COVID-19: No approval for vaccines, as NAFDAC DG, Adeyeye warns manufacturers

The Director General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, said the agency was yet to approve any COVID-19 vaccines.

She warned companies and Corporate bodies against dispensing vaccines in Nigeria without approval of NAFDAC, saying the agency was committed to guaranteeing drugs security

In a statement in Abuja on Friday, Prof. Adeyeye revealed that no application has been received from any manufacturers of vaccines and couldn’t have approved any vaccines yet by NAFDAC.

She warned Nigerians against taking vaccines that have not been certified by NAFDAC, adding that COVID-19 vaccines are new, and the side effects must be monitored, particularly that there were reports of fake COVID-19 vaccines in Nigeria.

According to her, fake.vaccines, if.taken, could cause illnesses in COVID-19 like manner and.eventually leading to death.

She expressed that the first thing for any manufacturers of COVID-19 vaccines to do was to submit applications to NAFDAC, stating that no government institutions should order for COVID-19 drugs without NAFDAC approval.

“However, NAFDAC is discussing with manufacturers of COVID-19 vaccines concerning potential Emergency Use Authorization (EUA), registration or licencing of their products as the case may be.”

Adeyeye, however, assured applicants of NAFDAC’s determination to approve vaccines for emergency use if phase three clinical data were convincing and robust with regards to safety and efficacy, and the vaccine had been submitted for the World Health Organisation (WHO) emergency use listing.

She emphasised the commitment of NAFDAC in using “Reliance” or “Recognition” to expedite Emergency Use Authorization (EUA) for vaccines already approved

by mature regulatory authorities.

“The full dossiers 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.”

The NAFDAC boss, who said that the agency would welcome the application for Emergency Use Authorisation in Nigeria, however, reiterated readiness to examine the safety of any vaccine.

She affirmed the collaboration of NAFDAC with sister agencies as the National Primary Health Care Development Agency (NPHCDA), Nigeria Centre for Disease Control (NCDC), UNICEF,

WHO and the Ministry of Health, aimed at achieving a holistic approach for effective immunisation and delivery.

“NAFDAC plans to also use Traceability with GS1 Technology to monitor vaccine distribution, using Global Trade Item Number (GTIN).

“The goal is to prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion.

“This effort will create a reliable and predictable supply chain. The multi-stakeholder technical working group has been meeting to address different issues from access to distribution to traceability to the monitoring of adverse events following immunisation.

“NAFDAC is also a member of Regulators Steering Committee of African Union -3S (Smart, Safety, Surveillance) with Ghana, South Africa and Ethiopia, collaborating

with UK Medicines Healthcare Products Regulatory Agency (MHRA) with funding from Bill and Melinda gates Foundation.

Adeyeye explained that the aim of the continental collaboration was to use COVID-19 vaccines distribution and immunisation as a pilot to actively monitor the distribution, delivery and monitoring of Adverse Effects Following Immunisation at the continental level, aimed at creating an African-based vigilance system for the safety of medicines.

Meanwhile, the National Primary Health Care Development Agency, NPHCDA, has announced that vaccines will arrive Nigeria by the end of January after which they will be shared among the States of the federation.

Executive Director of NPHCDA, Dr. Faisal Shuaibu gave the announcement at a news conference in Abuja on Wednesday, saying, by the first week of February, vaccines were expected to be heading to the various States based on numbers allocated to them, while the Committee has been constituted to secure the vaccines, once there arrived.