COVID-19: NAFDAC Approves Three Additional Vaccines For Emergency Use


 CHIOMA UMEHA; TOYIN ADEBAYO

LAGOS, ABUJA – 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.




Read the Source post on Independent Newspaper Nigeria.

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