids, have been developed, but none have been approved for clinical use. “The possible need for live variola virus for regulatory review of assays is being discussed at the time of writing,” it says. See also: The WHO has an emergency stockpile of 32.6 million doses of smallpox vaccine stored in Switzerland, according to an online report related to the WHA meeting. Nearly all (92%) of the stockpile is “second-generation” vaccine. Five member states—France, Germany, New Zealand, the United Kingdom, and the United States—have pledged another 31 million doses to the WHO if needed. “Therefore, AGIES felt that it may be more appropriate to focus on improving the animal models that use infection with other orthopoxviruses,” such as monkeypox, cowpox, rabbitpox, and mousepox viruses, “since these appear to be appropriate and adequate surrogates of human variola virus infection,” the report says. Report of the ACVVR’s 12th meeting in November 2010 Two days ago US officials at the WHA meeting introduced a resolution to retain the virus stocks, US Health and Human Services (HHS) Secretary Kathleen Sebelius said in remarks she prepared for a press briefing yesterday. Report by the WHO Secretariat to the WHA on smallpox stocks issuelast_img read more

U.S. Auto Parts Taps Financial Industry Veteran Barry Emerson as CFO

first_imgCARSON, CA — U.S. Auto Parts, an Internet-direct marketer of automotive aftermarket collision replacement parts and accessories, announced the hiring of Barry Emerson as its new vice president, treasurer and chief financial officer. With more than 20 years of experience in finance management, Emerson will manage its financial affairs along with supporting the strategic planning, future business development and growth. AdvertisementClick Here to Read MoreAdvertisement“I am very excited to be working with the U.S. Auto Parts team and look forward to helping lay the ground work necessary for the company to meet its future growth plans,” Emerson said. “I will work with the executive team to further develop the company’s long-term strategic plan, focusing on profitable growth, enhancement of the internal control environment, and establishing a sound financial infrastructure.” The management at U.S. Auto Parts is very confident in Barry’s financial direction,” stated Sol Khazani, founder of U.S. Auto Parts. “He will be a great asset to the team and we are happy to have him on board.” From 1999 to his current role at U.S. Auto Parts, Emerson was the CFO of Elite Information Group, a fast growing $100 million software developer. Elite’s annual revenue growth averaged nearly 20 percent during his tenure. Prior to Elite he was vice president and corporate controller at Wyle Electronics for 15 years. Wyle was a $1.7 billion public electronics distribution company with international operations. Emerson is a Certified Public Accountant with an MBA in Finance from UCLA. He earned his Bachelors degree in Accounting from California State University, Long Beach. His public accounting experience was gained while working for Arthur Andersen LLP. Advertisement_______________________________________ Click here to view the rest of today’s headlines.last_img read more

Russian in

first_imgTo access this article REGISTER NOWWould you like print copies, app and digital replica access too? SUBSCRIBE for as little as £5 per week. Would you like to read more?Register for free to finish this article.Sign up now for the following benefits:Four FREE articles of your choice per monthBreaking news, comment and analysis from industry experts as it happensChoose from our portfolio of email newsletterslast_img

Wison, VGS Sign LNG FRU Contract

first_imgWison Offshore & Marine announced the award of a binding agreement with Vessel Gasification Solutions (VGS) of New Jersey, USA, for the supply of the industry’s first barge-based floating LNG regasification unit (FRU) to be installed offshore India.The FRU, which will be owned by VGS, will consist of a newbuild, non-propelled barge equipped to perform the regasification and send out of a maximum of 1,000MMscf/d of gas. The facility will be moored on a jetty structure located approximately 8km offshore Andhra Pradesh on India’s eastern coast, to the northeast of the Kakinada Anchorage Port, alongside a permanent floating storage unit (FSU) that will be used as the LNG offloading point for trading tankers. Furthermore, the FRU will be adequately sized to allow for the future expansion of the regasification capability by an additional 750MMscf/d of gas within the next few years in order to meet the rapidly growing natural gas requirements in the region.Under the agreement, Wison Offshore & Marine affiliates will be responsible for the turnkey engineering, procurement, construction, installation and commissioning (EPCIC) of the unit and will lead the project from its Shanghai operational center with construction to be performed at Wison’s wholly-owned fabrication facility located in Nantong, China.“With the execution of this agreement, Wison has allowed VGS to significantly increase the first-mover advantage we have established on India’s East Coast,” said Gaurav Tiwari, President of VGS. “Taken with the appointment of Exmar to operate and manage the Kakinada LNG Import Terminal, along with the finalization of the Project’s insurance structuring, stitching up these three critical milestones keeps with the fast-track timetable with which we are driving the project forward. Now, with Wison and Exmar partnered for the Project’s implementation we can continue to move forward briskly, but also with great certitude.”“We are very excited to be moving forward with VGS on this project and provide another innovative LNG facility to the market,” added L. Dwayne Breaux, President of Wison Offshore & Marine “The FRU will be the integral part of VGS’s plan to meet a significant energy need in the Indian market. The fact that VGS has entrusted the delivery of this unit to Wison is a testament to our strong relationship with this key player in the LNG market and our growing position in the industry as a trusted supplier of LNG facilities.”[mappress]LNG World News Staff, January 21, 2014; Image: VGSlast_img read more

