COVID-19: NAFDAC Approves Three Additional Vaccines For Emergency Use
The National Agency for Food and Drug Administration and Control (NAFDAC) vaccine committee has approved additional three new COVID-19 vaccines for emergency use in Nigeria.
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 the World Health Organisation’s Emergency Use Listing Procedure (WHO EUL) and were given expedited approvals,” Prof Mojisola Adeyeye, Director-General of the agency, said in a statement on Thursday.
However, Adeyeye noted, “Sputnik V is yet to receive the EUL approval and therefore was subjected to a 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.”
The NAFDAC boss further said that the NAFDAC Vaccine Committee has granted approval of Moderna and AstraZeneca vaccines and conditional approval of Sputnik V vaccine.
She added 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).
Adeyeye elaborated that a COVID-19 vaccine that has gone through 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.
The NAFDAC DG noted 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.
She explained, this is 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.
Source: independent.ng
