We have not approved Covid vaccine for use in Nigeria – NAFDAC

Prof. Mojisola Adeyeye
DG, NAFDAC

The National Agency for Food and Drugs Administration and Control (NAFDAC) says no vaccine has been approved for use in Nigeria as it has not received any application for registration  from Covid vaccine manufacturers.

In a statement signed by the Director General of the agency, Prof. Mojisola Christianah Adeyeye today, NAFDAC urged the public not to use the vaccines, unless approved, saying Covid-19 vaccines are new, and the side effects or adverse events must be well monitored.

But another government agency, The Primary Health Care Development Agency (NPHCDA) had disclosed that the first 100,000 doses of the Pfizer coronavirus vaccine would be available by the end of January.

The government also announced plans to vaccinate 40% of the country’s population by the end of this year, with President Muhammadu Buhari and Vice President Yemi Osinbajo as the first recipients.

NPHCDA Executive Director, Dr. Faisal Shuaib told newsmen last week that the agency  had developed a “comprehensive deployment plan on how we are going to deploy these vaccines in phases.

“We’re aiming to cover up to 70% of the population just to ensure that we’re able to stop transmission,” he said,  stating  that  40% of the population was expected to get shots this year while the remaining 30% receive the vaccine by the end of next year.

But Adeyeye warned today that no government establishment or agencies should order Covid vaccines without confirming from NAFDAC if the vaccine has been approved.

Similarly, the agency warned that the 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,” the statement said.

The NAFDAC DG also alerted the public on the circulation of fake vaccines’

“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,” she warned. 

She however  disclosed that NAFDAC is discussing with manufacturers of candidate  COVID-19 vaccines concerning potential Emergency Use Authorization (EUA), registration or licensing of their product 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.

“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.

“Safety of The Covid Vaccine Is Premium to NAFDAC This is why active pharmacovigilance is being used. 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.

“Despite the use of Reliance for the EUA, NAFDAC will note clinical peculiarities in form of Serious or Adverse Events Following Immunisation (AEFIs) in the dossier or application as a guide and caution for what to look out for in each subject after immunization, i.e., during the active pharmacovigilance phase where monitoring of adverse events will be conducted. The Agency has been training her staff for this very  important aspect of the immunization.”

 

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