COVID-19: NAFDAC approves Pfizer-BioNTech Vaccine for emergency use authorization
The National Agency for Food and Drug Administration and Control (NAFDAC) says it has approved the Pfizer-BioNTech Vaccine for emergency use authorisation for COVID-19 in Nigeria.
Its Director-General, Prof. Mojisola Adeyeye, made this known at the weekend in a live/zoom media briefing in Lagos.
Adeyeye said, “We have approved Pfizer-BioNTech 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-bioNTtech 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,” she said.
Adeyeye said that data gathering on vaccine was not limited to NAFDAC.
She said that the agency belonged to an organisation called International Coalition of Medicine Regulatory Authorities( ICMRA).
“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,” NAFDAC director-general said.
According to her, the agency’s COVID-19 Vaccine Committee has worked to ensure that post vaccination regulation is put in place.
“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 is put in place.
“So, it is not just the vaccination alone, it is what happens after that,” she said.
On the storage of the Pfizer BioNtech Vaccine, Adeyeye said the country has what it took 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.
The Director-General also disclosed that the agency was reviewing the Johnson and Johnson Vaccine.
