What is the efficacy and adverse effects of the H1N1 influenza (swine flu) vaccine?

Updated: Apr 09, 2019
  • Author: Michael Stuart Bronze, MD; Chief Editor: Russell W Steele, MD  more...
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Answer

Zhu et al (2009) assessed the safety and immunogenicity of the 2009 H1N1 vaccine in a randomized clinical trial in populations ranging in age from 3-77 years. In the study, 2200 individuals received one dose, 2103 (95.6%) of whom received a second dose or placebo. A single 15-mcg dose of hemagglutinin antigen without alum adjuvant induced a typically protective immune response in most participants aged 12-60 years. Severe adverse effects were not observed. Mild injection-site reactions were reported in up to 16% of individuals. [45]

Communication from the US FDA Commissioner, Margaret Hamburg, summarized safety data after 11.3 million doses of intranasal and 34.9 million doses of injectable vaccine were distributed. Analysis of 3783 reports of adverse events was reported to the vaccine adverse event reporting system (VAERS) through November 24, 2009, based on 438,376 people vaccinated. The vast majority (94%) of adverse events described were classified as nonserious (eg, soreness at site of injection). No cases of Guillain-Barré syndrome have been reported. As of December 30, 2009, nearly 100 million doses of H1N1 vaccine had been distributed. [46]


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