Regulatory limits of aluminium content of vaccines have not been set based on toxicological studies

Aluminium-Based Adjuvants (ABAs) have been used in vaccines since the 1920s to boost immune responses. Despite their widespread use, their mechanisms of action remain only partially understood, and growing concerns exist about their long-term safety, particularly in vulnerable populations. This study examines the regulatory history of the aluminium content limit in vaccines and identifies major gaps in toxicological and epidemiological evaluation.

Through a detailed review of regulatory records, historical archives, Freedom of Information Act (FOIA) requests and responses, and scientific literature, we found that the current aluminium threshold of 0.85 mg per dose was set in the mid-20th century based on immunological efficacy - not on toxicological data- and remains in place despite changes in vaccination schedules and cumulative exposure. The key documents supporting this limit, which date back to 1947 and 1952, do not evaluate the potential toxicity of ABAs and are, in any case, no longer relevant to the current vaccination schedule.

There is an urgent need for independent pharmacokinetic and toxicological studies, transparent access to proprietary adjuvant compound, and a comeback to safer alternatives such as biocompatible calcium phosphate. Updating these standards is crucial for strengthening public confidence in vaccination policies.