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Revista Cubana de Investigaciones Biomédicas

On-line version ISSN 1561-3011

Abstract

FRANCO LACATO, Alex Omar; CHAPARRO MERIDA, Nataniel Aldo  and  PEREZ MARTIN, Oliver. Importance of post-marketing surveillance of SARS-CoV-2 vaccines. Rev Cubana Invest Bioméd [online]. 2024, vol.43  Epub Apr 10, 2024. ISSN 1561-3011.

Introduction:

Vaccination has been one of the most cost-effective health interventions, due to its impact on the control of immunopreventable diseases. The pandemic caused by SARS-CoV-2 led to the worldwide development of more than two hundred vaccines in different phases of research with diverse platforms.

Objective:

To characterize the quality control assessment of vaccines against SARS-CoV-2 and adverse events of those approved against other pathogens at different stages of preclinical and clinical trials.

Methods:

We searched Google Scholar and PubMed/Medline for articles published between 1969 and March 2021. The most relevant articles were selected.

Development:

Vaccines were developed in a short time in the face of the COVID-19 pandemic, without compromising the adequate control of clinical trials. Although they are safe, they are not free of adverse events; therefore, their safety should be monitored during the post-marketing process. Many of them have compromised their safety.

Conclusions:

Vaccines should possess proven immunogenicity, efficacy and safety. Adverse events can arise at any stage of research; therefore, post-marketing surveillance is essential.

Keywords : vaccine; SARS-CoV-2; COVID-19; adverse events; virus.

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