Additional studies should be conducted to further evaluate the potential biological mechanisms involved in HPV4 vaccine-associated SAAEs in animal model systems, and to examine the potential epidemiological relationship between HPV4 vaccine-associated SAAEs in other databases and populations. Previous case series of SAAEs and biological plausibility support the observed results. Cases with the outcomes of Guillain-Barre syndrome (OR = 0.75, 95 % CI = 0.42–1.3) or thrombocytopenia (OR = 1.3, 95 % CI = 0.48–3.5) were no more likely than controls to have received HPV4 vaccine. The vaccine adverse event reporting system (VAERS) database was examined for adverse event reports associated with vaccines administered from January 2006 through December 2012 to recipients between 18 and 39 years old with a listed residence in the USA and a specified female gender.
An epidemiological study was undertaken to evaluate concerns about the potential for HPV4 vaccination to induce serious autoimmune adverse events (SAAEs).
GARDASIL (Merck & Co., Inc., Whitehouse Station, NJ, USA) is a quadrivalent human papillomavirus (HPV4) vaccine.
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