The safety, quality evaluation, and lot release of COVID-19 vaccines imported and used in Nigeria from march 2021 to march 2022

Abstract

Coronavirus disease (COVID-19) caused by the Severe Acute Respiratory Syndrome Corona 2 Virus (SARS-COV-2 Virus) was a major global health crisis that resulted in severe illness and death around the globe. The swift development of effective vaccines against the disease to mitigate severe illness and death was one of the greatest public health scientific achievements. Most of these vaccines required cold storage and were exported to many developing countries with resource limitations to verify the quality of these products. The National Agency for Food and Drug Administration and Control (NAFDAC) regulates the quality of vaccines imported into Nigeria. This study provides summaries of data collected and QC measures conducted on all the COVID-19 vaccines imported into Nigeria within 2021–2022. Cold-chain parameters and other data requirements for meeting international standards for assessing the quality of vaccines were conducted in ISO17025-accredited laboratories of the Nigerian FDA. QC tests used to assess the safety of the products included tests for sterility, bacterial endotoxin, abnormal toxicity, pH, Physical appearance, extractable volumes, protein tests, and DNA: protein ratios. The products yielded satisfactory compliance, however, there were unsatisfactory sterility and protein test results for two batches of the samples tested. There are additional non-QC regulatory measures employed by NAFDAC to ensure the safety of the COVID-19 vaccines, including supply chain management. Out of ninety-five batches of different COVID-19 vaccines evaluated, 95.5% passed sterility testing. There is a 100% pass of all the vaccines for the Bacteria Endotoxin Test while an 80% pass was observed for the protein content.