Category: Health and Environment

Flowerbudnews

By Ahmed Kaigama

Jos (Plateau):  The National Agency For Food and Drugs Administration and Control (NAFDAC) has urged journalists to collaborate with the agency in the fight against circulation and use of bleaching creams in the country.

Prof. Mojisola Adeyeye, Director-General (D-G), NAFDAC, made the call in Jos on Friday while sensitising journalists in the North Central States on the dangers of bleaching creams.

The forum was the North Central zonal media sensitisation workshop on dangers of bleaching creams and regulatory controls, organised for the Association of Nigeria Health Journalists.

Adeyeye said the workshop was aimed at educating and challenging health journalists in Nigeria to play frontline role in the agency’s effort to eradicate the menace of bleaching creams.

The D-G was represented by Dr Leonard Omokpariola, Director, Chemical Evaluation and Research of the Agency.

“Bleaching creams damage vital organs in the body, cause skin irritation, allergy, skin burn, rashes, wrinkles and prolong healing of wounds.

“Black is beautiful, we don’t need to change our color.

“NAFDAC will constantly engage the mass media as we strive to bring down to the grass root levels positive impact of our regulatory activities,” she said.

On his part, Dr Abubakar Jimoh, Director, Public Affairs of the Agency, said: “The workshop was meant to educate the mass media with the right information and campaign against use of bleaching creams in Nigeria.

“Public ignorance is not an excuse before the law. The role of the mass media in promotion of public health is very important not only for cosmetics and all other NAFDAC regulatory products”.

In a remark, Mr Hassan Zaggi , President, Association of Nigeria Health Journalists, said: “Skin bleaching cream is a serious concern among the citizens in the country.

“Why would somebody use his hard-earned money to buy a cream that will endanger his skin?.

“As journalists, we have a responsibility to educate people on the dangers and as well shape the opinion of the people,” Zaggi said.

He appealed to the journalists to pay attention to the workshop for onward circulation of learning outcomes to members of the public. (NAN) www.nannews.ng / Flowerbudnews

Flowerbudnews

By Biola Lawal

Abuja: (Flowerbudnews):  The Director General of the National Agency for Food and Drugs Administration and Control (NAFDAC), Prof. Mojisola Adeyeye has warned Nigerians against use of a deadly eye drop which has led to death of some patients in the United States

Prof Adeyeye made the disclosure in an Alert to the public detailing the particulars of the dangerous eye drug – EzriCare and Delsam Pharma Artificial Tears eye drops made by Global Pharma Healthcare.

The NAFDAC Director General said that product was recalled  due to suspected contamination with pseudomonas aeruginosa, a highly resistant bacteria.

Prof Adeyeye disclosed in the warning alert that Since the recall, of the product, the US Centre for Disease Control (CDC) has reported 68 patients across 16 states who have suffered health problems from the bacteria, including eye infections, permanent loss of vision,  surgical removal of eyeballs and a case of death with a “bloodstream infection” had also been reported

She stated:

NAFDAC Is notifying the public that Global Pharma Healthcare have recalled EzriCare and Delsam Pharma Artificial Tears eye drops early in February.

The recall of the preservative-free eye drops were due to suspected contamination with pseudomonas aeruginosa, a highly resistant bacteria.

Since the recall, the US Centre for Disease Control (CDC) has reported 68 patients across 16 states who have suffered health problems from the bacteria, including eye infections, permanent loss of vision,  surgical removal of eyeballs and a case of death with a “bloodstream infection” had also been reported.

Laboratory testing identified the bacteria in opened EzriCare bottles from multiple sources, according to the CDC. Unopened bottles are currently being examined to check whether contamination occurred during manufacturing.

Pseudomonas is a type of bacteria (germ) that is found commonly in the environment, like in soil and in water. Of the many different types of Pseudomonas, the one that most often causes infections in humans is called Pseudomonas aeruginosa, which can cause infections in the blood, lungs (pneumonia), or other parts of the body after surgery.

Signs of infection include yellow, green, or clear discharge from the eye, discomfort or pain, redness, blurry vision and increased sensitivity to light.

Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.

Product details

The details of the products are as follows;

Product Manufacturer: Global Pharma Healthcare, Tamilnadu, India.

