Abstract

VAZQUEZ-ROMERO, Javier Eduardo  and  ROMEU-ALVAREZ, Belkis. Anti-COVID-19 vaccines: a look from the regulatory perspective. Vaccimonitor [online]. 2022, vol.31, n.2, pp. 90-99.  Epub Aug 01, 2022. ISSN 1025-0298.

The development of anti-COVID-19 vaccines has been one of the main priorities of the global scientific community. To date, multiple vaccines have been approved for use by numerous countries, and the World Health Organization has already included some of these in its emergency use listing program. This paper offers information on these aspects and analyzes the colossal challenge that facing the growing development of vaccines against COVID-19 has represented for the regulatory sector, ensuring their quality, safety and efficacy. Similarly, new approaches in the development of clinical trials are addressed, or modifications in existing regulatory procedures that have been carefully adapted by regulatory agencies, without losing their scrutiny capacity and the integrity of the scientific-regulatory evaluation.

Keywords : COVID-19; vaccines; medical device legislation; clinical trial.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )