Health
Takeda To Develop Zika Vaccine With $312m
By Modupe Gbadeyanka
Japanese firm, Takeda Pharmaceutical Company Limited, has announced that the Biomedical Advanced Research and Development Authority (BARDA) has selected its Vaccine Business Unit to develop a vaccine to support the Zika response in the US and affected regions around the world.
Initial funding from BARDA, which is a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the US Department of Health and Human Services, is for $19.8 million to cover the vaccine development through Phase 1, with potential funding of up to $312 million if ASPR/BARDA exercises all options to take the vaccine through Phase 3 trials and filing of the Biologics License Application (BLA) in the US.
On February 1, 2016, the World Health Organization declared the Zika outbreak to be a Public Health Emergency of International Concern. On February 8, 2016 the Centers for Disease Control and Prevention (CDC) elevated its Zika response efforts to its highest response level, Level 1. There is no vaccine or medicine for Zika2, and infection during pregnancy can cause a serious birth defect called microcephaly and other severe fetal brain defects.
Current research suggests that Guillain-Barre syndrome (GBS), which is an uncommon sickness of the nervous system, is strongly associated with Zika; however, only a small proportion of people with recent Zika virus infection get GBS. Many people infected with Zika will have no symptoms or mild symptoms that last several days to a week. The virus has spread in recent years into more than 60 countries and territories including the US.
Dr Rajeev Venkayya, Corporate Officer and President of the Global Vaccine Business Unit at Takeda, said: “The Zika emergency demands swift action by governments, public health agencies, medical and scientific communities, industry and others, and partnerships are essential for success.
“Working with BARDA, Takeda is deploying its world-class expertise and capabilities in vaccine development for emerging infectious diseases, and our outstanding team and manufacturing facilities in Hikari, Japan.
“This Zika vaccine program joins our work in dengue, norovirus, our partnership with the Japanese Government on pandemic influenza, and the recently announced partnership with the Bill & Melinda Gates Foundation to help eradicate polio.
“These efforts to develop a vaccine against the Zika virus reinforce Takeda’s commitment to the health of people everywhere, including the most vulnerable populations that are threatened by Zika.”
Given the Japanese Government’s commitment to preparedness for outbreaks of infectious diseases, recently reinforced by Prime Minister Abe at the G7 Summit in Ise-Shima, Japan, Takeda is in discussions with the Cabinet Secretariat of the Prime Minister Office regarding potential participation of Japanese health agencies in this collaboration. Takeda is working with ASPR/BARDA and the Japanese Government to explore these opportunities further.
Under the agreement, Takeda will develop an inactivated, adjuvanted, whole Zika virus vaccine. The objectives of the first stage of the work include developing and producing the investigational vaccine and completing pre-clinical studies, submission of an Investigational New Drug Application (IND) to the US Food and Drug Administration, and execution of a Phase 1 clinical trial. Manufacturing of the vaccine will occur at Takeda’s facilities in Hikari, Japan.
Takeda’s Commitment to Vaccines
Vaccines prevent more than two million deaths each year and have transformed global public health. For 70 years, Takeda has supplied vaccines to protect the health of people in Japan.
Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue, norovirus and polio. Our team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world’s most pressing public health needs.
By Adedapo Adesanya
The National Health Insurance Authority (NHIA) says the number of Nigerians enrolled in health insurance has risen to more than 22 million.
The Director-General of NHIA, Mr Kelechi Ohiri, said this resulted from the implementation of the mandatory health insurance, which has gained momentum nationwide.
He said this on Wednesday at the Annual General Meeting of the Nigerian Association of Insurance and Pension Editors (NAIPE) in Lagos.
Mr Ohiri said enrolment had increased to 22.03 million, representing a 35 per cent year-on-year growth, attributing this to stronger collaboration with state social health insurance agencies, ministries, departments and agencies, organised labour, employers, the private sector, and the gradual implementation of the mandatory health insurance provisions of the NHIA Act.
He said that the country had moved beyond policy formulation to delivering measurable improvements in healthcare access, service quality and consumer protection in line with the federal government’s health sector reform agenda.
According to him, Nigeria already has the necessary policies and legislation to achieve Universal Health Coverage, positing that the key challenge was effective implementation.
“The decisive variable is now implementation- consistent, rigorous and accountable execution that converts political commitment into healthcare access for real Nigerians,” he said.
Mr Ohiri said that the transition from the former National Health Insurance Scheme to the NHIA had strengthened regulation, consumer protection, accountability and strategic purchasing, while providing the legal and operational framework for achieving Universal Health Coverage.
He added that improving the experience of enrollees remained central to the Authority’s reform agenda.
According to him, NHIA has strengthened its complaints management system, introduced faster resolution timelines, and intensified compliance monitoring of Health Maintenance Organisations (HMOs) and healthcare providers.
He further added that NHIA had sanctioned facilities that failed to meet the required standards, adding that his organisation had resolved 3,878 complaints, representing an 87 per cent resolution rate, while 95 per cent of the cases were concluded within prescribed timelines.
Mr Ohiri noted that more than N14.2 million had been refunded to enrollees, while non-compliant healthcare facilities had been sanctioned.
He said NHIA had also introduced service standards, including a one-hour treatment commencement target for enrollees requiring urgent care, to improve access to timely and quality healthcare services.
