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

Bigham grafting to be Jack of all trades

first_img Tags: England Boys’ Squad, Hertfordshire, Jack Bigham 2 Mar 2020 Bigham grafting to be Jack of all trades Jack Bigham is looking to kick on from a season where he threatened leaderboards, made every cut and earned his place in the England set-up.The Hertfordshire teenager is a key member of the boys’ squad for 2020 after showing fine form at under 16 level.Bigham has always been a naturally powerful hitter and it’s amazing to watch him smash drives 290 yards down the range.This winter the 16-year-old has spent time working on his wedge play with England coach Rob Watts and leaning on putting expert Mike Kanski for tips with the flatstick.Stints at the National Golf centre at Woodhall Spa have helped him focus on what he must improve for the year ahead.Now a great week of work in the sunshine at Quinta Do Lago with the boys’ squad two weeks ago (see picture below) has him energised for the opportunities that lie in store.Bigham said: “Last year I started the season strongly at the McEvoy and Fairhaven and I got picked for the under 16s v Spain.“I was undefeated and the highest points scorer in that one.“I carried on and had more top tens and made every cut and was selected again.“My game has become technically better and throughout 2019 I was consistent.“But I’m always looking to get better and I’ve been working with Rob on wedge play and Mike on putting. I’ve seen improvements already.”Bigham will combine his golf this spring with preparing for GCSEs in Business Studies, History and PE.But once the books are packed away he has his eyes on some prizes with England.“I want to play in the Home Internationals and European Boys – they are great experiences,” added Bigham who plays out of Harpenden Golf Club.“You get more of a buzz playing for your country and it’s great to win.“I used to play a bit of football, but stopped that to carry on with golf.“My dad started me off. My brother plays as well and, because he was older, I followed them up the range and I loved it from the start.“I was naturally good from the start – I could hit it straight away.“Now I do hit it far for my age. The stats show that my long game is good.”Bigham admits he loves to study Tiger Woods’ game as much for his attitude as his skills on the course.“Tiger is unreal,” said Bigham with a smile.“I’ve watched all the videos of him and he’s just different. He always wanted to win. Even when he was behind you knew he would come back and never give up.“I like watching Justin Rose and the younger ones such as Matt Wallace. He’s from Hertfordshire too and that’s good for me.“I just want to be like them. I want to be a professional.“That’s been the case for a few years.“It’s hard work – especially when you have school as well. But you have to put in the work to achieve.”There’s an obvious camaraderie within the boys’ squad this season and that was shown at the last gathering at Woodhall Spa.The fun forfeits for losing out in tasks are now part of the weekend – and Bigham and team-mate Max Hopkins earned some strange glances when they headed for dinner after one of the challenges.“Me and Max had to carry weights from the gym into the restaurant and back to the hotel!” said Bigham with a wry smile.“I only lost out by a shot. We got some funny looks!“The get-togethers are intense and that’s good. You’re always learning either with work in the gym or on the range.“I enjoy the gym work. I do that with Hertfordshire every week and it’s about finding a way to fit in a couple of more days a week to boost my power and distance.”Main photograph credit: Leaderboardlast_img read more