Serious doubt about the safety and effectiveness of flu vaccine has a long history: Sir Macfarlane Burnet, 1960 Nobel laureate, made seminal contributions to our knowledge of influenza viruses; he once observed, "A vaccine is available but reduces the risk of catching flu only by half. This hardly measures up to our expectations for a modern vaccine. Furthermore,the remarkable propensity of influenza to undergo antigenic drift ensures that in any major new pandemic the virus will be one step ahead of the manufacturers." (1972, 'Natural History of Infectious Disease')
Anthony Morris was chief vaccine officer for the U.S. Bureau of Biologic Standards and the FDA. His unit's research yielded evidence that flu shots were ineffective, and he criticized the government for basing mass vaccination programs on claims made by the manufacturers. In 1980, after over 30 years of service and as part of the fallout from the "swine flu fiasco," he was forced into early retirement. ('Washington Post' obituary, 7/3/14)
Kenneth McIntosh counselled against routine flu vaccination of children because we lacked information about long-term risks and benefits; his advice was ignored in the U.S. (NEJM 342: 275, 2000)
Lone Simonsen found that from 1968 to 2001 U.S. flu deaths in the elderly increased in concert with their increasing use of flu vaccine. (Arch Int Med 165:265, 2005. Science 307:1026, 2005) She and other experts suggested that the evidence of protection from observational studies resulted from "healthy-user bias" and that widely publicized claims for large numbers of deaths prevented by vaccine were completely implausible.
Tom Jefferson, Peter Doshi and their colleagues at the Cochrane Collaboration published several reviews spotlighting the absence of high-quality evidence for flu vaccine's safety or effectiveness. (BMJ, Lancet, Cochrane Reviews, 2004-2014)
Rogier Bodewes has referred to the "double-edged sword" of annual vaccination because it subverts broad and lasting natural immunity. (Lancet Inf Dis 9:784, 2009. J Virol 85:11995, 2011)
Michael Osterholm and his CIDRAP colleagues completed a massive review of flu vaccines. Like Jefferson and colleagues they also found that the quality of the evidence was poor and that the vaccines are not very effective. (CIDRAP News 10/25/11. Lancet Inf Dis 12:36, 2012) Their public statements, however, have not been nearly as blunt as Jefferson's.
A few clinician-scientists cherish pious hopes for a broad, unbiased trial that will settle where, in the long run, the balance truly lies between the harms and benefits of annual vaccination. This will never happen; our best hope is for the development of a safe and effective universal vaccine that can be given once or twice or three times in the course of our lives. Not long ago I asked a Canadian flu expert about the feasibility for such a vaccine. She thought it was scientifically feasible, but she doubted that the manufacturers would willingly give up the guaranteed annual income of seasonal vaccines. Meanwhile the Massachusetts Nurses Association is suing Brigham and Woman's Hospital to block a mandate requiring annual flu shots as a condition for employment, citing state law, limited vaccine effectiveness and adverse effects. ('Boston Globe' 9/25 & 9/29/14)
Rapid Response:
Serious doubt about the safety and effectiveness of flu vaccine has a long history: Sir Macfarlane Burnet, 1960 Nobel laureate, made seminal contributions to our knowledge of influenza viruses; he once observed, "A vaccine is available but reduces the risk of catching flu only by half. This hardly measures up to our expectations for a modern vaccine. Furthermore,the remarkable propensity of influenza to undergo antigenic drift ensures that in any major new pandemic the virus will be one step ahead of the manufacturers." (1972, 'Natural History of Infectious Disease')
Anthony Morris was chief vaccine officer for the U.S. Bureau of Biologic Standards and the FDA. His unit's research yielded evidence that flu shots were ineffective, and he criticized the government for basing mass vaccination programs on claims made by the manufacturers. In 1980, after over 30 years of service and as part of the fallout from the "swine flu fiasco," he was forced into early retirement. ('Washington Post' obituary, 7/3/14)
Kenneth McIntosh counselled against routine flu vaccination of children because we lacked information about long-term risks and benefits; his advice was ignored in the U.S. (NEJM 342: 275, 2000)
Lone Simonsen found that from 1968 to 2001 U.S. flu deaths in the elderly increased in concert with their increasing use of flu vaccine. (Arch Int Med 165:265, 2005. Science 307:1026, 2005) She and other experts suggested that the evidence of protection from observational studies resulted from "healthy-user bias" and that widely publicized claims for large numbers of deaths prevented by vaccine were completely implausible.
Tom Jefferson, Peter Doshi and their colleagues at the Cochrane Collaboration published several reviews spotlighting the absence of high-quality evidence for flu vaccine's safety or effectiveness. (BMJ, Lancet, Cochrane Reviews, 2004-2014)
Rogier Bodewes has referred to the "double-edged sword" of annual vaccination because it subverts broad and lasting natural immunity. (Lancet Inf Dis 9:784, 2009. J Virol 85:11995, 2011)
Michael Osterholm and his CIDRAP colleagues completed a massive review of flu vaccines. Like Jefferson and colleagues they also found that the quality of the evidence was poor and that the vaccines are not very effective. (CIDRAP News 10/25/11. Lancet Inf Dis 12:36, 2012) Their public statements, however, have not been nearly as blunt as Jefferson's.
A few clinician-scientists cherish pious hopes for a broad, unbiased trial that will settle where, in the long run, the balance truly lies between the harms and benefits of annual vaccination. This will never happen; our best hope is for the development of a safe and effective universal vaccine that can be given once or twice or three times in the course of our lives. Not long ago I asked a Canadian flu expert about the feasibility for such a vaccine. She thought it was scientifically feasible, but she doubted that the manufacturers would willingly give up the guaranteed annual income of seasonal vaccines. Meanwhile the Massachusetts Nurses Association is suing Brigham and Woman's Hospital to block a mandate requiring annual flu shots as a condition for employment, citing state law, limited vaccine effectiveness and adverse effects. ('Boston Globe' 9/25 & 9/29/14)
Competing interests: No competing interests