NAFDAC approves Pfizer-BioNTech COVID vaccine for emergency use

The National Agency for Food and Drug Administration and Control has approved emergency use of Pfizer-BionTech COVID-19 vaccines for use in Nigeria.

Director-General of the agency, Prof Mojisola Adeyeye, announced this on Friday during a Zoom meeting.

She said the vaccine, which is only for emergency use, could be stored in -15oC to -25oC equivalent to freezer temperature.

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.

She said, “We used different mechanisms to approve 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.”

Adeyeye said that data gathering on vaccines was not limited to NAFDAC.

According to her, the agency belongs to an organisation called the 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,” NAFDAC director-general said.

The agency’s COVID-19 Vaccine Committee, she said, had 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 are 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 Biotech 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 said the agency was reviewing the Johnson and Johnson vaccine.