The National Agency for Food and Drug Administration and Control, NAFDAC, has given approval for the use of Moderna and AstraZeneca (Korea) vaccines and conditional approval for Sputnik V vaccine in Nigeria.
This follows several controversies around the safety of the vaccines as countries report cases of deaths and severe illnesses from its use, even after the world health organisation and European Medicines Agency (EMA) declared the Oxford-AstraZeneca COVID-19 vaccines safe for use.
NAFDAC had earlier approved AstraZeneca (India), Pfizer bioNTech, and Johnson & Johnson COVID-19 vaccines, in February and May 2021, respectively.
Meanwhile, the National Primary Healthcare Development Agency, had announced that it has successfully vaccinated 3,938,945 eligible persons across 36 States and FCT, using the 4,024,000 doses of Oxford/AstraZeneca vaccine it received from COVAX facility in March 2021.
Executive Director of NAFDAC, Faisal Shuaib said that the government in preparation to commencing the second phase has begun communication with suppliers for the delivery of another 3,924,000 doses of Oxford/AstraZeneca by end of July or early August 2021 from the COVAX facility.
Nigeria, like other countries recorded up to 14,550 cases of mild,moderate and severe Adverse Events following the use of the AstraZeneca vaccine.
However, the Director-General of NAFDAC, Mojisola Adeyeye, during a press briefing in Abuja on Thursday, said that the Agency’s vaccine committee has carefully assessed the vaccine to ensure its safety, even after they have gone through WHO’s Emergency Use Listing (EUL).
According to her, the Agency spent at least 15 days to thoroughly examine the submission package of the vaccine to ensure that the benefits of the vaccine far outweigh the risks.
“A COVID-19 vaccine that has gone through the prior approval from either of these two sources(Stringent regulatory countries and WHO) had gone through quality, safety and efficacy evaluation which is a prerequisite for acceptance by COVAX Facility.
“Most regulatory agencies across the world use this mechanism to expedite their own regulatory
approval to import and administer COVID-19 vaccines,” she said.
She further explained that the Agency will be using its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with respective sister agencies.
She said, “NAFDAC plans to also use the traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number (GTIN).
“This 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 and keep the public safe.”