FDA Still Monitoring COVID-19 Vaccines Used In Ghana
“The FDA investigated 4,149 reported adverse events following immunization (AEFls), and thrombosis with TTS was not among them. 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.”
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The Food and Drugs Authority (FDA) says it is monitoring reactions that accompany all vaccines used in the country following concerns about the AstraZeneca COVID-19 vaccine.
It noted that it is vigilant monitoring reactions to the vaccines through its Safety Monitoring Department and its Technical Advisory Committee on Safety of Vaccines and Biological Products.
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“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. Our Priority.”
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The assurance follows the suspension of production of the AstraZeneca vaccine by the Serum Institute of India over cases of Thrombosis Thrombocytopenia Syndrome (TTS) associated with the vaccine, a development that is standing a 100 million pound class action lawsuit in the UK.
The FDA in its statement said its Joint COVID-19 Vaccine Safety Review Committee (JCVSRC) studied various reports of adverse events during the rollout of the vaccines including TTS and managed according to national procedures.
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According to the Authority, the TTS is a rare condition associated with adenoviral COVID-19 vaccines like AstraZeneca’s Vaxzevria and the Johnson & Johnson/Janssen vaccine in persons aged 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.”
In Ghana, it said 10,545,038 people were vaccinated with AstaZeneca as of the end of March 2024.
“The FDA investigated 4,149 reported adverse events following immunization (AEFls), and thrombosis with TTS was not among them. 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.”
Source: Opemsuo
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