According to the FDA, the EUA process ensures a rigorous and expedited evaluation of safety, quality, and efficacy, allowing essential medical products to reach the public in a timely manner.

The Food and Drugs Authority (FDA) is by this release addressing renewed concerns about the AstraZeneca COVID-19 vaccine by providing an update on its safety status in Ghana.

The AstraZeneca vaccine, marketed as Covishield and Vaxzevria, was one of six COVID-19 vaccines granted Emergency Use Authorization (EUA) by the FDA in February 2021, enabling its use during the public health emergency.

According to the FDA, the EUA process ensures a rigorous and expedited evaluation of safety, quality, and efficacy, allowing essential medical products to reach the public in a timely manner.

"During the rollout of COVID-19 vaccines, the FDA's Joint COVID-19 Vaccine Safety Review Committee (JCVSRC) received various reports of adverse events. These reports were anticipated and managed according to national procedures. The JCVSRC also monitored global reports of vaccine side effects, including thrombosis with Thrombocytopenia Syndrome (TTS)," portions of the statement reads.

The FDA notes that Thrombosis with Thrombocytopenia Syndrome (TTS) is a rare adverse event linked to adenoviral COVID-19 vaccines, specifically AstraZeneca's Vaxzevria and the Johnson & Johnson/Janssen vaccine.

"TTS is a rare condition associated with adenoviral COVID-19 vaccines like AstraZeneca's Vaxzevria and the Johnson & Johnson/Janssen vaccine," it says.

According to the FDA, the latest figures show that a significant number of people have received the AstraZeneca vaccine, with the exact number standing at 10,545,038.

"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," it said.