By Deborah Musa, Abuja
THE National Agency for Food, Drug Administration and Control, NAFDAC, has given conditional approval of the Sputnik V Vaccine from Russia for use in Nigeria
Other Vaccines also granted approval of usage by the Agency in the country includes Moderna and AstraZeneca vaccine from Korea
The Director General of NAFDAC, Prof. Mojisola Adeyeye, made this disclosure at a press conference at NAFDAC headquarters on Thursday, in Abuja where she explained that “Sputnik V is yet to receive the WHO approval and therefore was subjected to full six-months review by NAFDAC and from it’s checks and findings, the agency approved the usage of Sputnik vaccine as it’s benefits outweighs the risks
Prof. Adeyeye explained that Moderna and AstraZeneca AZD1222 vaccines have received the World Health Organization Emergency Use Listing, EUL and were given expedited approvals. ”
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,”she explained.
Adeyeye said:”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 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.
“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.”
According to her,”National Agency for Food and Drug Administration 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. NAFDAC is the first National Regulatory Agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines,”she explained.
She said,”The guidance addressed many regulatory issues including the following: e Submission of dossiers by manufacturers and Market authorization holders e Assessment of Dossier through different mechanisms and using the common technical document for the rolling submission o Emergency Use Authorization o Expedited approval o Full review o Post-marketing Pharmacovigilance and Surveillance.”
Prof. Adeyeye said Moderna vaccine “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,”she said.
On the other hand,she said:” AstraZeneca AZD1222 COVID-19 vaccine is a recombinant ChAdOx! adenoviral vector encoding the structural surface glycoprotein (Spike protein) antigen of the SARS-CoV-2 from SK Bioscience Co Limited (Republic of Korea).”
She spoke:”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.
“Sputnik V Vaccine: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.
“The Agency did a thorough assessment of each vaccine and were found to have the quality, safety and efficacy attributes, with the benefits far outweighing the risks.
“Pharmacovigilance of Covid-19 Vaccines:Pharmacovigilance/Post-Marketing Directorate will conduct safety and monitoring studies on the vaccines to record the side effects and adverse effects following immunization. Other studies like immunological responses, incidences of reactogenicity and possible dose optimization will be done in a cohort of vaccinees.
“The Agency will be using its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with respective sister agencies. The App is free, and millions of healthcare workers can download it free for Adverse Drug Reaction (ADR) reporting. NAFDAC has begun incountry training on the use of the App for the healthcare workers.
“NAFDAC plans to also use the Traceability with GS] 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.”