“The EUA process allows for the availability of essential medical products during public health emergencies through a stringent, expedited process that ensures safety, quality, and efficacy,” it stated.
This was in a statement copied to the Ghana News Agency on Tuesday by the FDA to update the public on the vaccine’s safety status in Ghana.
It said during the rollout of COVID-19 vaccines, the FDA’s Joint COVID-19 Vaccine Safety Review Committee (JCVSRC) received various reports of adverse events, adding that the reports were anticipated and managed according to national procedures.
The statement indicated that the JCVSRC also monitored global reports of vaccine side effects, including thrombosis with Thrombocytopenia Syndrome (TTS).
“TTS is a rare condition associated with adenoviral COVID-19 vaccines like AstraZeneca’s Vaxzevria and the Johnson & Johnson/Janssen vaccine,” it stated.
The statement said; “Symptoms appear between four and 42 days after vaccination. The estimated risk of TTS after the first dose of the AstraZeneca vaccine is about two per 100,000 people vaccinated, with higher rates in individuals under 60. The risk decreases after the second dose.”
It said as of the end of March 2024, 10,545,038 people in Ghana had received the AstraZeneca vaccine and that the FDA investigated 4,149 reported adverse events following immunization (AEFIs), and thrombosis with TTS was not among them.
The statement noted that in Ghana, the EUA 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,” it stated.
It said despite this, the FDA remained 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.
The statement said during the pandemic, the JCVSRC, established by the FDA, worked with the Ghana Health Service Expanded Programme on Immunization to oversee vaccine safety.
“The JCVSRC suspended its regular meetings in 2023 as the number of adverse event reports declined, corresponding with reduced vaccine uptake,” it indicated.
The FDA assured 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.”
