Dec 7, 2004 (CIDRAP News) – The federal government is buying 1.2 million doses of flu vaccine made in Germany to augment the strained US supply, the Department of Health and Human Services (HHS) announced today.HHS Secretary Tommy Thompson announced the purchase of the vaccine, made by GlaxoSmithKline, at a news teleconference. “We’ll have it available this month,” he said. “This will allow us to get more vaccine into the hands of those who need it most.”Because the vaccine is not licensed in the United States and licensing is a lengthy process, it will be used under “investigational new drug” (IND) rules, Thompson said. That means people will have to sign a consent form acknowledging their awareness of possible risks before getting a shot. But Thompson and Lester Crawford, acting commissioner of the Food and Drug Administration (FDA), said the vaccine is safe.The vaccine, called Fluarix, is used in 30 countries. The FDA reviewed GlaxoSmithKline’s manufacturing processes and inspected the plant that makes the vaccine before HHS decided to buy it, Thompson said.The consent form will explain “what the public should expect in terms of risk,” said Crawford. “What the public should know at this point is that the vaccine is not investigational because we have real questions about it, but because the company elected not to enter the US market last year, so they didn’t apply for approval.” He called the probability of safety problems with the vaccine “very low indeed.”Thompson said GlaxoSmithKline has agreed to supply up to 4 million doses to the US under IND rules, but he didn’t predict how many doses HHS might buy beyond the initial 1.2 million.The 1.2 million doses will increase the total US supply for this season to slightly more than 62 million doses, which includes about 58 million doses from Aventis Pasteur and 3 million doses of MedImmune’s FluMist, Thompson said.Thompson said the Centers for Disease Control and Prevention will distribute the GlaxoSmithKline vaccine doses where they are needed and will release a distribution plan in a few days. The company is charging HHS about $7 per dose, but there will be some additional costs for distribution, he said.GlaxoSmithKline said the IND rules provide that the vaccine can be given to people at least 3 years old who qualify for vaccination under the current US guidelines, which reserve the shots for people in high-risk groups.Another foreign firm viewed as a potential supplier of flu vaccine to the United States, Canada’s ID Biomedical, announced today that it must save its remaining doses for Canada, according to a Canadian Press (CP) report. HHS officials had previously said they were considering buying 1.2 million doses from the Vancouver, B.C., company.The company said it was selling the doses on the Canadian market at the request of the government, according to the CP report. The story said reports of the US vaccine shortage spurred an unusual Canadian demand for flu shots earlier this fall, sparking fears of a shortage in Canada.At the news conference, Crawford acknowledged the ID Biomedical announcement but said the FDA was still discussing the possibility of buying some vaccine from the company. The CP report said FDA officials spent a week inspecting the firm’s vaccine plant in Ste.-Foy, Que.Crawford also said that two companies have announced this week that they want to enter the US flu vaccine market, one as early as 2005 and the other by 2007. This year Aventis Pasteur and MedImmune are the only companies providing licensed flu vaccines in the US. California-based Chiron Corp. was to have supplied up to 48 million doses before contamination problems at the company’s plant in Liverpool, England, prompted British authorities to shut down the plant, triggering the American vaccine shortage.Crawford didn’t name the two companies planning to enter the market, but ID Biomedical yesterday announced a long-term agreement to sell flu vaccine to three US wholesalers, starting as early as next year, depending on licensing of the vaccine. The company said the agreement covers at least 8 years. The firm’s production capacity in 2005 will be about 22 million doses, officials said.GlaxoSmithKline, in a news release about the sale of doses to HHS, said it has “a long-term strategy” to seek FDA licensing of Fluarix.In other comments, Crawford said the FDA has been reviewing proposals by Illinois, New Mexico, and New York City to buy a total of 750,000 doses of non-US-licensed flu vaccine made abroad by Aventis. “By the end of the week we expect to have gotten through all of the information,” but he didn’t predict whether the FDA will approve the plans.
ST JOHN’S, Antigua (CMC) – West Indies will fly a power-packed, 13-member squad to England for their one-off Twenty20 International with the home team next month.Cricket West Indies announced yesterday that Chris Gayle, Kieron Pollard and Sunil Narine, three of the most recognisable names on the Twenty20 franchise circuit, will be part of Carlos Brathwaite’s squad for the contest on September 16 at the Riverside Stadium in Durham.The sport’s regional governing body said that key leg-spinner Samuel Badree will however miss the trip, due to a prior commitment.“We have a good mix of experience and youth that should adapt to English conditions quickly,” said selection panel chairman Courtney Browne.“Coming off the win against India in July in the Caribbean, our expectations are to see the team play a highly competitive game and bring that T20 Caribbean atmosphere to England.”All of the players, except off-spinner Ashley Nurse, who takes Badree’s place, played in the one-off T20I against India on July 4 at Sabina Park in Jamaica which West Indies won handsomely by nine wickets, following an explosive second T20I hundred from left-hander opener Evin Lewis.Gayle, Walton, Fletcher and Lewis are among eight batsmen who have compiled more than 250 runs in the ongoing Caribbean Premier League in which Williams is the tournament-leading bowler with 15 wickets and the only member of the squad to crack 10 wickets.Squad:Carlos Brathwaite (captain), Ronsford Beaton, Chris Gayle, Evin Lewis, Jason Mohammed, Sunil Narine, Ashley Nurse, Kieron Pollard, Rovman Powell, Marlon Samuels, Jerome Taylor, Chadwick Walton, Kesrick Williams
Tigerair Australia has partnered with Mackay Airport, Mackay Regional Council and Mackay Tourism to launch an integrated promotional campaign to help promote Mackay to Melbourne.The campaign is utilizing the ‘101 Things To Do in the Mackay Region’ campaign which launched earlier this year to help turn outdated perceptions of the Mackay Region around.A range of new marketing initiatives commence this weekend that are focused on appealing directly to the leisure market in Victoria.A special episode dedicated to highlighting some of the tourism drawcards of Mackay will air in Victoria on Coxy’s Big Break travel show this Sunday 22 February 2015 at 5:30pm on Channel 7.TV show host “Coxy” flies from Melbourne to Mackay direct with Tigerair and uncovers a sample of the many hidden gems of the region including a platypus diving experience, Keswick Island, and the rainforest ziplining experience.A dedicated landing page promoting the Mackay Region as a leisure destination will be linked from the Tigerair website later this month and a social media campaign will encourage people to send in their own favourite things to do in Mackay.Mackay Tourism marketing officer Sarah Matheson, said this is an exciting partnership and thanked Mackay Airport, Mackay Regional Council and Tigerair Australia for their support.“With the launch of the new ‘The Mackay Region. Nature. Reserved.’ brand in late 2014, this is yet another way we can increase awareness of the unspoilt, natural attractions of our destination. We will continue to work with our key stakeholders to drive key messages about the region and look forward to working closely on more tourism projects in the future,” Ms Matheson said.Tigerair flies regularly between Melbourne and Mackay four times weekly and offers the only direct air link between the two destinations.Source = ETB Travel News: Lewis Wiseman