Nigerian company to make HIV, malaria test kits after US funding cut

LAGOS, June 19 (Reuters) - Nigerian manufacturer Codix Bio Ltd plans to make millions of HIV and Malaria test kits at its new plant outside Lagos for the local and regional market to help fill gaps in the wake of cutbacks at U.S. donor agency USAID, a company executive said.
The United States, the world's largest humanitarian aid donor, has cut funding for foreign assistance, half of which is
delivered via USAID.
The U.S. support to Nigeria, which reached $740 million in 2024 based on USAID data, is focused on preventing malaria and curbing HIV as well as delivering vaccines to local health centres across the country.
It is not yet clear how Nigeria will be affected by the cuts. The Nigerian government has said it will raise funds to continue some of the programmes that donors supported.
Codix Bio general manager Olanrewaju Balaja said the company will roll out kits later this month from its plant in partnership with the South Korean pharmaceutical producer SD Biosensor and support from the World Health Organization.
The plant has an initial capacity to produce 147 million kits annually, but this can be expanded to over 160 million.
"From the statistics of what is supplied (by USAID and PEPFAR) for a specific programme year, and looking at what we have currently in capacity for Nigeria, we have enough capacity to meet the demand," Balaja told Reuters.
He said if the company scaled up operations, "we can go to West and Sub-Saharan Africa, including other African countries."
Nigeria has the highest burden of malaria globally, according to WHO, with nearly 27% of the global burden. The country also has the world's fourth highest burden of HIV, according to UNAIDS.
"The focus was for us to be able to play in the field of supply of rapid diagnostic test kits for donor agencies, which particularly USAID was at the forefront," Balaja added.
Balaja said the Nigerian government and donor agencies like Global Fund were expected to purchase test kits from Codix Bio.

Try Our AI Features

Explore what Daily8 AI can do for you:

Learn with AIFact CheckingText to SpeechAI Summary

Related Articles

The Independent

2 hours ago

• The Independent

US approves breakthrough HIV jab – but aid cuts mean it may not get to millions in need

US medicines regulator the Food and Drug Administration (FDA) has approved a groundbreaking HIV prevention jab hailed as having the potential to quell the Aids pandemic. But the moment has been overshadowed by the spectre of aid cuts, placing in doubt whether this breakthrough injection – lenacapavir – will get to the people who need it most. Lenacapavir given in a twice-yearly injection stops HIV from replicating, protecting close to 100 per cent of people from developing the virus if they are exposed to it. This approval is one of the last crucial steps to getting the drug, branded Yeztugo, out to patients. Although the FDA's approval only applies to US patients, the World Health Organization (WHO) said it paved the way for its own recommendation of the drug and for approval in other countries. Director of WHO's Global HIV, Hepatitis and STI Programmes, Dr Meg Doherty described it as a 'regulatory milestone' adding: 'We are working with partners and national authorities to ensure lenacapavir reaches people who need it most – quickly, safely and equitably.' Researchers have raised concerns that, amid aid cuts, the jab will be too expensive to be taken up by lower-income countries. Gilead – the drugs company producing lencapavir – did not make public the cost of each dose to global funders but it announced a US price of $28,218 per year for each patient. 