Brand Name: EzriCare & Delsam Pharma

Product Description: Artificial Tears Lubricant Eye Drops

Affected Lots: All lots within expiry

Product Photos

Although the products are not in NAFDAC database, importers, distributors, retailers and consumers are therefore advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the above mentioned products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

Members of the public in possession of the above listed products are advised to discontinue sale or use and submit stock to the nearest NAFDAC office.

If you have batches of the products, please DO NOT use them. 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.

Healthcare professionals and consumers are advised 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

Similarly, Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal product 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)

Flowerbudnews

By Flowerbudnews

Enugu: The National Agency for Food and Drug Administration and Control (NAFDAC) has urged journalists and entertainers within the South-East to join the agency in its current war against use of bleaching cream.

The Director-General of NAFDAC, Prof. Moji Adeyeye, made the call on Wednesday in Enugu during an address at the South-East Media Sensitisation Workshop on Dangers of Bleaching Creams and Regulatory Controls.

Adeyeye, who was represented by Dr Leonard Omokpariola, Director of Chemical Evaluation and Research, noted that there was an imperative to warn people of South-East and Nigerians in general to the harmful effects of bleaching creams including cancer and damage to organs.

According to her, other dangers are skin irritation and allergy, skin burn and rashes, wrinkles, premature skin ageing and prolonged healing of wounds.

“Last year, the Secretary to the Government of the Federation, Mr Boss Mustapha, acting on the resolutions of the Senate wrote to NAFDAC stressing the need to take stringent regulatory actions to stem the dangerous tide of rampant and pervasive cases of Nigerians using bleaching creams.

 

“We immediately took some decisive steps such as sensitisation of the public through different media outlets, enforcement through intelligence and raids in trade fair complexes that have resulted in large seizures and destruction of violative products.

“One of such sensitisation actions was the flag-off of Media Sensitization Workshops organised for journalists in Abuja, Lagos, Kano, Ibadan, Port-Harcourt and today in Enugu.

 

“Today’s sensitisation workshop is therefore a fulfillment of my promise to cascade it to the six geo-political zones in the country.

 

“This is a deliberate strategy of mobilising, educating, sensitising, and challenging Nigerian Health Journalists to play a frontline role in our concerted efforts to eradicate the menace of bleaching creams and needless waste of scarce resources in Nigeria,” he said.

 

Adeyeye noted that the sensitization workshop is a training the trainers’ programme with the great expectation that participants would assume the role of champions in the vanguard of the campaign against use of bleaching creams.

She said that a World Health Organization (WHO, 2018) study revealed that use of skin bleaching creams was prevalent among 77 per cent of Nigerian women which was highest in Africa compared to 59 per cent in Togo, 35 per cent in South Africa and 27 per cent women in Senegal.

 

“This scary statistic has shown that the menace of bleaching creams in Nigeria has become a national health emergency that requires a multi-faced regulatory approach.

 

“Part of the multi-pronged approach is consultative/sensitisation meetings such as this and heightened raids on distribution outlets of bleaching creams,” he said.

 

In a goodwill message, the Enugu State Commissioner for Health, Dr Ikechukwu Obi, said that the state government and her institutions would continue to collaborate with NAFDAC in its mandate to safeguard the health of the nation.

 

Obi, who was presented by Mr Monday Obetta, Director of Pharmaceutical Services, said: “We want our people to join hands with NAFDAC to protect the skin which is an important organ, protecting other organs in the body”.

Speaking, Dr Abubakar Jimoh, Director of Public Affair in NAFDAC, said that NAFDAC wants to use human face to tackle the menace of bleaching cream by engaging the media practitioners in order to get Nigerians rightly informed against bleaching cream.

 

Jimoh noted that the agency wanted individual Nigerians, who are in the demand side of bleaching cream, to know the serious danger and negative consequences of using bleaching cream.

 

“We thank the media for their sustained support all these years; however, we want media practitioners to do more for us in this era of war against bleaching cream nationwide,” he said.

 

The President, Association of Nigeria Health Journalists, Mr Hassan Zaggi, urged health journalists to put the advocacy against use of bleaching creams to the front burner of media discourse and engineering public thoughts toward it.

