The National Agency for Food and Drug Administration and Control, (NAFDAC) yesterday announced the approval of Moderna and the Korea made AstraZeneca vaccines for use against COVID-19 pandemic in the country.
This is as the agency also gave conditional approval of Sputnik V vaccine, pending the approval of the world health bodies
The Director General of the agency, Mojisola Adeyeye who briefed the press in Abuja yesterday said, “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)”.
According to her, “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”.
Stating that most regulatory agencies across the world use the mechanism to expedite their own regulatory approval to import and administer COVID-19 vaccines, the Director General said the agency spent 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.
She said that any side effects are well noted for monitoring after vaccination by respective NAFDAC and Primary Health Officers.
The NAFDAC boss further said that EUL will allow Nigeria to receive supplies of the vaccines from the COVAX Facility.
Informing that the agency gave full reviews for vaccines that have not gone through EUL route, the Director General said “NAFDAC is the first National Regulatory Agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines”.
She called on Nigerians to go for the vaccination when available, maintaining that the agency did a thorough assessment of each vaccine and were found to have the quality, safety and efficacy attributes, with the benefits far outweighing the risks.
The DG assured that “the Pharmacovigilance of Covid-19 Vaccines. Pharmacovigilance/Post-Marketing Directorate will conduct safety and monitoring studies on the vaccines to record the side effects and adverse effects following immunization”.
She further stated that other studies like immunological responses, incidences of reactogenicity and possible dose optimization will be done in a cohort of vaccines, adding that the agency will be using its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with respective sister agencies.
