FDA Reassures Safety of Malaria Vaccine Implementation Programme

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The Food and Drugs Authority (FDA) says it has instituted proactive measures in collaboration with the Ghana Health Service (GHS) to monitor the Malaria Vaccine Implementation Programme (MVIP).

This follows queries received by the Authority about systems put in place to prevent, detect and respond to possible safety issues that might arise from use of the Mosquirix malaria vaccine.

Chief Executive Officer of the FDA, Delese A. A. Darko (Mrs.), in a release, indicated the measures are to ensure adverse events (side effects) following immunization (EPI) are promptly identified and reported through its established Safety Monitoring System. She stressed that the Authority will continue to strengthen the capacity of healthcare personnel involved in the vaccination to guarantee success of the exercise.

Selected healthcare professionals, she says, have also been specifically trained by the FDA and EPI and resourced by the GHS to visit healthcare facilities in vaccinating districts to monitor, detect and report safety issues suspected to have occurred after receiving the Mosquirix Vaccine.

“Any such side effects will be promptly investigated and assessed by the FDA’s independent Technical Advisory Expert Committees for causal relationship to the vaccine and recommendations made to the Ghana Health Service.”

“The FDA assures the public that it continuously monitors all registered vaccines and medicines to ensure approved standards are maintained,” the release stated.

The Authority urged the public to report any suspected safety issues of any regulated product to the FDA to enable the necessary regulatory actions to be taken.

Reports can be made through any of the following means: Hotline 0299 802 933; WhatsApp 0206 973 065; Mobile 0244 310 297 and email drug.safetydghana.gov.gh

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