Health

COVID-19 Vaccine: NAFDAC, Experts Disagree Over Clinical Trial

Published

3 years ago

January 3, 2021

The National Agency for Food and Drug Administration and Control (NAFDAC) and some virologists and infectious disease experts have disagreed over conducting a local clinical trial for the proposed N400bn COVID-19 vaccines before administering them on Nigerians.

A clinical trial, according to the WHO, is a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.

While NAFDAC has ruled out the possibility of conducting a local clinical trial of the vaccine, virologists and infectious disease experts are insisting that there is a need to conduct a clinical trial on the vaccines in the country before administering it on Nigerians.

The agency said since the World Health Organisation (WHO( had approved the vaccines there might not be need to conduct another clinical trial on the vaccines.

Speaking on the vaccines, NAFDAC’s Media Consultant, Sayo Akintola, said that owing to the exigencies of COVID-19, there may be no reason to conduct a trial before administering the vaccines.

“Once the vaccine arrives, a sample will be taken to the lab for a test. Once its safety and efficacy are certified by NAFDAC, it will be administered on Nigerians. We don’t expect anything to be different though.

“The truth is that once a vaccine is approved by the WHO, it is assumed that it has passed through some preliminary stage of the trial. It is a known fact that for the WHO to sanction a vaccine, it must have gone through a series of trial here and there,” he said.

Although he said NAFDAC’s evaluation of the vaccine would not be rigorous mainly because it’s not a new vaccine, Akintola noted that its efficacy and safety needed to be ratified.

He stated, “It is just for ratification. There is nothing on drugs or vaccines you will do without the consent of WHO. It is also expected that the regulatory body in each country would do its work in tandem with the WHO standard.”

However, a medical virologist at the Adeleke University, Ede, Osun State, Dr Elijah Kolawole, said it would be safer to conduct a mini clinical trial to determine the efficacy of the vaccine before rushing to administer it on a population of over 206 million.

He said, “This is because there is no evidence to show the earlier trial conducted in Europe had African volunteers. There is something we need to understand. In terms of human genetics, African-Americans are different and cannot be used to represent Africans in a trial.

“They could be similar but they cannot be regarded as a proper representation of Africans. That’s why you see a lot of differences in the way we respond to treatments based on our genetic make-up.”

On his part, a medical microbiologist at the Lagos State University, Prof Bola Oyefolu, said there was the need to conduct a clinical trial before administering the vaccines on Nigerians.

“Before any vaccine is given, there is a standard procedure for it. Before you can inject people with any vaccine, it must have gone through serious clinical trials, and when you look at the duration for that, it will take an average of three years.

“The clinical trial will prevent mortality; there is the need for more time to do a more open clinical trial to be sure that what we are giving to the people is safe.”

He also cautioned the Federal Government against procuring COVID-19 vaccines from abroad.

He said, “From the virological point of view, I don’t think Nigeria should go for the vaccines because everything is shrouded; it is not open. I’m just wondering why they are not doing clinical trials with their own people over there? Why must it be Africans? Are we guinea pigs? Unfortunately, most African leaders won’t look into the core of it; they will just go for the vaccines, maybe for the monetary gain.”

He added, “Once this vaccine is administered and it gives us a negative result, it can’t be reversed and that will be an indictment on the scientists in Africa.”

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Health

AUTISM: What You Need To Know

Published

3 weeks ago

April 6, 2024

Editor

By Silver Yeibake

Autism, commonly known as Autism Spectrum Disorder (ASD), is a neurodevelopmental disorder that affects communication, social interaction, and behavior. Autism is referred to as a spectrum condition since it can manifest in a variety of symptoms and abilities. While the actual cause of autism is unknown, evidence suggests that genetic and environmental factors interact to influence its development.

The risk factors include a sibling with autism, advanced age of parents, exposure to certain air pollutants and pesticides before birth, extreme prematurity, mothers with diabetes, immune system disorders or obesity, any difficulty with delivery leading to deprivation of oxygen to the baby’s brain, fever during pregnancy, lack of certain vitamins minerals during pregnancy, and certain genetic conditions, such as Down, fragile X, and Rett syndromes.

“Risk factors can not on their own cause a disease. However, they can increase the likelihood of that disease in a person.”

It is important to know that contrary to trending claims online, there is no scientific or medical evidence that vaccines or consumption of sugar are risk factors for autism.

Autism is defined by difficulties in social interaction and communication. Individuals with autism may struggle to grasp social cues, maintain eye contact, and engage in typical back-and-forth conversations. Some people may also engage in meaningless, repetitive actions, such as hand-flapping or rocking, and have strong interests in specific areas.

It is essential to remember that autism is a lifelong diagnosis, but with early intervention and adequate care, people with autism can live fulfilling lives.
Autism treatment frequently includes behavioral therapy, speech therapy, occupational therapy, and social skills training. Each individual with autism is unique, thus interventions should be tailored to meet their personal needs and strengths.

In spite of the difficulties that autism can cause, many people with autism possess unique talents and abilities. Some people may succeed in fields such as music, art, mathematics, or programming, thus it is important for society to acknowledge and honor the qualities and achievements of people with autism.

In summary, autism is a complicated and diverse disorder that affects individuals in various ways. By raising autism knowledge, understanding, and acceptance, we can build a more inclusive society in which people with autism can thrive and attain their full potential.

Dr. Yeibake, Weriwoyingipre Silver.
Senior Registrar,
Faculty Of Pediatrics,
WACP

Health

Don Confirms ‘Zobo’ As Antihypertensive Therapy

Published

1 month ago

March 10, 2024

Editor

The Deputy Vice Chancellor, University of Nigeria Enugu Campus, UNEC, Prof. Daniel Nwachukwu, after research findings and clinical trials in both animals and human, has confirmed that Hibiscus Sabdariffa, popularly called ‘zobo’ drinks, has all the curative potentials as an antihypertensive therapy.

