It is the responsibility of Medicines and Healthcare products Regulatory Agency (MHRA), with advice from the Commission on Human Medicines (CHM), to assess a medicinal product intended for desensitisation as a treatment for allergy (allergen immunotherapy). The products will need to establish quality, safety, efficacy and a favourable benefit:risk profile, as for any medicinal product. Neither the MHRA nor the CHM has any objection to the principle of immunotherapy for allergy. However, in view of the small risk of life threatening anaphylactic reactions associated with immunotherapy, the CHM has, naturally, been cautious in its approach to the licensing of desensitising vaccines.
There are three currently licensed desensitisation products:
Grazax (Timothy grass), a sublingual tablet for patients with hay fever;
Pollinex preparations (grasses and rye or tree pollen), for patients suffering from seasonal hay fever who have failed to respond to standard anti-allergy medication; and
Pharmalgen (bee/wasp venom extract), for patients with hypersensitivity to bee/wasp venom.
Each application was assessed on the scientific evidence provided taking account of the current prevailing medical and scientific opinion.