WHO international non-proprietary names: the need to distinguish COVID-19 vaccines

Abstract

The WHO International Nonproprietary Names Programme would like to highlight that international non-proprietary names (INNs), assigned to well defined pharmaceutical substances, including those used in vaccines, ensure that each substance is recognised globally by a unique and distinct name. Traditional vaccines that are based on live-attenuated or inactivated pathogens are assigned short, descriptive names by the WHO Expert Committee on Biological Standardization. However, new concepts and technologies in vaccine design, such as vaccines based on DNA, RNA, recombinant protein, recombinant virus, and peptides, encompass active ingredients that are well defined and fall within the scope of the INN nomenclature system.1WHOInternational nonproprietary names (INN) for biological and biotechnological substances (a review).https://www.who.int/medicines/services/inn/BioReview2019.pdfDate: 2019Date accessed: January 19, 2021Google Scholar As of January, 2021, several mRNA-based vaccines and one plasmid-based DNA vaccine have been assigned INNs, including the anti-rabies mRNA nadorameran,2WHOInternational nonproprietary names for pharmaceutical substances (INN). Proposed INN: list 113.WHO Drug Inf. 2015; 29: 195-301Google Scholar, 3WHOInternational nonproprietary names for pharmaceutical substances (INN). Recommended INN: list 75.WHO Drug Inf. 2016; 30: 93-170Google Scholar the anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNAs zorecimeran4WHOInternational nonproprietary names for pharmaceutical substances (INN). Proposed INN: list 124—COVID-19 (special edition).WHO Drug Inf. 2020; 34: 641-685Google Scholar and tozinameran,4WHOInternational nonproprietary names for pharmaceutical substances (INN). Proposed INN: list 124—COVID-19 (special edition).WHO Drug Inf. 2020; 34: 641-685Google Scholar and the anti-SARS-CoV-2 DNA plasmid reluscovtogene ralaplasmid.4WHOInternational nonproprietary names for pharmaceutical substances (INN). Proposed INN: list 124—COVID-19 (special edition).WHO Drug Inf. 2020; 34: 641-685Google Scholar Currently, there are no clear recommendations or a consensus in place regarding the global use of INNs assigned to newly developed SARS-CoV-2 vaccines. National or international legislation usually requires INNs for therapeutic medicinal substances; however, whether vaccines should be included in such requirements is unclear. In the context of the COVID-19 pandemic, this ambiguity has led to a situation in which some vaccine developers have applied for an INN, but others have not. Consequently, INNs for SARS-CoV-2 vaccines are not currently being included in vaccine labels and in most cases are also not listed on the respective regulatory websites. This lack of information could pose substantial safety issues for individuals who receive a SARS-CoV-2 vaccine during this pandemic, in addition to complicating pharmacovigilance efforts for health authorities. Some of the SARS-CoV-2 vaccine candidates require two injections several weeks apart for maximum protection, which presents a considerable risk if the identity of a vaccine is not globally ensured. Several competing SARS-CoV-2 vaccines are already being distributed and clear identification of each active substance might not always be confirmed. Future scenarios include the use of multiple active ingredients in different formulations and INNs would be the ideal tool to make this approach transparent. The assignment of a unique and distinct INN to the active substances in each vaccine would contribute to safe prescribing, transnational distribution, enhanced pharmacovigilance, and, ultimately, the safety of vaccine recipients, as it does for therapeutic medicinal substances. For the safety of vaccine recipients and the global recognition of vaccine ingredients, the WHO International Nonproprietary Names Programme encourages vaccine developers to submit INN requests for well defined vaccine ingredients and urges regulatory authorities to facilitate INN implementation. We declare no competing interests.