COVID-19: Why we’ve not approved vaccines for clinical trial -NAFDAC

* Approves conditional emergency use of test kits, PPEs, others for firms

Isola Moses | ConsumerConnect

Clarifying its position on the alleged approval or otherwise of any vaccines for the management of the deadly Coronavirus (COVID-19) pandemic in Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) says it has not approved any vaccines for clinical trial for the disease in the country.

ConsumerConnect learnt that NAFDAC’s approval for vaccines for clinical trial might not take place earlier that a year to 18 months, after all clinical trials must have been conducted in other countries.

According to the food and healthcare regulatory agency, this step will be followed by rigorous in-country assessment in line with laid down protocols to further ensure safety and efficacy.

Prof Mojisola Adeyeye, Director-General of NAFDAC, in a statement, said the agency had given what it called “conditional emergency use approval” of medical devices (COVID-19) antibody and antigen test kits, PPEs (Personal Protection Equipment), etc., to companies.

The agency stated that the approved antigen test kits could detect the COVID-19 antigen in patients with or without symptoms.

The antibody test kits (IgG/IgM) could be used in COVID-19 confirmed individuals, who could then be tested at the designated centres using the antibody kits, to confirm that they had antibodies and as such might not be infected again, NAFDAC explained.

Adeyeye stated: “National Agency for Food and Drug Administration and Control grants conditional emergency use approval of medical devices (COVID-19 Antibody and Antigen Test Kits, PPEs, etc.).

“The National Agency for Food and Drug Administration and Control, pursuant to the powers conferred on it by Section 5 of the NAFDAC Act to regulate and control the manufacture, importation, exportation distribution sale, use and advertisement of medical devices has taken some regulatory steps in the fight against COVID-19.

“The 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.[do_widget id=heateor_sss_sharing-2]