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

irector General of NAFDAC, Prof. Mojisola Adeyeye
  • FG sends fresh teams to Lagos, Kano
  • 184 new cases, six deaths bring tally to 4,971 with 1,070 discharged, 164 dead


Martins Ifijeh in Lagos, Onyebuchi Ezigbo, Alex Enumah in Abuja, and Victor Ogunje in Ado Ekiti

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.

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.”

NHRC Releases Mechanism for Protection of Patients’ Rights

The NHRC has introduced measures to enhance the protection of the rights of patients.
The move was occasioned by the alleged incessant violations of the rights of patients in treatment centres in some parts of the country.

The Executive Secretary of the NHRC, Mr. Tony Ojukwu, at a press conference in Abuja, blamed protests and abscondment by patients on alleged violations of their rights in some treatment centres.

The guidelines, according to Ojukwu, are to ensure that the basic rights of patients are guaranteed and protected.
While commending government and health authorities at federal and state levels for the efforts already made to put facilities in place at the centres as well as other palliatives, he urged them to “study and put a mechanism in place to implement the standard minimum guidelines.”

The NHRC boss also noted that patients whose rights have been violated will have the option of seeking redress before the commission or in court.

Ojukwu said the guidelines were issued in line with the mandate of the commission to protect and promote human rights in accordance with its establishment Act.

He said Section 5(1) of the National Human Rights Commission (Amendment) Act 2010 mandated the commission to “prepare and publish, in such manner as the commission considers appropriate, guidelines for the avoidance of acts or practices with respect to the function and powers of the commission under this Act.”

According to Ojukwu, “persons who have tested positive to COVID-19 and placed in treatment centres are in extremely vulnerable situations and their human rights to life, health and personal dignity should be of paramount concern and a major responsibility of the state.

“The guidelines have been designed to reflect the physical, emotional and mental needs of COVID-19 patients and have provided a basis for the protection of the rights of every patient without any form of bias or discrimination, including vulnerable persons such as children, persons with disabilities and older persons.”

Other major highlights of the guidelines are the protection of medical personnel and staff of the treatment centres, persons in intensive care units and participation of patients in clinical or during trials.

111 Residents Test Negative in Kogi, Says State Govt

The Kogi State Government has said it tested 111 residents for COVID-19 but that the tests returned negative.
TheCable quoted the state Commissioner of Information and Communication, Mr. Kingsley Fanwo, as saying that the tests were conducted using guidelines of Nigeria Centre for Disease Control (NCDC).

He said the state procured about 5,000 testing kits and the tested residents were randomly selected.

“Kogi State got testing kits independently but followed NCDC guidelines. One hundred and eleven COVID-19 rapid tests were conducted in Kogi State yesterday and all results came out negative.

”We brought in about 5,000 testing kits. Testing centres are located in three places. You can do it at the Ministry of Health.
“We shall not go to streets to pick people to be tested for COVID-19, but hospitals where people with similar symptoms are found and also based on any information of suspected cases.”

Kogi and Cross River are the two states yet to confirm a single case of the disease.

Lagos Discharges 26 More Patients

The Lagos State Government has discharged 26 more patients from its isolation centres, bringing to 528 the total number of successfully treated persons in the state.

According to the state Governor, Mr. Babajide Sanwo-Olu, 13 of the patients are females and the other 13 males.
He said: “Six of the patients were from Mainland Infectious Disease Hospital, Yaba, 11 from Onikan and nine from the Lagos University Teaching Hospital (LUTH) isolation centres.

“They tested negative twice consecutively to COVID-19. With this, the number of patients successfully managed and discharged in Lagos has risen to 528.”

Lagos Subjects Fresh Lockdown to Online Vote

The state government has also launched online voting for people to decide whether or not it should reintroduce lockdown in the state.

It said the decision was informed by the disregard for social distancing and other guidelines issued by the NCDC and health experts.

Commissioner for Information, Lagos State, Mr. Gbenga Omotoso, told THISDAY that the state would make its decision on reversing the lockdown relaxation based on experts’ advice and recommendations from residents.

