COVID-19: NAFDAC approves Moderna, AstraZeneca, Sputnik V vaccines for emergency use
The National Agency for Food and Drug Administration and Control (NAFDAC) has granted emergency-use-authorisation for Moderna, AstraZeneca and Sputnik V vaccines COVID-19 vaccines in Nigeria.
The NAFDAC director-general, Mojisola Adeyeye, announced this at a briefing in Abuja on Thursday.
The AstraZeneca approved is from the Republic of Korea (SK Bioscience Co Limited) as a result of the stall in the procurement of AstraZeneca vaccine, also known as Covishield, manufactured under licence by Serum Institute of India, due to the COVID-19 pandemic in the country.
Moderna is produced by Rovi Pharma Madrid, Spain while Sputnik V from Russia is by Gamaleya National Centre of Epidemiology and Microbiology.
The NAFDAC had previously approved AstraZeneca (India), Pfizer bioNTech as well as Johnson & Johnson COVID-19 vaccines in February and May 2021.
“While Moderna and AstraZeneca AZD1222 vaccines have received WHO emergency use listing (EUL) and were given expedited approvals, Sputnik V is yet to receive the EUL approval and the was subjected to full six-month review.
“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. COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator Is 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.
“National Agency for Food and Drug Administration also gives full reviews for vaccines that have not gone through the 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,” Adeyeye stated.