'If this game-changing medicine remains unaffordable, it will change nothing,' said Winnie Byanyima, executive director of the United Nations' Aids agency, UNAIDS. She called the approval of lenacapavir a 'breakthrough moment' adding the jab, 'could be the tool we need to bring new infections under control – but only if it is priced affordably and made available to everyone who could benefit. ' UNAIDS has seen research that lenacapavir can be produced for just $40 per person per year, falling to $25 within a year of roll out. It is beyond comprehension how Gilead can justify a price of $28,218.' Dr Andrew Hill, a pharmacology research fellow at the University of Liverpool, worked on the research which found lenacapavir could be provided for as little as $25, including a 30 per cent profit margin. 'Scientifically, it's a great moment that we have a drug which has been judged to be safe and efficacious by a leading regulatory authority in the world,'' he said. 'Public health-wise and in terms of the epidemic, it's tragic because the drug is so expensive that it's not going to get used'. It is also unlikely to be affordable in the UK, he said, despite government promises to end new cases of HIV in England by 2030. A Gilead spokesperson said, 'Yeztugo is priced in line with existing branded PrEP [pre-exposure prophylaxis] options. We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage in the US. 'We're taking unprecedented actions with urgency to plan for access to lenacapavir for PrEP globally—particularly in low- and lower-middle-income countries where the need is greatest.' Gilead signed agreements with six pharmaceutical companies in India, Pakistan, Egypt, and the US to allow them to make generic versions of the drug in order to increase supply and drive down the cost of the jab. This will take some time. Gilead also agreed to sell enough doses of the jab to protect at least two million people over three years in lower-income countries. These would be paid for by global funders led by the US President's Emergency Plan for Aids Relief (Pepfar) and the Global Fund to Fight Aids, Tuberculosis and Malaria. However, The Independent reported earlier in the month that these doses are now at risk because of US funding cuts. A significant chunk of the money to fund the doses of lenacapavir was set to come from the US-led global Aids response programme, Pepfar, as well as the Global Fund whose biggest donor was the US. This funding is now uncertain. Figures previously reported by The Independent suggest President Trump's slashing of foreign aid has derailed the projected end of the Aids pandemic and could lead to four million extra deaths by 2030. 'It does feel like this thing that could help us end the epidemic sooner is suddenly receding in the chaos,' said Prof Linda-Gail Bekker, whose trial demonstrated lenacapavir's effectiveness. The aid-funded doses are thought to cost much less than the US list price of almost $30k but still roughly five times more expensive than Dr Hill believes is necessary. And they are in an initial pilot phase, he said: 'We need to get into a different level where we're giving lenacapavir to tens of millions of people'. This is even more important as aid cuts are slashing the HIV prevention budgets of governments across Africa, he said. 'We're in this crazy position where we have a brand new highly effective vaccine-like drug and actually we will probably see the epidemic get worse over the next four years.'

