The Chief Executive Officer of Food and Drugs Authority (FDA), Delese Mimi Darko has addressed the safety concerns of the AstraZeneca COVID-19 vaccine, known as Covishield and Vaxzevria.
According to the FDA boss, the vaccine among six granted Emergency Use Authorization (EUA) by the FDA in February 2021, has been closely monitored for safety, quality, and efficacy during the ongoing pandemic.
“The FDA’s Joint COVID-19 Vaccine Safety Review Committee (JCVSRC) has diligently reviewed reports of adverse events related to the AstraZeneca vaccine, including rare cases of thrombosis with Thrombocytopenia Syndrome (TTS).
While TTS is a known risk associated with adenoviral COVID-19 vaccines like AstraZeneca’s Vaxzevria, the FDA has reported that no cases of TTS have been identified among the 4,149 adverse events reported following immunization in Ghana,” a statement released by the FDA indicated.
With over 10 million people in Ghana having received the AstraZeneca vaccine by the end of March 2024, the FDA said it continues to prioritise the safety of all regulated products, including COVID-19 vaccines.
Despite the global suspension of AstraZeneca vaccine production due to the emergence of new COVID-19 strains, the FDA expressed its committed to monitoring vaccine safety through its Safety Monitoring Department and Technical Advisory Committee on the Safety of Vaccines and Biological Products.
“While the Emergency Use Authorization for the AstraZeneca vaccine expired in Ghana in May 2023, the FDA reassures the public that it will continue to take swift regulatory action if any vaccine poses an unacceptable risk,” it said.
By Janet Odei Amponsah