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Malaria: Nigeria okays R21 vaccine for children

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By Matthew Denis

Barely few days after Ghana gave its nod, the Federal Government of Nigeria  has approved the use of R21 Malaria Vaccine (Recombinant, Adjuvanted).

This was disclosed by the the Director General of National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye in a press briefing on Monday.

According to her, the vaccine is manufactured by Serum Institute of India Pvt. Ltd. (SIIPL).

Prof. Adeyeye, said the approval is made by the Agency in exercising its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004.

She explained that the R21 Malaria vaccine is an adjuvanted protein vaccine presented as a sterile solution.

“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 a ready-to-use liquid formulation for intramuscular injection.

“The vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age. The storage temperature of the vaccine is 2-8 °C,” she said.

Adeyeye also said NAFDAC has several pathways for the registration of vaccines, and are in line with the Agency’s guideline for registration of imported drugs, vaccines and IVDs under collaborative registration procedure.

Speaking further, the DG stressed that the outcomes of the reviews were discussed, and the recommendations and queries/clarifications were consolidated to be referred to the manufacturers.

She said, “Overall, the R21 Malaria Vaccine dossier complied substantially with best international standards with which the dossier was benched-marked as mentioned above. The Joint Review Committee concluded that the data on the R21 Malaria vaccine were robust and met criteria for efficacy, safety, and quality. It was also adjudged that the vaccine’s known and potential benefits outweigh its known and potential risks, thereby supporting the manufacturer’s recommended use.

“Specific instances where queries/ clarifications and or additional data were required have been duly compiled to the manufacturers. These did not affect the overall adequacy of the dossier. The Joint Review Committee recognised the importance of an effective malaria vaccine (with a 75 per cent protection) as an additional interventional tool, as a critical need in Nigeria with the highest malaria burden.”

According to her, the Joint Review Committee also recommended additional phase 4 clinical trial/Pharmacovigilance study in-country in the implementation given the peculiarity and heterogeneous nature of malaria in Nigeria.

She said, “The joint Review Committee was also interested in reviewing data of the human-malaria parasite dynamics of the 25 per cent not covered to understand issues bothering on non-protection that could inform further research. This has created a potential research collaboration opportunity between NAFDAC and the affiliated respective universities of the NEVAC members.”

Prof. Adeyeye noted that a provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the the WHO’s Malaria Vaccine Implementation Guideline.

She said, “While granting the approval, the Agency has also communicated the need for expansion of the clinical trial conducted to include a phase 4 clinical trial/Pharmacovigilance study to be carried out in Nigeria.

“The brief on the approval of the R21 Malaria vaccine has been communicated to the Honourable Minister of Health and National Primary Health Care Development Agency for appropriate actions toward immunization in the respective population.”

She reassured that NAFDAC remains committed to ensuring that only products that are safe, high quality and efficacy are  made available for Nigerians.

 

Health

Outbreak: Zamfara Govt. confirms 4 deaths, 177 cases

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The Zamfara Commissioner for Health, Dr Aisha Anka has confirmed the outbreak of unknown illness in the state which recorded four deaths and 177 cases so far.

Anka confirmed this in a statement issued in Gusau on Friday by the Information Officer of the ministry, Malam Bello Ibrahim.

According to the commissioner, the disease is characterized by abdominal distension, accumulation of fluid in the abdomen, enlarge liver, enlarge spleen, fever and general body weakness.

“The illness is found in Maradun, Shinkafi and Gusau local government areas in the state.

“Children are mostly affected and the cases are associated with water consumptions.

“So far, four deaths have been recorded, 177 cases were detected,” Anka said.

“The incident has been reported to the National Centre for Disease Control (NCDC), partners and all other relevant stakeholders.

“The ministry of health is currently on the emergency response phase to identify the illnesses and causes.

“Various biological human and animal samples, soil samples, water samples, agricultural and foodstuff samples have been taken to Lagos and Abuja laboratories for analysis.

“The ministry will continue to update the general public and all relevant stakeholders and partners on any update about the outbreak,”she added. (

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Health

Assembly passes Kano Pre-Marital Health Screening Bill

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Kano State House of Assembly has passed a bill for a law to compel intending couples to undergo HIV, hepatitis and sickle cell anaemia screening before marriage.

The passage followed deliberations in the Committee of the Whole House during plenary session,
presided over by the Speaker, Ismail Falgore on Monday in Kano.

After deliberations, the lawmakers approved the 3rd reading of the bill, read by the Deputy Clerk, Alhaji Nasiru Magaji.

Shortly after passage of the bill, the Majority Leader of the house, Lawan Hussein (NNPP-Dala), stated that “any person
intending to marry shall first submit self for medical examinations.”

He said the bill was considered and passed after the 3rd reading, following various legislative processes.

The leader further said that the bill was passed because the state had been battling with different health issues, including
HIV because people go into marriages without medical screening.

He said that the bill, if signed into law, would save many lives and curb the spread of life-threatening diseases.

“The bill will safeguard the health of citizens by institutionalising pre-marital testing to check the spread of diseases
like hepatitis, HIV and sickle cell anaemia,” he added.

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WHO to begin vaccination against Human Papilloma Virus May 27 in Kogi

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The World Health Organisation (WHO), says it plans to commence vaccination against Human Papilloma Virus (HPV) on May 27 in Kogi.

The state’s Team Lead of WHO, Dr Muktar Toyosi, said this when he led his team on an advocacy visit to the State Council of the Nigeria Union of Journalists (NUJ) on Wednesday in Lokoja.

Toyosi said that the vaccination was meant for girl child of between the age nine and 14.

He said the ongoing sensitisation was to keep the people informed, and educate them on the vaccination of their children to protect them against cervical cancer in future.

”Kogi falls within the second phase of the programme. We are soliciting for the cooperation of the media in educating the people of the state on the HPV vaccination.

“There need for girls child across the state to take the vaccination to safeguard their future.

“Although the vaccine was initially scarce and difficult to get, the good news now is that it has been made available by the government,” Toyosi said.

Also speaking, the State Technical Assistant for WHO, Dr Ahmed Attah, said that the HPV mostly affect women, adding that the vaccination remained a preventive measure against the disease.

Attah, a former state Chairman of the Nigeria Medical Association (NMA) and a former Chief Medical Director (CMD), Kogi Specialist Hospital (KSSH) Lokoja, urged parents and guardians to avail their children of the vaccination to justify government’s investment.

In his response, the Kogi NUJ Chairman, Mr Seidu Ademu, described the health sector as very critical, stressing that the vaccination was a right step in the right direction.

Ademu promised a robust partnership with WHO to enable the team to achieve its set goals.
He stressed the need to inform, educate and sensitise the general public on the need to embrace the vaccine by ensuring that girls within the age range were vaccinated.

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