Ghana to pilot vaccine safety monitoring for pregnant women starting in 2026

Ghana will pilot a Pregnancy Registry in early 2026 to monitor vaccine safety among pregnant women and their babies.   

The initiative, under the Maternal Immunization Safety Monitoring Programme, will track adverse events from vaccinations.

It will be led by the Food and Drugs Authority (FDA) and funded by the Bill and Melinda Gates Foundation, with implementation by the Dodowa and Kintampo Health Research Centres.   

Pregnant women in health facilities within the catchment areas of the two research centres will receive vaccines and be monitored for safety during pregnancy and after delivery.   

Speaking at a stakeholder engagement in Accra, Dr. Edwin Nkansah, Director of Vaccines, Vigilance, and Clinical Trials at the FDA, said the project aims to establish an effective system for evaluating vaccine safety in pregnant women.   

“One of the things this project will do will be to monitor how pregnant women react at every state of their pregnancy when they receive a vaccine,” he said.   

Dr. Nkansah noted that the registry would provide the FDA with comprehensive data on vaccine effects on pregnant women and their children, ensuring proper monitoring of pharmaceutical products used during pregnancy.   

Dr. Frank Atuguba, Director of Dodowa Health Research Centre, said 150 women from the project areas had been selected for initial monitoring of maternal health records from early pregnancy until delivery.   

He explained that the process would continue after vaccination.   

“Generally, vaccines are the most cost-effective ways of preventing diseases, but there are some infections that can be effectively tackled by vaccinating a pregnant woman with the intention of protecting the unborn child,” Dr. Atuguba said.   

He added that the project would also include vaccine trials for Respiratory Syncytial Virus and Group B Streptococcal Pneumonia to protect both pregnant women and their babies in early life.   

Madam Adeli Ashie, Chief Regulatory Officer at the FDA Safety and Monitoring Department, said pregnant women face a higher risk of contracting diseases that could lead to mortality.   

She said the Pregnancy Registry aligned with the FDA’s mandate to monitor vaccine safety for pregnant women.

Source: GNA

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