20/04/23

Shina J O

The United States Centers for Disease Control and Prevention (US CDC)has hosted federal and state ministries of health, Government of Nigeria health agency leadership, and HIV program implementing partners for a two-day meeting to review President’s Emergency Plan for AIDS Relief (PEPFAR) program performance over the last six months.

According to a statement by the U.S. mission in Nigeria, The meeting is a follow-up to an event last October where the group developed a roadmap for HIV programs in US CDC-supported states to help Nigeria reach epidemic control.

United States CDC Country Director, Mary Boyd commended states and partners for their work over the last six months and highlighted recent US CDC-supported activities like the Nigeria Sustainability and HIV Impact Program.

She reiterated US CDC’s commitment to working with the Government of Nigeria, states, partners, and communities to increase the number of people with HIV who know their status and receive life-saving treatment.

The meeting served as a review of accomplishments, challenges, and best practices from the last six months.

It also focused on aligning national and state program activities with each other and the strategic pillars of PEPFAR’s new five-year strategy to ensure long-term program sustainability.

In a presentation given by the National AIDS and STDs Control Programme, the importance of strengthened collaboration between national, state levels, and local levels, as well as key partners, was emphasized at the meeting.

Also highlighted is the recently issued government-to-government award, which directly reengaged government institutions to strengthen national and state HIV program ownership.

A third program performance review and planning meeting will be held in six months to ensure Nigeria stays on track to end HIV/AIDS as a public health threat.

19/04/23

Daniels G.O

The Director General Of The Nigerian Institute Of Medical Research Professor Babatunde Salako And other Health Experts have called on the Federal Government to look inward and develop effective indigenous solutions to tackle diseases of public health Concerns

Speaking During the evaluation Presentation of an herbal mixture ABUAD VIRUCIDINE which is said to have the potentials of being licensed for the treatment of COVID-19 ,The experts said even
though work on the medicine is still at a preliminary stage, findings show that it is very promising and that what needs to be done is to move on to the next stage which is to conduct study in larger number of people, after which the regulatory agency will be confident to register it as a treatment for COVID-19 in Nigeria pending the results of the full clinical trials.”

Out of 72 participants screened for the trials, 44 enrolled, and 43 (97.7 percent) of the enrolled participants completed the study.

A higher proportion of participants in the Virucidine trial were SARS-CoV-2 negative by day 3

All participants were SARS-CoV-2 negative by Day 14. A significantly higher proportion of participants on Virucidine were also symptom free by Day 7th Day.
Findings also showed that the Liquid was well tolerated and there were no serious adverse events, clinical deterioration or death through the 28 days of follow-up.”

ABUAD VIRUCIDINE is a project done in collaboration with Afe Babalola University of Ado Ekit, And The Nigerian Institute Of Medical Research NIMR,

18/04/23

SHINA J.O

PRESS RELEASE

The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the R21 malaria vaccine manufactured by the Serum Institute of India.

The Director General of NAFDAC, Prof Mojisola Adeyeye, disclosed this on Monday at a press briefing in Abuja.

Said This makes Nigeria the second country to approve the new malaria vaccine developed at the University of Oxford, after Ghana.

Adeyeye said the vaccine is indicated for the prevention of clinical malaria in children from 5 months to 36 months of age.

She said the country expects to get at least 100,000 doses of the vaccine in donations soon before the market authorisation will start making other arrangements with the National Primary Health Care Development Agency.

Adeyeye said “NAFDAC in exercising its mandate as stipulated by its enabling law, NAFDAC Act CapN1, LFN 2004 is granting registration approval for R21 Malaria Vaccine (Recombinant, Adjuvanted) manufactured by Serum Institute of India Pvt. Ltd.

“The Marketing Authorization Holder is Fidson Healthcare Ltd in line with the Agency’s Drug and Related Products Registration Regulation 2021.

“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 the dossier of the vaccine was subjected to independent review at two levels and the dossier was reviewed by NAFDAC’s Vaccine Advisory Committee independently using standards of the World Health Organisation across relevant domains, in addition to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use guidelines, European Medicines Agency guidelines, scientific rigour on the vaccine and the context of malaria and specifically to Nigeria and best research and manufacturing governance.

“NEVAC members reviewed all sections independently using best review practices and met physically in plenary to assess and debate the reviews by sections, raised queries, and made recommendations accordingly.

“Overall, the assessment was scored as adequate -fully compliant with standards, and the report was submitted to the Director General.

“The review of NAFDAC’s Committee has always been guided by the same international standards and best practices with the same modality of an independent review by members followed by long hours of plenary where a rigorous assessment of each review took place.

The Committee also independentlyscored the assessment as satisfactory and forwarded it to the Director General.”

According to her, the R21 malaria vaccine dossier complied substantially with the best international standards with which the dossier was benched-marked.

She said the Joint Review Committee concluded that the data on the R21 Malaria vaccine were robust and met the 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.

“The Joint Review Committee recognised the importance of an effective malaria vaccine (with 75 per cent protection) as an additional interventional tool, as a critical need in Nigeria with the highest malaria burden.

“The Joint Review Committee also recommended additional phase four clinical trial, pharmacovigilance study in-country in the implementation given the peculiarity and heterogeneous nature of malaria in Nigeria.

“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.

“A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the WHO’s Malaria Vaccine Implementation Guideline,” she noted.

It has been reported that four African countries accounted for just over half of all malaria deaths worldwide – Nigeria (31.3%), the Democratic Republic of the Congo (12.6%), United Republic of Tanzania (4.1%) and Niger (3.9%).

In Nigeria, 97 per cent of the population are at risk of malaria.