Regulation of edible vaccines distribution

Regulatory concerns include lot-to-lot consistency, uniformity of dosage and purity.

Controversies still exist as to whether edible vaccines are to be regulated under food, drugs or agricultural products and what vaccine component should be licensed - antigen itself, genetically engineered fruit or transgenic seeds. They will be subjected to very close scrutiny by the regulatory bodies in order to ensure that they never enter the food supply. This will include greenhouse segregation of medicinal plants from food crops to prevent cross-breeding and will necessitate separate storage and processing facilities. Although edible vaccines fall under "GM" plants(genetically modified), it is hoped that these vaccines will avoid serious controversy, because they are intended to save lives. This is because of lack of investors' confidence in returns on investments in GM foods.

Edible vaccines are considered safer than injectable ones because their manufacture has absolutely nothing to do with the germs that cause disease.

While regulations for the production of active compounds in plants are being developed in the USA, similar actions are also to be taken in the EU(European Union). Although several European laboratories are involved in transgenic plant vaccine research, difficulties come from national and regional regulations that do not yet discriminate between transgenic plants as sources of food and as therapeutic agents.

Transgenic plant products could be delivered in their native form or could be the starting material for the production of processed edible vaccines. These could be administered as dried formulations, such as capsules, a powder to add to milk or other liquids. Regardless of their form, plant-based vaccines will have to be considered as pharmaceutical products and handled according to the same regulations as any other drug. Appropriate measures, such as growing in closed green houses, are being planned to prevent mixing of these transgenic plants with normal plants.

References:
a. http://www.gene.ch/genet/2001/Jan/msg00082.html
b. http://www.nature.com/embor/journal/v1/n5/full/embor535.html
c. Lal P, Ramachandran VG, Goyal R, Sharma R. Edible vaccines: Current status and future. Indian J Med Microbiol [serial online] 2007 [cited 2008 May 2];25:93-102. Available from: http://www.ijmm.org/text.asp?2007/25/2/93/32713