Ian McGlinn vs everybody else

first_imgStay at the forefront of thought leadership with news and analysis from award-winning journalists. Enjoy company features, CEO interviews, architectural reviews, technical project know-how and the latest innovations.Limited access to industry news as it happensBreaking, daily and weekly e-newsletters To continue enjoying, sign up for free guest accessExisting subscriber? LOGIN Subscribe now for unlimited access Get your free guest access  SIGN UP TODAY Subscribe to Building today and you will benefit from:Unlimited access to all stories including expert analysis and comment from industry leadersOur league tables, cost models and economics dataOur online archive of over 10,000 articlesBuilding magazine digital editionsBuilding magazine print editionsPrinted/digital supplementsSubscribe now for unlimited access.View our subscription options and join our communitylast_img read more

Justice minister: we’ll stop weekend courts pilot if critics are right

first_imgNew justice minister Jeremy Wright today said the government would cancel plans for weekend court hearings if the trial proves to be unsuccessful. Wright, in his first public speech since joining the department last month, said it would be ‘crazy’ to pursue the policy nationwide if concerns raised by the profession about the ongoing regional tests proved to be correct. The former criminal barrister told a fringe meeting of the Conservative Party conference that he had met the Bar Council this morning to hear its view that weekend and evening sittings at court would not succeed. But Wright urged sceptics to give the pilot a chance before dismissing it, and said his own experience of the court system had convinced him improvements were necessary and possible. ‘I understand the concerns about weekend courts. Lots of cases won’t work in the evening or weekends but others will. Witnesses have to take several days of time out of work to sit around in a court building only to be called at the end of day three. ‘Asking them to go in on a Saturday might be an advantage to them. We will not be expecting [lawyers] to come in routinely on Sunday mornings but there may be a case for being a little more flexible about what hours we work,’ he said. The minister outlined a number of other efficiency savings he would to introduce in the court process, including reducing the number of papers and calling witnesses – especially police officers – and defendants by video link-up where appropriate. Wright, whose portfolio includes prisons, said the Ministry of Justice was committed to 23% savings on its budget – around £2bn – every year until 2015. The Gazette understands that Chancery Lane has been told that participating courts will choose from a ‘menu of options’, including extended court sittings on weekdays and Saturday afternoons, Sunday court sittings and extended use of virtual courts and video links to prisons. The Law Society, which opposes the scheme, said: ‘It is inappropriate for the courts to sit outside normal business hours and to require solicitors to attend weekend hearings, where there is no emergency and the cases are not of the sort usually undertaken at weekend sittings.’ It said the initiative will increase costs to law firms and ‘will be an expensive way of making the magistrates’ courts less efficient, at a time of decreasing workloads and when all the criminal justice agencies are struggling with budget cuts.’ The Society said it plans to monitor the pilots and gather evidence from solicitors about the problems caused and costs incurred, which it will share with the MoJ when it evaluates the pilots in the new year. Wright denied the MoJ’s savings plans would mean a cap on prisoner numbers and said it was a matter for the courts, rather than ministers, to decide who would go to prison. He did reveal that he would not support any reduction in the number of short sentences passed by magistrates and judges, despite criticism that they offer no rehabilitation to the offender. ‘Short prison sentences do work for public protection,’ he added. ‘There’s no doubt that the reoffending rates for short term sentences is pretty horrendous, but I am not of the view that all those who would have received a short sentence shouldn’t have one.’ Wright said that those expecting immediate reform of the probation and prison service would have to wait. Four new ministers were appointed to the department in David Cameron’s reshuffle last month and Wright said they needed to ‘pause for breath’ before introducing any new legislation.last_img read more

