NAFDAC speaks on when it will give approval for COVID-19 vaccines when it arrives in Nigeria

The National Agency for Food and Drug Administration and Control has said it will give emergency approval for COVID-19 vaccines once they arrive in Nigeria.

NEWSCASTARS.COM gathered that the Director-General of NAFDAC, Prof Moji Adeyeye, said this during an interview with PUNCH saying NAFDAC would be doing something called, “Emergency Use Authorisation.”

The NAFDAC boss 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 (the vaccine), we will go through their approval.

“For example, we are going through the EMA approval of Pfizer now. We are doing this in readiness of when they (Pfizer) will submit their own application. So, we have started doing our own work before they approve the application. We are already in touch with them.

“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. We have asked Pfizer to send it since it has been approved in the US and some other regulatory agencies. It will not take time at all. Reliance means you rely on what another strong agency has done.”

On how long it would take for NAFDAC to give final approval, Adeyeye said she would not want to be pre-emptive adding that it would not take long at all.

“We don’t expect it to be long at all. But again, it depends on what we have. That is if they have the same papers that they submitted to other regulatory agencies. If what is submitted to NAFDAC is different from what was submitted to FDA, it will take longer because we will need to ask questions.

“Hopefully that will not happen. It will be an expedited review. 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,” she said.

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