By Tobias Lengnan Dapam
National Agency for Food and Drug Administration and Control (NAFDAC), has announced the approval of Moderna and AstraZeneca vaccines and conditional approval of Sputnik V vaccine.
Speaking yesterday during a press conference in Abuja, NAFDAC boss,
Prof Mojisola Adeyeye, said its Vaccine Committee has been carefully assessing several vaccines despite the fact the vaccines have been approved by stringent regulatory countries or have received WHO’s Emergency Use Listing (EUL).
“A COVID-19 vaccine that has gone through the 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.
“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). Its aim is 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 added that the National Agency for Food and Drug Administration also gives full reviews for vaccines that have not gone through EUL route. “This mechanism is explained in our guidance developed by the COVID-19 Vaccine Committee.”
She boasted that NAFDAC is the first National Regulatory Agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines.
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