NAFDAC Approves AstraZeneca COVID-19 Vaccine for Emergency Use

Onyebuchi Ezigbo in Abuja

The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the emergency use of AstraZeneca as COVID-19 vaccine in Nigeria.

AstraZeneca, from India, is one of the two vaccines received by Nigeria and forwarded to NAFDAC for scientific study.

The other one, Sputnik, developed by Russia, is still being studied by the agency.
NAFDAC’s Director-General, Prof. Mojisola Adeyeye, at a press conference yesterday Abuja said the agency had evaluated the safety and efficacy of the vaccine for Nigerians.

She said the vaccine could be stored in two to eight degrees Centigrade, adding that three more vaccines are being evaluated.
According to her, the evaluation of AstraZeneca shows that the vaccine is effective against the United Kingdom variant of the virus, which has been reported in Nigeria while the South African variant has not been reported in Nigeria.

She also said the agency was reviewing over 30 herbal medicines for listing.
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 the review was done as planned.

“The recommendation for Emergency Use Authorisation was based on rigorous scientific considerations.”
While explaining the process of the vaccine evaluation, Adeyeye said from phases two and three 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 said.

On the vaccine quality, she stated that the active substance is manufactured and controlled by Serum Institute of India Private Limited (SIIPL), adding that a GMP certificate and manufacturing licence issued by the India National Regulatory Authority (NRA) has been presented and found to be authentic and valid.
The NAFDAC boss added that the multidose (2 doses or 10 doses) vial is stored at two to eight degrees centigrade, while one dose (0.5ml) contains 5 x 1010 virus particle.

According to her, stability data showed that the AstraZeneca vaccine has a proposed drug product shelf life of six months.
The use of AstraZeneca/Oxford COVID-19 vaccine, a recombinant ChAdOx1 adenoviral vector encoding the structural surface glycoprotein (Spike protein) antigen of the SARS-CoV-2 was given an approval for Emergency Use Listing by the World Health Organisation (WHO) on Monday.

The WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX facility vaccine supply.

It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. The EUL will allow Nigeria to receive the first batch of the vaccine from COVAX facility within weeks subject to approval by NAFDAC.
Adeyeye also spoke on the rollout plan for the vaccine, saying the agency has initiated multi-stakeholder collaboration with the National Primary Health Care Development Agency (NPHCDA), Nigeria Centre for Disease Control (NCDC), UNICEF, GAVI, WHO and Ministry of Health.

She added that the agency has adopted 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.
She said the focus was to use a holistic approach for the 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 the monitoring of adverse events following immunisation,” she said.
Adeyeye added that the agency will be using its recently launched Med Safety App for active pharmacovigilance of the vaccines in collaboration with sister agencies.

According to her, 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 stated.
In addition, NAFDAC plans to 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 and create a reliable and predictable supply chain, she said.

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