The National Agency for Food and Drug Administration and Control is predicted to offer emergency approval for COVID-19 vaccines once they arrive in Nigeria.
The Director-General of NAFDAC, Prof Moji Adeyeye, said this during an interview with journalists on Friday.
Adeyeye said NAFDAC would be doing something called, “Emergency Use Authorisation.”
She said the agency had been in touch with Pfizer since May and had already received a preliminary report which might guide NAFDAC’s decision.
Adeyeye explained that vaccines that had been approved by reliable bodies just like the us Food and Drug Administration could easily pass the test in Nigeria but that wasn’t to mention that NAFDAC wouldn’t be doing its own independent examination.
The NAFDAC boss said, “Any vaccine which will be utilized in Nigeria must undergo NAFDAC. it’ll be an accelerated approval because we’ll use what’s called reliance. Reliance mechanism means if a robust regulatory authority just like the FDA or European Medicine Agency has approved it (the vaccine), we’ll undergo their approval.
“For example, we are browsing the EMA approval of Pfizer now. We do this in readiness of once they (Pfizer) will submit their own application. So, we’ve started doing our own work before they approve the appliance . We are already in-tuned with them.
“Pfizer visited us in May and that we told them to continue doing what they’re doing and once they get to Phase 3, they will submit their own application. But due to this reliance, it’ll make it in no time for approval. we’ve asked Pfizer to send it since it’s been approved within the US and a few other regulatory agencies. it’ll not take time in the least . Reliance means you believe what another strong agency has done.”
Asked how long it might deem NAFDAC to offer final approval, Adeyeye said she wouldn’t want to be pre-emptive adding that it might not take long in the least.
Read also: NAFDAC reveals Nigeria would start manufacturing its vaccines
She said there might be unforeseen problems if, as an example , Pfizer did not send its complete paperwork, explaining that if there have been no hitches, the vaccine would be approved in record time.
“We don’t expect it to be long in the least . But again, it depends on what we’ve . that’s if they need an equivalent papers that they submitted to other regulatory agencies. If what’s submitted to NAFDAC is different from what was submitted to the FDA, it’ll take longer because we’ll got to ask questions.
“Hopefully which will not happen. it’ll be an expedited review. NAFDAC is doing EUA which suggests Emergency Use Authorisation. So, it’s not as if they’re coming to register a product but it’ll still need approval. it’s not as if immediately the vaccines are brought, we might tell people to start out using it subsequent day. we’ll do a desk review,” she said.
Also speaking with our correspondent, the Minister of State for Health, Dr Olorunnimbe Mamora, noted that the govt would believe NAFDAC for approval before the vaccines would be used.
On when the N400bn allow the procurement and distribution of vaccines would be submitted to the National Assembly, Mamora said it might be next year.
He said the figures were still being collated, adding that it cuts across different ministries. He also said the Presidential Task Force on COVID-19 headed by the Secretary to the govt of the Federation, Boss Mustapha, would be responsible of the vaccines.
The minister said this was the rationale the President extended the tenure of the task force.
He said, “We haven’t yet submitted the budget. We are still putting estimates together and zip has been finalised. it’ll be ready early next year. it’s not just the Ministry of Health. The President has handed management of the vaccines to the PTF. That was why the President extended the tenure of the PTF till the top of the primary quarter next year once we would have started vaccine procurement and administration.”
On whether Nigerians would be forced to require the vaccine, Mamora said there was no such plan. He, however, said there was a requirement to teach Nigerians on the importance of the vaccines because some people had already started rejecting them.
On when the vaccines would be ready to be used , Mamora said, “I think it depends on the assessment report provided by NAFDAC; if favourable and recommended, the federal may approve emergency use authorisation.”
Meanwhile, it had been learnt that the Federal Government’s COVID-19 response may hit N1tn by next year.
The President had in April approved N500bn for the COVID-19 response within the supplementary budget which was approved by the National Assembly.
It was learnt that if the N400bn is approved by the National Assembly next month, this is able to imply that about N900bn would be spent on the pandemic.
This is aside from the sum that several states have individually spent on prevention and treatment of COVID-19 vaccines also as intervention programmes.
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