There have
been concerns about the safety of this ingredient because high concentration of
formaldehyde can damage DNA and cause cancerous changes in cells (2). Formaldehyde
is a one-carbon aldehyde and highly water soluble. It is used in some vaccines
to inactivate viruses and detoxify bacterial toxins as part of the
manufacturing process. In the purification process it where steps are taken to
remove all formaldehyde in vaccines (4). Sometimes however, some residual
formaldehyde may remain but the levels that is left is less or equal to 0.02%
(3). This is because in the manufacturing process formaldehyde is diluted (2). The
amount of formaldehyde in vaccines is actually several hundred times lower than
the amount known to actually cause harm to people, even infants. An example is
the DTP-HepB and Hib 5 in 1 vaccine contains less than 0.02% formaldehyde per
dose, or less than 200 parts per million (4).
Formaldehyde is even produced naturally in
the human body as part of normal metabolic functions to produce energy and
build basic materials that are needed for important life process, such as amino
acids (2). Human bodies are not able to distinguish between formaldehyde from
vaccines or formaldehyde that naturally occur in the body. The amount of formaldehyde
in a person’s body actually depend on their body weight. Therefore, even though
while babies weigh less than adult they still average a weight of 6-8 pounds
and so the amount of formaldehyde in their bodies is 50-70 times higher than
the upper amount they are able to receive in a single dose of a vaccine (1).
Resources:
- Biologics Evaluation and Research, & Food and Drug Administration. (2018, April 30). Common Ingredients in U.S. Licensed Vaccines. Retrieved April 30, 2020, from https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/common-ingredients-us-licensed-vaccines
- Children's Hospital of Philadelphia. (2014, November 6). Formaldehyde. Retrieved April 30, 2020, from https://www.chop.edu/centers-programs/vaccine-education-center/vaccine-ingredients/formaldehyde
- Mitkus, R. J., Hess, M. A., & Schwartz, S. L. (2013). Pharmacokinetic modeling as an approach to assessing the safety of residual formaldehyde in infant vaccines. Vaccine, 31(25), 2738–2743. doi: 10.1016/j.vaccine.2013.03.071
- World Health Organization. (n.d.). Components of a Vaccine. Retrieved April 29, 2020, from https://vaccine-safety-training.org/vaccine-components.html
