FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Bethesda, Maryland, on February 22, 2010, to select the influenza viruses for the composition of the influenza vaccine for the 2010-2011 U.S. influenza season. During this meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2009-2010 vaccines, and the availability of candidate strains and reagents.
The committee recommended that vaccines to be used in the 2010-2011 influenza season in the U.S. contain the following:
* an A/California/7/09 (H1N1)-like virus; * * an A/Perth /16/2009 (H3N2)-like virus; ** * a B/Brisbane/60/2008-like virus.***
The influenza vaccine composition to be used in the 2010-2011 influenza season in the U.S. is identical to that recommended by the World Health Organization on February 18, 2010, for the Northern Hemisphere's 2010-2011 influenza season.
*A/California/7/09 (H1N1)-like virus is the pandemic (H1N1) 2009 influenza virus. A monovalent vaccine containing this strain was made available to the United States in the fall of 2009.
**A/Perth/16/2009 (H3N2)-like virus is a change from the 2009-2010 influenza vaccine formulation.
***and B/Brisbane /60/2008-like virus is a current vaccine virus.
WHO Swine Flu Experts Tied To Roche, GlaxoSmithKline -Report Last update: 6/4/2010 3:37:33 AM
DOW JONES NEWSWIRES Scientists who drew up key World Health Organization guidelines advising governments to stockpile drugs in the event of a flu pandemic had previously been paid by drug companies which stood to profit, according to a report out Friday, The Guardian says on its Web site. An investigation by the British Medical Journal and the Bureau of Investigative Journalism, the not-for-profit reporting unit, shows that WHO guidance issued in 2004 was authored by three scientists who had previously received payment for other work from Roche Holding AG (ROG.VX), which makes Tamiflu, and GlaxoSmithKline PLC (GSK), manufacturer of Relenza.
City analysts say pharmaceutical companies banked more than $7 billion as governments stockpiled drugs. The issue of transparency has risen to the forefront of public health debate after dramatic predictions last year about a swine flu pandemic didn't come true, the U.K. newspaper says. "The tentacles of drug company influence are in all levels in the decision-making process," said Paul Flynn, the U.K. Labour lawmaker who sits on the council's health committee. "It must be right that the WHO is transparent because there has been distortion of priorities of public health services all over Europe, waste of huge sums of public money and provocation of unjustified fear."
Although the experts consulted made no secret of industry ties in other settings, declaring them in research papers and at universities, the WHO itself didn't publicly disclose any of these in its seminal 2004 guidance, the paper says.
WHO Identifies Conflicted Pandemic Panel Members Now that the World Health Organization has officially declared that the swine flu pandemic is over ( http://www.who.int/mediacentre/news/statements/2010/h1n1_vpc_20100810/en/index.html ), the agency has finally released the names of the scientific advisors who helped with pandemic decisions and their declared conflicts of interest, such as paid work for drugmakers. The move comes four months after the WHO denied the pharmaceutical industry had undue influence over its decisions about the extent of the pandemic and two months after the Council of Europe issued a report harshly criticizing the agency’s lack of transparency around the handling of the swine flu pandemic (back story here and here). For its part, the WHO called the accusations “conspiracy theories,” but refused to release the conflict of interest forms filed by the 16 members of its emergency pandemic committee that advised WHO director Margaret Chan. In releasing the list now, though, the WHO says “the interests summarized…do not give rise to a conflict of interest such that the experts concerned should be partially or totally excluded from participation in the Emergency Committee. However, following WHO’s policy, they were disclosed within the Committee so that other members were aware of them. All other Members of the Emergency Committee declared no relevant interests.” [Our thought: the WHO should have disclosed the info from the start, especially if it was confident any conflicts were not an impediment.] What sorts of conflicts are we talking about? Here is the list of disclosures http://www.who.int/ihr/emerg_comm_members_2009/en/ and you can judge for yourself whether people with these backgrounds should have served on the committee: Arnold Monto, a professor of epidemiology at the University of Michigan at Ann Arbor, declared current and past consultancies in pandemic and seasonal flu GlaxoSmithKline, Novartis, Roche, Baxter and Sanofi less than $10,000 each. In addition, his research unit at the university received a grant from Sanofi Pasteur for a clinical trial conducted in 2007-2008 on the comparative efficacy of inactivated and live attenuated influenza vaccines. John Wood, a principal scientist in the virology division of the UK’s National Institute for Biological Standards and Control, disclosed that his unit performed contract research for Sanofi Pasteur, CSL, IFPMA, Novartis and Powdermed in influenza vaccine research and development. Maria Zambon, who heads the respiratory virus unit in the virus reference department at the Health Protection Agency, Centre for Infection in London, disclosed that her employer receives funding from vaccine makers, including Sanofi, Novartis, CSL, Baxter and GSK, for contract work in her lab. Neil Morris Ferguson, a chair in mathematical biology in the department of infectious disease epidemiology at the Imperial College Faculty of Medicine in London, has acted as a consultant for Roche and GSK Biologicals (ending in 2007), with total remuneration under $7,000 in 2007. And Nancy Cox, the director of the influenza division at the Centers for Disease Control and Prevention, disclosed that her public health and surveillance research unit receives financial support from the International Federation of Pharmaceutical Manufacturers & Associations, an industry trade group. http://www.pharmalot.com/2010/08/who-identifies-conflicted-pandemic-panel-members
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