Ghana records over 9000 COVID-19 vaccine adverse events

The Food and Drugs Authority’s Safety Monitoring System from March 2021 to November 2022, has recorded 9,000 side effects – known as Adverse Events Following Immunization (AEFI) from the over 21 million doses administered to persons.

This means for 100, 000 COVID-19 doses administered about 43 persons complained of AEFI.

The World Health Organization defines AEFI as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the usage of the vaccine.

These reports were received by persons who called the FDA through the designated call centre, or persons for, which their healthcare professionals completed a form to report or followed up after vaccinated by healthcare professionals to solicit for these adverse events.

The top ten side effects reported for the COVID-19 vaccines were headache, fever, weakness, vomiting, muscle ache, chills, dizziness, body pains, pains at injection site and malaise which were all known to be caused by the COVID-19 vaccines and provided in the product information by the manufacturers of the vaccines.

Mr George Sabblah, the Head of Safety Monitoring Department at the Food and Drugs Authority (FDA), told the Ghana News Agency (GNA) that the rate of the events reported from the vaccinations were less than the reporting rate during clinical trials of the vaccines.

He said out of the over 9,000 cases reported, a total of 64 were categorised as serious – side effects which resulted in a person’s being hospitalized.

Mr Sabblah said the causality assessment conducted by the Joint COVID-19 Vaccine Safety Review Committee (JCVSRC) revealed that the reported serious side effects were not due to the vaccines.

“The meaning of the painstaking investigations and causality assessment conducted by JCVSRC meant that those conditions that made the persons to visit the hospital were not linked to the vaccine. It means that the events would have happened anyway had they not taken the COVID-19 jab,” he said.

The JCVSRC is an eleven-member independent Committee of experts formed to act as a forum of advice to the FDA on matters relating to the post-approval safety monitoring for COVID-19 vaccines and review of all safety information from the deployment of the vaccines.

The Committee includes an Epidemiologist, Endocrinologist, Gastroenterologist, Immunization Specialist, Pathologist, Clinical Pharmacist, Cardiologist, Pulmonologist, Pharmacovigilance and Vaccine Safety Expert.

The mandate includes making recommendations to the Authority regarding the continued use of a COVID-19 vaccine(s) based on safety issues reviewed.

Dr Kwame Amponsa-Achiano, the Programme Manager, Expanded Programme on Immunization at the Ghana Health Service, told the GNA that none of the adverse events following immunization reported was out of the documented conditions listed by the vaccine manufacturers.

He said the country’s Expanded Programme on Immunisation (EPI) had over the years contributed to poverty reduction by reducing the magnitude of vaccine preventable diseases through immunisation as an essential component of Primary Health Care.

Ghana’s EPI, he stated, had chalked many successes and “conquered” Vaccine Preventable Diseases and served as springboard for COVID-19 vaccination.

Ghana’s vaccination campaign, which started on 2nd March 2021, has seen about 12 million persons receiving 21 million doses of the vaccine out of which nine million people are recorded to have been fully vaccinated.

The vaccines are Oxford/AstraZeneca, Pfizer, Moderna, Johnson & Johnson and Sputnik V.

The country received 34 million doses of vaccines from donor partners out of which about 30 million were distributed across the country.

Source: GNA

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