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

Green: We need perfect run

first_imgGoalkeeper Rob Green admits QPR need a perfect finish to the season if they are to avoid relegation from the Premier League. An unmarked Leroy Fer volleyed home a corner with 17 minutes to go but Nedum Onuoha’s afternoon took a disastrous turn within the space of five minutes as he was booked for the shirt pull on Martin Skrtel which led to a penalty – which Green saved from Gerrard – before seeing yellow for a second time for a hack on substitute Jordon Ibe. Liverpool ramped up the pressure and three minutes from time Gerrard nipped in to head in Coutinho’s corner. QPR have the worst record in the Premier League for the number of points conceded in the last 10 minutes and it left the players deflated. “It is a feeling of immense disappointment really the way the game went,” added Green. “It is another defeat in the last few minutes against a team no-one would have expected us to take anything from. “It comes down to a good ball into the box and Stevie G meeting it like he did. “Those are the finite details you are working with in the Premier League against top-quality players. “You have a player like Coutinho who can whip in a ball like he can and Steven Gerrard who can attack a ball like he can. “If you concede a lot of corners at some point they are going to be able to meet one.” Head coach Chris Ramsey was equally frustrated. “I have said it week after week: I would rather start the game at 80 minutes,” he said. “We have left so many points on the table after 80 minutes. At 87 (against Liverpool), 88 at Chelsea, 89 at Hull, after 80 at Aston Villa. “Our lapses in concentration are there for everyone to see. We were admirable even after we went down to 10 men.” Steven Gerrard’s 88th-minute header in Liverpool’s 2-1 win at Anfield left the Hoops needing a miracle to stay up. They are seven points from safety with three matches to go and head to the Etihad Stadium to face Manchester City next Sunday knowing they realistically have to win that. However, should other results go against them – although it would involve the improbably scenario of all four teams who are catchable winning – the previous day there is a chance they could already be down before they reach Manchester. But Green is in no doubt they have to win at the Etihad to ensure their remaining two fixtures against fellow strugglers Newcastle and Leicester do not become irrelevant. When the England goalkeeper was told of how other results had gone against them he said: “Great. We need to win all our games. “We probably need a perfect run between now and the end of the season, starting at the Etihad – which is a big ask.” Green said news of the death of team-mate Rio Ferdinand’s wife Rebecca to cancer hours before kick-off had not affected their performance. “We had to go about our business the same as we always do,” he added. “You have adversity in football and everyone at the club is with Rio and his family at this moment.” QPR looked to have given themselves a fighting chance at Anfield as they weathered a storm – mainly helped by Liverpool’s lack of a cutting edge up front – after going behind to Philippe Coutinho’s 19th-minute goal. Press Associationlast_img read more

The Latest: Browns announce two COVID-19 related moves.

first_imgOfficials last week declared “substantial completion” of 65,000-seat Allegiant Stadium after nearly 1,000 days were spent building the $2 billion home for the Raiders.Both the New York Jets and Giants previously announced they would play without fans this season. Most other teams are hoping to be able to have at least limited crowds.The Raiders relocated from Oakland, California, after last season.___The National Hockey League says there have been zero positive coronavirus test results since 24 teams entered quarantined bubbles in Toronto and Edmonton, Alberta. Share This StoryFacebookTwitteremailPrintLinkedinRedditThe Latest on the effects of the coronavirus outbreak on sports around the world:___The Cleveland Browns have placed third-string quarterback Garrett Gilbert on the reserve/COVID list and activated punter Jamie Gillan. He had tested positive for coronavirus. Seven St. Louis Cardinals players and six staff members tested positive for COVID-19, causing Major League Baseball to postpone the team’s four-game series at Detroit.The series was to have been played at Comerica Park from Tuesday through Thursday.St. Louis has been in quarantine since Thursday in Milwaukee, where the Cardinals’ series last weekend was postponed, and the team is being tested daily. St. Louis last played July 29 at Minnesota and is tentatively set to resume its schedule this Friday at home against the Chicago Cubs.The Cardinals are the second team sidelined by the novel coronavirus since the season started July 23. The league announced it had administered more than 7,000 tests to players, coaches, staff and officials over the past week. Teams with 52-member traveling parties entered the bubbles July 26.There were also zero positives the previous week when teams were still in their home cities for training camp.___Results of COVID-19 testing conducted Sunday show there were no new positive results for the Philadelphia Phillies. The team was traveling to New York to resume its schedule against the Yankees in a night game. Associated Press The Phillies (1-2) have not played since July 26. Their opponent in that opening series, the Miami Marlins, had at least 18 players test positive for the coronavirus. Although the Phillies didn’t have any players test positive, their games last week were postponed as a cautionary measure.___Danish organizers say the Tour de France start due to take place in Copenhagen next year has been moved to 2022 to avoid being held in the same month as the rescheduled Tokyo Olympics and the European Championship soccer tournament.Copenhagen Mayor Frank Jensen says the move means the three-stage Tour start in his city will now be planned for July 1-3, 2022, adding that he hopes the coronavirus pandemic will have passed by then.The 2021 Tour was scheduled set to start on July 2. The Miami Marlins are set to resume play Tuesday in Baltimore following an outbreak within their traveling party that sidelined half the players. Miami has not played since July 26.Because the outbreak occurred in the visiting clubhouse at Citizens Bank Park, the Phillies were sidelined for a week while they were tested daily.___The Raiders will play their first season in Las Vegas without any fans at their home games because of the COVID-19 pandemic.The team sent a letter to season ticket holders on Monday saying that after discussion with health care officials and local leaders, the decision was made not to allow fans. August 3, 2020 The Tour’s French organizers have yet to announce a replacement city for Copenhagen, although there have been reports that the three-week event could start from the French region of Brittany in 2021.This year’s Tour, which was supposed to start in June, will now be held Aug. 29-Sept. 20 — starting in Nice.___More AP sports: https://apnews.com/apf-sports and https://twitter.com/AP_Sports The Browns also placed safety Karl Joseph on the active/physically unable to perform list with a foot injury. He was signed during the offseason and is expected to start. Gilbert joined the Browns last season to back up Baker Mayfield, a close friend from their high school days in Texas. Gilbert is third on the depth chart now after the Browns signed veteran QB Case Keenum. Last week, first-year Browns coach Kevin Stefanski said he didn’t see the need to keep his quarterbacks separated because of the virus. Other teams have considered the move in case of an outbreak.Gillan set a team record for net average last year as a rookie. He was placed on the COVID list last week after testing positive when veterans reported.___ The Latest: Browns announce two COVID-19 related moves.last_img read more