Alyssa Valdez, other PVL stars to visit WVSU

first_imgJohn B. Lacson Foundation Maritime University – Molo SAC Office Iloilo City government Sports Development Division Iloilo National High School Sports Office Ateneo de Iloilo Army & Navy Store (Iloilo Central Market) West Visayas State University Sports Office [av_one_full first min_height=” vertical_alignment=” space=” custom_margin=” margin=’0px’ padding=’0px’ border=” border_color=” radius=’0px’ background_color=” src=” background_position=’top left’ background_repeat=’no-repeat’ animation=”][av_heading heading=’Alyssa Valdez, other PVL stars to visit WVSU ‘ tag=’h3′ style=’blockquote modern-quote’ size=’30’ subheading_active=’subheading_below’ subheading_size=’15’ padding=’10’ color=” custom_font=”]BY ADRIAN STEWART CO[/av_heading][av_textblock size=” font_color=” color=”]Thursday, October 12, 2017[/av_textblock][av_image src=’’ attachment=’120303′ attachment_size=’full’ align=’center’ styling=” hover=” link=” target=” caption=” font_size=” appearance=” overlay_opacity=’0.4′ overlay_color=’#000000′ overlay_text_color=’#ffffff’ animation=’no-animation’][/av_image] [av_textblock size=’18’ font_color=” color=”]BEFORE their exhibition games at the Iloilo Sports Complex, Premier Volleyball League (PVL) on Tour star players are expected to visit the adjacent West Visayas State University (WVSU) in La Paz, Iloilo City on Oct. 17.Their morning visit during “Westival: A Sem-ender Festival” aims to give inspiration to the WVSU students, event organizer Ruding Villaruz told Panay News.Among those seen to grace the university event are Alyssa Valdez, Julia Morado, Myla Pablo, Melissa Gohing, Nicole Tiamzon, Jemenea Ferrer, Amy Ahomiro, Bea Tan, and Jorella De Jesus.In the afternoon, the PVL stars will plunge into action, with Philippine Air Force Jet Spikers taking on Pocari Sweat Lady Warriors at 4:30 p.m. and Creamline Cool Smashers battling Perlas-BanKo Lady Spikers at 6:30 p.m.Tickets for the Iloilo leg exhibition match are still available at the following outlets:Central Philippine University Athletics Office Those who will buy exhibition match tickets at the WVSU Sports Office will have a secured spot during the PVL stars’ school visit, according to the WVSU Student Council./PN[/av_textblock][/av_one_full]last_img read more

Japan qualifies for Beijing Games

first_img GET THE BEST OF THE JAPAN TIMES STUTTGART, Germany – Japan missed out on a place in the women’s team final Sunday but did just enough to secure a berth at next year’s Beijing Olympics after finishing 12th in the qualification standings at the World Gymnastic Championships. The world championships double as qualifiers for Beijing and Japan’s score of 228.175 points meant it narrowly earned a ticket to China. The top 12 finishers qualify for the Olympics. Japan will be appearing in the women’s team event at an Olympics for the first time since the 1996 Atlanta Games. IN FIVE EASY PIECES WITH TAKE 5last_img

FA Cup: Niger Tornadoes Blow Off Rivers United as Kano Pillars Break Down Calabar…

