The National Agency for Food and Drug Administration and Control (NAFDAC) has clarified that it had not approved any vaccine for clinical trial in Nigeria.
Clinical trials for any vaccine including Covid-19, she said, can only take place in Nigeria if it has been done in other countries.
This is contrary to the rumours making the rounds that the clinical trial of Covid-19 vaccine will soon commence in African countries including Nigeria.
The Director General of NAFDAC, Mojisola Adeyeye, made the clarification in a statement in Abuja, Thursday.
She further disclosed that her agency has granted what she described as conditional and emergency use of medical devices including Personal Protective Equipment (PPEs), antibody and antigen test kits used in the fight against Covid-19 to diagnostic companies.
“Please note, no vaccines have been approved for any clinical trial.
“That may not happen before one year to eighteen months, after clinical trials must have been conducted in different countries.
“This will be followed by rigorous in-country assessment in line with laid down protocols to further ensure safety and efficacy.”
Speaking further on the conditional emergency approval to diagnostic companies, the NAFDAC DG said: “The current COVID-19 pandemic has necessitated that NAFDAC put measures in place to ensure access to health commodities that have the potential to impact positively on public health outcomes.
“These include, but are not limited to, diagnostics necessary to support public health infrastructure and guide the response necessary to combat and address the pandemic.
“The antibody test kits (IgG/IgM) can be used in COVID-19 confirmed individuals who can then be tested at the designated centers using the antibody kits to confirm that they have antibodies and as such may not be infected again.
“The antigen tests kits on the other hand, can detect the COVID-19 antigen in patients with or without symptoms. The results are only qualitative (positive or negative)
“There has been a global effort by innovative diagnostic companies to develop test kits to aid in detection of the virus in patients to guide the management of the disease.
“The Agency has recently received many requests for Emergency Use Authorization for some of such diagnostic test kits to support the national response and ensure expanded testing capabilities.”
Despite the conditional emergency approval, she said, NAFDAC has put in place regulatory measures to ensure that quality, safety and efficacy criteria are assessed.
These measures, according to her, are supported by documentation which include, “prior registration and approval by reference regulatory authorities such as those of Japan, USA, Germany, Canada, European Medicine Agency, etc.
“Registration by the Regulatory Authority in the Country of Manufacture; declaration of conformity and validation/ performance valuation / Clinical Evaluation Report.”
She maintained that: “In addition to these requirements, the full approval of any diagnostic/test kit by NAFDAC for COVID-19 will be subject to in-country validation to assess the sensitivity or rate of failure (i.e., indication of false positives), and specificity.
“Failure to comply could lead to revocation of any approval granted for importation of the products and forfeiture of same to the agency for destruction.”
