By Nneka Nwogwugwu
The National Agency for Food and Drug Administration and Control, NAFDAC, on Thursday announced the approval of Moderna and AstraZeneca vaccines.
Recall that it granted conditional approval for Sputnik V vaccine.
In a press statement signed by the Director-General of the Agency, Prof Mojisola Christianah Adeyeye, approval was granted after a careful assessment by the NAFDAC Vaccine Committee despite the fact that the vaccines have been approved by stringent regulatory countries or have received WHO’s Emergency Use Listing (EUL).
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She said as quoted by Vanguard, “A COVID-19 vaccine that has gone through prior approval from either of these two sources 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.
“The Agency spends at least 15 days to thoroughly examine the dossier or submission package of the vaccine to ensure that the benefits of the vaccine far outweigh the risks and any side effects are well noted for monitoring after vaccination by respective NAFDAC and Primary Health Officers. The EUL will allow Nigeria to receive supplies of the vaccines from the COVAX Facility.
She noted that the COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Acceleratoris jointly led by the Global Alliance for Vaccines and Immunisation (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO) aimed to accelerate the development and manufacture of COVID-19 vaccines and to guarantee fair and equitable access to low-middle income countries (LMIC) of which Nigeria is one.
She further explained that the National Agency for Food and Drug Administration also gives full reviews for vaccines that have not gone through EUL route.
