FDA addresses concerns of AstraZeneca covid-19 vaccine safety in Ghana

The Food and Drug Authority has assured the public that it will proactively monitor all regulated products to ensure they are safe, effective and of high quality.

It added that it will take swift regulatory action to safeguard public health should any product present an unacceptable risk.

This was contained in a press release following concerns raised about the AstraZeneca COVID-19 vaccine.

It said the vaccine, sold as Covishield and Vaxzevria, was one of six COVID-19 vaccines granted Emergency Use Authorisation (EUA) by the FDA in February 2021.

It said 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.

FDA added that 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). TTS is a rare condition associated with adenoviral COVID-19 vaccines like AstraZeneca’s Vaxzevria and the Johnson & Johnson/Janssen vaccine. Symptoms appear between 4 and 42 days after vaccination,” it stated

It said 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 and the risk decreases after the second dose.

The FDA noted that 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.

According to the FDA, the Emergency Use Authorisation granted for the AstraZeneca vaccines expired in May 2023 and was 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.

It stated that the AstraZeneca vaccine's manufacturers have suspended their production globally due to the development of new vaccines for emerging COVID-19 strains. The vaccine will therefore no longer be available for use globally.

It added that 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.

“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 said.