first_img2017 FA Cup finalists, Niger Tornadoes and 2018 finalists Kano Pillars are both through to the finals of the 2019 Aiteo sponsored FA Cup.Rivers United took on Niger tornadoes in a battle of Nigeria Professional Football League (NPFL) sides at the Agege Township Stadium, Lagos while Kano Pillars took on surprise semi-finalists, Calabar Rovers at the Aper Aku Stadium, Makurdi.At the Soccer Temple, in a game filled with early end-to-end action, Eric Frimpong scored first for Tornadoes in the 10th minute, but his lead will only last for six minutes, as Kehinde Samson Adedipe leveled in the 16th minute.Both sides chose to apply caution so as not to concede the next goal, but as cautious as United tried to be, they conceded a foul just outside the penalty box of their half. Ivorian midfielder Dosso Saib stepped up to curl the ball over the wall and beyond the reach of the stretching Rivers United goalkeeper.It would remain like that for the rest of the game as Niger tornadoes held on to reach their second Aiteo Cup final in three years.In the other match of the day, Kano Pillars had to wait until the lottery of penalties before dislodging a stubborn Calabar Rovers side. The game ended 1-1 at regulation time before extending into penalties.Pillars proved superior to their opponents from the South with a 4-1 victory from the spot to advance to their second Aiteo Cup final in two years.Aiteo Cup Semifinal ResultsNiger Tornadoes 2 – 1 Rivers UnitedCalabar Rovers 1(1) – (4) 1 Kano PillarsRelatedTornadoes Evict Giant Killers Smart City as Rivers United Dash Lobi Stars’ Continental DreamJune 29, 2019In “FA Cup”2019 AITEO Cup Final: Kaduna Comes Alive as Pillars, Tornadoes, Amazons, and Angels Battle for GloryJuly 28, 2019In “Federation Cup”FA CUP: Eguma Apologizes To Fans, Blames Tornadoes Defeat On Waterlogged Pitch (AUDIO)July 8, 2019In “NPFl”last_img read more

Hubert Lawrence | Carifta is good for Jamaica

first_imgThe current Jamaican anti-Carifta Games sentiment isn’t new. Jamaica is so dominant at the 48-year-old track and field junior event that some fans might just be bored. Add the tight schedule between the ISSA/GraceKennedy Boys and Girls’ Athletics Championships and the Carifta Trials and between the Games themselves and the Penn Relays this year, and the discontent has been aggravated. However, the Games still play an important role. It is the first opportunity for young Jamaican athletes to experience international competition. The Carifta experience takes them out of familiar surroundings to other countries via air travel, and out of their school teams into a national team. It builds loyalty to the black-green-and-gold. Just as importantly, it simulates what they will experience at the highest level of the sport. EMULATE CARIFTA There’s nothing else quite like it. In fact, international officials, including IAAF President Sebastian Coe, have urged other regions to copy it. Take the Carifta Games off the calendar and you find there isn’t anything else that plays the experience-building role for the youngest ones. Every two years, the Caribbean Union of Teachers stages a 15 and under event. In 2017, the IAAF staged the last World Under 18-Championships in Nairobi, Kenya. That’s where Wayne Pinnock of Kingston College rededicated himself to athletics. Now, he is one of the globe’s pre-eminent long jump prospects. The landscape also features the Youth Olympics and the Commonwealth Youth Games, which cater to athletes under 18 years of age. However, these wonderful events are often staged so late in the year that rest for the youngsters is compromised. This was the case with the 2018 Youth Olympics in Buenos Aires, Argentina, which took place in October. The remainder of the international junior calendar caters to athletes from age 16 to 19. That bars the terrific Clayton twins, Tina and Tia, from competing at this year’s Pan-American Junior Championships. Believe it or not, Tia and Tina are just 14. Many of the region’s greats, including Usain Bolt, Veronica Campbell-Brown, Yohan Blake and Melaine Walker, benefited from exposure at Carifta and the World Under-18 Championships. Now that the latter meet is off the schedule, Carifta is a little bit more crucial. One guess about Asafa Powell’s disappointing 2004 Olympic 100-metre showing is that he lacked experience on the international stage. Discovered as a diamond in the rough, Powell missed the ladder of junior meets that moulded his peers. Perhaps, if the former footballer had turned to track earlier and gotten experience at the Carifta Games, his 2004 Olympic debut might have had a happy ending. Thankfully, he matured, brought the 100-metre world record to Jamaica, and became a three-time Olympic 100-metre finalist and a winner of individual medals at two World Championships. In the same way, the Penn Relays helps by confronting our young athletes with the vagaries of weather. At the 2017 World Championships, a strong Jamaican team was undone by the London chill. Bolt went down, baton in hand, in the 4x100m final. Anniesha McLaughlin-Whilby suffered the same way in the women’s 4x400m final. Ronald Levy pulled just before his 110-metre hurdles heat. Blake couldn’t run flat out in the 200 metres because of the 13-degree weather and the risk of injury. Lest we forget, Jamaica’s only gold medal came from hurdler supreme Omar McLeod, who is accustomed to cold weather from his ongoing sojourn in the United States. In addition, Penn Relays often sees non-stars get college scholarships. The underlying point is that Carifta and Penn still are helpful to the Jamaican track and field effort. We remove them at our peril. Hubert Lawrence is a well-respected international track and field analyst and commentator.last_img read more