Edinburgh Reporter

3 hours ago

• Edinburgh Reporter

Turning Data into Decisions The Power of Clinical Data Management in Modern Trials

Every clinical trial, no matter how complex or straightforward, generates data. From laboratory results and electronic case report forms to adverse event reports and patient-reported outcomes, the flow of data is constant and massive. Yet, raw data alone is not useful — it must be structured, validated, and transformed into reliable evidence that supports regulatory approval and, ultimately, clinical decisions. This is where clinical research data management services play an indispensable role. Why Is Data Management So Critical in Clinical Trials? In today's clinical environment, the speed and success of a study are increasingly determined by how efficiently data is handled. Sponsors, regulators, and investigators depend on high-quality, timely information to make protocol adjustments, conduct safety reviews, and prepare submissions. Poor data management can delay a trial, increase costs, or even invalidate results. Good data management ensures: Integrity of the study database Compliance with global regulatory standards Real-time monitoring of trial progress Faster insights for interim and final analyses Improved collaboration across teams Modern clinical trials cannot afford to treat data handling as an afterthought. It must be embedded from day one. What Do Data Management Services Typically Include? Clinical research data management services encompass a wide range of responsibilities, technologies, and workflows — all aimed at ensuring clean, accurate, and compliant data throughout the trial lifecycle. Some of the core components include: Case Report Form (CRF) design : Structuring questions and data fields for clarity and completeness : Structuring questions and data fields for clarity and completeness Electronic Data Capture (EDC) systems : Platforms for collecting and storing data securely : Platforms for collecting and storing data securely Query management : Identifying and resolving discrepancies or missing data : Identifying and resolving discrepancies or missing data Database validation and cleaning : Regular checks for consistency, outliers, or protocol deviations : Regular checks for consistency, outliers, or protocol deviations Data coding : Standardizing medical terms (e.g., MedDRA, WHO-DD) for analysis : Standardizing medical terms (e.g., MedDRA, WHO-DD) for analysis Data transfer and locking: Secure sharing of final datasets with statisticians and regulatory teams A well-functioning data management team works quietly behind the scenes, but their impact is felt throughout the trial — especially when problems are avoided or quickly resolved. EDC platforms (e.g., Medidata, Veeva, REDCap) Clinical Trial Management Systems (CTMS) ePRO and eCOA tools for patient input Risk-based monitoring dashboards Validation scripts and automated edit checks Image by Konstantin Kolosov from Pixabay Challenges and Solutions in Managing Trial Data Despite advances in technology, data management is not without its hurdles. Trials are becoming more decentralized, data sources are more diverse, and expectations for real-time insights are growing. Managing this complexity requires both technical skill and strategic thinking. Let's explore some common challenges and how experienced data managers address them: Decentralized data collection With patients submitting data via mobile apps, wearables, or home diagnostics, data managers must integrate and validate new input formats without compromising consistency. With patients submitting data via mobile apps, wearables, or home diagnostics, data managers must integrate and validate new input formats without compromising consistency. Protocol amendments mid-trial When protocols change, CRFs and data pipelines must be updated immediately — without jeopardizing data already collected. Agile EDC systems and flexible coding structures are essential. When protocols change, CRFs and data pipelines must be updated immediately — without jeopardizing data already collected. Agile EDC systems and flexible coding structures are essential. Cross-system integration Studies often involve multiple software platforms. Data teams must ensure smooth integration and unified reporting, especially when working with third-party labs or imaging providers. Studies often involve multiple software platforms. Data teams must ensure smooth integration and unified reporting, especially when working with third-party labs or imaging providers. Global data privacy compliance Regulations like GDPR and HIPAA mandate strict controls over patient information. Data managers ensure anonymization, encryption, and secure access at every stage. Regulations like GDPR and HIPAA mandate strict controls over patient information. Data managers ensure anonymization, encryption, and secure access at every stage. Fast database lock expectations Sponsors want results quickly. Data teams must balance speed with quality, preparing for interim analyses or regulatory submissions without rushing validation. Experienced providers of clinical research data management services anticipate these issues. Their processes are built to handle complexity, mitigate risks, and deliver results — often under significant time pressure. Why Outsourcing Data Management Makes Sense Many sponsors — especially smaller biotech or device companies — don't have in-house capacity to manage trial data effectively. Partnering with an external data management provider offers: Access to specialized expertise and tools Scalable support across multiple studies Greater consistency in data standards and coding Seamless integration with biostatistics and regulatory teams Cost-efficiency through centralized infrastructure However, choosing the right partner is essential. Sponsors should evaluate potential providers not only on technology, but also on experience with specific therapeutic areas, audit history, and adaptability to evolving trial designs. From Numbers to Knowledge Ultimately, the true value of data management lies in its ability to turn chaos into clarity. Clean, structured, and timely data enables more than just trial completion — it fuels insights, accelerates innovation, and drives better health outcomes. Whether through centralized databases, AI-assisted cleaning tools, or dedicated query resolution teams, modern clinical data handling has become a cornerstone of successful studies. In a world where speed, safety, and transparency are non-negotiable, data management is no longer a back-office function — it's a front-line driver of progress. Like this: Like Related

