Aluminum is incorporated into some vaccines as an adjuvant. The purpose of formulating vaccines with adjuvants is to increase the immune response to the,
antigen (the component of the vaccine that stimulates the immune system to make antibodies). When FDA evaluates a vaccine for safety and effectiveness, an adjuvant such as aluminum, is considered to be a part of the vaccine, rather than a component that is licensed separately.
Vaccines containing an aluminum adjuvant have a demonstrated safety profile of over six decades of use and have only uncommonly been associated with severe local reactions. But because the public has expressed concerns that aluminum in vaccines might pose a risk to infants, FDA performed an updated analysis of the safety of aluminum adjuvants.
The authors of the paper based their calculations of infant exposure to aluminum on the following updated parameters:
an updated list of recommended vaccines for infants
baseline aluminum levels at birth
more recent information on how the body accumulates aluminum
new information on how the infant kidney filters out potentially toxic substances from the blood
more accurate information on how quickly aluminum spreads away from the site of vaccine injections and into the body
the latest information on safety levels for aluminum in the body
the most recent information on infant weights from age 0 to 60 months
The authors based their calculations on the series of vaccinations that deliver the maximal possible levels of aluminum during an infant’s first year of life and the assumption that infants would receive the entire recommended schedule of vaccines during this time. The recommendations for the schedule of vaccinations in the first year of life are those of the Advisory Committee on the Immunization Practices an advisory committee to the Centers for Disease Control and Prevention.
The FDA study found that the maximum amount of aluminum an infant could be exposed to over the first year of life would be 4.225 milligrams (mg), based on the recommended schedule of vaccines. Federal Regulations for biological products (including vaccines) limit the amount of aluminum in the recommended individual dose of biological products, including vaccines, to not more than 0.85-1.25 mg. For example, the amount of aluminum in the hepatitis B vaccine given at birth is 0.25 mg.
Aluminum is found naturally in large quantities in the environment, often consumed through drinking water or ingesting certain foods, such as infant formula. Using the updated parameters, the authors found that the body burden of aluminum from vaccines and diet throughout an infant’s first year of life is significantly less than the corresponding safe body burden of aluminum, based on the minimal risk levels established by the Agency for Toxic Substances and Disease Registry.
Connect With Us