The online poll, organised by the Ministry of Health on its Twitter handle, gave residents until tomorrow to vote in any of its three categories – Lockdown, Don’t Lockdown and Neutral.

The health ministry said: “Considering the level of compliance with government’s directives on limiting the spread of COVID-19 in Lagos State, should the government impose another lockdown or not?”

So far, 63,299 Twitter users have voted in the poll with 50 per cent calling for the reversal of lockdown relaxation, while 39 per cent do not want another lockdown. Eleven per cent voted neutral.

In an interview with THISDAY, Omotoso said the state was going into another phase of the COVID-19 intervention, which includes home care, adding that a lockdown would not be totally out of place to achieve it.

He said: “Lagos is not one that will do things anyhow. The decision lies with the public, and we will follow expert advice. If experts in the Ministry of Health in their wisdom feel we should do a lockdown for us to halt this spread, then we will do it.
“I think if the lockdown will come, it will help us prepare for a new stage in tackling the disease. The new stage of care will involve personnel entering communities, movement of logistics, among others.”

He added that any decision taken by the government will be for the interest of the public.


Ekiti to Start Random Testing for Residents

Also, to avert the community spread of the pandemic, the Ekiti State government will next week begin random testing for residents.

The government also restated its commitment not to allow security agencies enforcing the lockdown to infringe on the rights of suspected offenders.

The Commissioner for Health, Dr. Mojisola Yaya-Kolade, spoke in Ado Ekiti, yesterday while giving an update on the pandemic in the state.

The commissioner added that all the claims by institutions that they have produced a herbal cure for the virus must be scrutinised and made to pass through medical screening before approval.

She said the random testing, which will be done across the 16 local government areas, must be undertaken in view of the geometric increase in a number of victims.

He said it would not be done by coercion, but through sensitisation and volition.
Yaya-Kolade stated that the state would soon set up a molecular laboratory to boost its testing capacity, so that many people can know their status and be aware of their safety.


FG Sends Special Teams to Lagos, Kano

The federal government yesterday sent a team to the two epicentres of the pandemic, Lagos and Kano, to help encourage the frontline health workers in their intervention to contain the spread of the virus.

A source at the Federal Ministry of Health told THISDAY yesterday that President Muhammadu Buhari had asked the presidential task force to immediately send a tripartite team comprising representatives of the Ministry of Health, Ministry of Labour and Employment, Nigerian Medical Association (NMA) and National Association of Resident Doctors to visit Lagos and Kano States as a way of showing the federal government’s support and concern for the difficult challenges facing the health workers.

Minister of Labour and Employment, Senator Chris Ngige, also confirmed the development to THISDAY, saying he was represented in the team by the Director of Occupational Health in his ministry.


NCDC to Issue New Testing Guidelines

Meanwhile, NCDC has reviewed its testing strategy for COVID-19 regarding the management of confirmed cases and will soon issue the guidelines.

The new strategy may require patients to be discharged after testing negative once for the disease, unlike the present case where patients test negative twice before discharge.

TheCable quoted the spokesman of NCDC, Mr. Emeka Oguanuo, as saying that the agency will soon publish the new guidelines with further details.


Pandemic May Never Go Away, Says WHO

Despite all the global efforts to find a cure for the novel virus disease, the World Health Organisation (WHO) has said the virus may never go away.

Executive Director of WHO’s Emergencies Programme, Mr. Mike Ryan, said the virus might just become one of the viruses around the world that kill people annually.

“This virus just may become another endemic virus in our communities and this virus may never go away. HIV hasn’t gone away.
“We’ve come to terms with the virus and we have found the therapies and we have found the prevention methods, and people don’t feel as scared as they did before.

“There are no promises in this and there are no dates,” Ryan said yesterday.
According to him, an early discovery of vaccine is the only way out.

“We may have a shot at eliminating this virus but that vaccine will have to be available; it will have to be highly effective; it will have to be made available to everyone and we’ll have to use it.

“I’m not comparing the two diseases but I think it is important that we’re realistic. I don’t think anyone can predict when or if this disease will disappear.

“This disease may settle into a long-term problem or it may not be,” he added.