Dec 14, 2004 (CIDRAP News) – As part of efforts to improve the nation’s long-term supply of influenza vaccine, the federal government is launching a clinical trial to help get a German-made vaccine licensed for regular use in the United States.The Department of Health and Human Services (HHS) announced Dec 7 it would buy 1.2 million doses of the Fluarix vaccine made by GlaxoSmithKline (GSK) Biologicals to help ease the shortage. The vaccine is used in 70 countries, but because it is not licensed in the United States, people will have to sign a form acknowledging possible risks before they receive it.Two days after that announcement, federal officials announced plans to recruit 1,000 healthy adults for a clinical trial of the vaccine at four sites. The National Institute of Allergy and Infectious Diseases (NIAID) is collaborating with GSK Biologicals, based in Rixensart, Belgium, on the trial.Dr. Pamela McInnes, deputy director of the NIAID’s Division of Microbiology and Infectious Diseases, said the trial was prompted by the US flu vaccine shortage, which arose when contamination problems forced Chiron Corp. to cancel its shipment of 48 million doses in October. “We’re doing whatever we can to secure the vaccine supply for the next season,” McInnes told CIDRAP NewsMcInnes said the NIAID is funding the clinical components of the trial, such as recruiting volunteers and administering the vaccine, while GSK will cover some infrastructure costs and the testing of blood samples to assess the immune response. She said she couldn’t estimate the cost of the trial at this point.The trial will be conducted by four NIAID-supported Vaccine and Treatment Evaluation Units, at the University of Rochester Medical Center, Cincinnati Children’s Hospital, the University of Maryland School of Medicine in Baltimore, and Baylor College of Medicine in Houston.In the NIAID announcement, lead investigator John Treanor, MD, of the University of Rochester, said, “Although the vaccine we are testing has a very long safety record in Europe and other parts of the world, the type of study we are conducting must be done before the vaccine can be licensed for use in the United States.”Four of every five participants in the trial will receive Fluarix, while the fifth will receive a placebo, the NIAID said. Those receiving the placebo will be offered US-licensed vaccine at the end of the month-long study.When HHS announced its plan to buy GSK vaccine last week, the company said it had long-term plans to seek a US license for the product. A Dec 9 Washington Post report quoted the company as saying it intends to sell 10 million to 20 million doses in the United States for next year’s flu season if it gets a license.In other recent flu-vaccine developments, the United Kingdom’s drug regulatory agency said last week it was extending the license suspension for Chiron’s Liverpool vaccine plant for another 3 months. The Medicines and Healthcare Products Regulatory Agency (MHRA) suspended the plant’s license because of contamination problems Oct 5, forcing cancellation of the company’s vaccine shipments to the United States.”This new suspension does not result from any newly identified safety issues or findings at the Liverpool plant,” the MHRA said. “It is routine regulatory action to give Chiron more time to carry out the extensive and detailed remedial plan which is now being put in place.”The MHRA said it was keeping the US Food and Drug Administration (FDA) well informed of developments and would include FDA inspectors on an upcoming visit to check Chiron’s progress in fixing problems at the plant. The FDA has come under fire for not predicting Chiron’s problems and reacting to them sooner.”The suspension can be lifted at any time if Chiron is able to satisfy the MHRA that it has rectified the site’s problems,” the MHRA statement added.Also last week, Chiron announced it had received an FDA warning letter asking for more information about the company’s investigations of problems at the Liverpool plant. The letter, stemming from a remediation plan the company submitted in November, asks for more details about investigations into “current Good manufacturing Practices deviations” and related studies.The FDA gave Chiron 15 working days to respond to the letter, the company said.See also:Dec 9 NIAID news release
Tag: 辽宁 一品楼 论坛
