In order to tackle and adequately contain the spread of the COVID-19 third-wave pandemic, the National Agency for Food and Drug Administration and Control (NAFDAC) has announced the approval of three new vaccines for use in the country.
This was disclosed in a statement issued on Thursday by the Director-General of NAFDAC, Professor Mojisola Adeyeye in Abuja.
Adeyeye gave their names as Moderna of Rovi Pharma Madrid, Spain, AstraZeneca AZD1222 of SK Bioscience Co Limited, Republic of Korea and Sputnik V of Gamaleya National Centre of Epidemiology and Microbiology, Russia.
However, she noted that Sputnik is still undergoing further analysis while Moderna and Korea’s AstraZeneca have been given full approval.
An excerpt from the statement reads, “NAFDAC is announcing the approval of Moderna and AstraZeneca vaccines and conditional approval of Sputnik V vaccine.
“The NAFDAC 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.
“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.
NAFDAC is the first National Regulatory Agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines.”
