The Nation (Nigeria)
NAFDAC okays Russian, Spanish vaccines emergency use
THE National Agency for Food and Drug Administration and Control (NAFDAC) has announced the emergency use approval of Moderna and Astrazeneca vaccines as well as conditional approval of Sputnik V vaccine.
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. Sputnik V from Russia is by Gamaleya National Centre of Epidemiology and Microbiology.
NAFDAC had previously approved Astrazeneca (India), Pfizer biontech, and Johnson & Johnson COVID-19 vaccines in February and May 2021.
Its Director-general, Prof. Mojisola Adeyeye, stated these yesterday during a news briefing at its headquarters in Abuja.
She explained that 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, therefore, was subjected to full six-months 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 COVID19 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 Organisation (WHO),” she said.