The National Agency for Food and Drug Administration and Control (NAFDAC) has approved Moderna and AstraZeneca vaccines to combat the spread of the dreaded COVID-19 pandemic in Nigeris.
It also gave Sputnik V vaccine conditional approval
Director General of the agency Prof Mojisola Christianah Adeyeye at a press conference hinted that the NAFDAC Vaccine Committee has been assessing several vaccines despite the fact that the vaccines have been approved by stringent regulatory countries or have received WHO’s Emergency Use Listing (EUL).
According to her,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 : “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 EUL will allow Nigeria to receive supplies of the vaccines from the COVAX Facility.
“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.”
Adeyeye also noted that National Agency for Food and Drug Administration 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.
She added that, “NAFDAC is the first National Regulatory Agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines https://www.nafdac.gov.ng/wp- content/up loads/Files/Resources/
“The guidance addressed many regulatory issues including the following: Submission of dossiers by manufacturers and Market authorization holders.
Assessment of Dossier through different mechanisms and using the common technical document for the rolling submission; Emergency Use Authorization o Expedited approval; Full review; Post-marketing Pharmacovigilance and Surveillance
“Moderna and AstraZeneca AZD1222 vaccines have received WHO EUL listing and were given expedited approvals. Sputnik V is yet to receive the EUL approval and therefore was subjected to full six-months 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”.
Speaking on the newly approved Moderna vaccine , Adeyeye dropped said 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). It is a two-dose vaccine. Unopened vaccine vials can be stored and/or transported frozen at -25°C to – 15°C for up to 7 months and 30 days when stored at 2 to 8°C, protected from light.
Also speaking on AstraZeneca AZD1222 COVID-19 vaccine is a recombinant ChAdOx1 adenoviral vector encoding the structural surface glycoprotein (Spike protein) antigen of the SARS-CoV-2 from SK Bioscience Co Limited (Republic of Korea).
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.
On the Sputnik V Vaccine , the NAFDAC boss stated that the Gam-COVID-Vac COVID-19 Vaccine is supplied as a two-component product, both of which are 3ml (5 doses) solution for intramuscular injection in glass vial. It is a two-dose injection. Each 0.5ml dose of the Component I is formulated to contain virus particles (1.0+0.5) x 10!’ of Ad26 vector encoding the S glycoprotein of SARS-CoV-2. The product has a shelf life of six (6) months when stored at -18°C or three (3) months when stored at 2-8°C.
554800cookie-check COVID-19: NAFDAC Approves Moderna, AstraZeneca Sputnik Vaccines
