PAHO Approval Process for COVID-19 Vaccines in Colombia and EUL Criteria

Bogotá, November 30, 2023 (PAHO) – Regarding the approval process of vaccines against COVID-19, the Pan American Health Organization (PAHO) indicates that the vaccines used in Colombia are included in the WHO emergency use list (EUL). These vaccines have phase 1-3 results (immunogenicity, safety, efficacy against hospitalization and death) at the time WHO granted prequalification and the SAGE (WHO Scientific Advisory Group of Experts for Vaccines and Immunizations) committee made the recommendation.

The Emergency Use Listing (EUL) procedure evaluates the suitability of new medical devices during public health emergencies. The goal is to make medicines, vaccines and diagnostic tests available as quickly as possible to address the emergency, while respecting strict safety, efficacy and quality criteria. The evaluation weighs the threat posed by the emergency, as well as the benefit that using the product would entail against the possible risks.

The EUL procedure involves a rigorous evaluation of data from late-stage Phase II and Phase III clinical trials, as well as important additional data on safety, efficacy, quality, and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine in question, plans to monitor its use, and plans to conduct additional studies. As part of the EUL procedure, the company producing the vaccine must commit to continuing to generate data on its quality, safety and effectiveness. WHO/PAHO regularly reviews the evidence and SAGE makes new recommendations or adjusts existing ones.

Vaccination, in conjunction with other infection control measures, reduced the impact on deaths and hospitalizations from COVID-19 in the world and remains a key tool to avoid severe disease, especially in high-risk priority groups. Today the different technical advisory groups on vaccination of the WHO and PAHO, and regulatory agencies recommend the reinforcement of vaccines against COVID-19, especially for health workers, pregnant women, people with comorbidities, immunosuppressed people and adults over 60. years.

2023-12-01 00:57:50
#Approval #vaccines #COVID19 #World #Health #Organization

Leave a Comment

This site uses Akismet to reduce spam. Learn how your comment data is processed.