Aluminum salts have been used as adjuvants in vaccines for nearly a century, enhancing the immune response to purified antigens and ensuring durable protection against serious infectious diseases. Despite their longstanding record of safety and effectiveness, aluminum adjuvants have become a focus of public concern, with claims linking them to developmental, neurologic, allergic, and autoimmune diseases. This review summarizes the immunologic rationale for aluminum adjuvants and evaluates the evidence for proposed safety risks. Aluminum salts have consistently been demonstrated over nearly a century of use to enhance the immune responses elicited by vaccines while also being well-tolerated by nearly all who take them. Pharmacokinetic studies show that aluminum released from intramuscular vaccines is slowly absorbed and efficiently cleared by the kidneys, contributing minimally to systemic levels. Large-scale clinical and epidemiologic studies consistently demonstrate no association between aluminum-adjuvanted vaccines and autism spectrum disorder, neurotoxicity, allergic disease, or autoimmune disease. Clinically, vaccines adjuvanted solely with aluminum salts generally do not result in systemic reactogenicity, though local reactions are common. Collectively, the evidence strongly supports the safety of aluminum adjuvants and their necessity in certain vaccines. Clinicians can reassure caregivers that aluminum-containing vaccines provide clear benefits, with risks largely limited to transient local reactions and no systemic toxicity signal in large clinical and epidemiologic studies.
Nirenberg et al. (Wed,) studied this question.