In a live/zoom media briefing in Lagos on Friday, April 30, 2021, the Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Professor Mojisola Adeyeye, disclosed that the agency has approved the use of the Pfizer Biotech Vaccine in Nigeria for COVID-19, on an emergency use authorization basis.
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‘We have approved Pfizer Biotech Vaccine for possible use in the country. Our COVID-19 vaccine team must carefully review it to make sure that the science behind it is well understood, and also in accordance with our own regulation.’
Prof. Mojisola Adeyeye
Commenting further, Prof. Adeyeye revealed that the approval of the vaccine was based on different mechanisms and pointed out the fact that the approval is just for the period of getting people vaccinated for COVID-19.
‘We used different mechanisms to approve the COVID-19 vaccine, and one of them is called reliance, meaning that a more matured regulatory agency across the globe has already approved such vaccine. We can use that as a basis for our own review by getting the assessment report, know the peculiarities and our COVID Vaccine Committee will then do their job. We also can go ahead to review, if the World Health Organisation (WHO) has given emergency use lifting, meaning they have done their job. For Pfizer biotech vaccine, both cases are through, because more matured agencies have approved the vaccine. The approval is not a full approval, it is within the period of getting people vaccinated and gathering of data about the adverse effect following immunization.’
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The NAFDAC boss also revealed that COVID-19 vaccines data gathering is not limited to NAFDAC, noting that the agency belongs to the International Coalition of Medicine Regulatory Authorities( ICMRA), an organization reputable for being a global gathering of regulatory agencies.
Prof. Adeyeye also stated that NAFDAC’s COVID-19 Vaccine Committee has made tremendous efforts to ensure that post-vaccination regulation is put in place.
‘We belong to ICMRA, which is a global gathering of regulatory agencies across the country, where we share our experiences, like that of Oxford Astrazeneca Vaccine…Our committee started their work to ensure all the Is are dotted and the Ts are crossed to ensure that post-vaccination regulatory activities such as pharmacology vigilance or safety monitoring are put in place…So, it is not just the vaccination alone, it is what happens after that.’
On Nigeria’s ability to effectively store the Pfizer Biotech Vaccine, Adeyeye said the country is well-to-do and also revealed that NAFDAC is currently reviewing the Johnson and Johnson Vaccine.
‘We have the capability because the freezer temperature is now -30 degrees unlike when it was -80 to -60 degrees temperature. So, the storage is not an issue in Nigeria.’
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