Updated – Covid-19: NAFDAC okays Pfizer biotech vaccine for emergency use

The National Agency for Food and Drug Administration and Control (NAFDAC) has disclosed that it had approved the Pfizer Biotech Vaccine for emergency use authorisation for Covid-19 in Nigeria.

Its director-general, Prof. Mojisola Adeyeye, made the disclosure Friday in a live/zoom media briefing in Lagos.

“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.

According to her, the vaccine was approved based on different mechanisms known to the agency.

“We used different mechanisms to approve Covid-19 vaccine, and one of them is called reliance, meaning that a more mature regulatory agency across the globe has already approved such a vaccine.

“We can use that as a basis for our own review by getting the assessment report, know the peculiarities and our Covid-19 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 further that data gathering on vaccines 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.”

According to her, the agency’s Covid-19 Vaccine Committee has worked to ensure that post vaccination regulation is put in place.

On the storage of the vaccine, she the country had 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, storage is not an issue in Nigeria.”

Adeyeye also disclosed that the agency was reviewing the Johnson and Johnson Vaccine. (NAN)

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