By Royal Ibeh,
The National Agency for Food and Drug Administration and Control (NAFDAC) on Friday, said it has not received any application from Covid-19 Vaccine manufacturers yet and no vaccines have been approved by the agency for public use.
The director general, NAFDAC, Prof Mojisola Christianah Adeyeye, who disclosed this in a press statement, made available to LEADERSHIP, said Covid-19 vaccines are new, and the side effects or adverse events must be well monitored, adding that if NAFDAC does not approve, the public should not use.
This is coming on the heels that there are reports of fake vaccines in Nigeria, says Adeyeye, adding that, “NAFDAC is pleading with the public to beware. No Covid-19 Vaccines have been approved by NAFDAC. Fake vaccines can cause Covid-like illnesses or other serious diseases that could kill.”
On the purchase of Covid-19 vaccines by private companies, the DG said, “Vaccines should not be ordered by any company or corporation. The companies that manufacture the vaccines if they are genuine companies know they have to submit their application to NAFDAC.”
Also, no government establishment or agencies should order Covid-19 vaccines without confirming from NAFDAC if the vaccine has been approved, she adds.
However, NAFDAC is discussing with manufactures of candidate COVID-19 vaccines concerning potential Emergency Use Authorization (EUA), registration or licensing of their product, says Adeyeye, adding that, “The Agency assures applicants that if Phase 3 clinical data are very convincing and robust with regards to safety and efficacy, and the vaccine has been submitted for WHO for Emergency Use Listing, NAFDAC will welcome the application for Emergency Use Authorisation in Nigeria.”
She said the Agency has established COVID-19 Vaccine Committee that has been busy developing the guidelines and guidance and has collaborated with National Primary Health Care Development Agency (NPHCDA), Nigeria Center for Disease Control (NCDC), UNICEF, WHO and Ministry of Health, as the focus is to use a holistic approach for the effective immunization or delivery of the vaccines and monitor any Adverse Events Following Immunisation (AEFI).
“The Agency will also use its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with the sister agencies. The App is free, and millions of healthcare workers can download it free for ADR reporting. In-country training on the use of the App has begun for the healthcare givers,” she said.
On tracking and tracing of the Vaccines, Adeyeye said, NAFDAC plans to use the Traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number (GTIN), adding that the goal is to prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion.
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