The Director-General of NAFDAC, Prof Moji Adeyeye, said the National Agency for Food and Drug Administration and Control will grant emergency approval for COVID-19 vaccines soon as they get into the country.
She said the agency will explore a provision known as “Emergency Use Authorisation.”
Adeyeye stated that NAFDAC and Pfizer have been in talks since May and the agency has received preliminary report which would aid NAFDAC in reaching a decision.
She explained that vaccines that have the approval of reputable institutions like the United States Food and Drug Administration would succeed in getting approval in Nigeria. She however stated that NAFDAC still carries out its independent examination despite the aforementioned.
The NAFDAC boss said, “Anyvaccine 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.
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“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.”
When asked the length of time it would take NAFDAC to grant final approval, the agency’s boss stated that given a hitch-free scenario, the approval process wouldn’t take much time.
“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.
