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

We cherish family bonds: Irfan

first_imgMumbai, June 1: Cricketer Irfan Pathan says his family cherishes bonds and their values very dearly. Cricketers and brothers Yusuf and Irfan Pathan shot for an episode of the dance reality show “High Fever…Dance ka Naya Tevar”, a statement said. Sharing his thoughts about being on the show, Irfan said: “Hailing from a joint family ourselves, we cherish family bonds and family values very dearly and this show is surely making family bonds stronger with dance.”Instead of sharing few dance moments on stage, the brothers played cricket in a slow-motion style. “High Fever… Dance ka Naya Tever” is aired on &TV. IANSlast_img read more

Victor Osimhen: Tipped to Replace Icardi at Inter?

first_imgHis loan deal with Charleroi has a clause agreed with Wolfsburg for him to be signed permanently for a fee in the region of €5m although his current market value is double that amount now.Inter Milan contacted his representatives about a possible deal and it is believed that he is their prime target for former captain Mauro Icardi who is currently involved in a row with the club after he was stripped of the captain band and his relationship with the management seems to have hit rock bottom levels.The deal for Osimhen will no doubt encounter some complications as Charleroi are willing to use every means available to trigger the clause of buying him permanently before selling him for a hefty profit and also a percentage of his future sale.Wolfsburg, on the other hand, want the striker back after his loan spell but it is believed they want to trade him off as their player to recoup some of their investment in the player they signed in 2015 following his exploits at the U-17 World Youth Championship.Super Eagles youngster has revealed the secrets behind his incredible form on-loan at Belgian club Charleroi since arriving Belgium from VfL Wolfsburg.His impressive form earned him a recall to the Super Eagles squad for the 2019 Nations Cup qualifier against South Africa and he also started in 0-0 friendly draw against Uganda in Asaba.“My confidence level was very low at some point and what going out on loan to Charleroi has done for me is unexplainable,” Osimhen told BBC Sport.“It was tough in Germany because of the high expectations – some people started doubting me and also pushed me to start doubting myself as well.“The football in Belgium has helped, I also have a wonderful group of players around me and the coaching crew have been great with me.“As a young player, you hear people comparing you to other stars who emerged from the U-17 World Cup and never fulfilled their potential.“But now at Charleroi I have comfortably found my happiness again, and I thank everyone in Belgium and at Wolfsburg for the opportunity and support.”Osimhen was the top scorer as Nigeria clinched a fifth U-17 World Cup title in 2015 with 10 goals in Chile, which saw him win the Golden Boot and Silver Ball.After the tournament he decided against joining English side Arsenal, to sign with the 2009 German champions Wolfsburg in January 2016, but injuries restricted him to 16 appearances for the club in all competitions.Despite being a part of the squad for two years, his lack of games meant he missed out of the 2018 World Cup with Nigeria.“I am still young and I think it wasn’t meant to be, but I can still look forward to the future,” he added.“I thank coach Gernot Rohr for the opportunity to return to the squad and I hope to keep working hard to stay in his plans.”On the back of his impressive performance at 2015 U-17 World Cup with the Nigerian emerging the top scorer to claim both the Golden Boot and Silver Ball, the attacker joined the former German Bundesliga champions.However, the 19-year-old failed to settle into the Wolves’ senior set-up amid injury struggles and was shipped on loan to Charleroi this summer.Since moving to Belgium, the youngster has rediscovered his form, scoring seven goals in 12 outings across all competitions.The rise to prominence of Osimhen looked set to address a long-standing problem of Nigerian football: the lack of a dead-eye centre-forward . Not since the passing of Rashidi Yekini, the famed Super Eagles goleador has there been anything close to a sure thing, a player with the ability to ruthlessly home in on goal.A move to Germany always seemed a problematic fit, as Wolfsburg, whom he joined, are lacking in stability, and have been for quite a while. The constant upheaval, both managerially and administratively, would provide no kind of proper environment for fostering a promising young player.It seems now as though the intervening period has been rather wasted, as has some of his lustre. The German side were eager to farm him out in the summer, and he suffered the indignity of a number of trials in Belgium and the Netherlands, before finally earning a loan move to Charleroi.Not the most auspicious of clubs then or even manner of arrival, given his promise and the fact that he was still only 19.That is not to say that Osimhen is that good; merely that he may be ready now to lead and if flights of fancy are acceptable, then how far off an invitation to the senior national team is he?Rohr extended invitations to him in his early days as Super Eagles boss, all the ,while the 19-year-old was barely getting minutes at Wolfsburg.There really is something there and while there are still a few rough edges, the diamond is just starting to peak out. What is however not clear is if he could stand the pressure of filling the vacuum left by the Icardi at Inter Milan.Share this:FacebookRedditTwitterPrintPinterestEmailWhatsAppSkypeLinkedInTumblrPocketTelegram With several names, including Edin Dzeko and Higuian linked to Inter Milan in the past as a replacement for their exiting striker, Mauro Icardi, Nigeria’s Victor Osimhen is the latest name strongly linked to the San Siro giants. However, observers still have doubts as to whether the Charleroi striker is strong-hearted enough to fill the big shoe left by the ArgentineVictor Osimhen could join Inter Milan in the summer and not their city rivals AC Milan who were keen on signing him during the recently concluded January transfer window.Osimhen has taken the Belgium league by storm this season with 10 league goals to his name for modest side Charleroi and despite the option of signing him permanently in the summer, there’s every chance of the forward leaving.last_img read more

Independent management the way forward for PNG NRL

first_imgChow highlighted that the independent management of the competition will allow franchise owners to focus on the development of the game in their provinces, in their regions.“They can focus more on preparations of their teams. We believe this will be a significant advantage and benefit for the way forward,” said the chairman.“The franchise owners will continue to be represented by their association – PNG NRL Incorporated.”Coming under the umbrella of the PNG Rugby Football League (PNGRFL) will allow the PNG NRL to draw on the resources of the PNGRFL to professionally run the competition.“We can draw on the experience and success they’ve had over several years now in running the SP Hunters program,” said Chow.The PNG NRL Competition will kick off on the weekend of June 22-23.last_img read more