No COVID Vaccines have been approved by NAFDAC, Says DG

pharmacy

• As agency warns on the dangers of fake vaccines

Director General, National Agency for Food and Drug Administration and Control (NAFDAC) Prof. Moji Adeyeye has distant the agency from the approval of any COVID vaccines for use in Nigeria, warning the public to be wary of fake vaccines in circulation as the adverse effects are deadly.

Addressing journalists in a virtual press conference on Friday, Adeyeye also placed an embargo on government establishment, agencies, private companies and corporation from ordering COVID vaccines without approval from the agency, stating that manufacturers of genuine vaccines ought to submit application to NAFDAC.

Meanwhile, the Federal Government has ordered for 100,000 doses of Pfizer Inc.’s vaccine, which it expects to receive at the end of January through the Covax initiative, Faisal Shuaib, chief executive officer of Nigeria’s National Primary Health Care Development Agency, said Thursday.

Although critics have described the plan as unrealistic as shipping of the vaccines is yet to commence and no definite date fixed yet for the distribution of the vaccines.

The NAFDAC boss however disclosed that the agency is in discussion with manufacturers of candidate COVID-19 vaccines concerning potential Emergency Use Authorization (EUA), registration or licensing of their products as the case may be. The Agency assures applicants that if Phase 3 clinical data are very convincing and robust with regards to safety and efficacy, and the vaccine has been submitted for WHO for Emergency Use Listing, NAFDAC will welcome the application for Emergency Use Authorisation in Nigeria.

“There are reports of fake vaccines in Nigeria. NAFDAC is pleading with the public to beware. No COVID vaccines have been approved by NAFDAC. Fake vaccines can cause COVID-like illnesses or other serious diseases that could kill.

“Vaccines should not be ordered by any company or corporation. The companies that manufacture the vaccines if they are genuine companies know they have to submit their application to NAFDAC.

“No government establishment or agencies should order COVID vaccines without confirming from NAFDAC if the vaccine has been approved”, she warned.

Speaking on post-marketing active pharmacovigilance or phase 4 clinical trial of vaccines, Adeyeye said safety of COVID vaccines is of utmost importance to the agency, and that explains why active pharmacovigilance is being used.

She said Phase 4 pharmacovigilance is one of the core regulatory activities of the agency. “For COVID-19 vaccines, the agency has been preparing for the COVID-19 vaccines and vaccination since the early phase of the pandemic – around April 2020. NAFDAC was positioned to a great extent to work online during the lockdown due to digitalization of many of our processes and continuous improvement.

“NAFDAC will use “Reliance” or “Recognition” to expedite Emergency Use Authorisation (EUA) for vaccines already approved by more matured regulatory authorities. The full dossier submitted by the manufacturer or Market Authorisation Holder (MAH) will be thoroughly reviewed by the Vaccine Committee that is made up of multiple Directorates in the Agency – Drug Registration and Regulatory Affairs, Drug Evaluation and Research, Pharmacovigilance and Post Marketing Surveillance, Drug, Biologics and Vaccines Laboratory Services”, she averred.