2. Academic Validation
  3. International Nonproprietary Names (INN) for novel vaccine substances: A matter of safety

International Nonproprietary Names (INN) for novel vaccine substances: A matter of safety

  • Vaccine. 2022 Jan 3;40(1):21-27. doi: 10.1016/j.vaccine.2021.11.054.
James S Robertson 1,  Ursula Loizides 2,  Akinola Adisa 3,  Ana López de la Rica Manjavacas 4,  Vicente Rodilla 5,  Colette Strnadova 6,  Karin Weisser 7,  Raffaella Balocco 8
Affiliations

Affiliations

  • 1 Independent Expert, St Albans, United Kingdom.
  • 2 INN Programme and Classification of Medical Products, INN/HPS/MHP, World Health Organization, 1211 Geneva, Switzerland.
  • 3 Therapeutic Goods Administration, Department of Health, Woden ACT 2606, Australia.
  • 4 Agencia Española de Medicamentos y Productos Sanitarios, Madrid 28022, Spain.
  • 5 Universidad CEU Cardenal Herrera, Alfara del Patriarca, 46113 Valencia, Spain.
  • 6 Health Canada, Health Products and Food Branch, Ottawa, Ontario K1A 0K9, Canada.
  • 7 Division Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biomedicines), Paul-Ehrlich-Strasse 7, 63225 Langen, Germany.
  • 8 INN Programme and Classification of Medical Products, INN/HPS/MHP, World Health Organization, 1211 Geneva, Switzerland. Electronic address: baloccor@who.int.
PMID: 34844820 DOI: 10.1016/j.vaccine.2021.11.054
Abstract

International Nonproprietary Names (INN) are assigned by the World Health Organization (WHO) to pharmaceutical substances to ensure global recognition by a unique name. INN facilitate safe prescribing through naming consistency, efficient communication and exchange of information, transnational access and pharmacovigilance of medicinal products. Traditional vaccines such as inactivated or live-attenuated vaccines have not been assigned INN and provision of a general name falls within the scope of the WHO Expert Committee on Biological Standardization (ECBS). However, novel vaccines that contain well-defined active ingredients such as nucleic acids or recombinant proteins fulfil the criteria to be assigned INN. In the current environment where multiple SARS-CoV-2 vaccines are being developed to combat the COVID-19 pandemic and with virus variants emerging, assigning INN to well-defined vaccine substances will strengthen pharmacovigilance and ultimately enhance the safety of vaccine recipients. This article examines the background to INN for vaccines and explains the applicability and value of assigning INN to novel well-defined vaccines.

Keywords

COVID-19; International Nonproprietary Names; Novel vaccine substances; Patient safety; Pharmacovigilance; SARS-CoV-2; Viral vector vaccines; mRNA vaccines.

Figures
Products