 

“Media practitioners should do more by creating time to talk one-on-one to people around them on the dangers of bleaching cream,” Zaggi said.

The workshop featured paper presentation on: “An Overview of Skin Bleaching: The NAFDAC Perspective”; “Role of Mass Media in Promoting Public Health in Nigeria”; “Safe Handling of Chemicals and Ingredients in the Cosmetics Industry” and “The Cosmovigillance Best Practices” among others. (Flowerbudnews)

Flowerbudnews

By Biola Lawal
Lagos (Flowerbudnews): The  Director General of the National Agency for Food and Drug Administration and Control, NAFDAC), Prof Mojisola Adeyeye, has enjoined packaged and sachet water producers in the country to maintain Good Manufacturing Practices GMP  to protect health of consumers.

The admonition was given by Director General at the 2023 World Water Day commemoration in Lagos on Wednesday, a statement by Sayo Akintola, NAFDAC Resident Media Consultant,  copy of which was made available to Flowerbudnews in. Abuja, disclosed.

Prof Christianah Mojisola Adeyeye who was represented by the Director, Food Registration and Regulatory Affairs, Mrs. Abayomi Bolaji Juliana mni, noted that poor quality water kills faster than what could be imagined when consumed by unsuspecting consumers.

CAPTION
L-R: Director, Lagos State Office LSO, Dr Monica Eimunjeze, Director, Food Registration and Regulatory Affairs, Mrs. Abayomi Bolaji Juliana mni, Director, Laboratory Services, Drugs and Biologics, Mr. Victor Abiola, all of the National Agency for Food and Drug Administration and Control NAFDAC and National President, Water Producers Association of Nigeria WAPAN, Mr. Odiri Mackson Egberi, at the 2023 World Water Day celebration in Lagos. Wednesday.

With the theme, ‘’Accelerating Change’’ to solve water and sanitation crisis, Prof. Adeyeye stated that ‘’water affects us all, we need everyone to take actions; that means, you and your family, churches, mosques, markets, communities etc. can make a difference by changing the way we use, consume, and manage water in our lives.’’

She said World Water Day is celebrated each year to focus attention on the value of freshwater and encourage others towards the sustainable use of freshwater resources.

‘’Right now, we are seriously off-track to meet the sustainable development goal; water and sanitation for all in 2030’’, she said, adding that dysfunctionalities throughout the water cycle undermines progress on all major global issues, from health to hunger, gender equality to jobs, and education to industries.

According to her, the reason for the UN agencies’ continued annual campaign for water includes public sensitization on water problems and coordination of efforts with other countries. She further stated that this year’s occasion would identify various water related challenges and provide solutions to reduction of these challenges.

She however, urged Nigerians not to wait for a water crisis to erupt before acting, stressing that there is a great deal of interaction between the biotic and abiotic worlds.

L-R: Director, Food Registration and Regulatory Affairs, Mrs. Abayomi Bolaji Juliana mni, Director, Laboratory Services, Drugs and Biologics, Mr. Victor Abiola, all of the National Agency for Food and Drug Administration and Control NAFDAC and National President, Water Producers Association of Nigeria WAPAN, Mr. Odiri Mackson Egberi, at the 2023 World Water Day celebration in Lagos.Wednesday.

The Director General admonished all present to always boil water from boreholes and wells to avoid water-borne diseases such as diarrhea, dysentery, typhoid fever, and cholera as children are most susceptible to these illnesses.

She further admonished parents to be careful with where they source bottled or sachet water and that NAFDAC acting on her mandate on the regulation and control of water would continue to monitor water manufacturers for compliance to NAFDAC regulations.

She appreciated the self-regulation efforts by the sector and noted that regulatory sanctions would be meted out to any manufacturer that fails to comply with regulations and guidelines.
She concluded by stating that ‘’water is one of the things that give us life. Conserve and use water to prolong life’’. (Flowerbudnews)

Flowerbudnews

By Monday Ajogun

Onitsha (Anambra):  The National Agency for Food and Drug Administration (NAFDAC) on Friday bursted a store at the Bridge Head Market, Onitsha, which specialises in the sale of expired sex enhancement drugs.

