BY PATIENCE IVIE IHEJIRIKA, Abuja
The National Agency for Food and Drug Administration and Control (NAFDAC), has approved the use of AstraZeneca vaccine in Nigeria.
Director-general of NAFDAC, Prof. Mojosola Adeyeye, who disclosed this during a press briefing on Thursday in Abuja, said that the vaccine can be stored at 2 to 8-degree centigrade.
The Astrazeneca vaccine was recently approved for emergency use by the World Health Organisation (WHO).
Adeyeye said NAFDAC received the vaccine dossier from Serum Institute of India last week and that the Agency Vaccine Committee commenced the expedited review immediately.
“The multidose (2 dose or 10 dose) vial is stored at 2-8OC, one dose (0.5ml) contains 5 x 1010 virus particle. On available stability data, the applicant has proposed a drug product shelf life of 6 months.
“From the Phases 2/3 conducted, COVISHIELD 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,” she explained.
She noted that the safety of the vaccine is premium to NAFDAC and a lot of efforts are being put into the regulatory function.
Adeyeye said the Agency has initiated multi-stakeholder collaboration with National Primary Health Care Development Agency (NPHCDA), Nigeria Center for Disease Control (NCDC), UNICEF, GAVI, WHO and Ministry of Health.
The focus, she said is to use a holistic approach for the effective immunisation or delivery of the vaccines and monitor any Adverse Events Following Immunisation (AEFI), adding that 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 immunization.
The DG informed that NAFDAC will be using its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with the sister agencies.
She said the App is free, and millions of healthcare workers can download it free for Adverse Drug Reaction (ADR) reporting. “In-country training on the use of the App has begun for the healthcare givers,” she said.
To prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion as well as create a reliable and predictable supply chain, NAFDAC said it plans to also use the Traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number (GTIN).
“At the continental level, NAFDAC is on the Regulators Steering Committee of African Union -3S (Smart, Safety Surveillance) with Ghana, South Africa and Ethiopia. The committee was formed as a preparatory caucus for safety monitoring of medicines but using COVID-19 vaccine as a pilot,” Adeyeye explained.
Subject to approval by NAFDAC, the EUL will allow Nigeria to receive the first batch of the vaccine from COVAX Facility within weeks.
Meanwhile, the federal government and the WHO Nigeria, had said earlier that Nigeria was expecting 16 million doses out of the 88 million AstraZeneca/Oxford vaccine doses allocated to African countries for the first phase, by end of February.