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FDA addresses concerns over AstraZeneca COVID-19 vaccine safety in Ghana

The Food and Drugs Authority (FDA) has updated the public on the safety of the AstraZeneca COVID-19 vaccine, following renewed concerns.

The vaccine, marketed as Covishield and Vaxzevria, was among the six COVID-19 vaccines granted Emergency Use Authorization (EUA) by the FDA in February 2021.

The EUA allows essential medical products to be available swiftly during public health emergencies, ensuring their safety, quality, and efficacy through a stringent, expedited process.

Throughout the vaccine rollout, the FDA’s Joint COVID-19 Vaccine Safety Review Committee (JCVSRC) monitored adverse events both locally and globally.

Reports of side effects, including thrombosis with Thrombocytopenia Syndrome (TTS), were anticipated and managed according to national procedures.

TTS, a rare condition linked to adenoviral COVID-19 vaccines such as AstraZeneca’s Vaxzevria and Johnson & Johnson’s Janssen, typically manifests between 4 and 42 days post-vaccination.

The estimated risk of TTS after the first dose of the AstraZeneca vaccine is approximately 2 per 100,000 people, with higher rates in individuals under 60.

This risk decreases significantly after the second dose.

By the end of March 2024, 10,545,038 people in Ghana had received the AstraZeneca vaccine.

The FDA investigated 4,149 reports of adverse events following immunization (AEFIs), with no cases of thrombosis with TTS reported.

The EUA for AstraZeneca vaccines in Ghana expired in May 2023, coinciding with the de-escalation of COVID-19 as a global public health emergency.

Globally, AstraZeneca’s manufacturers have ceased production of the vaccine due to the development of new vaccines targeting emerging COVID-19 strains.

Despite the suspension of AstraZeneca vaccine production, the FDA continues to vigilantly monitor the safety of all vaccines used in Ghana.

This is done through the FDA’s Safety Monitoring Department and its Technical Advisory Committee on Safety of Vaccines and Biological Products.

During the pandemic, the JCVSRC collaborated with the Ghana Health Service’s Expanded Programme on Immunization to oversee vaccine safety.

The JCVSRC suspended its regular meetings in 2023 as the number of adverse event reports declined alongside reduced vaccine uptake.

The FDA reassures the public of its unwavering commitment to ensuring the safety, efficacy, and quality of all regulated products.

Should any product pose an unacceptable risk, the FDA pledges to take swift regulatory action to protect public health.

Story by: Joshua Kwabena Smith



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