Editor’s note: This story was revised Mar 7 to clarify information about global influenza vaccine production capacity.March 6, 2007 (CIDRAP News) – The British pharmaceutical company GlaxoSmithKline (GSK) unveiled new findings yesterday suggesting that its inactivated H5N1 influenza vaccine may protect humans from more than one strain of the virus, which may build a stronger case for prepandemic vaccination and spur more countries to consider stockpiling.Researchers from GSK detailed recent findings from two studies at a symposium in Hong Kong, the company said in a press release yesterday. In July 2006, the company had reported that its vaccine triggered a good immune response in humans at a much lower dose than other H5N1 vaccines under development.GSK’s vaccine, based on an H5N1 virus collected in Vietnam in 2004, contains a proprietary adjuvant (an immune-stimulating chemical). Adjuvants enable vaccine makers to produce more doses from a limited supply of antigen.Though the GSK vaccine is made with older egg-based production methods, which are slower and more laborious than newer cell-culture or DNA technology, the dose-sparing effect of the adjuvant is crucial. The current world population is more than 6 billion, but the World Health Organization (WHO) has estimated the maximum global production capacity for seasonal flu vaccines at only about 350 million doses.In November, the WHO cautioned governments against spockpiling prepandemic vaccines, because many fundamental questions about H5N1 vaccines remained, such as whether vaccines would work against more than one strain of the virus.However, vaccines that are effective against more than one strain could strengthen the case for building prepandemic vaccine stockpiles. David Stout, president of GSK Pharmaceuticals, commented in the press release, “We believe this vaccine will provide governments with a new option to help protect their populations against the threat of a future human influenza pandemic.”Study resultsThe first study GSK presented at the Hong Kong meeting involved 400 adults and found that very low levels of GSK’s inactivated, adjuvanted H5N1 vaccine (two 3.8-microgram [mcg] doses administered 21 days apart) elicited strong cross-reactive immunity against an Indonesian strain of the virus. The response was 25 times greater than that observed in a control group that received a nonadjuvanted version of the vaccine, GSK said in its press release. Immunity was assessed by measuring the level of neutralizing antibodies.”This means that proactive administration of our prepandemic vaccine before or just after the start of a pandemic could help to substantially slow down the spread of the disease,” said Jean Stephenne, president of GSK Biologicals.For comparison, an H5N1 vaccine made by Sanofi Pasteur that was recently recommended for approval by a US Food and Drug Administration panel required two 90-mcg doses to yield an immune response in less than half of patients tested.In the second study, researchers immunized ferrets with the GSK vaccine and then infected them with an Indonesian strain of H5N1 virus. Only 1 of the 23 infected animals died, which translates to a 96% protection rate, GSK reported.Findings difficult to evaluateGregory Poland, MD, a vaccine expert at the Mayo Clinic in Rochester, Minn., told CIDRAP News that it’s hard to evaluate GSK’s findings, because the company has not yet published any clinical trials in peer-reviewed medical journals. “It’s certainly exciting news, but it needs to be confirmed,” he said. Researchers are eager to learn more about the adjuvant that GSK used, particularly its safety profile and reactivity.The report of a robust immune response with a low dose of vaccine is promising, and in a prepandemic setting, a two-dose course isn’t likely to be problematic, said Poland, who is a professor of medicine in infectious diseases at the Mayo College of Medicine and directs the Mayo Vaccine Research Group and Program in Translational Immunovirology. “It’s tempting to go overboard, and I’m excited, but cautiously so,” he added.Besides positioning its vaccine as a prepandemic measure for national stockpiles, GSK would also like to market the vaccine someday to medical clinics and individuals, according to a Canadian Press story published yesterday.In November 2006, the US Department of Health and Human Services awarded GSK a $40 million contract for a supply of its H5N1 antigen in bulk form, and in January it granted the company $63.3 million to develop antigen-sparing H5N1 influenza vaccines.See also:Jul 2006 CIDRAP News article “Glaxo says its H5N1 vaccine works at low dose”
The Bengals are off to a 3-0 start and will face New England in their next game. This game should give the fans a good idea on whether the Bengals can compete for the Super Bowl this year. They have already defeated the Ravens on the road, and a win over the Patriots would go a long way to erasing some of the disappointments that the fans have endured in past years.This years Bengal team is very consistent in all aspects of the game. They can pass the ball, run the ball, and their special teams are very good. The new offensive and defensive coordinators are off to great starts in their positions just like the team is.The continuity with Marvin Lewis at the helm appears to be paying dividends as this Bengal team hasn’t shown the mental lapses that have plagued the Bengals in past years. After Sunday we should have a good idea on how this season is going to play out.
The Planning and Land Use Management committee approved Wednesday an amended proposal for renovating the University Village during a meeting at Los Angeles City Hall.Councilman Ed Reyes, a member of the committee, said USC’s cooperation led to the approval. About 200 stakeholders attended the meeting, most of whom were in support of USC’s $1 billion plan to create new retail space and student housing in the University Village.The vote followed an agreement between local representatives that USC pay $20 million in benefits to preserve affordable housing. The university originally allocated $2 million but has increased the figure during months of negotiations.The university also agreed to providing residents priority in the hiring process and creating a counseling service within the Gould School of Law for residents with tenant-landlord conflicts.Patricia Alarcon, executive assistant for local government relations for USC, said the decision will benefit both USC and the surrounding community.“It’s wonderful that this is going to move forward because it has been nine years in the making,” Alarcon said. “This is a win-win for USC and the community.”Several union representatives expressed support for the project because the university said it plans to use contractors who hire union members. About a dozen business owners who currently work in the University Village, however, voiced concerns over the future of their businesses.Wendy’s franchise owner Ketan Sharma, who employs 35 people, said the current proposal does not adequately address concerns over the future of his business, which he has owned for 22 years.“Sixty percent of my business is drive-thru, but USC has not guaranteed I can keep it,” Sharma said. “The only guarantee is that they will talk before demolition — the first right of refusal as it is has no teeth in it. This keeps me awake at night.”Working with local stakeholders has been a priority for the university, Alarcon said.“USC has from the beginning known that it was important for community members to be present at these discussions,” Alarcon said. “From day one, USC has listened to members of the community and responded to their comments.”Rachel Bracker contributed to this report.