*Approves Moderna, AstraZeneca
*Grants conditional Approval for Sputnik V
By Ernest Omoarelojie
The National Agency for Food and Drug Administration and Control, NAFDAC, has announced that it found both the Moderna and AstraZeneca vaccines good enough for use in the country hence it gave immediate approval for their deployment for the control of the covid-19 virus. The agency said it also gave a conditional approval to Russia’s Sputnik V vaccine.
The approval was announced in a statement signed by the director general, Prof Mojisola Christianah Adeyeye, on Thursday following the confirmation that Nigeria has officially embraced the third wave of the pandemic,
According to the statement, NAFDAC explained that it gave approval for the use of the vaccines after a careful assessment by its committee even though they have already gone through stringent regulatory control approval including having received Emergency Use Listing, EUL, of the World Health Organizations, WHO.
“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,” Prof Adeyeye clarified.
The agency’s boss noted that COVAX, the 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. According to her, NAFDAC 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 noted.
In the main, Prof Adeyeye stated that Moderna and AstraZeneca AZD1222 vaccines have already received WHO EUL listing hence NAFDAC gave them expedited approvals, adding that the agency received 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 only exception, she said, is Sputnik V, which only receive the EUL approval hence it was subjected to full six-month review by NAFDAC,
Prof Adeyeye disclosed that the agency’s 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,“ she disclosed.
According to her 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.”