AAHS

ARTICLE

Sesilje B Petersen, Christian Gluud

Was amorphous aluminium hydroxyphosphate sulfate adequately evaluated before authorisation in Europe?

BMJ Evidence-Based Medicine, Vol 26, Issue 6

https://ebm.bmj.com/content/26/6/285

Amorphous Aluminium Hydroxyphosphate Sulfate

Vaccines containing AAHS:

DTaP/IPV/Hib/HepB (6 in 1) 

Vaxelis

HPV

Gardasil

Documentation from Danish authorities and answers from the European Medicines Agency (EMA) suggest that AAHS may not have been sufficiently evaluated.

Documentation from the Danish Medicines Agency shows discrepancies in the trial documents of two prelicensure clinical trials with Gardasil in 2002 and 2003. For both trials, the Agency seems to have authorised potassium aluminium sulfate as the adjuvant and not AAHS. In addition, the participants in the trial launched in 2002 were informed that the comparator was saline, even though the comparator was AAHS in an expedient consisting of L-histidine, polysorbate-80, sodium borate and sodium chloride.