The Federal Government has endorsed importation of more COVID-19 vaccines to sustain treatment of the pandemic.
The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, disclosed the development in Abuja on Thursday, July 15.
Adeyeye, said approval had been given to Moderna, a vaccine from the Rovi Pharma Madrid, Spain.
Other vaccines also approved are: AstraZeneca AZD1222 produced by SK Bioscience Company Limited from Korea and Sputnik V, produced by Gamaleya National Centre of Epidemiology and Microbiology.
She said that the NAFDAC Vaccine Committee had been carefully assessing the vaccines and several others; in spite of the approval by stringent regulatory countries and the World Health Organization (WHO) Emergency Use Listing (EUL).
She added that all the COVID-19 vaccines that had gone through the process of approval had been certified for quality, safety, and efficacy evaluation, a prerequisite for acceptance by the COVAX facility.
The Director General said most regulatory agencies across the world use this mechanism to expedite their own regulatory approval to import and also administer the vaccines.
She noted that NAFDAC spent 15 days to thoroughly examine the dossier; or submission package of the vaccines to ensure that the benefits outweighed the risks; and any other side effects for proper monitoring.
She said “the EUL will allow Nigeria to receive supplies of the vaccines from the COVAX facility. COVAX is the pillar of the Access to COVID-19 Tools (ACT) accelerator’s jointly led by the Global Alliance for Vaccines and Immunisation (GAVI); as well as the Coalition for Epidemic Preparedness Innovations (CEPI) and the 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.
“NAFDAC also gives full review for vaccines that have not gone through EUL route. This mechanism is explained in our guidance developed by the COVID-19 Vaccine Committee.”
On Moderna and AstraZeneca AZD1222 vaccines, she said that the vaccines had received WHO EUL; and were also given accelerated approval; while Sputnik V was yet to receive the EUL approval, subjected to six months review by NAFDAC.
She said that NAFDAC was granted access to the dossiers; and prior assessment reports of Moderna and AstraZeneca AZD1222 from the WHO website at different times over the past two months.
Adeyeye said the agency did a thorough assessment of each vaccine; and was found to have the quality, safety, as well as efficacy attributes, with the benefits far outweighing the risks.