The Director General of Nigeria’s food and drug regulating agency(NAFDAC), Mojisola Adeyeye, during a press briefing in Abuja on Thursday, announced that the agency has given approval for Russian Sputnik Covid-19 vaccine to be used in the country.
The approval is coming after the World Health Organization, the European Union and UNICEF expressed concerns over the vaccine.
WHO had stated that the UN health agency during its inspection of the four Sputnik V manufacturing sites, found six issues during the visit to the Pharmstandard Ufa Vitamin Plant in Ufa, southern Russia.
The report also stated that inspectors had concerns with the data integrity and testing results from monitoring during manufacturing and quality control, and with the monitoring and control of aseptic operation and filling.
The inspection also identified issues with the traceability and identification of vaccine batches.
There were also concerns over the filling lines, sterility assurance, sterile filtration validation and the risks of cross-contamination.
The EU also cited same concerns while the UNICEF in a statement had stated that the procurement of the Sputnik vaccine by UNICEF will be under the condition of the product achieving an Emergency Use Listing from WHO, to confirm the quality, safety and efficacy of the vaccine.
However, the NAFDAC DG added that despite the vaccine not getting approval from the World regulatory bodies, the agency had done a thorough assessment of the vaccine.
She said, “Sputnik V is yet to receive the EUL approval and therefore was subjected to full six-months review by NAFDAC. The Agency was granted access to the dossiers and prior assessment reports of Moderna and AstraZeneca from the WHO website at different times over the past two months.
“The Agency did a thorough assessment of each vaccine and were found to have the quality, safety and efficacy attributes, with the benefits far outweighing the risks.”
Adeyeye also added that two other vaccines, Moderna and AstraZeneca of SK bioscience Co limited, Republic of Korea had been approved.
She said, “Moderna and AstraZeneca AZD1222 vaccines have received WHO EUL listing and were given expedited approvals.”