COVID-19 Vaccine Safety Monitoring Studies in Low- and Middle-Income Countries (LMICs)—A Systematic Review of Study Designs and Methods

Malede Mequanent Sisay; MONTESINOS GUEVARA, CAMILA MARGARITA; Alhadi Khogali Osman; Putri Widi Saraswati; Binyam Tilahun; Tadesse Awoke Ayele; Fariba Ahmadizar; Carlos E. Durán; Miriam C. J. M. Sturkenboom; Peter van de Ven; Daniel Weibel

doi:10.3390/vaccines11061035

COVID-19 Vaccine Safety Monitoring Studies in Low- and Middle-Income Countries (LMICs)—A Systematic Review of Study Designs and Methods

Journal

Vaccines

ISSN

2076-393X

Date Issued

2023-05-29

Author(s)

Malede Mequanent Sisay

MONTESINOS GUEVARA, CAMILA MARGARITA

Facultad de Ciencias de la Salud Eugenio Espejo

Alhadi Khogali Osman

Putri Widi Saraswati

Binyam Tilahun

Tadesse Awoke Ayele

Fariba Ahmadizar

Carlos E. Durán

Miriam C. J. M. Sturkenboom

Peter van de Ven

Daniel Weibel

DOI

10.3390/vaccines11061035

URL

https://cris.ute.edu.ec/handle/123456789/372

Abstract

Background: Post-marketing vaccine safety surveillance aims to monitor and quantify adverse events following immunization in a population, but little is known about their implementation in low- and middle-income countries (LMICs). We aimed to synthesize methodological approaches used to assess adverse events following COVID-19 vaccination in LMICs. Methods: For this systematic review, we searched articles published from 1 December 2019 to 18 February 2022 in main databases, including MEDLINE and Embase. We included all peer-reviewed observational COVID-19 vaccine safety monitoring studies. We excluded randomized controlled trials and case reports. We extracted data using a standardized extraction form. Two authors assessed study quality using the modified Newcastle–Ottawa Quality Assessment Scale. All findings were summarized narratively using frequency tables and figures. Results: Our search found 4254 studies, of which 58 were eligible for analysis. Many of the studies included in this review were conducted in middle-income countries, with 26 studies (45%) in lower-middle-income and 28 (48%) in upper-middle-income countries. More specifically, 14 studies were conducted in the Middle East region, 16 in South Asia, 8 in Latin America, 8 in Europe and Central Asia, and 4 in Africa. Only 3% scored 7–8 points (good quality) on the Newcastle–Ottawa Scale methodological quality assessment, while 10% got 5–6 points (medium). About 15 studies (25.9%) used a cohort study design and the rest were cross-sectional. In half of them (50%), vaccination data were gathered from the participants’ self-reporting methods. Seventeen studies (29.3%) used multivariable binary logistic regression and three (5.2%) used survival analyses. Only 12 studies (20.7%) performed model diagnostics and validity checks (e.g., the goodness of fit, identification of outliers, and co-linearity). Conclusions: Published studies on COVID-19 vaccine safety surveillance in LMICs are limited in number and the methods used do not often address potential confounders. Active surveillance of vaccines in LMICs are needed to advocate vaccination programs. Implementing training programs in pharmacoepidemiology in LMICs is essential.