Looking Back at the CIDRAP Influenza Vaccine Report
Every year, beginning in early fall, public health messages go out to the American public encouraging influenza immunizations. The reason for this is simple to understand. Influenza causes yearly epidemics during the cold months in each hemisphere – December to March in the northern hemisphere and June to September in the southern hemisphere. To prevent illness and even death from influenza, public health authorities encourage influenza vaccination of all people age 6 months and older. The vaccine – available as an injection or a nasal spray – has been promoted as “the best way to reduce the chances that you will get seasonal flu and lessen the chance that you will spread it to others.”
Shortly after the 2009 influenza pandemic, the Center for Infectious Disease Research and Policy (CIDRAP), based at the University of Minnesota, undertook a Comprehensive Influenza Vaccine Initiative (CCIVI). The primary objectives of the CCIVI “were to provide a comprehensive review of all aspects of 2009-2010 pandemic A(H1N1)pdm09 influenza vaccine preparedness and response based on the events of the pandemic vaccine effort and to review the scientific and programmatic basis for the current seasonal influenza vaccine efforts.” This review took about three years, and it was an exhaustive analysis of many aspects of what goes into getting those yearly influenza vaccines from the manufacturer and into the arms or noses of consumers.
You can read the executive summary here (PDF) and the full report here (PDF). The report notes ten key findings and makes six recommendations. Among the findings was the observation that the injected and the nasal spray influenza vaccines provide different levels of protection based on age. For the injected influenza vaccine, the group found “1) evidence of moderate protection (pooled estimate of 59%) for healthy adults 18 to 64 years of age, (2) inconsistent evidence of protection in children age 2 to 17 years, and (3) a paucity of evidence for protection in adults 65 years of age and older.” With regard to the nasal spray influenza vaccine, the group found “(1) evidence of high protection (pooled estimate of 83%) for young children 6 months to 7 years of age, (2) inconsistent evidence of protection in adults 60 years of age and older, and (3) a lack of evidence for protection in individuals between 8 and 59 years of age.” Another finding was that the perception of the vaccine’s efficacy (the reduction in the number of cases of the disease) has kept new influenza vaccines from being developed. In other words, the vaccines have been perceived to be good enough, so why change them?
The CCIVI report also pointed out that the Advisory Committee on Immunization Practices (ACIP) has made decisions to expand influenza vaccine coverage “based on professional judgment and not on scientifically sound data.” This wasn’t because the ACIP members were deliberately ignoring data: rather, the data came from “studies with suboptimal methodology.” (The report criticized, for example, older studies that are still cited in which vaccine antigen was not measured as it is today, or that were conducted with outdated methods of influenza vaccine manufacturing.) Other key findings in the report showed that new vaccine technologies are being researched – such as a universal flu vaccine – but the regulatory process and lack of financial incentives are hampering that development.
Based on the findings in the report, the CCIVI made six recommendations. First, “game-changing” vaccines are needed; vaccines that are more effective and safer than the current vaccines. Second, because data drives policy, those data must come from methodologically sound studies. Third, influenza vaccine must be plentiful and effective enough before the next pandemic. Fourth, the barriers to those game-changing vaccines must be removed. Fifth, the US government must take the lead in pushing the development of these game-changing vaccines through policy and funding, leading other global stakeholders toward the same goal. Finally, vaccine efficacy and effectiveness should be standardized so that data coming from all over the world can be measured against the same standard, preventing misinterpretations of the data when it comes to policy decisions.
Reaction to the report in the media and blogosphere was extreme. Roni Caryn Rabin wrote in the New York Times that the report was “a step tantamount to heresy in the public health world.” A blogger for Gaia Health wrote that the report shows that “the vaccines now in existence simply aren’t any good.” Public health officials, however, were quick to point out that the report acknowledged that the influenza vaccine provides moderate levels of protection against influenza and has a good safety profile. And one of the report’s authors, Michael T. Osterholm, MD, in the same New York Times article that alleged heresy, noted “I say, ‘Use this vaccine’ … The safety profile is actually quite good. But we have oversold it. Use it — but just know it’s not going to work nearly as well as everyone says.”
Nicholas Kelley, PhD, research associate at CIDRAP and one of the contributors to the CCIVI report said to us that “It is important that the best evidence available is driving our promotional activities, guiding our research strategies, and informing our policies to enable the influenza vaccine enterprise to research, develop, license, and market the necessary game-changing influenza vaccines we need.” Will the CCIVI report provide the impetus to change the game regarding influenza vaccines? It’s certainly sparked a heated discussion about the current status of US influenza vaccination policy and programs.
“Preventing Seasonal Flu with Vaccination,” Centers for Disease Control and Prevention. http://www.cdc.gov/flu/protect/vaccine/index.htm
“General Influenza and Flu Vaccine Information,” Center for Infectious Disease Research and Policy. http://www.cidrap.umn.edu/cidrap/content/influenza/general/index.html
"Reassessing Flu Shots as the Season Draws Near," New York Times, November 5, 2012. http://well.blogs.nytimes.com/2012/11/05/reassessing-flu-shots-as-the-season-draws-near/
"Scientists: Flu Vaccine Is Overhyped and Scientists Lie About," Gaia Health. http://gaia-health.com/gaia-blog/2012-11-21/scientists-say-flu-vaccine-is-overhyped-governments-lie-about-it/