Category: Health and Environment

Flowerbudnews

By Aderogba George
Abuja: The National Agency for Food and Drug Administration and Control (NAFDAC) said it has granted approval to Serum Institute Pvt. Ltd. (SIIPL) R21 malaria vaccine for
the treatment of malaria in Nigeria.

The Director-General, Prof. Mojisola Adeyeye, said this at a news conference on Monday in Abuja.

She said that the granting of registration/approval was in line with the agency’s mandate as stipulated
by its enabling law — NAFDAC Act CapN1, Law of the Federation of Nigeria (LFN) 2004.

Adeyeye said that it became necessary to grant approval for the vaccine following the 2021 World Malaria Report that Nigeria had the highest number of global malaria cases of 27 per cent.

She said the highest number of deaths stood at 32 per cent of global malaria deaths in 2020, adding that Nigeria accounted for an estimated 55.2 per cent of malaria cases in West Africa in 2020.

“Malaria is one of the most important public health concerns in the world, the latest World Health Organisation (WHO)
Malaria Report shows there were 247 million cases of malaria in 2021 compared to 245 million cases in 2020.’’

She explained that the estimated number of malaria deaths stood at 619000 in 2021 compared to 625000 in 2020.

“Over the two peak years of the pandemic (2020–2021), COVID-related disruptions led to about 13 million more malaria
cases and 63000 more malaria deaths.

“The WHO African Region continues to carry a disproportionately high share of the global malaria burden. In 2021 the
region was home to about 95 per cent of all malaria cases and 96 per cent of deaths.

“Children under five years of age accounted for about 80 per cent of all malaria deaths in the region. Four African countries
accounted for just over half of all malaria deaths worldwide, with Nigeria; 31.3 per cent, the Democratic Republic of the Congo;
12.6 per cent, United Republic of Tanzania; 4.1 per cent and Niger; 3.9 per cent respectively.

“Malaria is transmitted throughout Nigeria, with 97 per cent of the population at risk. The duration of the transmission
season ranges from year-round transmission in the south to three months or less in the north,’’ she stressed.

She said that the Marketing Authorisation Holder’s (MAHs) for the vaccine is Fidson Healthcare Ltd,
which had the agency’s Drug and Related Products Registration Regulation 2021.

According to Adeyeye, the R21 malaria vaccine is an adjuvanted protein vaccine presented as a sterile solution.

She explained that “a dose, which is 0.5ml, is composed of R21 Malaria antigen 5µg and Matrix-M1 50µg as an
adjuvant filled in a vial as ready to use liquid formulation for intramuscular injection.’’

She said that the vaccine is indicated for prevention of clinical malaria in children from five months to 36 months
of age, adding that the storage temperature of the vaccine is 2-8 °C.

The NAFDAC boss said the agency had several pathways for registration of vaccines, in line with the agency’s guideline
for registration of Imported Drugs, Vaccines and IVDs under Collaborative Registration Procedure.

Adeyeye said the agency received the dossier of the R21 Malaria manufactured by SIIPL and subjected it
to independent review at two different levels.

She added that as a matured regulatory agency, it is expected as part of global benchmarking that external advisory
committee was put in place to give advise upon invitation on certain functions of the agency.

She said that as a new biological molecule being given consideration for full registration, the independent review
by an external body became imperative to further safeguard public health.

The external advisory body known as NAFDAC’s Vaccine Advisory Committee (NEVAC) is made up of four highly
recognised, well-published experts from Nigeria’s tertiary institutions, she said.

She listed the institutions where the advisory body members were selected as Nnamdi Azikwe University, Awka, Anambra State; University of Lagos, Lagos State, University of Ibadan, Oyo State and Usman Dan Fodio University, Sokoto, Sokoto State.

Adeyeye said that the agency also had in-house Vaccine Review Committee (NEVAC) extracted from different directorates of NAFDAC
to oversee, evaluate, as well as carry out clinical trials on vaccine before approval was made.

She said that the dossier was reviewed using WHO standard across relevant domains, in addition to the European Medicines
Agency guidelines (where appropriate), scientific rigor on the vaccine.

According to her, the review of NAFDAC’s committee has always been guided by the same international standards and best
practices with the same modality of independent review by members.

“This is followed by long hours of plenary where rigorous assessment of each review took place.’’

She said that the committee also independently scored the assessment as satisfactory, which was then forwarded to the director-general and that upon submission of the reviews of both committees, the NAFDAC boss called for a joint review session on April 14.

Adeyeye said that the joint review process provided the opportunity to harmonise the assessments, the outcomes of the reviews were discussed, and the recommendations and queries/clarifications were consolidated to be referred to the
manufacturers.

She said that the R21 Malaria Vaccine dossier complied substantially with best international standards with which the dossier was benched-marked.

