The Food and Drugs Authority (FDA) has reaffirmed its commitment to monitoring the safety of all vaccines used in Ghana, including COVID-19 vaccines.
The FDA says that the Emergency Use Authorization (EUA) for AstraZeneca vaccines which expired in May 2023, coincided with the World Health Organization listing COVID-19 as no longer a global public health emergency concern.
In a statement issued on Tuesday, May 21, the FDA said despite the global suspension of AstraZeneca vaccine production due to the development of new vaccines for emerging COVID-19 strains, it remains vigilant in ensuring the safety of all vaccines administered in the country.
“Despite this, the FDA remains vigilant in monitoring the safety of all vaccines used in Ghana, including COVID-19 vaccines, through its Safety Monitoring Department and its Technical Advisory Committee on Safety of Vaccines and Biological Products,” part of the statement said.
The Authority said that during the pandemic, the Joint COVID-19 Vaccine Safety Review Committee (JCVSRC), established by the FDA, worked with the Ghana Health Service Expanded Programme on Immunization to oversee vaccine safety.
The FDA said that the committee also monitored global reports, including those related to Thrombosis with Thrombocytopenia Syndrome (TTS), a rare condition linked to adenoviral COVID-19 vaccines like AstraZeneca’s Vaxzevria and the Johnson & Johnson/Janssen vaccine.
“Symptoms appear between 4 and 42 days after vaccination. The estimated risk of TTS after the first dose of the AstraZeneca vaccine is about 2 per 100,000 people vaccinated, with higher rates in individuals under 60. The risk decreases after the second dose.
“As of the end of March 2024, 10,545,038 people in Ghana had received the AstraZeneca vaccine. The FDA investigated 4,149 reported adverse events following immunization (AEFIs), and thrombosis with TTS was not among them,” the FDA said.
The Authority therefore assured the public of its commitment to the continuous and proactive monitoring of all regulated products to ensure they remain safe, effective, and of high quality.
“Should any product present an unacceptable risk, the FDA will take swift regulatory action to safeguard public health,” the statement added.