Nigeria Approves Sputnik .V, AstraZeneca And Moderna Vaccines

The federal government has approved Moderna, AstraZeneca, and Sputnik V vaccines for COVID19 Emergency Use Listing.

The Director-General, National Agency for Food and Drug Administration and Control (NAFDAC), Professor Mojisola Adeyeye at an emergency media briefing in Abuja said the vaccines have been approved by stringent regulatory countries and received WHO’s Emergency Use Listing (EUL).

NAFDAC is announcing the approval of Moderna and AstraZeneca vaccines and conditional approval of Sputnik V vaccine. The 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). 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.

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

The Agency 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.

The NAFDAC DG explained that vaccines are presented as a white to off-white, ready-to-use dispersion for intramuscular injection, and it’s a two-dose vaccine.

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 Organization (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.

The product 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).

Professor Adeyeye however cautioned against posting fake news that could discourage Nigerians from taking the approved vaccines, especially through social media.

“NAFDAC plans to also use the Traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number (GTIN). This is to prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion. This effort will create a reliable and predictable supply chain
and keep the public safe.” she added.

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