Grants conditional approval for Sputnik V vaccine
By Chioma Obinna
As Nigeria slipped into the third wave of the COVID-19 pandemic, the National Agency for Food and Drug Administration and Control, NAFDAC, on Thursday announced the approval of Moderna and AstraZeneca vaccines even as it granted conditional approval for Sputnik V vaccine.
In a press statement signed by the Director-General of the Agency, Prof Mojisola Christianah Adeyeye, it noted that the approval was granted after a careful assessment by the NAFDAC Vaccine Committee despite the fact that 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 EUL will allow Nigeria to receive supplies of the vaccines from the COVAX Facility.
She noted that the 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) aimed 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.
She further explained that the 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
“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 noted
Adeyeye stated that Moderna and AstraZeneca AZD1222 vaccines have received WHO EUL listing and were given expedited approvals while Sputnik V is yet to receive the EUL approval and therefore was subjected to a full six-month 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.
On Pharmacovigilance of COVID-19 Vaccines, she said the Pharmacovigilance/Post-Marketing Directorate would 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 vaccines.
“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. “
Adeyeye further announced that NAFDAC has begun in-country training on the use of the App for 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.”