The National Agency for Food and Drug Administration and Control (NAFDAC) says it has reports of the importation of fake COVID-19 vaccines into Nigeria.

Director General of the agency, Prof Mojisola Adeyeye, who stated this during a virtual press conference, urged Nigerians to avoid the fake vaccines, saying, “They can cause COVID-like illnesses or other serious diseases that could kill.”

She said the agency had not received any application from COVID vaccine manufacturers yet and therefore no vaccines had been approved by NAFDAC.

“COVID-19 vaccines are new, and the side effects or adverse effects must be well monitored, therefore, if NAFDAC does not approve, the public should not use,” the NAFDAC boss said.

Adeyeye said no government establishment or agencies should order COVID-19 vaccines without confirming from NAFDAC if the vaccine had been approved.

However, she said NAFDAC “is discussing with manufacturers of COVID-19 vaccines” concerning potential Emergency Use Authorisation (EUA), registration or licensing of their product.

She assured applicants that if Phase 3 clinical data are very convincing and robust with regard to safety and efficacy, and the vaccine submitted for WHO for Emergency Use Listing, “NAFDAC will welcome the application for Emergency Use Authorisation in Nigeria.”

She added that companies manufacturing the vaccines cold submit their application to NAFDAC if genuine.

On the issue of the EUA, the NAFDAC DG said it would use “reliance” or “recognition” to expedite action on approvals for vaccines already approved by more matured regulatory authorities.

However, she said that the full dossier submitted by the manufacturer or Market Authorisation Holder (MAH) would be thoroughly reviewed by the vaccine committee 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.

Despite the use of Reliance for the EUA, NAFDAC DG said it would note clinical peculiarities in form of serious or Adverse Effects Following Immunisation (AEFIs) in the dossier or application as a guide and caution on what to look out for in each subject after immunisation.

She said that the agency had been training its personnel for this very important aspect of the immunisation.

“The agency established COVID-19 Vaccine Committee that has been busy developing the guidelines and guidance. NAFDAC is the first National Regulatory Agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines.

“NAFDAC initiated multi-stakeholder collaboration with National Primary Health Care Development Agency (NPHCDA), Nigeria Centre for Disease Control (NCDC), UNICEF, WHO and Ministry of Health. The focus is to use a holistic approach for the effective immunisation or delivery of the vaccines and monitor any Adverse Effects Following Immunisation (AEFI).

“The agency will also use its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with the sister agencies. The App is free, and millions of healthcare workers can download it free for ADR reporting. In-country training on the use of the App has begun for the healthcare givers,” she said.

The NAFDAC boss said once approval was given by the agency, it would thoroughly monitor the distribution and use of COVID-19 vaccines in the country to safeguard Nigerians from any possible adverse effects.

Adeyeye said NAFDAC planned to use the traceability with GS1 technology to monitor the vaccine distribution in Nigeria using Global Trade Item Number (GTIN).

She said the goal was to prevent fake vaccines from infiltrating the supply chain and to ensure there was no diversion, adding that the effort would create a reliable and predictable supply chain.

According to her, a multi-stakeholder technical working group has been meeting to address different issues, from access to distribution to traceability (track and trace) of the vaccines, to monitoring of adverse effects following immunisation.

Lagos reopens two isolation centres

Meanwhile, Lagos State Government has announced that it will be reopening two COVID-19 isolation centres which were initially decommissioned, following the increased cases of coronavirus in the state.

According to the state Commissioner for Health Prof. Akin Abayomi, the reopening will boost confidence in tackling cases as they arise.

Abayomi said, “Just to be on the safe side, we are reopening two of our decommissioned facilities, that is at Ajah and Ikeja. We are also reopening Gbagada isolation facility.

“This is just to give us the confidence that in case we suddenly continue to see higher numbers of severe cases, we will have somewhere to manage them.”

The commissioner also revealed that the state government was working on building oxygen plants for more health facilities.

Abayomi added, “In addition, we are making our own oxygen so we just erected the first of two plants at IDH. The second one will be at Gbagada and that plant produces oxygen on the grounds of our hospital and it can produce up to 60 cylinders a day. A very sick patients can use up to four or six cylinders in 24 hours.”

• The story was first published by Thisday and adapted by Newstrends with minimum correction.