NAFDAC Approves New Vaccines For Use

NAFDAC has approved new COVID-19 vaccines for use in Nigeria.

Gatekeepers News reports that National Agency for Food, Drug Administration and Control, NAFDAC, has approved three new vaccines for 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).

The Director-General of NAFDAC, Professor Moji Adeyeye announced this at a news conference in Abuja, FCT.

Adeyeye explained that although the Sputnik vaccine has not yet been approved by the World Health Organisation (WHO), NAFDAC has carried out independent checks on the vaccine and found that the benefits prevail over the risks.

Adeyeye was Represented by the Director, Planning, Research and Statistics, Mr Fori Tatama.

She vowed that health, safety and environment-based issues were taken seriously by NAFDAC.

She said: “The WHO is carrying out an audit of NAFDAC, which will enable the country to start manufacturing vaccines; the programme started on Monday and will last till Friday.”

Adeyeye further stated 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 observed that NAFDAC 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.

She noted that other studies like immunological responses, incidences of reactogenicity and possible dose optimisation will be done in a cohort of vaccines while NAFDAC will be using its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with respective sister agencies.