COVID-19 vaccine: 1,679 side effects reported – FDA

Some 1,679 reports of adverse side effects after the administration of 490,000 doses of Covishield vaccines in Ghana have been reported.

This was disclosed by the Food and Drugs Authority (FDA) in a statement signed by its Chief Executive Officer (CEO) Mrs. Delese A. A Darko.

According to the FDA, the most commonly reported adverse events were headache, fever, weakness, body pains, chills, pains at the injection site, malaise and dizziness.

The FDA noted that at the joint COVID-19 Vaccine Safety Review (JCVSR) Committee at its 3rd meeting held on 26th March 2021 discussed these reported adverse events in addition to an in-depth review of nine suspected serious adverse events following assessment of causality.

The FDA said the JCVSR concluded that eight of the serious events were unrelated to the vaccine but one (a case of febrile illness) was considered as vaccine product related.

“The Committee maintained that based on a review of the side effects received and the expected benefit of the vaccine to prevent covid-19 infections, hospitalisation and reduce deaths, the Covishield Vaccine continues to have a positive benefit-risk profile in Ghana and should be used as part of the key strategies to contain COVID-19,” the statement said.

The Committee according to the FDA endorsed the Authority’s continuous education and awareness creation programmes targeted at the healthcare professionals and the public to encourage reporting of all suspected adverse events after COVID-19 vaccine administration.

The FDA said it will continue to promote reporting of adverse events and continuously review all safety data received in Ghana and from all over the world and will update the general public of any changes in the benefit-risk profile of the Covished Vaccine.