Danish firm expects to sell smallpox vaccine to US

first_imgApr 18, 2007 (CIDRAP News) – Bavarian Nordic, a Danish company, announced this week that the US government plans to buy 20 million doses of the company’s Imvamune smallpox vaccine, but a US official said no decision has been made yet.Imvamune is Bavarian’s version of modified vaccinia Ankara (MVA), which is considered safer than the conventional smallpox vaccine, particularly for people with weakened immune systems, pregnant women, and children.”Following a competitive RFP process, Bavarian Nordic has received notification from the US Department of Health and Human Services that it intends to procure 20 million doses of the company’s third-generation IMVAMUNE smallpox vaccine for the strategic national stockpile,” the company said in an Apr 16 statement.But Holly Babin, an HHS spokeswoman in Washington, DC, said no decision has been made on the vaccine. “We can’t comment on it now,” she told CIDRAP News, but added that an announcement is expected within the next few weeks.Bavarian Nordic and the British drug company Acambis each received an HHS contract in early 2003 to develop and test a vaccine based on MVA. In September 2004 HHS awarded each company a further contract calling for production of 500,000 doses of the vaccine and clinical trials. But Acambis announced in November 2006 that HHS had notified it that the company’s vaccine was too expensive.Bavarian said the expected HHS contract would require the company to win US Food and Drug Administration approval for use of the vaccine in healthy people and those with limited immunity.Peter Wulff, Bavarian’s chief executive officer, said the company plans to begin phase 3 clinical trials early in 2008 and expects to win a US license for the vaccine in 2010, according to an Apr 16 Bloomberg News story.”While the principal terms of the agreement [with HHS] have been reached, the contract is currently being finalized,” the company statement said. “It is expected to be the first procurement contract under the BioShield program since enactment of the Pandemic and All-Hazards Preparedness Act in December 2006.”Bavarian said it has built a facility that can produce at least 40 million doses of Imvamune annually.The BioShield program was established in 2004 to promote the development of medical treatments for the effects of chemical, biological, and other unconventional weapons. But major drug companies showed little interest in the program. In passing the All-Hazards Preparedness Act in December, Congress tried to revitalize the program by authorizing partial payments to companies working under BioShield contracts before final delivery of their products.Existing smallpox vaccines are made with live vaccinia virus—a cousin of the smallpox virus—which in rare cases can cause serious or life-threatening side effects such as a severe rash or encephalitis. MVA is a strain of vaccinia that cannot replicate inside human cells and therefore cannot cause a severe or spreading infection, HHS has said.An MVA-based vaccine was found to be safe when it was given to 120,000 Germans in the 1970s, according to HHS. But research on MVA ended when smallpox was declared eradicated in 1980.Although smallpox was eradicated, disease experts fear that terrorists may have supplies of the virus, which the Soviet Union made in large quantities during the Cold War. Since 2001, HHS has stockpiled enough doses of the conventional smallpox vaccine to immunize the entire US population. The United States and Russia still hold samples of the smallpox virus for research purposes.See also:Oct 4, 2004, CIDRAP News story “Further contracts awarded for weakened smallpox vaccine”Feb 25, 2003, CIDRAP News story “HHS awards contracts to develop safer smallpox vaccine”Dec 15, 2006, CIDRAP News story “Congress passes public health preparedness bill”last_img read more

Toure wants to make history

first_imgYaya Toure is determined to keep Manchester City powering on towards title glory. Press Association Toure set up the win by scoring the first two goals from the penalty spot and then curling home a sublime third at the Etihad Stadium. Fernandinho and Martin Demichelis added gloss to the scoreline late on. Toure, the former Barcelona midfielder who also scored a brilliant goal to help win the Capital One Cup earlier this month, told City TV: “I came to the club to make history and I hope to continue to the end of my contract. “I think the club and the fans need trophies, need history and need great players to come here and try to make this club great. “We have the team, we have the players, we have the manager as well. “I hope at the end of the season we lift this trophy for these fans who love City.” Toure’s treble took his tally for the season to 20. He is the third City player to reach that landmark this season after Sergio Aguero and Alvaro Negredo while Edin Dzeko, who missed the game through sickness, has 18. The Ivory Coast international attributes his fine goalscoring form this season to the confidence placed in his offensive ability by attack-minded manager Pellegrini. The 30-year-old said: “He gave me more freedom up front, he gave me more confidence to attack more. Toure, City’s midfield talisman, scored a hat-trick in Saturday’s convincing 5-0 win over 10-man, relegation-threatened Fulham. The victory lifted Manuel Pellegrini’s side to third in the Barclays Premier League, six points behind leaders Chelsea with three games in hand. “When you play full attack you can leave some space and it is very hard because when we win it is fine, but when we lose we get some criticism by some people who think they understand football more. “But that is part of the job, that is why we love football. We are very happy to score five goals in front of the fans and I hope we will continue to the end.” City were not at their best but were still far too strong for Fulham. They went ahead after Fernando Amorebieta kicked Negredo in the backside to concede, perhaps harshly, a penalty after 26 minutes. But there was no contesting Amorebieta’s second indiscretion as he felled David Silva early in the second half to give away another spot-kick and earn a red card. Toure sent goalkeeper David Stockdale the wrong way for a second time and City then cruised to victory. City have 10 league games remaining and their title credentials will be tested in two away games at Manchester United and Arsenal in the coming week. Goalkeeper Joe Hart is confident City have the belief and ability to achieve their aim. The England international said: “The fans, players, and staff – everyone needs to pull each other through if we want to get over the line first. “I do think we have the squad to win the league. We can’t get too wrapped up in the away games we still have to play. “We still have the chance to do something really special and do something this club hasn’t done for 44 years by winning two trophies in one season. “So we need to press on and try and create a bit of history.” Hart has now re-established himself as Pellegrini’s first-choice goalkeeper after a series of mistakes led to a spell out of the side earlier in the season. Yet he feels he has to constantly keep working to maintain his position and accepts Costel Pantilimon, who played the League Cup final, will also get opportunities. Hart said: “I don’t feel it’s a case of that side of things being really solved. “I’m still training hard – as I would be whether I was in or out of the team – and I’m always working to improve my game. “I don’t want it to seem as though everything is fine or that it was part of my life that I will forget, because I’m still living it and I am trying to live in the moment more recently. “The past is the past and we don’t know what lies ahead in the future so it’s better to live day by day. “We are going to get some wonderful opportunities at this club – some I will be playing in, some that I won’t – and I’m just trying to look at things the best I can.” last_img read more