Cochrane to review Aluminum adjuvants used in vaccines
Aluminium adjuvants used in vaccines versus placebo or no intervention
More than 10 years has passed since the systematic review by Jefferson and colleagues, new adjuvants are being introduced continuously, and FDA and WHO do not require genotoxicity or cardiotoxicity studies of new aluminium adjuvants (WHO 2014a; FDA 2015). Lately, symptoms following HPV vaccination have been suspected of being caused by the addition of aluminium adjuvant (Tomljenovic 2011; Lee 2012; Poddighe 2014; Brinth 2015a; Gruber 2015; Martinez-Lavin 2015). A recent animal study by Inbar and colleagues managed to spark further controversy by demonstrating behavioral abnormalities in mice administered the aluminium-containing HPV vaccine Gardasil (Inbar 2016a). Compared to previous animal studies on HPV vaccines, the authors included two control groups: one where mice were administered aluminium adjuvant alone and another with placebo without adjuvant (Inbar 2016a). Inbar and colleagues concluded that Gardasil via both its aluminium adjuvant and HPV antigens can trigger neuro-inflammation and autoimmune reactions, leading to behavioural changes in mice (Inbar 2016a). Upon submission to a peer-reviewed journal, the paper was accepted with revisions, and published. However, it was soon withdrawn by the editor (Inbar 2016), only to be published in a competing journal shortly thereafter (Inbar 2016a). The initial withdrawal was allegedly due to "unsound scientific results"; an assertion which was not supported by the final publisher. The theory that aluminium adjuvant is responsible for symptoms following HPV vaccination is impossible to refute or prove based on the current data. Aluminium adjuvant has been administered to both experimental and control group in the vast majority of randomised clinical trials on HPV vaccines, thus masking its potentially harmful effects (Exley 2011). Clinical trials designed to administer vaccine adjuvants to the experimental group as well as the placebo group do, de facto, not compare an intervention against a true placebo, and therefore, do not adequately assess safety (Exley 2011). Indeed, aluminium adjuvants, new or old, should be evaluated for benefits and harms on their own merits.
Aluminium is the most frequently used adjuvant, introduced in vaccination programmes worldwide (Tritto 2009). While the consequences of adding aluminium to vaccines have been discussed broadly, no systematic review has been conducted to assess the effects of aluminium adjuvants across vaccines. The effects of aluminium adjuvants remain to be properly assessed using Cochrane methodology to determine whether they are beneficial, or causally linked to the numerous adverse events reported following immunisation.