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…. WHO Lists COVAXIN® in EUL

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By Laide Akinboade

 World Health Organization (WHO) said it has issued an emergency use listing (EUL) for COVAXIN® (developed by Bharat Biotech), adding it to growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2.

In a statement issued by WHO, said the organization.

have  assessed  the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply.
It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

According to Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products,  “This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic  .

‘But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory.”

The statement reads, “COVAXIN® was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability. The Technical Advisory Group (TAG), convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used globally.

“The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.

“COVAXIN® was also reviewed on 5 October by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women).

 “The SAGE recommended use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. COVAXIN® was found to have 78% efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements.

“Available data from clinical trials on vaccination of pregnant women are insufficient to assess vaccine safety or efficacy in pregnancy; however, initial studies were reassuring. The vaccine has been given to over 120 000 pregnant women in India, with no short-term adverse effects noted.  Further studies in pregnant women are planned.

The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data, as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.

SAGE is the principal advisory group to WHO for vaccines and immunization. It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and immunization technology, research and development, to delivery of immunization and its linkages with other health interventions. SAGE is concerned not just with childhood vaccines and immunization, but all vaccine-preventable diseases.

Health

FG Promises Access To Eye Care For Every Nigerian

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Dr Iziaq Salako, the Minister of State for Health and Social Welfare says the Federal Government will ensure that every Nigerian has access to the eye care they need.

Salako said this in Abuja on Thursday at the Eyeball Summit organized by the Optometrists and Dispensing Opticians Registration Board of Nigeria (ODORBN).

The summit’s theme was “Shaping the Future of Eye Care in Nigeria: Strengthening Systems Through Strategic Alliances”.

According to Salako, the theme is quite apt and aligns with the ministry’s current line of investment in the health sector.

He said that it also aligned with the overall goal of the Renewed Hope Agenda to ensure that Nigerians are provided with the healthcare they need at any point in time without financial hardship.

He said that in the face of rising challenges, such as the increasing burden of visual impairment and the growing demand for eye care services, the ministry may not address the issue of eye health in isolation.

“By working together, we can ensure that every Nigerian, regardless of their geographical location or economic status, has access to the eye care they need.

“This summit serves as an important platform to collectively strategise and propose concrete solutions that can strengthen the eye care system in Nigeria.

“It can not be optimally productive without strategic alliances, collaboration and cooperation.

“It is through partnerships that we can pool resources, share expertise and develop innovative solutions to overcome the gaps in eye care provision,” Salako said .

According to him, it will include increasing awareness about the importance of regular eye check-ups, ensuring that the necessary infrastructure and human resources are in place to support the delivery of services.

He said that the partnership would also promote eye health friendly policies and provide continuous professional development training to ensure that eye health care givers are up to date in their knowledge and skills.

“The government is committed to ensuring that you have the necessary tools, policies, and an enabling environment to carry out your work effectively.

“Under this administration, we will continue to expand access to affordable eye care services, which are critical in a country where a large proportion of the population live in underserved areas,” he said.

Dr Obinna Awiaka, Registrar of the board, said that the summit was, a testament to their collective commitment, resilience, and aspiration.

Awiaka said that it symbolised the board’s relentless pursuit of excellence, the prioritisation of knowledge, innovation, partnership, and an unyielding devotion to preserving and enhancing the gift of sight for all Nigerians.

According to him, in an era marked by rapid technological change, shifting patient needs, and complex healthcare challenges, it is imperative that the custodians of vision health, stay ahead of the curve.

“We must constantly evolve, embracing innovation while upholding the highest ethical and professional standards.

“The theme speaks to a fundamental truth: No single entity, no matter how skilled or committed, can achieve transformative change alone,” he said.(NAN)

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Health

FG Pledges Mentorship, Leadership Support For Boy Child

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 The Ministry of Youth Development has reaffirmed its commitment to creating platforms that promote mentorship and leadership development for the boy child.

Mr Ayodele Olawande, Minister of Youth Development, said this on Friday in Abuja during a news conference to commemorate the International Day of the Boy Child.

The day is marked annually on May 16, with the 2025 theme, “Boys’ Mental Health and Well-being.

Olawande stated that the government believed every boy, regardless of background or economic status, deserved quality mentorship to help him thrive.

“As a government, we are committed to creating platforms that promote mentorship and leadership development for the boy child.

Through initiatives like this, we can provide them with the support they need to succeed,” he said.

The minister emphasised that the goal was to empower Nigerian youth, including boys, with the skills, knowledge, and opportunities necessary for success.

“In today’s world, many fathers have little time for their children, especially their sons. This can negatively impact their development and well-being,” Olawande noted.

He stressed the importance of mentorship in filling that gap: “Without positive male role models, many boys struggle to develop the skills and values needed to become responsible, productive members of society.”

He added that mentorship offered guidance, support, and helped boys build self-confidence, make sound decisions, and form positive relationships with adults.

Olawande also acknowledged the United Nations for recognizing the significance of supporting boys through mentorship, saying the International Day of the Boy Child reflected global commitment to promote their well-being and development.(NAN)

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Health

Enugu To Upgrade Health Facilities For Maternal, Newborn Care

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 The Enugu State Government has pledged to upgrade secondary healthcare facilities across its 17 Local Government Areas to reduce maternal and newborn mortality.

The commitment was made by the State Commissioner for Health, Prof. Emmanuel Obi, during a dissemination meeting on the assessment of health facilities for Comprehensive Emergency Obstetric and Newborn Care (CEmONC), in Enugu on Friday.

The meeting, themed “Strengthening Emergency and Newborn Care Through Evidence-Based Assessment,” was organised by the Enugu State Ministry of Health.

It was held in collaboration with the Federal Ministry of Health’s Sector-Wide Approach (SWAP) programme and Jhpiego, an affiliate of Johns Hopkins University, USA.

Prof. Obi explained that the initiative aimed to ensure Enugu had efficient secondary healthcare systems capable of providing emergency maternal and newborn care.

He noted that the state had already commenced its own facility assessment, which would now be harmonised with the CEmONC assessment.

“This is an official presentation of findings from the facility assessments conducted by the Federal Ministry of Health, the SWAP Office, and our State Ministry of Health,” he said.

He added that the upgrade would enable Enugu to access federal funding under the “Hope Health” programme and SWAP, based on performance-linked disbursement indicators.

Mrs Francisca Ewoh, SWAP Desk Officer, described the programme as part of Nigeria’s Health Sector Renewal Initiative aimed at reducing maternal and neonatal mortality nationwide.

According to her, pooled partner funds will be allocated to states that meet readiness requirements, with 35,000 dollars available per qualified facility in each council area.

“Eligibility is based on providing adequate infrastructure, utilities, and staffing in secondary healthcare centres.”

Dr Chinyere Ezendu, the Enugu State focal person for the CEmONC assessment, said only two facilities in the state met the basic standards for infrastructure, amenities, water, and electricity.

She added that none of the assessed facilities had the full capacity to manage neonatal complications.

 “We are hopeful the findings will be used to develop actionable plans to reduce maternal and neonatal deaths in the state,” she said.

Dr Chioma Oduenyi, a representative of Jhpiego, reaffirmed their technical support to both the national and state-level SWAP efforts in facilitating the implementation process.(NAN)

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