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

Warri Peace Marathon to Hold May 28

first_imgPreparations are in top gear for the maiden Warri Peace Marathon billed for May 28 in Warri Delta StateAccording to organisers of the event, the 10km race is opened to local athletes and keep fit enthusiasts in Delta and environs.The Athletics Federation of Nigeria (AFN) has permitted the race, while the Delta State government has pledged moral and financial support for a successful outing in the first edition.Race Promoter, Joyce Bozimo, said at the weekend that plans were at advanced stage to make the marathon a success. “Things are shaping up for the event and we are looking forward to a good outing on May 28.“The major reason for the marathon is to propagate peaceful coexistence among the tribes and communities that make up Delta State. We also want to reassure the youths that there is much more to life and healthy living instead of taking to crime and violent conducts,” said Mrs Bozimo.She disclosed that the Delta State government is keying into the event as part of its SMART agenda to move the state towards sustainable development and progress.“We have a lot talented youths in the state and sports are one of the avenues the government is looking at as a vehicle to help build capacity for the youths.“The government is also committed to peaceful coexistence in the state. So we are working together with the Delta Sports Commission to deliver a memorable marathon,” concludes the race promoter.Share this:FacebookRedditTwitterPrintPinterestEmailWhatsAppSkypeLinkedInTumblrPocketTelegramlast_img read more

Cowboys COO on coach Jason Garrett: ‘Everybody’s back is against the wall right now’

first_imgStephen Jones wants the Cowboys to “take the next step.”Jason Garrett is entering the final year of his contract and Jones, the team’s vice president and chief operating officer, addressed the coach’s future when he spoke with reporters Tuesday. “No one wants Jason to be around here for the long term more than the Jones family,” Jones said. “No one thinks more of him than we do. But at the same time … everybody’s back is against the wall right now.”The Cowboys have reached the postseason three times during Garrett’s eight full seasons with the team. They finished 2018 with a 10-6 record and advanced to the divisional round of the playoffs, where they fell to the Rams. Related News “We’ve got a really good young team,” Jones said. “We’ve got high expectations for this young team. And everybody, from Jason to his staff, to our players, to ownership, to the organization, feels the pressure to take the next step. Our fans deserve that.”Garrett has tallied a 77-59 record during his time with the Cowboys.center_img Cowboys DE Randy Gregory suspended indefinitely, report says NFL free agency: Cowboys will explore adding safety, Jerry Jones sayslast_img read more