NAFDAC Chief Laboratory Technologist, Mr Usman Amen, who led the Investigation and Enforcement Directorate team from Lagos, told the News Agency of Nigeria (NAN) in Onitsha that the store was notorious for dealing in unregistered and expired drugs.

According to him, the operation was carried out, following a tip off on the nefarious activities going on in the market.

NAN reports that the store is situated at the Progressive Science and Allied Dealers Lane in the market.

Amen said the drugs included delay viagra, afrofranil, breast enhancement, ass enhancement, rocket in pocket men gel and tramadol, among others.

He said: “We came from Lagos on a tip off, before we arrived here, the owner of these sex enhancement drugs abandoned his store and ran away.

“In view of this, we had to break the store and on entering inside, we saw some expired drugs, like tramadol, breast enhancer and all kinds of sexual drug enhancers.

“We ensured that we evaluated the drugs and sealed up the store.

“The owner will have to come to our office in Lagos for interrogation.

“We also sealed the store in Ogbo-Ogwu Bridge Head Market because a particular drug we were informed about was not found but the invoice indicated when the drug was last sold.

“The second store was sealed because their were some drugs that are not allowed to be sold in the market, we evaluated them and sealed the store,” Amen said.

He called on the public to be vigilant, saying that the drugs being produced and sold in the market were not worth consuming.

The leader of the lane in the market, Mr George Opara, described the activities of the dealer as “embarrassing and disturbing”.

Opara said that the market was known for dealing in genuine drugs and other goods.

He said that punitive actions would be meted to the runaway shop owner for engaging in such illegal business and bringing shame to the lane. (NAN)(www.nannews.ng) /Flowerbudnews

Flowerbudnews

 

Isaiah Eka/Nathan Nwakamma

Port Harcourt:  The National Agency for Food and Drug Administration and Control (NAFDAC) has warned Nigerians not to use unapproved cosmetics because the dangers were largely irreversible.

 

The Director-General NAFDAC, Prof. Mojisola Adeyeye, gave the warning during the media sensitisation workshop on dangers of bleaching creams and regulatory controls for South South Journalists in Port Harcourt on Tuesday.

 

Adeyeye, who was represented by Dr. Leonard Omokpariola, Director, Drug Evaluation and Research, said the menace of unapproved cosmetics such as bleaching creams in Nigeria had become a national health emergency that required multi-faced regulatory approach.

According to the NAFDAC D-G, the unapproved cosmetics used banned and toxic chemicals to achieve skin lightening effects that leaves the user with undesirable effects.

 

She listed some of the harmful effects of bleaching creams to include cancer, damage to vital organs of the body like kidney and liver.

It also causes skin cancer, irritation and allergy, skin burn and rashes, wrinkles, premature skin ageing and prolonged healing of wounds.

The DG said that the World Health Organisation in a 2018 study, revealed that use of skin bleaching creams was prevalent among 77 per cent of Nigerian women which was highest in Africa, compared to 59 per cent in Togo, 35 per cent in South Africa and 27 per cent women in Senegal.

 

She said that the essence of the sensitisation workshop was to train Journalists and stakeholders, who will inform the public on the dangers of those cosmetics.

 

Adeyeye added that the sensitisation workshop was a Train the Trainers’ programme with the great expectation that participants would assume role of champions in the campaign against use of bleaching creams in the country.

 

She added that after the sensitisation campaign, the agency would take stringent regulatory actions to stem the dangerous tide of rampant and pervasive cases of Nigerians using bleaching creams.

The director general thanked journalists and stakeholders for their collaboration and support for NAFDAC to rid the country of the menace of substandard and falsified medicines, unwholesome foods, corrosive cosmetics and other substandard regulated products.

 

Representatives of Pharmaceutical Society of Nigeria, cosmetics manufacturers, supermarket operators, Nigerian Customs Health officials, amongst other stakeholders attended the workshop.

 

Earlier, Dr Abubakar Jimoh, NAFDAC Director of Public Affairs, said the war against menace of bleaching cream across the country was sequel to a resolution of the 2022 Senate, promoted by Sen Oluremi Tinubu.

