Chiron gets FDA nod to ship flu vaccine

first_imgOct 13, 2005 (CIDRAP News) – Armed with full federal approval for the first time in more than a year, Chiron Corp. says it may start shipping influenza vaccine to US distributors next week.Chiron’s first shipments since contamination problems blocked the company’s vaccine shipments last year could help ease vaccine shortages caused by slow deliveries, a Centers for Disease Control and Prevention (CDC) official said.The Food and Drug Administration (FDA) yesterday approved the first three lots of Chiron’s Fluvirn vaccine for shipment, according to company officials. The lots amount to about 1.5 million doses.Chiron spokeswoman Alison Marquiss in Emeryville, Calif., said the company needs to complete its own testing on the three lots before shipping them, which could happen in a few days.”We’re very close to the finish line for these first lots,” she told CIDRAP News. “We’d expect to release them to distributors in the coming days for them to ship to their customers.”In a survey of 120 local health departments last week, all but six reported that vaccine shipments were delayed or orders were not completely filled, according to an Associated Press report today. The survey was done by the National Association of City and County Health Officials (NACCHO).The survey indicated that somewhere between zero and 40% of flu vaccine orders have been filled so far, Curtis Allen of the CDC’s National Immunization Program in Atlanta told CIDRAP News.”A lot depends on who they ordered from and when they ordered it,” Allen said. “Many of those that have ordered from Sanofi [Sanofi Pasteur] have received at least 20% of their orders.” He said Sanofi has been trying to make sure that customers get enough vaccine to cover people who have an increased risk of serious flu complications.With Chiron having received FDA clearance, Allen added, “Hopefully those who have ordered vaccine from Chiron should be getting some soon.”In September the CDC recommended that flu shots be reserved for people in high-risk groups until Oct 24. Despite the delayed deliveries, the agency has no current plans to change that date, Allen said.Contamination problems at Chiron’s Liverpool, England, vaccine plant forced the company in October 2004 to cancel the planned shipment of about 48 million doses to the United States.British authorities restored Chiron’s manufacturing license last March, and the FDA inspected and approved the Liverpool plant in August. In September the FDA approved the company’s vaccine formulation for this year. The agency also must inspect and approve each lot of vaccine before it can be shipped.”The [FDA] release yesterday was the last regulatory step,” said Marquiss.”In the past year we’ve been working on remediating our facility and at the same time producing vaccine for this upcoming season,” she said. “So what we’re doing right now is a step that normally would’ve happened a month ago. We just need to catch up.”As reported previously, Chiron expects to produce between 18 million and 26 million doses of flu vaccine this year, Marquiss said. “Our third-quarter earnings report is October 25, so we hope to have a more concrete number then, or even before then.”She predicted it would take until early December to finish delivering vaccine for this season.Allen said the CDC has not changed its estimate of flu vaccine supplies for this year: 60 million doses from Sanofi Pasteur, 8 million from GlaxoSmithKline, 3 million from MedImmune, and 18 million to 26 million from Chiron. That comes to 89 million to 97 million doses in all, as compared with about 60 million doses made available last year.last_img read more

Russia defiant as team slashed to smallest in 104 years

first_imgWhat goes around, comes aroundRussian Olympic Committee president Alexander Zhukov took a swipe at the track and field ban, which affects top stars like pole vault world record-holder Yelena Isinbayeva and 110m hurdles world champion Sergey Shubenkov.Zhukov said it was “unfair” that athletes from other countries who have previously served drugs bans, such as American sprinter Justin Gatlin, will compete in Rio.“We think it’s unfair that some Russian athletes like Yelena Isinbayeva and Shubenkov, who have never been accused of doping, are not allowed to compete this time,” Zhukov told a press conference.“However in contrast some other athletes, like the American runner Gatlin, have been admitted to the Games.”Russian swimming great Alexander Popov also hit out at the track and field ban and levelled a personal attack on Britain’s Sebastian Coe, president of the IAAF.“I hope that he will not regret his decision about Russian athletes because as you can say, what goes around comes around,” Popov said of Coe earlier.“I hope that he will sleep well at night,” the four-time gold-medallist added, in comments after an International Olympic Committee (IOC) session in Rio.Among 31 swimmers cleared by the investigation are Vladimir Morozov and Nikita Lobintsev, who were initially banned.While all Russian weightlifters have been banned, all of the country’s boxers have been allowed to compete.World Sailing has also let a competitor initially banned back into the contest.“The Russian team may have experienced the toughest checks of the Olympics, because they had to go through multiple tests and checked,” Zhukov said.“On top of all that, Russian athletes are going through additional testing which is taking place at the Olympic village.“So as of now, the Russian team is probably the cleanest in Rio.”Share on: WhatsApp Russia vowed to win a hatful of medals and hit out at the expulsion of some of their top athletes on Thursday as they announced their smallest Olympic team in 104 years after a major doping scandal.Despite drugs investigations which have robbed Russia of nearly a third of its original team, the mood in the camp was bullish on the eve of the Rio Games’ gala opening.Russian Olympic gold medal-winners said the team had been galvanised by the fall-out of revelations of state-orchestrated doping on a grand scale.The ensuing crackdown on Russia’s team has slashed numbers from 389 to 271, the fewest since the pre-World War I Olympics of 1912 when they competed as the Russian Empire.But Elena Zamolodchikova, a two-time gymnastics gold medallist, said Russia was determined to finish top-10 on the medals table, a position they have occupied since the 1950s.“Yes, sure,” Zamolodchikova told AFP at the Russia House team base at Rio’s Copacabana, when asked if they would stay in the top 10.“We’ll do our best and I’m sure we’ll be in the top 10. Knowing the Russian character, we will compete.”Former pistol champion Mikhail Nestruyev said Russia expected to win “many” medals, adding that the troubled build-up had given them added incentive to do well.“We’re a small team but we have strong sportspeople,” he said. “I think this tense atmosphere has done us some good. Now all athletes are much stronger.” Russia entered 389 athletes but many competitors implicated in last month’s bombshell World Anti-Doping Agency report, which uncovered state-backed drug cheating, have been eliminated by sports federations.A three-member International Olympic Committee panel reviewed the list submitted by the federations and announced a final figure of 271 on Thursday.Russia’s track and field team had already been suspended in separate action by the sport’s governing body, the IAAF, following similar revelations of state-backed doping last year.last_img read more