The Indian Infrastructure magazine has just announced that their 8th annual conference on ‘Dredging in India’ will take place on September 6-7, at The ITC Maratha, Mumbai. In the past few years, dredging has emerged as a distinct industry in itself. The industry is being driven largely by the growing dredging requirements at Indian ports and inland waterways, Indian Infrastructure said in its announcement.The government has, in the recent past, also been quite proactive in this area. New dredging guidelines for major ports along with amendments to the guidelines for chartering foreign flag dredgers, and easing the process of vessel registration have been the major steps announced by the government to solve some of the long-pending issues of the industry.The government’s flagship program, Sagarmala, identifies dredging as a major thrust area to achieve the objective of port modernization and capacity enhancement. In addition, the development of six new ports as part of the program will require a significant amount of dredging.Apart from ports, inland dredging has emerged as a major growth driver for the industry. The launch of the Jal Marg Vikas, the declaration of 106 new national waterways (NWs), etc. have opened up significant opportunities for contractors. So far, the Inland Waterways Authority of India (IWAI) has largely managed the dredging needs through its own dredgers, Indian Infrastructure said.The situation is changing with IWAI looking to outsource more work. It is also exploring assured depth contracts in a few upcoming stretches and, if successful, it plans to use this format on a much bigger scale.The past one year has seen the award of some key dredging projects at ports and inland waterways.Boskalis, in a joint venture with Jan De Nul, secured a EUR250 million contract for deepening and widening the access channel at the JNPT. The Dredging Corporation of India (DCI) secured a five-year contract for maintenance dredging at Haldia in a global bidding and emerged as the winner for the dredging work of the Farakka-Kahalgaon stretch on NW-1.India also signed an agreement with Bangladesh to dredge the Brahmaputra river from Sadiya in Assam to Chittagong port in Bangladesh.To meet the growing requirements, private dredging companies will need to play a bigger role. DCI alone cannot meet the entire industry demand, the event organizers stated.
When Wisconsin’s No. 1 singles player, Alex Kasarov, graduated last year, he left his brother Lachezar to lead the team. The brother-duo comes from a town in Bulgaria named Burgas. “It is about the same size as Madison,” Lachezar said.Both brothers began to play tennis at the age of four, and grew up playing the sport together.Their dad would take them to the courts, and Lachezar felt he was good compared to most kids his age, so he was motivated to continue playing. He began to win a lot of tournaments, and his confidence kept growing.Eventually, Alex left home to attend UW, and Lachezar was quick to follow.Both brothers attended Wisconsin for two years, until Alex left after his senior year to start a career as a tennis instructor in Chicago.With his brother’s departure, Lachezar is now one of the leaders on the team and is hoping to follow in his brother’s footsteps.Both brothers already have similar styles of play.”We both are very aggressive players on the court,” Lachezar said.They also both have their focus and mindset as offensive players.”It is rare for either of us to hit defensive shots,” Lachezar added.But off the court is a different story. They are completely different people with many different characteristics.”I am known as the bad kid, while Alex is known to be quiet and considerate,” says Lachezar. “Each of us is distinct in our own way, so I feel no pressure to be like Alex.”This year Lachezar plays three or four singles, but he is really concerned about his team as a whole. His goal for this year is to reach the NCAA tournament with the team. “Individually I have no specific goals, mainly I want our team to improve and move higher in the rankings,” Lachezar said.As of right now UW’s record is 3-1, and the team is currently not ranked in the top 30, but Lachezar said, “We definitely have a chance, our team is much better now then we used to be, and our record does not show.”This past weekend UW suffered its first loss on the season to No. 5 Pepperdine.”This match showed we have a lot of potential and can beat many other teams,” Lachezar said.Overall, Lachezar is a pretty optimistic guy, always looking on the bright side. His inspiration is Mike Tyson because he loves his style and attitude inside and out of the ring.As for the future Lachezar would like to continue to play tennis and see where it takes him. Right now Lachezar is studying finance, so he is open to job opportunities in that field. One thing is for certain — he is going to remain in the United States.But for now, Lachezar is looking forward to going to Miami for spring break with the team to play in a tournament.”I love Miami because the beach and hot weather remind me of my hometown.”