The National Agency for Food and Drug Administration and Control(NAFDAC)is expected to give emergency approval for COVID-19 vaccines once they arrive in Nigeria, Saturday PUNCH has learnt.
The Director-General of NAFDAC, Prof Moji Adeyeye, said this during an interview on Friday.
She said NAFDAC would be doing something called, “Emergency Use Authorisation.”
She said the agency had been in contact with Pfizer since May and had already received a preliminary report which would guide NAFDAC’s decision.
Adeyeye explained that vaccines that had been approved by reliable bodies like the United States Food and Drug Administration could easily pass the test in Nigeria but that was not to say that NAFDAC would not be doing its own independent examination.
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.”
Asked 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.
She said there could be unforeseen problems if, for instance, Pfizer failed to send its complete paperwork, explaining that if there were no hitches, the vaccine would be approved in record 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.