NAFDAC okays conditional emergency use for test kits
• Academies of Science seeks greater international cooperation
• Nigeria, others can screen more people as WHO lists diagnostics for emergency use
The National Agency for Food, Drug Administration and Control (NAFDAC) has granted conditional emergency use approval of medical devices for COVID-19 antibody, as well as antigen test kits to manufacturing companies and importers of such devices.
It explained that the test kits (IgG/IgM) could be used on COVID-19 confirmed individuals, who could then be tested at designated centres to confirm that they have anti-bodies and as such may not be infected again.
The agency added that the antigen tests kits could also detect the COVID-19 antigen in patients with or without symptoms and that the results could only be positive or negative.
NAFDAC, however, cautioned that no vaccines have been approved for any clinical trial and that it might not happen between a year and 18 months, after clinical trials must have been conducted in different countries, followed by rigorous in-country assessment in line with laid down protocols to further ensure safety and efficacy.
Director General of NAFDAC, Professor Mojisola Adeyeye, who disclosed this in Abuja, noted that the COVID-19 pandemic necessitated that the agency put measures in place to ensure access to health commodities that have the potential to impact positively on public health outcomes.
In a related development, the G-Science Academies of Science and Medicine from across the globe, including academies of the G-7 countries have advocated greater international cooperation to contain coronavirus.
The 15 Academies of Sciences and Medicine made the clarification in a joint statement issued by Executive Secretary, Nigerian Academy of Science (NAS) and Chair, INGSA-Africa (Science Academies in Africa), Dr. M. Oladoyin Odubanjo.
Among other demands, they canvassed rapid, accurate and transparent international communication about the unfolding epidemiology of the disease, including patterns of transmission, incubation period, its lethal nature and the efficiency of the various intervention methods.
Meanwhile, Nigeria and other countries including the United States (U.S.) could now test more people for COVID-19) as the World Health Organisation (WHO) has listed the first two diagnostic tests for emergency use during the pandemic.
In a statement yesterday, the WHO said the decision was part of efforts to increase countries’ capacities to test more people for COVID-19 and access to quality-assured, accurate tests for the disease.
The United Nations agency said the move should help increase access to quality-assured, accurate tests for the disease. It also means that the tests can now be supplied by the United Nations and other procurement agencies supporting the COVID-19 response.
Minister of Health, Dr. Osagie Ehanire, and the Director General (DG) of the Nigeria Centre for Disease Control (NCDC) had told The Guardian that results from rapid kit tests could not be validated and the country was working to improve its capacity to test more people.