NAFDAC approves emergency use of three additional Covid-19 vaccines for Nigeria
Written by freshadmin3 on July 15, 2021
The National Agency for Food and Drug Administration and Control (NAFDAC) vaccine committee has approved the emergency use of additional three new Covid-19 vaccines.
The vaccines include the Moderna (Rovi Pharma Madrid, Spain) AstraZeneca AZD1222 [SK Bioscience Co Limited (Republic of Korea)] Sputnik V (Gamaleya National Centre of Epidemiology and Microbiology, Russia).
“Moderna and AstraZeneca AZD1222 vaccines have received WHO EUL listing and were given expedited approvals,” Director General of the agency, Prof Mojisola Adeyeye said in Abuja on Thursday.
“Sputnik V is yet to receive the EUL approval and therefore was subjected to full six-months 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.”
Adeyeye further stated that the NAFDAC Vaccine Committee has granted approval of Moderna and AstraZeneca vaccines and conditional approval of Sputnik V vaccine adding that the agency 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).
She explained that 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 adding that most regulatory agencies across the world use this mechanism to expedite their own regulatory approval to import and administer COVID-19 vaccines.
According to Adeyeye, NAFDAC 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.