California Chrome, Dumb Ass Partners win Preakness; Triple try next

first_imgIn this May 3, 2014, file photo, jockey Victor Espinoza celebrates aboard California Chrome after winning the 140th running of the Kentucky Derby horse race at Churchill Downs in Louisville, Ky. (AP Photo/David J. Phillip, File)BALTIMORE (AP) — It gets even harder from here on out for California Chrome.He won easily in his home state of California, he dazzled in the Kentucky Derby and he dug deep to win the Preakness on Saturday.Now comes the toughest test of all, the Belmont Stakes in three weeks.The chestnut colt with four white feet will attempt to sweep the Kentucky Derby, Preakness and Belmont, something that hasn’t been done since Affirmed in 1978. Since then, 12 horses have won the first two legs and failed to complete the sweep in the 1 ½-mile Belmont; the last was I’ll Have Another, who was scratched on the eve of the Belmont two years ago.“You have to have a very good horse to win these three races,” said Art Sherman, the winning 77-year-old trainer. “I’m hoping I’ve got one right now.”Maybe the horse with the modest pedigree and average Joe owners is the one.California Chrome defeated Ride On Curlin by 1 ½ lengths in the Preakness, covering 1 3/16 miles in 1:54.84 on a sunny and cool day at Pimlico.He’s now won six straight races. The streak started with four in a row in California by a combined 24 ¼ lengths. Then California Chrome coasted home in the Derby by 1 ¾ lengths after opening up a big lead in the stretch. The margin dwindled in the Preakness as he fought off multiple challengers.California Chrome’s co-owner Steve Coburn shed tears after his colt crossed the finish line, dabbing them away with a blue-and-white bandanna.“I don’t mean to be bold or cocky or arrogant,” Coburn said. “I saw this baby when he was a day old, I told my wife, ‘Carolyn, this horse is going to do something big. I don’t know what it is, but we’re going to stay in the game to make sure this colt gets to be the best that he can be.’”Quite a statement from a guy with a one-horse stable.Coburn and partner Perry Martin bred an $8,000 mare to a $2,500 stallion to produce California Chrome. Based on the colt’s humble breeding, he probably shouldn’t be on the verge of making history.His mother, named Love the Chase, won just one race.The owners were long shots to get this far, too.Coburn and Martin named their operation DAP Racing, which stands for Dumb Ass Partners. Their silks include an image of a donkey. Coburn and Perry who live on each side of the California-Nevada border get up early for their jobs — Coburn working as a press operator and Martin running a lab that tests high-reliability equipment.“We just hope that this horse is letting America know that the little guy can win,” Coburn said.Sent off as the overwhelming 1-2 favorite by a record crowd of 123,469, California Chrome bounced out of the gate running, with jockey Victor Espinoza moving the colt into the clear. Pablo Del Monte, a 34-1 shot, charged to the lead and was soon joined by filly Ria Antonia.Espinoza tucked California Chrome into third, an ideal spot behind the leaders. They stayed there until making their move approaching the final turn.“I had to move early today,” Espinoza said. “I had to start moving at the half-mile pole, which is tough for a horse to start moving early and keep going all the way to the end. California Chrome proved he can move.”California Chrome went for the lead, catching Pablo Del Monte while Social Inclusion joined the chase. Pablo Del Monte soon dropped back along the rail, and California Chrome sprinted away from Social Inclusion at the top of the stretch.But there was one more challenge to come.Ride On Curlin, next-to-last in the 10-horse field, ranged up and briefly appeared ready to overtake California Chrome. Once again showing his class, California Chrome denied the threat.“It’s an awesome feeling,” Espinoza said. “Today it was just a crazy race. I got more tired mentally than physically. I see another horse go to the front. I was going to sit second. … I sit back, as soon as the other horse got clear of me, it worked out perfect.”California Chrome paid $3, $3 and $2.40. Ride On Curlin returned $5.60 and $3.80, while Social Inclusion was another 6 ½ lengths back in third and paid $3.40 as the 5-1 second choice.General a Rod was fourth, followed by Ring Weekend, Pablo Del Monte, Dynamic Impact, Kid Cruz, Bayern and Ria Antonia.Espinoza will get another crack at trying to complete the Triple Crown, after missing with War Emblem in 2002. He finished eighth in the Belmont that year.“You have to be a super horse to win,” the jockey said. “Hopefully, California Chrome comes back good, and he’s the one that hopefully can do it.”Bob Baffert trained War Emblem, one of his three Triple tries that ended in failure. He missed with Silver Charm in 1997 and again the following year with Real Quiet, who lost the Belmont by a nose.“California Chrome is something. He’s a cool customer,” Baffert said after the race. “He does everything right. He’s fast enough to stay out of trouble.”last_img read more