Apr 5, 2007 (CIDRAP News) – CSL Biotherapies, the US branch of an Australian vaccine producer, announced this week it has applied for Food and Drug Administration (FDA) approval to market a seasonal influenza vaccine in the United States.The company, with US headquarters in King of Prussia, Pa., has requested an expedited review from the FDA, with the intention of having the vaccine ready for distribution for the 2007-08 flu season, company spokeswoman Sheila Burke told CIDRAP News by e-mail. The number of doses to be made available is yet to be determined and will depend on the FDA approval and antigen yields from various virus strains.”By extending our influenza vaccine franchise into more geographies, including the U.S., our goal is to help address a large and growing critical public health need,” said Paul Perreault, executive vice president of CSL Biotherapies worldwide commercial operations, in a press release.The flu vaccine, which is intended for people 18 years and older, is a purified, inactivated, trivalent vaccine made in embryonated eggs. It will be available in both single-dose, thimerosal-free, prefilled syringes and in multi-dose vials.A clinical trial sponsored by the National Institutes of Health (NIH) and involving 1,359 adults at nine sites began last June to test the vaccine’s safety and immunogenicity. Results of the phase 3 study have not yet been published, Burke said.There have been 26 clinical trials of the vaccine in various countries, according to a June 2006 CSL press release. The company already supplies the vaccine in 16 other countries, including the United Kingdom.The vaccine will be manufactured in Melbourne, Australia, at the facilities of CSL Limited, the parent company. It will then be finished in Marburg, Germany and distributed out of Kankakee, Ill., Burke reported.CSL Limited plans to invest $60 million to double the capacity of the Melbourne facility to about 40 million doses per season, according to a company statement released in February. After the expansion project, the company plans to supply up to 20 million doses per season to the US market, the statement said.With FDA approval, CSL Biotherapies would become the fifth provider of seasonal flu vaccines in the United States, joining Sanofi Pasteur, GlaxoSmithKline, Novartis, and MedImmune. The four companies distributed more than 100 million doses of vaccine for the 2006-07 season, according to the Centers for Disease Control and Prevention.See also:April 3 CSL news releaseCSL Biotherapies Submits BLA to Introduce Flu Vaccine to U.S. MarketFeb 7 CSL news releaseCSL to Seek Approval for US Flu Vaccine June 5, 2006, CSL news releaseFlu Vaccine Trial Begins
Baltimore is a double-digit favorite against Cleveland, and the Ravens would almost certainly sit all their stars in the season finale against Pittsburgh with home field advantage locked up. Robert Griffin III isn’t nearly the same talent as the heavy favorite to win the 2019 NFL MVP, Lamar Jackson, so Pittsburgh would have a golden opportunity to steal a victory provided Baltimore takes care of business this week.Meanwhile, Tennessee will likely be an underdog against New Orleans and could be an underdog to Houston. If the Texans lose to the Buccaneers, they will need to beat the Titans to win the division, and they will be favored in that game by three to four points assuming they are relatively healthy. A Houston win and a Tennessee loss next week would give the Texans the division though, making the Titans a road favorite over the Texans in Week 17 as A.J. McCarron would get the start over Deshaun Watson. The oddsmakers believe Tennessee will sneak into the playoffs over Pittsburgh, giving the Titans shorter AFC championship odds than the Steelers. Tennessee would most likely be the No. 6 seed and have to face Kansas City in the first round, and the Titans are likely to be a touchdown underdog in that game. Texans now -700 favorites to win the AFC SouthPrior to Sunday’s result, Houston was a slight favorite to win the division over Tennessee. The Texans and Titans were seen as relatively evenly matched sides by oddsmakers, and the two teams were set to meet twice in the last three weeks of the season. However, Houston has a much easier third game than Tennessee. While the Texans will travel to Tampa Bay to take on the Buccaneers this week, the Titans host the Saints. Houston is favored by two points over Tampa Bay on Saturday afternoon, and New Orleans opened as a 3-point favorite over Tennessee in Nashville on Sunday. Next week’s clash with Tampa Bay won’t be an easy one for Houston, though. The Buccaneers have won four straight games, and Jameis Winston is a human lottery ticket at this point. When Winston is on, he is one of the best quarterbacks in the league, able to make any throw look pedestrian. He leads the league in passing yards with 4,573 yards through the air this season, but he has thrown a league-high 24 interceptions as well. Winston has thrown six more picks than any other quarterback in the NFL, and he has thrown multiple interceptions in half his starts.Tennessee is an underdog against New Orleans, as the Saints are playing for home field advantage throughout the postseason. New Orleans is 11-3 coming into its game with Indianapolis, tied with Green Bay, Seattle and San Francisco.The Saints have the best chance of claiming the top spot in the conference, though, as their final two games are against Tennessee and Carolina. San Francisco and Seattle will meet in Week 17 with the winner likely winning the NFC West, while Green Bay must get past Minnesota this week. That means the Saints won’t be resting anyone against the Titans since the three 11-3 teams in the NFC play outdoors, and the Saints desperately want to play indoors during the postseason. MORE: How Texans’ win over Titans impacts AFC South, wild-card racesTitans’ wild-card chances The Titans will have the tiebreaker edge over the Steelers provided these two teams finish with the same conference record. Currently, Pittsburgh is a half-game up on Tennessee in this regard, but that’s because the Titans have played one more divisional game. Pittsburgh will close its season out with two road games, boosting Tennessee’s hopes. However, the Steelers are expected to be favored to win both games. They are favored by a field goal over the Jets this week, and they will likely be favored on the road against Baltimore next week. As long as the Ravens go on the road and beat the Browns in Cleveland this week, they will have nothing to play for in Week 17. The Texans are on the precipice of winning their fourth AFC South title in five years after beating the Titans 24-21 in Tennessee on Sunday. That victory moved Houston to 9-5, giving the Texans a one-game lead over the Titans in the division race. Houston is now a sizable favorite to win the AFC South by the NFL futures odds following the win, and Tennessee’s best hope to make the playoffs is by edging out Pittsburgh for the final wild-card spot. MORE: Get the latest NFL odds & betting trends at Sports Insider
COMMUNITY SERVICE AWARD—Jeff Marion holds his Pa. Proclamation he received from State Rep. Ed Gainey for “Excellence in Service Rendered to the Community.”Jeff Marion recently received a proclamation from State Rep. Ed Gainey for “Excellence in Service Rendered to the Community. ”The proclamation stated that coach Marion far exceeded the communities’ expectation as a coach of youth football, basketball and baseball.Marion stated that it all is his way of giving youth something positive to do all year long and keeping them off the streets. Marion coaches in several youth leagues in an attempt to help youth gear their energy in a positive direction through sports.Marion is also the circulation manager for the New Pittsburgh Courier.
Mallard’s Source for sports would like to congradulate the Bantam House Leafs with Team of the Week honours.The team includes, Jim O’Meara, Asst. Coach, Cody St. Thomas B, Aiden Mushumanski F, Cale O’Meara B, Blair Sookro F, Alex Laing (asst. Captain) B, Jaden Dyck B, Mike Zarikoff F, Noah Marsh, Josh Schacher, Tyler Lakeman (Captain B),Ben Price F, Keanu Tromans F, Charles Curiston (the little head beside Keanu), Noah Whiffen B (the tall guy in back), Max Spielman F (directly in front of Whiffen), Bradey Sookero F, Kylan Palm F, Ava Young F, and Dave Zarikoff Head Coach. The Nelson Bantam Leafs capped off an incredible season by capturing the West Kootenay Bantam House Title Sunday in Nelson.The Bantam Leafs edged Trail 4-3 in a championship thriller.