Nigeria’s food and drug regulatory agency, NAFDAC, has approved the
Oxford AstraZeneca COVID-19 vaccine for use in Nigeria.
NAFDAC boss, Prof. Mojisola Adeyeye, announced the approval at a news
conference in Abuja.
She said that the NAFDAC Vaccine Committee commenced expedited review
immediately the agency received the Oxford AstraZeneca COVID-19 vaccine
dossier from Serum Institute of India on February 10.
She explained that the recommendation for the emergency use
authorisation was based on rigorous scientific consideration.
Mrs. Adeyeye noted that “the vaccine can be stored at two to
eight-degree centigrade temperature.
“The active substance is manufactured and controlled by Serum Institute
of India Private Limited (SIIPL). A GMP certificate and
a manufacturing licence 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 to 8 degree
centigrade, one dose (0.5Ml) contains 5 x10) virus particles. On
availability stability, the applicant has proposed a drug product shelf
life of six months.
“On vaccine safety from the phases two and three conducted, COVISHIELD
was found safe and well-tolerated in adults above 18 years of age,” she
said.
Mrs. Adeyeye said that the focus was to use holistic approach for
effective immunisation, including delivery of the vaccines and
monitoring of any adverse
effects.
She added that the multi-stakeholders technical working group had been
meeting to address different issues, noting that the agency would use
its recently launched Med Safety App for Active Pharmacovigilance of the
vaccine.
The director general, who added that NAFDAC would collaborate with
sister agencies on the task ahead, explained that “the App is free and
can be downloaded by healthcare workers to monitor Adverse Drug Reaction
(ADR).”
She said three additional vaccines were currently undergoing evaluation,
“but the evaluation on AstraZeneca shows that the vaccine is effective
against the UK variant of the virus, which has been reported in
Nigeria.”
According to her, the South African variant has not been reported in
Nigeria and that the agency has over 30 herbal medicines undergoing
review for listing.
“The Oxford AstraZeneca vaccine, also known as ChAdOx1 nCoV-`9, or
AZD1222, is a viral vector vaccine. Scientists used an adenovirus,
originally derived from chimpanzees, and modified it with the aim of
training the immune system to mount a strong response against SARS-CoV-2
(the virus that causes COVID-19).
“Nigeria is expected to get the first batch of the COVID-19 vaccines by
the end of February.
(NAN)