Vaccines currently routinely recommended to the general population in the U.S. have not been shown to cause systemic lupus erythematosus (SLE).
The 2012 report by the Institute of Medicine (IOM) , now called the National Academy of Medicine (NAM), described four studies assessing exacerbation of SLE and influenza vaccine [2-5] and one study assessing onset of SLE and hepatitis B vaccine ; however, these studies did not provide convincing evidence due to a lack of validity and precision. The IOM found no relevant studies of quality in the literature assessing either exacerbation of SLE and hepatitis B vaccine or onset of SLE and influenza vaccine .
Two cohort studies published since the 2012 IOM report, a retrospective cohort of people over 60 years of age who received the herpes zoster vaccine (Zostavax)  and a prospective cohort of women receiving quadrivalent HPV vaccine (Gardasil) , found no association between vaccination and SLE. A controlled trial in Brazil randomized 54 SLE patients to receive either varicella vaccine or placebo and vaccinated 28 healthy matched controls, and found no difference in adverse event frequency between groups .
Proposed biological mechanism: There is evidence that natural infection may exacerbate symptoms in SLE patients . Inflammation is present both during SLE exacerbations and during immune responses to infection or vaccination. One possible mechanism is activation of the complement system, in which a cascade of proteolysis and successive release of cytokines functions to amplify the immune response but can damage host cells if not properly regulated. Other mechanisms that could contribute to onset or exacerbation of SLE include autoantibodies or T cells, and formation of immune complexes.
The 2012 IOM report described some experimental evidence and one case of SLE after hepatitis B vaccination ; however, the IOM concluded that this mechanistic evidence was weak. The IOM also concluded that there was no mechanistic evidence for an association between SLE and influenza vaccine, as the publications reviewed provided little evidence beyond a temporal association .
1. Institute of Medicine. In: Stratton K, Ford A, Rusch E, Clayton EW, eds. Adverse Effects of Vaccines: Evidence and Causality. Washington (DC): National Academies Press (US); 2012.
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