NAFDAC Recommends The Following Vaccines For Emergency Use Authorization
July 15, 2021,
Moderna (Rovi Pharma Madrid, Spain)
AstraZeneca AZD1222 [SK Bioscience Co Limited (Republic of Korea)]
Sputnik V (Gamaleya National Centre of Epidemiology and Microbiology, Russia)
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.
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 https://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/DRUG_GUIDELINES/Guidance-document-on-Covid-19-vaccine-preparedness-finalized.pdf
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
o Emergency Use Authorization
o Expedited approval
o Full review
o 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.
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.
AstraZeneca AZD1222 Vaccine
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 5ml solution that contains 5 x 1010 virus particles for injection in a 5ml clear glass multidose vial that could be stored at 2-8OC. It is given as a two-dose injection of 0.5ml/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 1011 of Ad26 vector encoding the S glycoprotein of SARS-CoV-2. The product has a shelf life of six (6) months when
stored at -180C or three (3) months when stored at 2-80C.
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 in- country training on the use of the App for the healthcare workers.
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.
NAFDAC………safeguarding the health of the Nation!!!
Prof Mojisola Christianah Adeyeye, PhD, FAS