The  HPV vaccine (Gardasil) has been shown to contain viral DNA impurities that have been related to fatal adverse events (SAEs, Refs.: e.g. Lee SH, 2012a Advances Biosc Biotech, 3: 1214-24; Lee SH, 2012b J Inorg Chem, 112: 85-92, Lee SH 2013, Advances Biol Chem, 3:76-85). What is the impact of these pertinent findings on the benefit/risk ratio? Shouldn’t the marketing authorization be reconsidered (see recent open letter of complaint to the Director-General of the WHO, Dr Margaret Chan)

 

a.    Based on the literature, aluminum is involved with ’autoimmune/autoinflammatory syndrome induced by adjuvants’ (ASIA) syndrome (refs. e.g. Shoenfeld Y & Aron-Maor A, 2000, J Autoimmun 14: 1-10; Shoenfeld Y & Agmon-Levin N, 2011, J Autoimmun, 36: 4-8). This syndrome has been described in several animal models (Refs. in textbook ’Vaccines & Autoimmunity’ 2015, edited by Shoenfeld, Y, Agmon-Levin N & Tomljenovic L, pp. 35-41). Has the possibility of aluminium induced ASIA syndrome been acknowledged before approval of marketing authorization for Cervarix or Gardasil, or at some point afterwards? Do these findings have any implications for human safety? If yes, what?