Medical Writing Vaccines and Immunotherapies Allergen immunotherapy in the European regulatory environment

Volume 27, Issue 1 - Vaccines and Immunotherapies

Allergen immunotherapy in the European regulatory environment


Allergen immunotherapy (AIT) modulates the immune system to prevent and relieve allergic symptoms. Unlike allergen avoidance and medication to control symptoms, AIT targets the underlying pathophysiology of allergic diseases. AIT is now considered a type of therapeutic vaccination. This article focuses on the current regulatory environ - ment in the EU and the special considerations in designing clinical trials evaluating AIT products.

Download the full article


  1. Pfaar O, Bonini S, Cardona V, Demoly P, Jakob T, Jutel M et al. Perspectives in allergen immunotherapy: 2017 and beyond. Allergy. 2018 Jan;73 Suppl 104:5–23.
  2. Roberts G, Pfaar O, Akdis CA, Ansotegui IJ, Durham SR, van Gerth Wijk R et al. EAACI Guidelines on Allergen Immuno - therapy: Allergic rhino conjunctivitis. Allergy. 2017 Sep 23. doi:10.1111/ all.13317. [Epub ahead of print]
  3. Pfaar O, Bachert C, Bufe A, Buhl R, Ebner C, Eng P et al. Guideline on allergenspecific immunotherapy in IgE-mediated allergic diseases: S2k Guideline of the German Society for Allergology and Clinical Immunology (DGAKI), the Society for Pediatric Allergy and Environmental Medicine (GPA), the Medical Association of German Allergologists (AeDA), the Austrian Society for Allergy and Immunology (ÖGAI), the Swiss Society for Allergy and Immunology (SGAI), the German Society of Dermatology (DDG), the German Society of Oto- Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), the German Society of Pediatrics and Adolescent Medicine (DGKJ), the Society for Pediatric Pneumology (GPP), the German Respiratory Society (DGP), the German Association of ENT Surgeons (BV-HNO), the Professional Federation of Paediatricians and Youth Doctors (BVKJ), the Federal Association of Pulmonologists (BDP) and the German Dermatologists Association (BVDD). Allergo J Int. 2014;23(8):282–319.
  4. Bonertz A, Roberts G, Hoefnagel M, Timon M, Slater J, Rabin R et al. Challenges in the implementation of EAACI Guidelines on Allergen Immunotherapy: A global perspective on the regulation of allergen products. Allergy. 2017 [cited 2017 Aug 11]. Allergy. 2018 Jan;73(1):64–76.
  5. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use Official Journal L - 311, 28/11/2004, p. 67-128; 2004.
  6. 2001/20/EC D. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. In: Official Journal of the European Communities. 2001. Available from:
  7. Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases: European Medicines Agency (EMEA). Committee for Medicinal Products of Human Use (CHMP); 2008.
  8. Passalacqua G, Baena-Cagnani CE, Bousquet J, Canonica GW, Casale TB, Cox L et al. Grading local side effects of sublingual immunotherapy for respiratory allergy: Speaking the same language. J Allergy Clin Immunol. 2013;132(1):93–8.
  9. Cox L, Larenas-Linnemann D, Lockey RF, Passalacqua G. Speaking the same language: The World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System. J Allergy Clin Immunol. 2010;125(3):569–74, 574.e 1-574.e7.
  10. Pfaar O, Demoly P, van Gerth Wijk R, Bonini S, Bousquet J, Canonica GW et al. Recommendations for the standardization of clinical outcomes used in allergen: immunotherapy trials for allergic rhinoconjunctivitis: An EAACI Position Paper. Allergy. 2014;69(7):854–67.
  11. Rösner-Friese K, Kaul S, Vieths S, Pfaar O. Environmental exposure chambers in allergen immunotherapy trials: Current status and clinical validation needs. J Allergy Clin Immunol 2015;135(3): 636–43.
  12. Durham SR, Nelson HS, Nolte H, Bernstein DI, Creticos PS, Li Z et al. Magnitude of efficacy measurements in grass allergy immunotherapy trials is highly dependent on pollen exposure. Allergy. 2014;69(5):617–23.
  13. Pfaar O, Hohlfeld JM, Al-Kadah B, Hauswald B, Homey B, Hunzelmann N et al. Dose-response relationship of a new Timothy grass pollen allergoid in comparison to a 6-grass pollen allergoid. Clin Exp Allergy. 2017;47(11):1445–55.
  14. Corrigan CJ, Kettner J, Doemer C, Cromwell O, Narkus A. Efficacy and safety of preseasonal-specific immunotherapy with an aluminium-adsorbed six-grass pollen allergoid. Allergy. 2005;60(6): 801–7.



Vaccines and immunotherapies
President's Column
A history of EMWA
An introduction to vaccines and immunotherapies
Immuno-oncology: Harnessing our immune system to fight cancer
Changing methods to assess targeted therapies in oncology
HIV vaccine clinical trials: An overview
Allergen immunotherapy in the European regulatory environment
Pharmacovigilance for vaccines and immunotherapies
Addressing vaccine hesitancy in writing
Results of the 2017 EMWA salary survey
Lay writing: Strategies for improving assent forms
The perils of the unknown: Missing data in clinical studies
Medical writing in China: Trends and opportunities
PhD student: A medical writer in the making!
News from the EMA
Medical Communications
Journal Watch
In the Bookstores
The Webscout
Teaching Medical Writing
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Entering medical communications as a non-native English speaker
Out on Our Own
Lingua Franca and Beyond


The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board


Raquel Billiones


Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir


Jennifer Bell


Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer


Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha


Tiziana von Bruchhausen


Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk