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