Types of adjuvants
Vaccine development has been advancing over the years. New types of vaccines, such as DNA-based, recombinant subunits, recombinant viruses, and conjugates have been developed and introduced commercially. These vaccines tend to be safer and less reactogenic than older-style vaccines made from live or killed whole organisms. Use of new adjuvants that work with these vaccine types and that are less reactogenic has not kept pace with vaccine technology. Part of the barrier is the stringent regulatory environment. The hurdles in the U.S. and in Europe to gain approval are high (see, for example, Guideline on Adjuvants in Vaccines for Human Use by The European Medicines Agency). In nearly 80 years since the first vaccine adjuvant was approved by the FDA (United States Food and Drug Administration), no other adjuvant has been approved by the FDA for use in humans. The FDA only approves adjuvants in combination with vaccines and does not approve adjuvants alone. Nevertheless, substantial investment in adjuvant technology continues as evidenced by patent application filings and by clinical studies.
Adjuvants used in vaccines given to humans
Aluminium salts were the first adjuvants approved by the FDA for use in humans. Use of alum salts began in the 1930s, before regulatory guidelines became more stringent. More recently, approvals have been obtained in Europe for MF59 as an adjuvant component of flu vaccine for elderly patients (Fluad(r) , Novartis Vaccines) and AS04 (combination of alum and MPL, GlaxoSmithKline) as the adjuvant for a viral vaccines (hepatitis B, HPV).
Categories of adjuvants in development, testing, or use
Mineral salts - e.g., alumuninium hydroxide ("alum"), aluminium phosphate, calcium phosphate;
- Oil emulsions - e.g., MF59, a detergent-stabilised oil-in-water emulsion;
- Particulate adjuvants - e.g., virosomes, ISCOMS (structured complex of saponins and lipids);
- Microbial derivatives - e.g., MPL(TM) (monophosphoryl lipid A), CpG motifs, modified toxins;
- Plant derivatives - e.g., saponins (QS-21);
- Endogenous immunostimulatory adjuvants - e.g., cytokines.
- Glenn and O'Hagan (2007) Adjuvants: progress, regress and pandemic preparedness. Expert Rev. Vaccines 6(5) 651-652.
- Petrovsky et al. (2007) New-age vaccine adjuvants: Friend or foe? BioPharm International.
- Vogel et al. A compendium of vaccine adjuvants and excipients (2nd Edition)
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