The NHIA boss further disclosed that capitation payments to healthcare providers had been increased by 93 per cent.
He said fee-for-service reimbursements rose by 378 per cent to enable providers to invest more in personnel, equipment and infrastructure.
According to him, 7,592 healthcare facilities have been assessed under the SafeCare quality framework as part of efforts to institutionalise continuous quality improvement across the country.
Mr Ohiri also highlighted interventions targeted at vulnerable groups, including support for more than 48,500 pregnant women, expanded maternal and newborn healthcare services, the Vulnerable Group Fund, and improved access to healthcare for pensioners and retirees.
He said Universal Health Coverage could only be achieved if every Nigerian, regardless of income or location, had access to quality healthcare services.
By Modupe Gbadeyanka
The new one-hour authorisation response time ultimatum policy introduced by the National Health Insurance Authority (NHIA) has received the full backing of SUNU Health Nigeria Limited.
This policy was introduced by the agency to ensure enrollees get prompt approval codes to access care.
Healthcare service providers have been urged to report any Health Maintenance Organisation (HMO) that violates this initiative through an email, with the HMO in copy and a timestamp attached as evidence of the request. They may proceed to offer services to enrollees thereafter.
Speaking at the company’s second-quarter Providers’ Forum for the Lagos-Ogun region in Lagos recently, the chief executive of SUNU Health, Dr Moyosore Olomola, expressed optimism that this policy would improve healthcare delivery in the country, especially for enrollees, who crave quality service.
At the event themed Improving Quality and Access to Care Through Stronger Provider Network, and held at the Nigerian Institute of Medical Research (NIMR) in Yaba, Lagos, Mr Olomola reaffirmed the HMO’s commitment to operating within legal and operational frameworks to guarantee adequate care for enrollees.
“Access to care and quality of care remain key priorities in our healthcare systems. We know quite well that deliberate collaboration, strategic partnerships, and a shared commitment to excellence are required to achieve these priorities.
“A strong provider network is doubtless the backbone of any effective healthcare system. It ensures that our mutual enrollees receive the right care, at the right time, in the right place, and at the right price,” Mr Olomola, represented at the programme by the organisation’s Chief Operating Officer (COO), Dr Faith Nwachi, stated.
He further assured that SUNU Health would strictly adhere to the one-hour authorisation limit, stressing that this aligns seamlessly with one of the organisation’s core values—promptness and its corporate slogan, Humanity is the centre of our initiatives.
In a bid to further improve access and quality of care, SUNU Health also demonstrated its new operational software and Mobile app, aptly named SUNU Legacy.
Also speaking at the event, the NHIA Lagos State Coordinator (Ikeja), Dr Bethuel-Kasimu Abraham, noted that the forum’s expected outcome is to significantly reduce delays in accessing medical care.
Other key expectations include ensuring continuity of care, improving patient outcomes, and strengthening accountability among HMOs.
Addressing specific pain points faced by enrollees, the NHIA Ogun State Coordinator, Mr Dare Adefeso, acknowledged that the agency had received complaints regarding out-of-stock drugs and the discrimination of enrollees by certain providers.
He affirmed that the NHIA is actively addressing these issues, stressing that moving forward, every facility must ensure enrollees are properly catered to regardless of their status, provided they have an active health insurance plan.
Corroborating the long-standing legacy of SUNU Health, the Ogun State Director of the National Orientation Agency (NOA), Mrs Aishat Tiamiyu, shared that her agency is responsible for public information dissemination and has been enrolled with SUNU Health for over 25 years.
Commending the HMO’s stellar service over two decades, she called for the immediate enrollment of new NOA staff into the scheme.
The Providers’ Forum remains one of the strategic channels employed by SUNU Health to consistently engage healthcare providers, understand their operational challenges, introduce new software updates, and solidify partnerships aimed at fostering premium healthcare delivery across Nigeria.
By Aduragbemi Omiyale
The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the recall of a sexual enhancement product known as WAP Sensual Enhancement Capsules.
In a statement on Monday, the Nigerian agency disclosed that the recall is due to “undeclared pharmaceutical ingredients” in the product, whose country of origin is unknown, but is marketed and distributed online in the US through eBay.
It was emphasised that the recall is being “voluntarily” made by the manufacturer, Best Supplements Best Prices Company.
The detection of the undeclared pharmaceutical ingredients was made by the US Food and Drug Administration (FDA).
Laboratory analysis by the US FDA revealed that the product contained undeclared sildenafil, tadalafil, and flibanserin, which were not mentioned on the product label. Such substances may include phosphodiesterase type-5 (PDE-5) inhibitors or related compounds commonly used for the treatment of erectile dysfunction, the statement by NAFDAC stated.
Sildenafil and tadalafil are ingredients in FDA-approved prescription drugs used to treat erectile dysfunction.
It was noted that these undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Flibanserin is the active ingredient in an FDA-approved prescription drug used to treat low sexual desire in women. Flibanserin can cause drowsiness, sedation, dangerously low blood pressure, and fainting, especially when combined with alcohol.
Consumers have been encouraged to report compromised products (medicines or medical devices) to the nearest NAFDAC office, call 0800-162-3322, or send an email to sf******@********ov.ng.
