The National Agency for Food and Drug Administration and Control says it has approved the Pfizer Biotech Vaccine for emergency use for COVID-19 in Nigeria.
Its Director-General, Prof. Mojisola Adeyeye, made this known on Friday in a live Zoom media briefing in Lagos.
Adeyeye said: “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.”
She said the vaccine was approved based on different mechanisms known to the agency.
“We used different mechanisms to approve COVID-19 vaccine, and one of it 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 immunisation.”
Adeyeye said that data gathering on vaccine is not limited to NAFDAC.
She said the agency belongs to an organisation called International Coalition of Medicine Regulatory Authorities.
“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,” the NAFDAC DG said.
According to her, the agency’s COVID-19 Vaccine Committee has worked to ensure that post-vaccination regulation is put in place.
She said: “Our committee started their work to ensure all the ‘i’s are dotted and the ‘t’s are crossed to ensure that post-vaccination regulatory activities such as pharmacology vigilance or safety monitoring is put in place.
“So, it is not just the vaccination alone; it is what happens after that.”
On the storage of the Pfizer Biotech Vaccine, Adeyeye said the country has what it takes to store the vaccine effectively.
“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,” she said.
