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.
Press Association Harry Redknapp has claimed “people with their own agendas” had a hand in his resignation as QPR manager, describing the situation as “a bit of a soap opera”. He said: “I always thought I had everyone pulling with me and suddenly I felt some were and some weren’t. I didn’t know who was on my side at the end and who wasn’t. “Behind the scenes, I always thought there were one or two people with their own agendas. “There was always talk about Tim Sherwood coming in. It was like a bit of a soap opera. “QPR was in the paper every day. I’ve been at lots of other clubs, big clubs as well, where you didn’t get that. That got on my nerves. That was the big problem for me. “As soon as we lost a few games, it would begin. I always thought there was someone mischievous causing it. I’d never had that before at any club I’d been at. “I didn’t see the teams below us getting the same sort of headlines every other week. It wore me down a little bit.” Redknapp left the team second from bottom of the table and they are now two points from safety under the leadership of Chris Ramsey. However, Redknapp, who also claimed he did not fall out with chairman Tony Fernandes because of the club’s lack of business in the January transfer window, added: “I felt I’d have kept them up.” The 68-year-old blamed knee problems for his decision to leave the Barclays Premier League strugglers in February. However, Redknapp told BBC Sport’s Football Focus there was more to his decision than health problems. Redknapp was replaced at the helm by Ramsey – who has guided the club to four points from their last two games to keep alive their hopes of survival. But, responding to Redknapp’s remarks, he believes the day-to-day running of any football club can be compared to a work of fiction. Ramsey said: “Football is a soap opera. Any club you go to, League One or League Two clubs, it is going to be a soap opera. It just depends how it is going to play out. “I’m not sure if things have settled down now, it is probably a different script.” Fernandes has been vocal on Twitter ever since he took over at QPR, offering both positive and negatives takes on the goings on at Loftus Road. Ramsey believes the Malaysian has curbed the number of QPR-related Tweets he has been posting recently, taking some of his personal feelings out of the public realm “I’m not on it but it seems like he has been on it less,” he said of Fernandes on Twitter. “I think Twitter is a thing people do when they are in emotional states. I’ve got family memebers that are on it. “It doesn’t always represent what people feel at the time. It is sometimes a knee-jerk reaction as to what has gone on. Once it is out there, it is out there.”