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NAFDAC To Give Emergency Approval Of COVID-19 Vaccines

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NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC) has said once the expected COVID-19 vaccines arrive in Nigeria, they will be approved for urgent use.

While noting that NAFDAC will be using the technique of  “Emergency Use Authorisation,” Mrs Adeyeye said Nigeria had already received a preliminary report from Pfizer, having been in contact with the pharmaceutical company since May.

She noted that NAFDAC would be doing its own independent examination even though strong regulatory bodies like the FDA and European Medicine Agency had already approved the vaccines.

While speaking to The Punch, Prof. Adeyeye said, “Any vaccine that will be used in Nigeria must go through NAFDAC. It will be an accelerated approval because we will use what is called reliance. Reliance mechanism means that if a strong regulatory agency like the FDA or European Medicine Agency has approved it, we will go through their approval.

“Pfizer visited us in May and we told them to continue doing what they are doing and when they get to Phase 3, they can submit their own application. But because of this reliance, it will make it very fast for approval.

Speaking on how long it would take for NAFDAC to give final approval of the vaccine, the DG said it will not, however, noting that unforeseen circumstances should not be overruled.

She added:

“We don’t expect it to be long at all.

“NAFDAC is doing EUA which means Emergency Use Authorisation. So, it is not as if they are coming to register a product but it will still need approval. It is not as if immediately the vaccines are brought, we would tell people to start using it the next day. We will do a desk review.”

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