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

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.