According to Jimoh, the Senate resolution crystallised to a memorandum from the Secretary to Government of the Federation directing NAFDAC to strengthen its regulatory functions to curb the menace. (NAN) (www.nannews.ng)/Flowerbudnews

Flowerbudnews

Lagos: The Nigeria Customs Service, Federal Operations Unit (FOU), Zone A, Ikeja, has handed over seized expired drugs, valued at about N1.4 billion to the National Agency for Food and Drug Administration and Control (NAFDAC).

The FOU Zone A Acting Controller of the Service, DCG Kehinde Ejibunu, did the handing over on Tuesday at the service seized items yard, Ikeja, Lagos.

Ejibunu said that the drugs were manufactured in India and Malaysia, adding that the warehouse where the goods were seized from was sealed and the owner was still ion the run.

“The Duty Paid Value is N1.4 billion. The importer would have relabeled the drugs, to sell them to the public.”

“ As a part of the results achieved from the re~worked strategy; expired, illicit, and other drugs that did not comply with the statutory import requirements were intercepted at different times and locations.

“ They are constructively warehoused in 39 x 140 ft and 2 x 20 ft containers by this Unit, and will be handed over to NAFDAC,” he said.

DCG Kehinde Ejibunu of FOU Zone A Ikeja presenting seized drugs to NAFDAC officials on Tuesday in Lagos

Receiving the drugs, the NAFDAC Director of Investigation, Mr Francis Onaniwu, commended the NCS for saving members of the public from more health challenges , which the expired drugs would have caused should they be used.

He said that the drugs expired in November 2021, stressing that the agency would investigate and analyse the drugs, to ascertain their potencies.

Onaniwu added that the agency was already investigating a case relating to similar drugs, stressing that one of the findings was to ascertain if the importer is same with the one they were investigating.

The director noted that the importer smuggled the drugs into the country because he knew if presented to the agency, they will not pass the laboratory tests.

Onaniwu said that the agency had dealt with such drugs and importers in the past.

He explained that the Controller of NCS handed over expired drugs, which was in large quantities, to NAFDAC.

“This is huge. Imagine if this quantity of drugs that are in these containers get to members of the public.

“The drugs , one is not sure of the quality, because from the one I am holding in my hand, the drug already expired in November 2021 and we know the implications of expired drugs.

“We are sure that if they have not been confiscated by NCS, definitely, if they enter circulation, the importers will not want to lose their investment.

“He will change the expired date to new date and relabel the drugs. People consuming such would have consumed poison,” he said. (NAN) www.nannews.ng / Flowerbudnews

Flowerbudnews

 

By Aderogba George

Abuja: The National Agency for Food and Drug Administration and Control (NAFDAC) on Wednesday in Abuja sealed two shops for allegedly selling unapproved products to Nigerians.

The shops are located in the Zuba Central motor park and Utako main market.

The News Agency of Nigeria (NAN) reports that some of the unregistered products said to be aphrodisiacs are: “Hajiya Ayesha Snuff, AK47, Bulletproof and Hajiya Aysha Maisanda”.

Mr Tamanuwa Baba, Deputy Director, investigation and Enforcement directorate, NAFDAC, said the operation followed intelligence reports received about the shops.

“The products are meant to boost sexual performance and some were said to have been manufactured in Ghana.

“NAFDAC laboratory analysis indicates that these products contain a chemical substance called Pyridine which is a potentially harmful to the human body.

“We found a lot of unregistered products in the two shops. We will begin immediate investigations ,” he said.

 

Baba said that the agency has apprehended the sales representative in the Zuba shop pending when the owner of the shop will return from his journey.

“We will get in touch with the owner of the shop on where he is sourcing these products from, but from the label on the products, some of them were allegedly manufactured in Ghana.

“What the sellers are saying is that these products usually make them high and some said that the product is used as an aphrodisiac.

“After the investigation, these products are going to be destroyed because they have not been registered by us.

He said similar set of products were also discovered in a shop at Utako known as Kabo Investment Limited.

He said that it was scary that  some of the products have flooded the Nigerian market and that they are fast spreading because the agency conducted a similar operation in Sokoto where some of the products were removed from a shop.

“I can tell you that  Pyridine which is the chemical that is contained in some of these products can cause cancer, skin irritation and even lead to death. (NAN) (www.nannews.ng/ Flowerbudnews

By Aderogba George

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