The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the approval of the use of AstraZeneca/Oxford COVID-19 Vaccine for an Emergency Use Listing (EUL).
An initial approval given by WHO on Monday, February 15, 2021.
WHO’s EUL assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply.
Disclosing this in a statement released by the agency today, NAFDAC stated that, “It 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 to ensure that review was done as planned.”
The recommendation for Emergency Use Authorisation was based on rigorous scientific considerations as summarized below:
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.
Dose Pack and Storage: The multidose (2 dose or 10 dose) vial is stored at 2 – 8°C, 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.
VACCINE SAFETY AND EFFICACY
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.
PHARMACOVIGILANCE OF COVID-19 VACCINES
The focus is to use a holistic approach for the effective immunization 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 immunization.
Furthermore, the Agency will be using its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with sister Agencies. The app is free and millions of healthcare workers can download it for Adverse Drug Reaction (ADR) Reporting.
NAFDAC plans to use the Traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number. This is to prevent fakes from infiltrating the supply chain and ensure there is no diversion. This will create a reliable and predictable supply chain.
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.