Aug 16, 2007 (CIDRAP News) – The British pharmaceutical company GlaxoSmithKline (GSK) recently announced another major order of prepandemic H5N1 influenza vaccine from the US Department of Health and Human Services (HHS), along with plans to launch a North American clinical trial of the vaccine.HHS ordered enough vaccine in bulk form to provide 22.5 million 15-microgram (mcg) doses, the company announced on Aug 3. The order is in addition to the bulk equivalent of 5 million 15-mcg doses that HHS ordered in November 2006, officials said.The cost of the new vaccine order is $97 million, according to Marc Wolfson, a spokesman for the HHS Office of the Assistant Secretary for Preparedness and Response in Washington, DC.The new order includes 9 million doses produced in the 2006 “manufacturing campaign” and 13.5 million doses to be produced in the 2007 campaign, GSK reported. The vaccine is based on clade 2 strain of the H5N1 virus.GSK will make the bulk vaccine at its facility in Ste. Foy, Quebec, and store it in Marietta, Pa.When HHS announced the plan to buy H5N1 vaccine from GSK in November 2006, the agency said it was ordering 800,000 doses, not the 5 million doses cited in the company’s Aug 3 announcement. Wolfson of HHS and Ken Inchausti, a GSK spokesman in Philadelphia, explained that the two announcements involve the same amount of bulk vaccine, but the HHS statement was based on a dose of 90 mcg, whereas the company announcement assumed a dose of 15 mcg.”The confusion between the 5 million doses that GSK talks about and what we have is that we’re still ordering it at the bulk rate of 90 [mcg] per dose,” Wolfson told CIDRAP News. “They’re doing tests that could possibly take it down to 15 [mcg] per dose, and if you do the math, that’s where the difference comes.”Based on 90 mcg per dose, HHS currently has 2.3 million doses of GSK vaccine in its H5N1 vaccine stockpile, Wolfson reported.The vaccine contract provides that HHS may direct the company to formulate the bulk vaccine into doses in the future, GSK said. In addition, HHS has an option to buy the vaccine in combination with one of the company’s proprietary adjuvants, or immune-boosting chemicals, which could reduce the amount of vaccine antigen needed to induce a protective immune response, the company reported.Funds for the vaccine contract will come through the Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response, according to GSK.Clinical trial startingGSK also announced the start of the first North American clinical trial of its prepandemic H5N1 vaccine. The trial is described as a phase1/2 study that will compare the safety and immunogenicity of the H5N1 antigen alone and in combination with one of GSK’s adjuvant systems in 675 adult volunteers. Inchausti said the trial will be conducted at sites in Montana, California, Florida, Georgia, Alabama, Kansas, and Nevada and in Halifax and Quebec, Canada.The company said it plans to follow up later this year with a phase 3 trial that will involve about 4,400 volunteers. Results of the phase 1/2 trial are expected in early 2008.Last March, GSK reported that in a clinical trial, one of its adjuvanted H5N1 vaccines triggered a strong immune response with two 3.8-mcg doses, or about half of the 15-mcg dose typically used for each viral strain in seasonal flu vaccines. The company also said tests showed that the vaccine, based on a Vietnam strain of H5N1, generated cross-reactive immunity against an Indonesian strain.GSK, Baxter sign vaccine deals with UKIn other developments, both GSK and US-based Baxter International today announced agreements to sell vaccine to the United Kingdom in the event of a flu pandemic.Under the GSK agreement, the company will make preparations to provide a “tailored” vaccine as soon as possible after a pandemic is declared by the World Health Organization, according to a company news release. GSK said it also has agreements to sell pandemic vaccines to Switzerland, Denmark, and Iceland.Baxter, based in Deerfield, Ill., said its European subsidiary in the UK signed an agreement giving the UK an option to buy Baxter’s vaccine in the event of a pandemic. The company’s candidate pandemic vaccine is produced in vero cell culture rather than in eggs, the conventional medium for flu vaccine production. Baxter said it recently enrolled volunteers for a phase 3 clinical study of its cell-based H5N1 vaccine in Europe.See also: Mar 6 CIDRAP News story “Glaxo H5N1 vaccine may work against multiple strains”Nov 20, 2006, CIDRAP News story “HHS awards 3 contracts for more H5N1 vaccine”
FSB selects Glenn Elliott as new COO August 12, 2020 Related Articles Share Share StumbleUpon XLMedia completes takeover of 101GreatGoals.com July 17, 2020 Submit Nektan ceases trading on London AIM May 18, 2020 London AIM-listed mobile gambling specialist Nektan Plc has today confirmed the departure of Leigh Nissim as its Chief Executive Officer.Issuing a corporate update, Nektan governance detailed that Nissim will officially leave the business this coming August, with founder and Non-Executive Director Gary Shaw retaking the firm’s CEO position on an interim basis.Nissim a former IGT and GTECH executive joined Nektan in May 2016, replacing former leader David Gosen who had departed the company five months prior to Nissim’s appointment.Taking over the leadership of Nektan, Nissim was charged with spearheading the mobile specialist’s commercial initiatives and further transitioning the business from a ‘white label’ operator to a B2B solutions and services provider.Updating investors, the Nektan board detailed that it had begun its executive search for Nissim’s replacement, with an appointment expected to be made in the coming months.Nektan governance further highlighted that the company was in advanced discussions with regards to concluding its next round of funding, the details of which it expects to announce in due course.
