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NAFDAC approves Moderna, AstraZeneca Covid-19 vaccines

…gives conditional approval for Sputnik V vaccine

The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the use of Moderna and AstraZeneca vaccines, while giving conditional approval for Sputnik V vaccine. Director General NAFDAC, Prof Mojisola Adeyeye, who made the disclosure on Thursday in Abuja, noted that although approved by stringent regulatory countries and on WHO’s Emergency Use Listing (EUL), all vaccines were carefully assessed by the NAFDAC Vaccine Committee before approved for use in the country by the agency.

While disclosing that full reviews were also given for vaccines that have not gone through EUL route, Adeyeye added that NAFDAC was the first regulatory agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines. She said: “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. “Moderna and Astra- Zeneca AZD1222 vaccines have received WHO EUL listing and were given expedited approvals. Sputnik V is yet to receive the EUL approval and therefore was subjected to full six-month 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.”

 

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