COVID-19 Vaccine: No One Has Applied for Approval, Says NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC) has said that despite Nigeria’s earnest search for a cure for COVID-19, it is yet to receive any pharmaceutical or herbal drugs for analysis of their efficacy as a prelude to their approval for treatment of the disease.

The National Human Rights Commission (NHRC) has also introduced measures to enhance the protection of the rights of patients of the pandemic.

The virus, however, infected 184 and killed six more persons wednesday, bringing the tally to 4,971 cases, 1,070 discharged and 164 deaths.

Announcing this last night, the Nigeria Centre for Disease Control (NCDC) said Lagos recorded 51 new cases, Jigawa 23, Bauchi and Katsina 16 each, Kano 10, Federal Capital Territory (FCT) and Rivers 10 each, Kwara nine, Delta and Kaduna five each, Sokoto and Oyo four each, Kebbi, Nasarawa and Osun three each, Ondo two, while Ebonyi, Edo, Enugu, Anambra, Plateau and Niger one each.

On the search for a cure, NAFDAC explained yesterday that it was still awaiting the local cure for COVID-19 reportedly submitted by the Complementary and Alternative Medicine Department of the Federal Ministry of Health to the agency for evaluation.

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The Presidential Task Force (PTF) on COVID-19 had last Thursday said some of the claims for COVID-19 cure that met preliminary requirements had been submitted to NAFDAC for evaluation and listing.

But in a statement yesterday, the Director-General, NAFDAC, Prof. Mojisola Adeyeye, said claims for the cure of COVID-19 in Nigeria must be domiciled only in either the conventional news media or social media.

She said: “NAFDAC as at the time of this press release has only received an application from one company for a product, the company is presenting for approval to the agency for the treatment of the symptoms of COVID-19, and not for the cure of COVID-19 as a disease.

“A claim of a cure must be subjected to clinical evaluation through well-controlled, randomised clinical trials following an approved clinical trial protocol.”

According to her, because no vaccine yet exists to prevent further spread of the virus, it behoves the medical world to develop a cure or at best, a treatment for the deadly virus.

She added: “In a bid to discover a cure, therefore, the public has witnessed quite a number of claims from different quotas – complementary and alternative medicines practitioners, traditional healers and academia.

“It is pertinent to note, however, that these claims are domiciled in either the conventional news media or social media.

“That Africa as a continent is blessed with diverse plants and herbs that constitute a source of food and medicine is incontrovertible. The drugs of today’s modern society are products of research and development by major pharmaceutical companies. Among the most important raw materials researched and developed are naturally occurring materials obtained especially from plants.

“It should be mentioned also, however, that many plants are similarly very poisonous. As the agency that has been saddled with the mandate of safeguarding the health of the citizenry, NAFDAC will continue to make sure that only medicinal product, including herbal remedies that have proven safety data will be approved for use by the public.”

She added that presently, the agency lists herbal medicines based on a historical perspective on the use of the products after carrying out toxicological and microbiological evaluations in the laboratories to ensure that they are, at the minimum, safe. The listing status is valid for two years and is renewable.

“It does not validate the efficacy claims being for the products hence, the labels must bear a disclaimer informing the consumer ‘The claims have not been evaluated by NAFDAC.’ This minimum requirement of ‘proof of safety’ is the agency’s way of encouraging the production of herbal remedies from the country’s rich diversity of plants.

“Part of the efforts to advance herbal products development informed the setting up of the Nigerian Herbal Medicine Product Committee (HMPC). The platform brings together manufacturers, academia, researchers and relevant stakeholders by bridging the gap often created between traditional medicine practitioners (possible patent holders) and drug manufacturers, whose responsibility it would be to formulate the products.”

THisday

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