Angels’ poor pitching spoils an Albert Pujols milestone LOS ANGELES — It seems like the All-Star break came at a very good time, for both the Dodgers and their fans.After a period where people in L.A. got so used to walk-off victories that it seemed as if they could be dialed up on demand, some harsh reality intruded this weekend. Los Angeles lost three of four to San Diego, including Sunday’s 5-3 loss at the hands of two homers and four RBIs by Fernando Tatis Jr., and maybe those visions of Dodger Exceptionalism were a wee bit premature.Premature, of course, not necessarily being the same as wrong.The Dodgers still go into the break with the best record in baseball at 60-32, one game ahead of the Yankees (57-31), 5 1/2 clear of their nearest National League pursuer, Atlanta (54-37), and 13 1/2 in front of Arizona in the NL West. Newsroom GuidelinesNews TipsContact UsReport an Error On Mamba Night, the Lakers make short work of Blazers to take 3-1 series lead Horse dies after injury during workout at Del Mar Photos: Lakers defeat Trail Blazers in Game 4 of first-round playoff series Chris Paul, Russell Westbrook and other NBA stars pay tribute to Kobe Bryant The larger sample size, over the entire 92-game body of work, suggests there really shouldn’t be that much to worry about for the balance of the regular season. The Dodgers still have a potential MVP in Cody Bellinger; All-Stars make up three-fifths of their starting rotation (Hyun-Jin Ryu, Clayton Kershaw and Walker Buehler); their offense is explosive; and let’s just say their bullpen isn’t the worst in baseball, as much as Dodger fans grouse about it. (And Andrew Friedman is working on it between now and the July 31 trade deadline.)Is this collection better than the last two World Series teams? Perhaps. But there’s no way of really knowing that until October, is there?So it is best to take these last three games for what they’re worth. The Padres are two games back of a wild-card spot going into the break, so a team that has been in a rebuild for the last three years is now actually playing for something. And their young talent on display this weekend – led by Tatis, the wunderkind shortstop who is just 20 – suggests that the ultimate result of the rebuild could be scary good.“Tatis kind of showed how good he is, and what competing against him for the next six years is going to look like,” Ross Stripling said while mulling the solo home run he gave up leading off the first and the three-run bomb Pedro Baez surrendered to Tatis in the fifth, after Max Muncy lost Austin Hedges’ popup in the sun to prolong the inning. The rivalry in the stands may still be one-sided, considering the way Dodger fans invade Petco Park (and infuriate the Padre faithful). But it’s getting closer to becoming a fair fight on the field.“I see why they play with confidence,” Stripling said. “They just really don’t have a hole in their lineup. You think about years past and it was kind of, get through a couple of guys and then you can really start pitching to them now. You know, there’s just power through that whole lineup.”The scariest hitter in the Padres’ lineup, Franmil Reyes, was kept in the park through the four games. But Manuel Margot hit two home runs in the series, including his fifth homer of the year Sunday in the second inning, and Hunter Renfroe continued his assault on Dodgers pitching with his 26th and 27th homers of the year in this series (and fifth and sixth this season against L.A.).So, then, we stipulate that this was a particularly motivated opponent, and one more dangerous than might have been figured. Should there be reasons to worry, especially when the first series after the break is a 2018 World Series rematch in Fenway Park beginning Friday?“I don’t think so,” Muncy said. “This team played the first half with such high energy and emotion that we were bound to go into a lull at some point. There’s no team in the history of baseball that keeps it up all year long.“The good thing for us is that this is coming at a time where we have a break right afterward, instead of at a time where we still have another two or three weeks to go. So, thankfully, it’s a chance for guys to go home, see their families, unwind a little bit and freshen up, come back and have the same energy that we’ve had all of the first half.”Or else they can go to Cleveland. The Dodger delegation packing their special All-Star duffel bags Sunday included Ryu (the NL All-Star starting pitcher), Buehler, Kershaw, Bellinger and Muncy, plus Home Run Derby participant Joc Pederson, plus manager Dave Roberts and his coaching staff and probably assorted clubhouse guys, trainers, etc.For them it will be a different type of relaxation, still baseball activity but less stressful than the normal grind. And the message Roberts sent to the rest of his team was simple: See you in Boston Friday.“We’ve got a lot of guys that have been through this before, and everyone’s got their own plans,” Roberts said. “So there’s no gathering or message to the team (or) rallying the troops for the second half. We know what we can do.”And if four days off is beneficial for the uniformed personnel, maybe it will be just as good for those fans who ride the daily emotional roller coaster along with them. For now, we will refrain from discussing the haunting nature of that last number in this franchise’s history. Google it if you must but don’t blame me, Dodger fan, if you get frightened.Related Articles