Findings are at Odds with Federal Regulations Requiring Satisfactory Evidence of Safety
STAFFORDSHIRE, ENGLAND / ACCESSWIRE / October 12, 2016 / The prestigious NatureResearch journal published results from the first study comparing the reactivity and fate of aluminum adjuvants commonly used in vaccines, findings that are at odds with Code of Federal Regulations Title 21 requiring satisfactory evidence of safety.
Aluminum-containing adjuvants have been used with most childhood vaccines by convention based on their adjuvanticity in animals,1 often without a clearly demonstrated safety and/or enhanced immune response or protection in humans. The need and benefits of using an adjuvant with a vaccine should be demonstrated in humans, as animal models have not been good predictors of effectiveness of most human vaccines. This would require an extra group in clinical trials for the vaccine without an adjuvant.
As per 21 CFR 610.15, "an adjuvant shall not be introduced into a product unless there is satisfactory evidence that it does not affect adversely the safety or potency of the product."2 Aluminum-containing adjuvants have been known to be associated with adverse reactions after vaccinations.3.4 There are no sound scientific studies or controlled clinical trials to understand adjuvant effect and toxicity of aluminum-containing adjuvant.
A simple explanation of how an aluminum adjuvant works is that its injection into the muscle or under the skin produces toxicity. In most recipients of a vaccine this toxicity is seen as mild inflammation or reddening and swelling of tissue at the injection site. However, in a small minority of individuals the consequences of this toxicity are more severe and can lead to serious adverse events including autoimmune disease and brain encephalopathies.
Breakthrough in Study of Aluminum Adjuvant Impact on Immune Response
Research at Keele University led by Professor Christopher Exley aims to understand the toxicity of aluminum adjuvants in vaccinations and their latest findings are now published in Nature's 'Scientific Reports' (http://www.nature.com/articles/srep31578 ).
In a project funded by the Medical Research Council (MRC) and the Dwoskin Foundation the group at Keele investigated the relationship between the physicochemical properties of aluminum adjuvants and the immune response. Specifically, they show that the reaction of the aluminum adjuvant at the injection site will determine its subsequent fate and therefore its activity both at the injection site and away from the injection site.
One form of aluminum adjuvant which is most commonly used in vaccines is an aluminum hydroxyphosphate salt and is more toxic at the injection site than the second form of aluminum adjuvant, also commonly used in vaccines, aluminum oxyhydroxide salt. However, the latter is more easily loaded into immune reactive cells with the possibility to be transported throughout the body. It is suggested by the Keele research that this loading of aluminum into viable cells offers a mechanism whereby significant amounts of aluminum, a known neurotoxin, might be translocated throughout the body and even across the blood brain barrier and into the central nervous system.
Aluminum Adjuvants Not Clinically Approved
Professor Exley adds that there are no clinically-approved aluminum adjuvants only clinically approved vaccines which use aluminum adjuvants. This makes it imperative that all vaccine trials which use aluminum salts as adjuvants must not use the aluminum adjuvant as the control or placebo. This has been common practice for many years and has resulted in many vaccine-related adverse events due in part or in entirety to aluminum adjuvants being unaccounted for in vaccine safety trials. This is in violation of the regulatory requirement that, "An adjuvant shall not be introduced into a product unless there is satisfactory evidence that it does not affect adversely the safety or potency of the product."2
The National Childhood Vaccine Injury Act (Public Law 99-660)5 and the Vaccine Compensation Amendments (Public Law 100-203) in 19876,7 provide mechanism of monetary compensation of victims by creating a trust which is funded by a $0.75 excise tax on vaccines recommended by the Centers for Disease Control and Prevention (CDC) for routine administration to children. The Act and subsequent amendments also require the public health agencies to find the causes for side effects, causal relations between severe side effects and vaccines, and improvement of vaccines. Unfortunately, the 3 large public health agencies in the US responsible for approving vaccines (FDA), recommending their use in population (CDC) and performing research on understanding the safety and adjuvanticity of most commonly used adjuvants (NIH, CDC and FDA), have not done much in this regard and in improving the childhood vaccines. An enormous amount of surplus money is lying in the trust fund created under the National Childhood Vaccine Injury Act, which is also meant to improve the vaccines.
Based on the findings of Professor Exley, further research funded by the trust fund is warranted to understand the safety and adjuvanticity of aluminum-containing adjuvants. It is required by the law (21CFR610.15),2 that the FDA should not approve a vaccine with any adjuvant unless it is clearly demonstrated that it does not adversely affect the safety and potency. This can only be known when vaccine is used without adjuvant in one group of the clinical trial and placebo group without aluminum-containing adjuvant. Instead of working for the public in approving safe vaccines developed as per the law, the FDA has been favoring the vaccine industry in not requiring demonstrating clearly the safety of and need for aluminum-containing adjuvants.
For further information contact Professor Chris Exley (firstname.lastname@example.org), The Birchall Centre, Lennard-Jones Laboratories, Keele University, Staffordshire, ST5 5BG, UK.
- Gupta, R.K. Role and application of adjuvants and delivery systems in vaccines. In: Wang, W. and Singh M., eds, Biological Drug Products: Development and Strategies, Wiley, 437-468, 2014.
- 21 CFR 610.15. Constituent Materials
- Gupta, R.K. and Relyveld, E.H. Adverse reactions after injection of adsorbed diphtheria-pertussis-tetanus (DPT) vaccine are not due only to pertussis organisms or pertussis components in the vaccine. Vaccine 9:609-702, 1991.
- Gupta, R.K., Relyveld, E.H., Lindblad, E.B., Bizzini, B., Ben-Efraim, S. and Gupta, C.K. Adjuvants - A balance between toxicity and adjuvanticity. Vaccine 11: 293-306, 1993.
- Public Law 99-660, Title III, Vaccine Compensation, National Childhood Vaccine Injury Act of 1986, November 14, 1986. https://history.nih.gov/research/downloads/PL99-660.pdf
- Public Law 100-203, Title IV, Medicare, Medicaid, and other Health-Related Programs, Subtitle D, Vaccine Compensation, December 22, 1987, https://www.congress.gov/bill/100th-congress/house-bill/3545
- Title 42 USC Chapter 6A – Public Health Service, SubChapter XIX – Vaccines, Part 2 – National Vaccine Injury Compensation Program. http://www.hrsa.gov/vaccinecompensation/authorizinglegislation.pdf
SOURCE: Children's Medical Safety Research Institute