Chiron’s UK plant to resume making flu vaccine

first_imgMar 3, 2005 (CIDRAP News) – British regulators have cleared Chiron Corp. to resume making influenza vaccine at its plant in Liverpool, England, which should improve the chances of an adequate vaccine supply in the United States next winter.British officials suspended Chiron’s license to make flu vaccine in October 2004 because of contamination problems at the plant. That forced the company to cancel delivery of 48 million doses of vaccine to the United States, close to half of the nation’s expected supply for the 2004-05 flu season.The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) announced the lifting of Chiron’s license suspension yesterday. “The MHRA inspectors have concluded that satisfactory progress has been made in the manufacturing areas which had previously caused concern,” the agency said.The suspension was officially lifted at 5 p.m. yesterday. “The company . . . is now free to recommence full manufacturing of the vaccine,” the MRHA said.The US Food and Drug Administration (FDA) welcomed the announcement but indicated it was not yet certain that the company could supply vaccine for the US market next season.In a news release, Dr. Jesse Goodman, director of the FDA Center for Biologics Evaluation and Research, said, “FDA considers MHRA’s action today an extremely important milestone in Chiron’s efforts to supply influenza vaccine for the U.S. market for the coming flu season, but work remains. FDA and MHRA will continue to closely monitor Chiron’s progress as manufacturing proceeds.”When all critical stages of manufacturing are in full swing, and needed corrective actions can be fully evaluated, FDA plans to conduct a comprehensive inspection of Chiron’s Liverpool facility to assure that Chiron can produce a safe and effective vaccine.”Chiron, based in Emeryville, Calif., promised to continue working to get the plant back on track. Chief Executive Officer Howard Pien said in a statement, “Our employees have worked tirelessly and we are extremely proud of this result. This is a significant accomplishment. In this new beginning we remain focused on continuing to remediate and improve so Chiron can successfully deliver on the results required to supply influenza for the 2005-2006 season.”The statement did not say how much vaccine the company expects to be able to make. Flu vaccine is grown in chicken eggs; production usually begins in late winter or early spring and takes roughly 6 months.The loss of Chiron vaccine this season raised the specter of a shortage and prompted the Centers for Disease Control and Prevention (CDC) to recommend that available doses be reserved for people with an increased risk of flu complications. The fear of a shortage triggered long lines at flu-shot clinics last fall.The nation’s other flu-vaccine sources stepped up their production in response to the situation. Sanofi Aventis (formerly Aventis Pasteur) said it would produce an extra 2.6 million doses, for a total of about 58 million doses of inactivated vaccine, and MedImmune planned to make an extra 1 million doses of its live intranasal vaccine, FluMist, for a total of about 3 million.In addition, the government arranged to buy 1.2 million doses of a GlaxoSmithKline flu vaccine that is not licensed in the United States. The vaccine, though considered safe, was to be used under investigational new drug rules, which require vaccine recipients to sign a consent form.The nation ended up with an estimated total of about 62 million doses of vaccine. The flu season has turned out be relatively mild, and some of the vaccine supply has gone unused, despite the earlier fears of a shortage.A CDC official was quoted yesterday as saying about 7% of the approved vaccine doses produced for the US market this year have not been used. Dr. Jeanne Santoli told the New York Times that 3 million to 3.5 million doses of inactivated vaccine and 1 million doses of live vaccine have not been sold.See also:UK MHRA news releaselast_img read more

Death of Kivú the lion unleashes blame game

first_imgThe body of Kivú, the last of Costa Rica’s living lions, is currently under forensic evaluation  to determine the exact cause of his death, but the Environment Ministry (MINAE) and Simón Bolívar Zoo are blaming each other for his passing last Friday.Fundación Pro Zoológicos (FUNDAZOO), the administrator of the San José zoo where Kivú lived most of his 18 years, released a statement denying any responsibility for the lion’s death. The statement said Kivú never showed any symptoms of chronic kidney disease during examinations conducted at the zoo.Zoo officials blamed MINAE and the Agriculture and Livestock Ministry for the deterioration of Kivú’s health. Taking the lion to ZooAve, a private refuge in Alajuela province, was the reason for his health problems, the statement said.The document adds that “the quick death of the lion at ZooAve, following its forced relocation on Dec. 5, was the result of [MINAE and MAG’s] disregards of all warnings about the risks of moving him outside Simón Bolívar Zoo.”It cites a Nov. 2 report from FUNDAZOO’s veterinarian Randall Arguedas that was submitted to both ministries at the time to prevent the relocation. Arguedas said that moving the lion to another location with different temperature, relative humidity and other environmental conditions than those in downtown San José could severely affect Kivú’s health.The zoo’s statement says Kivú’s kidney problems were a result of conditions of his new enclosure at ZooAve, “built using metal roof sheets and lacking proper ventilation.” Those factors caused a temperature spike that required additional water intake, “but stress prevented him from drinking enough water and that likely led to a kidney failure.”Following Kivú’s death, many people commented on the zoo’s Facebook profile, blaming zoo administrators for keeping the lion inside a metal cage during most of his life, and for disregarding orders to move him to a better home.MINAE respondsMINAE officials on Tuesday responded with another news release saying that Kivú’s death “was a result of the chronic disease that started affecting him before his relocation.”The lion stopped eating last week and a general check-up showed his chronic renal disease had worsened. Officials, however, stressed that the lion’s quality of life improved at his new and more spacious home.The ministry’s statement describes how living conditions at the Simón Bolivar Zoo prevented the 18-year-old lion from engaging in natural behavior, and argues that zookeepers failed to follow recommendations to improve the lion’s diet by giving him not only meat but also bones, feathers, fur and innards to stimulate his instincts.The response also noted that spending most of his life inside the 70-square-meter cage the zoo provided had a direct impact on Kivú’s life. It critized FUNDAZOO for failing to relocate the lion to a more appropriate home, “despite a public commitment issued upon his arrival in 1999 to take him and his sister Kariba to a refuge in Santa Ana.”MINAE’s statement says the decision to relocate Kivú was based on the results of physical and laboratory tests that showed the chronic kidney disease.“The decision was based on an in-depth analysis conducted by 10 feline experts, including international consultants,” the ministry said.Ban on zoosNegative reactions and comments following the first news reports of Kivú’s deteriorating health also included requests for the closure and ban of all zoos in Costa Rica.Rafael Ortiz Fábrega, a legislator representing the Social Christian Unity Party, filed a draft bill last week asking for amendments to the country’s Wildlife Law to ban zoos. Solís’ plan states that Costa Rica should ban the opening of new zoos and calls for a five-year period “for the closure or transformation of all existing ones.”Current zoos would be forced “to change their operation to follow that of sanctuaries, refuges or conservation centers,” Solís said. He also proposes a ban on the capture or import of animals for public exhibition purposes.Solís says that the operation of the country’s zoos “is not appropriate for the 21st century, as captive animals face terrible suffering,” and added that zoos give Costa Rica a bad environmental image.The Environment Ministry said that experts are currently working on various projects to improve the quality of life of captive animals. However, a proposal for closing or banning zoos is not currently under consideration at the Ministry.In December, President Luis Guillermo Solís posted one of the last videos of Kivú at ZooAve. Related posts:Kivú’s health condition worsens; officials evaluate options Ministries confirm relocation orders for Kivú the lion Environment officials move Kivú the lion to a new home Kivú the lion recovers at his new home Facebook Commentslast_img read more