NAFDAC approves Moderna, Spuntinik COVID-19 vaccines

The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the approval of Moderna from Rovi Pharma Madrid in Spain, AstraZeneca AZD1222 from SK Bioscience Co Limited, Republic of Korea and conditional approval of Sputnik V from Gamaleya National Centre of Epidemiology and Microbiology in Russia for emergency use.

Director General of NAFDAC, Professor Mojisola Adeyeye, stated that the agency’s vaccine committee has been assessing several vaccines despite the fact the vaccines have been approved by stringent regulatory countries or have received World Health Organisation (WHO)’s Emergency Use Listing (EUL).

Adeyeye stressed that 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.

She added that most regulatory agencies across the world use this mechanism to expedite their own regulatory approval to import and administer COVID-19 vaccines.

Adeyeye further revealed that the agency spent at least 15 days to 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.

Adeyeye noted that COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Acceleratoris jointly led by The Global Alliance for Vaccines and Immunisation (GAVI), the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organisation (WHO) is aimed to accelerate the development and manufacture of COVID-19 vaccines and also to guarantee fair and equitable access to low-middle income countries (LMIC) of which Nigeria is one.

“NAFDAC also gives full reviews for vaccines that have not gone through EUL route. This mechanism is explained in our guidance developed by the COVID-19 Vaccine Committee and NAFDAC is the first National Regulatory Agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines”

While describing the features of the vaccines, Adeyeye said Moderna vaccines is presented as a white to off-white, ready-to-use dispersion for intramuscular injection in a multi-dose vial containing 6.3ml (10 doses) in a 10-vial pack.

“Each dose (0.5ml) contains 100 micrograms of messenger RNA (mRNA) (embedded in SM-102 lipid nanoparticles that serve as the delivery matrix). It is a two-dose vaccine.””

“The AstraZeneca AZD1222 COVID-19 vaccine solution is colourless to slightly brown, clear to slightly opaque packed as a Sml solution that contains 5 x 10!° virus particles for injection in a Sml clear glass multidose vial that could be stored at 2-8°C. It is given as a two-dose injection of 0.5mI/dose.”

She added that Sputnik V Vaccine is the Gam-COVID-Vac COVID-19 Vaccine whic is supplied as a two-component product, both of which are 3ml (5 doses) solution for intramuscular injection in glass vial.

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