She added that the Joint Review Committee concluded that the data on the R21 malaria vaccine were robust and met criteria for efficacy, safety and quality. (NAN)(www.nannews.ng)/Flowerbudnews

By Biola Lawal

Abuja: (Flowerbudnews) The Director-General of the National Agency for Food and Drugs Administration and Control (NAFDAC), Prof Moji Adeyeye has warned Nigerians against use of a suspected cough syrup, NATURCOLD said to have caused death of six children in Cameroon.

Prof. Adeyeye gave the warning in a NAFDAC public alert entitled: Alert on Killer Cough Syrup Manufactured by Fraken in Cameroon, detailing dangers of the suspected substandard drug as made available by the Cameroonian Ministry of Health.

The NAFDAC Boss disclosed that the suspected substandard product, which is said to be manufactured by Fraken Group was believed to have caused the deaths of six children under the age of five at a health facility in the health district of Fundong in North-West region of Cameroon.

Prof. Adeyeye said: The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public that the Ministry of Public Health in Cameroon has issued an alert regarding a suspected substandard cough syrup named NATURCOLD .

According to the North-West Regional of Cameroon delegate for Public Health, the children showed a decrease in kidney function after consuming the suspected substandard cough syrup.

The product is not authorized for marketing in Cameroon and was purchased from unauthorized sources.

The NAFDAC Boss stated that ‘although the product is not in NAFDAC database, importers, distributors, retailers, and consumers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the substandard (contaminated) syrups.

Prof Adeyeye urged that all medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

The NAFDAC Boss implored members of the public to desist from purchasing medicinal products from unauthorized sources such as roadside vendors and street hawkers as fake drugs are mostly smuggled into the country from neighbouring countries and distributed through such inappropriate channels,

She advised further that ”anyone in possession of the above-mentioned product is advised to discontinue sale or use and submit stock to the nearest NAFDAC office.

” If you, or someone you know, have used these products, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.

Prof Adeyeye also urged Healthcare professionals and consumers are advised to report any suspicion of sale and use of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng

She also advised: ‘:healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng   (Flowerbudnews)

The National Agency for Food and Drug Administration and Control in Nigeria said it would commence the random sampling of Indomie noodles, including the seasoning from the production facilities and the markets tomorrow (Tuesday).

NAFDAC also said the importation of Indomie noodles into Nigeria had been banned for many years and the products were on the prohibition list.

This is following the detection of a compound called ethylene oxide, a potentially cancer-causing substance in Indomie’s “special chicken” flavour noodles by health officials in Malaysia and Taiwan.

Both Malaysia and Taiwan have recalled the product.

Meanwhile, the makers of Indomie noodles, Indofod, defended the safety of its products, saying all instant noodles produced by the ICBP in Indonesia were processed in compliance with the food safety standards from the Codex Standard for Instant Noodles and standards set by the Indonesian National Agency for Drug and Food Control.

“ICBP has exported instant noodles to various countries around the world for more than 30 years.

The company continuously ensures that all of its products are in compliance with the applicable food safety regulations and guidelines in Indonesia as well as other countries where the ICBP’s instant noodles are marketed,” a press statement by Indofood read in part.

According to the National Cancer Institute, ethylene oxide is a flammable colourless gas with a sweet odour at room temperature

It is used primarily to produce other chemicals, including antifreeze. In smaller amounts, ethylene oxide is used as a pesticide and a sterilising agent. The ability of ethylene oxide to damage DNA makes it an effective sterilising agent but also accounts for its cancer-causing activity,” the institute said.

Indomie is a brand of instant noodles produced by the Indonesian company, Indofood and Nigeria is one of the biggest consumers of instant noodles.

Indomie is also exported to more than 90 countries around the world.

Meanwhile, the Director-General of NAFDAC, Prof Mojisola Adeyeye told The PUNCH on Monday that the agency has started investigating and responding immediately to the news of the recalled Indomie noodles by Taiwan and Malaysia authori

ties.

The National Agency for Food and Drug Administration and Control (NAFDAC) said on Tuesday that Noodles made in Nigeria have nothing to do with the noodles produced in Taiwan and Malaysia. The regulator also said that noodles made in Nigeria are safe for consumption.

Speaking as a guest on a popular TV show, Your View, aired on TVC television, Director-General, NAFDAC, Mojisola Adeyeye, further added that “foreign noodles have been banned from entering the country by the Nigerian government many years ago and this is on the Nigerian Customs Service importation prohibition list and this is to encourage local production of noodles and backward integration of the economy.”

NAFDAC also said it is working to ensure that foreign-made noodles are not smuggled into the country. NAFDAC Food Safety and Applied Nutrition (FSAN) organisation, has commenced post-marketing surveillance (PMS) and the Food Lab Services Directorate has also been activated on the issue.

According to the Group Corporate Communications and Event Manager, Dufil Prima Foods Plc, Tope Ashiwaju, said “Indomie Nigeria is different and a separate entity from Indomie Taiwan, and Indomie Malaysia. Indomie instant Noodles is locally produced in the country and operations have been ongoing for at least three decades. Dufil Prima has improved local capacity utilisation and has aided enhanced production to meet market demand, rather than depending on importation.”