Nwachukwu, who is a Professor of Cardiovascular Physiology in the university, stated that the antihypertensive effectiveness of the Hibiscus Sabdariffa (zobo) was comparable to those of known antihypertensive drugs that are popular in the retail pharmacies, adding that zobo’s availability, cheapness and absence of side effects make it attractive as an alternative therapeutic agent in mind to moderate hypertensive subjects.

He however cautioned that care should be applied to avoid abuse in the consumption of Hibiscus Sabdariffa (zobo), adding that the therapy could interfere with some anti-malaria drugs while its high dose was also reported to have toxic effects on the liver and kidney.

Nwachukwu’s discoveries were contained his 201st Inaugural Lecture of the University of Nigeria with the topic “The Marriage Between the Cardiovascular System and Hibiscus Sabariffa: Let no One Put Asunder,” delivered at the moot court hall, Law faculty of the University of Nigeria, Enugu campus.

The DVC warned that Hibiscus Sabariffa consumption is not recommended for persons with low blood pressure because of its well established hypotensive action, advising that during combined therapy with antihypertensive drugs, the blood pressure, BP, must be carefully monitored.

He recommended that industrialists and investors should support large scale production of Hibiscus Sabariffa beverage and its distribution to rural communities in Nigeria, particularly since the raw materials (Hibiscus Sabariffa calyx and water) are cheap and readily available.

According to Nwachukwu, “This lecture is intended to draw the public attention to our research efforts and unveiling the antihypertensive ability of Hibiscus Sabariffa which is called zobo in our common parlance. What we used for our studies was the same concentration as the locally produced zobo, and we found out that it exerted significant antihypertensive ability, in some cases even higher than the antihypertensive drugs and also did combination therapy with other antihypertensive drugs.

“What is significant is that this zobo is within us, it’s very cheap and it does not have any side effects compared to other antihypertensive agents. The raw material is just to buy zobo, prepare it under hygienic conditions, boil water and put it, sieve it and drink. It may have a sour taste but we do not encourage people to add things like pineapple or sugar in order to make it sweet, because once you do that, you are diluting or reducing its antihypertensive effectiveness.

“We have demonstrated it, both in animal studies and in humans. We are the first to do clinical trials, using mild to moderate antihypertensive Nigerians and we found it very useful. Some of the results show that one can actually use it and we equally saw that you can use it to prevent even diabetes from occurring because it reduces the rise in glucose level.”

Vice Chancellor of the University, Professor Charles Igwe while summarizing the lecture said that the lecture was in three dimensions; one on health grounds, another in academics and the third an economic value.

“Its economic in the sense that we can also begin to use what God has given us to make money. Maybe because God gave us everything in abundance in this country, we don’t recognize the simplest things God gave us in our environment. Therefore, what we are saying is that we should begin to, at all these pure water productions and incorporate zobo production so as to make money out of it.

“The university has made its contribution through our laboratories and it’s now left for the business community and the industries to come and buy into it and start widening it and make it very economic,” Igwe suggested.
Vanguard

Health

Glaucoma: What You Need To Know

Published

2 months ago

March 8, 2024

Editor

By Silver Yeibake

Hi, did you know that Tuesday 12th March, 2024 is world Glaucoma day?Kindly avail yourself of this opportunity to learn about this important health issue as presented below:

Glaucoma is a dangerous eye disorder that damages the optic nerve, causing visual impairment or permanent blindness if not treated.
The optic nerve transmits visual information from the eye to the brain. Damage to this nerve might cause gradual visual loss that is not immediately obvious.

Worldwide, this disease affects 67 million people and contributes 6.7 million of blindness in this population. Glaucoma is the leading cause of blindness in the world.
The total number of cases is expected to increase to 111 million by 2040. Males are slightly more affected than females.

One of the basic causes of glaucoma is an increase in intraocular pressure (pressure within the eyeball), which can eventually damage the optic nerve (the nerve that makes seeing possible). This increase in pressure could be caused by an accumulation of aqueous humor, the fluid that nourishes the eye.

FROM THE AUTHOR: Food Poisoning: What You Need To Know

There are several forms of glaucoma, including open-angle glaucoma, angle-closure glaucoma, normal-tension glaucoma, and secondary glaucoma, each with unique characteristics and treatment choices.

Some of the risk factors for glaucoma include sustained elevation of intraocular pressure, family history of glaucoma, race (African, Asian), short-sightedness, long-sightedness, age over 50, previous eye injury or surgery, hypertension, diabetes mellitus, migraines, and prolonged steroid therapy.

Glaucoma symptoms may not appear until the problem has advanced sufficiently, therefore regular eye checks are essential for early detection. Blurred vision, eye pain, nausea, and light halos are some of the most frequent glaucoma symptoms. However, these symptoms might be mild or readily misinterpreted as other eye problems, emphasizing the significance of regular eye examinations.

Glaucoma treatment tries to reduce intraocular pressure and protect the optic nerve from further damage. This can be accomplished using a variety of approaches, including prescription eye drops, oral medicines, laser therapy, and surgical procedures. Treatment options are determined on the kind and severity of glaucoma, as well as personal characteristics such as overall health and medical history.

To summarize, glaucoma is a serious eye disorder that requires timely diagnosis and treatment to prevent irreversible vision loss. Regular eye examinations, early detection, and commitment to treatment plans are critical for protecting vision and eye health in glaucoma patients.
Thank you.

Dr. Yeibake, Weriwoyingipre Silver, a
Senior Registrar, Faculty Of Pediatrics, West Africa College of Physician (WACP), writes from Yenagoa, Bayelsa State.