Ghana FDA reassures public on safety of AstraZeneca COVID-19 vaccine

GHANA— The Ghana Food and Drugs Authority (FDA) has attempted to ease concerns about the safety of the AstraZeneca COVID-19 vaccine in Ghana following its global withdrawal.

This reassurance came in a statement to the Ghana News Agency on May 21, which updated the public on the safety status of the vaccination in Ghana.

In February 2021, the AstraZeneca vaccine, commercialized as Covishield and Vaxzevria, was one of six COVID-19 vaccinations granted Emergency Use Authorization (EUA).

According to the FDA, the vaccine has undergone the EUA protocol, which enables the provision of important medical supplies during public health emergencies through a stringent, expedited process that ensures safety, quality, and efficacy.

The statement went on to explain that throughout the distribution of COVID-19 vaccines, the FDA’s Joint COVID-19 Vaccine Safety Review Committee (JCVSRC) received several reports of adverse events that were anticipated and treated in accordance with national protocols.

According to the statement, the JCVSRC also examined global reports of vaccination side effects, including thrombosis with Thrombocytopenia Syndrome (TTS), a rare illness linked to adenoviral COVID-19 vaccines such as AstraZeneca’s Vaxzevria and the Johnson & Johnson/Janssen vaccine.

The FDA further stated that TTS symptoms emerge between four and 42 days following immunisation, with an estimated risk of two cases per 100,000 people immunised, with a higher risk in those under 60. The risk diminishes following the second dose.

As of the end of March 2024, 10,545,038 Ghanaians had received the AstraZeneca vaccine. The FDA examined 4,149 documented adverse events following immunization (AEFIs), and thrombosis with TTS was not among them.

The statement stated that in Ghana, the EUA granted for the AstraZeneca vaccines expired in May 2023, in accordance with Section 4.4 of the FDA’s EUA rules, when the COVID-19 pandemic was no longer classified as a worldwide public health emergency of international concern.

However, the statement emphasised that AstraZeneca’s manufacturers had halted production of the vaccine due to the development of alternative vaccinations for emerging COVID-19 strains, making it unavailable for usage worldwide.

Despite this, the FDA continues to monitor the safety of all vaccines used in Ghana, including COVID-19 vaccines, via its Safety Monitoring Department and Technical Advisory Committee on Vaccines and Biological Products.

During the pandemic, the FDA-established JCVSRC collaborated with the Ghana Health Service’s Expanded Programme on Immunisation to ensure vaccine safety.

“The JCVSRC suspended its regular meetings in 2023 as the number of adverse event reports declined, corresponding with reduced vaccine uptake,” stated the statement.

The FDA finished by reminding the public that it is committed to continuing and proactive monitoring of all regulated products to guarantee their safety, effectiveness, and high quality.

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