Nigeria is a major consumer of instant noodles, with Indomie Instant Noodles dominating the market. The World Instant Noodles Association (WINA) said Nigeria is one of the largest consumers of instant noodles, with 1.92 million. The ban on the importation of instant noodles is not a recent development, as instant noodles have been on the importation prohibition list of the Federal Government for a long time.

By Abujah Racheal

Flowerbudnews

By Biola Lawal
Abuja(Flowerbudnews): NAFDAC Director-General, Prof Mojisola Adeyeye has warned Nigerians to beware of PrimeZEN Black 6000 male enhancement capsules.

Prof Adeyeye disclosed in an official alert that the product had been recalled due to the presence of life-endangering undeclared ingredients.

In the Public Alert No. 015/2023, the NAFDAC Boss informed the public that ”Volt Candy is voluntarily recalling one lot of PrimeZen Black 6000, 2000 mg capsule, to the consumer level”.

Prof Adeyeye said that the ”recall is following an FDA analysis which found PrimeZen Black 6000 capsules to contain undeclared ingredients (tadalafil and sildenafil). Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction.

”The presence of sildenafil and tadalafil in PrimeZen Black 6000 capsules renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.

PrimeZen Black 6000 capsules containing sildenafil and tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are most at risk from these products.

Product details:
The details of the product are as follows;
Product Name: PrimeZEN Black 6000 male enhancement capsules
Product Manufacturer: Volt Candy, 324 S. Diamond Bar Blvd #212, USA.
Lot Number: NPINPB 1003
UPC code: 728175521891
Expiration Date: Aug. 16, 2025

PrimeZen Black 6000 is marketed online as a dietary supplement for male enhancement and is packaged in a blister card with one capsule.

The product can be identified by the card color in black with the name on it PrimeZen Black 6000.

The NAFDAC DG implored members of the public in possession of the above product to stop the sale or use of the product and handover product to the nearest NAFDAC office.

”If you have this falsified product, please DO NOT use it. If you, or someone you know, have used the product, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional”, Prof Adeyeye counsels the public.

She urged Healthcare professionals and consumers to report any suspicion of adverse drug reaction, substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng

”Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng”, the NAFDAC DG advised.

Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng (Flowerbudnews)

By Aderogba George

The Office of the National Security Adviser on Wednesday entered into a partnership with the National Agency for Food and Drug Administration and Control to curb the use of illicit drugs across the country.

According to a statement by the Director, Strategic Communications, ONSA, Ozoya Imohimi, the National Coordinator, National Counter Terrorism Centre, ONSA, Rear Admiral Yaminu Musa (retd.), said the use of illicit drug was “fueling insecurity” in the country.

The statement read in part, “Drug is one of those foods fueling insecurity in Nigeria and the need to strengthen collaborations among relevant government’s Ministries, Departments, and Agencies, particularly, NAFDAC, to tackle this menace, must be sustained for a safe and resilient society.”

NAFDAC’s Director General, Prof. Mojisola Adeyeye, called on all Nigerians to expose those selling illicit drugs, adding that the future of many young people had been destroyed using drugs.

She promised that her agency’s continued collaboration with the NCTC in the ONSA would lead to more positive outcomes for the benefit Nigeria

The National Agency for Food and Drug Administration and Control, NAFDAC, sealed a shop in Zuba, a suburb of the Federal Capital Territory, on Thursday for allegedly selling unapproved aphrodisiacs to Nigerians.

The News Agency of Nigeria (NAN) reports that some of the aphrodisiacs are Garin Yansun, Sabon Mai-Siket, Ruwan Jaraba, Tunkude, Fenugreek powder, and Al-Khausara herbal syrup.

Bubuchiki Godiya, a member of the Federal Taskforce, Investigation, and Enforcement Directorate of NAFDAC, said that “the agency received intel that Yunusa Adamu was manufacturing unregistered herbal preparation.

Godiya said that the agency sent some of its team members to investigate, and on arrival, they found that there were many unregistered herbal drugs.

According to him, even though Adamu gave the invoice for some of the products to the team, he still denied producing any drugs.

We will investigate for more evidence; the shop has more than 15 different varieties of products. Many of them have pornographic pictures, which are not acceptable, and the agency cannot register a drug or any product with pornographic pictures.

“The drugs are all over the shop; that is why we have evacuated as much as we can, and we are still going to seal the place until we conclude our investigation. We will go with the suspect in order to record his statement and investigate more to know our next line of action,” Godiya said.

He said that the agency’s standard of procedure would be to investigate the suspect.

Samples would be taken to the laboratory for analysis, and with the result, the agency would know the way forward, he said.

On his part, Adamu told NAN that he bought the drugs from Kano and Kaduna markets and that he had been in business for a very long time, saying that “it is what people know me for.”

He said that his chairman, who was not available, would bring the necessary documents to the agency