By Sola Ogundipe & Joseph Erunke
The National Agency for Food and Drug Administration and Control, NAFDAC, has approved the AstraZeneca/Oxford COVID-19 vaccine for use in Nigeria.
The approval came on the heels of the World Health Organisation’s listing of the vaccine for emergency use on Monday.
Under the WHO Emergency Use Listing, EUL, the quality, safety and efficacy of COVID-19 vaccines are assessed as a prerequisite for the COVAX facility vaccine supply.
Announcing the approval at a media briefing in Abuja yesterday, NAFDAC Director-General, Prof. Mojisola Adeyeye, said the evaluation of AstraZeneca/Oxford vaccine, codenamed Covisheild (AZD1222), showed it was effective against the variant of the coronavirus first discovered in the UK, several cases of which had been reported in Nigeria.
Adeyeye said the agency obtained the dossier of the vaccine last week and its safety committee immediately began evaluating its safety and efficacy for Nigerians.
She said the recommendation for emergency use authorisation was based on rigorous scientific considerations.
Adeyeye said: “NAFDAC received the AstraZeneca/Oxford COVID-19 vaccine dossier from Serum Institute of India on February 10, 2021. The NAFDAC Vaccine Committee commenced the expedited review immediately and the members of the committee have worked assiduously to ensure that review was done as planned.
“The active substance is manufactured and controlled by Serum Institute of India Private Limited (SIIPL). A GMP certificate and manufacturing license issued by the India National Regulatory Authority (NRA) has been presented and found to be authentic and valid.
“The multidose (2 dose or 10 dose) vial is stored at 2-8 degrees Centigrade, one dose (0.5ml) contains 5 x 1010 virus particle. On available stability data, the applicant has proposed a drug product shelf life of six months.
“From the phases 2/3 conducted, Covisheild was found safe and well-tolerated in adults above 18 years of age. The incidence of solicited, unsolicited AEs and SAEs was comparable in the study control. groups. No causally related SAE was caused by the study vaccine.
“Safety of the vaccine is premium to NAFDAC and a lot of efforts are being put into this regulatory function. The agency initiated multi-stakeholder collaboration with National Primary Health Care Development Agency, NPHCDA, Nigeria Centre for Disease Control, NCDC, UNICEF, GAVI, WHO and Ministry of Health.
“The focus is to use a holistic approach for the effective immunisation or delivery of the vaccines and monitor any Adverse Events Following Immunisation, AEFI.
‘’The multi-stakeholder technical working groups have been meeting to address different issues, from access to distribution to traceability (track and trace) of the vaccines, to monitoring of adverse events following immunisation.”
Three other COVID-19 vaccines are being evaluated by the agency. The AstraZeneca/Oxford vaccine is the second COVID-19 vaccine to receive the WHO authorisation, after Pfizer-BioNTech vaccine.
The World Health Organisation listed two versions of the AstraZeneca-Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through COVAX facility.
The approved vaccines are being produced by the Serum Institute of India, and by SKBio in South Korea.
Nigeria has been allocated 16 million doses of the Oxford-AstraZeneca vaccine under the COVAX facility, while more doses are being expected under the Africa Union arrangement.
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), aims to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.
COVAX is also poised to ensure that 92 eligible Low- and Middle-Income Countries get access to COVID-19 vaccines through GAVI.
Adeyeye said the agency will be using its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with the sister agencies.
“The App is free, and millions of healthcare workers can download it free for Adverse Drug Reaction (ADR) reporting,” Adeyeye said.
In-country training on the use of the App has begun for the healthcare givers.
“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,’’ she said.