The National Agency for Food and Drug Administration and Control (NAFDAC) has explained that it has not approved any vaccine for clinical trials to combat the coronavirus (COVID-19) pandemic in the country.
Clearing the air on the rumours that clinical trials of COVID-19 vaccine will soon begin in African countries, including Nigeria, the agency stressed that before any clinical trial begins in the country, it must have been conducted in different countries, which may not happen before one year to eighteen months.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, made this known in statement in Abuja on Thursday.
According to her, “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”.
She further disclosed that NAFDAC has granted conditional emergency use approval of medical devices (COVID-19 Antibody and Antigen Test Kits, PPEs, etc.) to diagnostic companies.
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According to her, “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 centres 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”.
The NAFDAC boss further explained that regulatory measures have been put in place to ensure quality, safety and efficacy criteria are assessed. These measures are: “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 evaluation /Clinical Evaluation Report”.
“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.
“NAFDAC has reduced the ‘registration to approval’ time from 120 working days to 10 working days due to the COVID-19 pandemic. Thus far, the Agency has processed seventeen (17) applications using the expedited review process but has only granted Emergency approval to seven (7) companies using the criteria listed above,” she added.