The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the emergency use of Astrazeneca’s Coronavirus vaccine in Nigeria, it’s Director-General, Prof. Mojisola Adeyeye, said on Thursday.
Recall that the Astrazeneca vaccine was recently approved by the World Health Organisation (WHO) for emergency use to curtail the spread of COVID-19.
Adeyeye said at a press conference in Abuja that NAFDAC got the dossier of the vaccine a week ago, while its safety committee went to work immediately to evaluate its safety and efficacy on Nigerians.
While affirming that the vaccine could be stored at two to eight degrees Centigrade, Adeyeye explained that there were three additional vaccines undergoing evaluation.
According to her, the evaluation of the Astrazeneca vaccine shows that it is effective against the United Kingdom variant of the virus, which has been reported in Nigeria.
The NAFDAC DG stressed that the South African variant had not been reported in Nigeria, while the agency had over 30 herbal remedies undergoing review for listing.
The text of the programme read by her was titled: ‘NAFDAC Vaccine Committee review of Astrazeneca/Oxford COVID-19 (Covishield) Vaccine (Serum Institute of India): Recommendation for emergency use authorisation’.
The document reads, “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 WHO on Monday, February 15, 2021. WHO’s emergency use listing 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.
“NAFDAC has been preparing for the COVID – 19 Vaccines and vaccination since the early phase of the pandemic – around April 2020. NAFDAC was positioned to a great extent to work online during the lockdown due to digitalisation of many of our processes and continuous improvement.
“Global meetings have been held continuously since April with focus on understanding the disease and the advent of vaccines. The DG has been meeting every other week with International Coalition of Medicine Regulatory Authorities (ICMRA) while DG and respective Directors and staff have been meeting with WHO, African Medicine Regulatory Harmonisation, WAHO and AVAREF.
“Finally, 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 recommendation for emergency use authorisation was based on rigorous scientific considerations.”
Health Minister Zweli Mkhize said on Sunday the government would await advice from scientists on how best to proceed, after disappointing results in a trial conducted by the University of the Witwatersrand.
