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FDA reassures public on safety of AstraZeneca COVID-19 vaccine

Following some public criticism of the product leading to withdrawal of it from some market, the Food and Drugs Authority (FDA) of Ghana has reassured the public about the safety of the AstraZeneca COVID-19 vaccine, also known as Covishield and Vaxzevria.

AstraZeneca COVID-19 vaccine was one of the six vaccines granted Emergency Use Authorization (EUA) in the country in February 2021.

“The FDA assures the public that it is dedicated 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 FDA said in a statement.

According to the FDA, as of end of March 2024, over 10.5 million Ghanaians had received the AstraZeneca vaccine, and the 4,149 reported adverse events did not include any cases of Thrombocytopenia Syndrome (TTS). Highlighting that, the EUA for the AstraZeneca vaccines expired in May 2023 as the COVID-19 pandemic was no longer considered a global public health emergency.

“In Ghana, the Emergency Use Authorization granted for the AstraZeneca vaccines expired in May 2023 in line with Section 4.4 of the FDA’s guidelines on EUA when the COVID-19 pandemic was no longer listed as a global public health emergency of international concern.”

“Globally, the AstraZeneca vaccine’s manufacturers have suspended its production due to the development of new vaccines for emerging COVID-19 strains. The vaccine will therefore no longer be available for use globally.”

The statement assured the public that FDA remains vigilant in monitoring the safety of all vaccines used in Ghana, including COVID-19 vaccines, through its Safety Monitoring Department and Technical Advisory Committee on Safety of Vaccines and Biological Products.

“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.”