Reuters

8 hours ago

• Reuters

Insight: Trump aid cuts deal a blow to HIV prevention in Africa

June 20 (Reuters) - Emmanuel Cherem, a 25-year-old gay man in Nigeria, tested positive for HIV two months after U.S. President Donald Trump's administration cut access for at-risk groups like gay men and injecting drug users to medication that prevents infection. Cherem admits he should have been more careful about practicing safe sex but had become accustomed to using the U.S.-supplied pharmaceutical. The drug - known as Pre-Exposure Prophylaxis, or PrEP - is typically taken daily as a tablet and can reduce the risk of contracting HIV through sex by 99%. "I blame myself... Taking care of myself is my first duty as a person," Cherem said at his gym in Awka, the capital of Nigeria's southeastern state of Anambra. "I equally blame the Trump administration because, you know, these things were available, and then, without prior notice, these things were cut off." Trump ordered a 90-day pause on foreign aid after taking office in January and halted grants by the U.S. Agency for International Development (USAID). The agency was responsible for implementing the bulk of the assistance under the President's Emergency Plan for AIDS Relief (PEPFAR), the world's leading HIV/AIDS initiative. Sub-Saharan Africa remains the epicenter of the AIDS pandemic. Trump's cuts have restricted the availability of drugs that millions of Africans have taken to prevent infection - particularly vulnerable communities such as gay men and sex workers - as aid groups and public health systems in Africa strove to roll back the disease. The number of initiations, or people who have taken at least one dose of the drug, rose in Africa from fewer than 700 in 2016 to more than 6 million by late 2024, according to PrEPWatch, opens new tab, a global tracker. More than 90% of new initiations last year were financed by PEPFAR, using cheap generic versions of the drug. Sub-Saharan Africa had 390,000 AIDS-related deaths in 2023, or 62% of the global total, according to UNAIDS, the United Nations AIDS agency. However, progress has been made: that death toll was down by 56% from 2010, according to the World Health Organization. Now, some of those who've lost access to the preventative medication because of U.S. cutbacks are already testing positive, according to 10 patients, health officials and activists. Restrictions on PrEP have coincided with dwindling supplies of more widely used HIV prevention tools like condoms and lubricants "because of the US funding cuts", according to a UNAIDS fact sheet, opens new tab from May. The combination is creating what nine activists and three medical experts described as a major threat to prevention across the continent. "I just see this as incredibly short-sighted because we were on a winning path," said Linda-Gail Bekker, an HIV expert at the University of Cape Town. She said that many African governments did not have the resources to spend on PrEP drugs on top of treatment for HIV infections, risking a worsening of the pandemic. "It's as predictable as if you take your eye off a smouldering bushfire and the wind is blowing: a bushfire will come back." Trump has said that the United States pays disproportionately for foreign aid and he wants other countries to shoulder more of the burden, as he seeks to reduce U.S. government spending across the board. The U.S. disbursed $65 billion in foreign assistance last year, nearly half of it via USAID, according to government data, opens new tab. "It's a question of who has primary responsibility for the health needs of citizens of other countries, and it's their own governments," said Max Primorac, a former senior USAID official who is now senior research fellow at The Heritage Foundation's Margaret Thatcher Center for Freedom. "We all know, and this is a bipartisan issue, that aid dependency doesn't help these people - that the best solution is for these countries to be able to take over the responsibility of these programs." UNAIDS says the permanent discontinuation of PEPFAR-supported prevention and treatment programs could lead to an additional 2,300 new HIV cases globally per day. There were 3,500 new cases per day in 2023. Reuters spoke to 23 health workers, PrEP users and activists, nearly all of whom said that the increase in HIV infections since the funding cuts was impossible to quantify because many organisations working with vulnerable populations have been defunded. A State Department waiver issued on February 1 allowed some PEPFAR activities to restart, but only covered HIV prevention for mother-to-child transmission. That means PEPFAR-financed PrEP is no longer available for gay and bisexual men, sex workers and injecting drug users who are especially exposed to the virus. Many African governments had specifically targeted these groups in their PrEP programs. A spokesperson for the State Department, which oversees USAID and the PEPFAR program, told Reuters it "continues to support lifesaving HIV testing, care and treatment, and prevention of mother to child transmission services approved by the Secretary of State." "All other PEPFAR-funded services are being reviewed for assessment of programmatic efficiencies and consistency with United States foreign policy," the spokesperson said. The spokesperson did not directly respond to a question about why the waiver had excluded vulnerable groups from PrEP distribution. In East and Southern Africa, the sub-region that accounts for more than half of all people living with HIV, the U.S. had been funding nearly 45% of HIV prevention programming, UNAIDS said in March, opens new tab. Some countries like Malawi, Zimbabwe and Mozambique were almost entirely dependent on PEPFAR for their HIV prevention programs, the agency said. In some wealthier nations, like South Africa and Kenya, PEPFAR represented less than 25% of spending on HIV prevention. Russell Vought, the director of the U.S. Office of Management and Budget, told a Congressional committee on June 4 that, due to high U.S. debt levels, Africa needed to shoulder more of the burden in fighting AIDS. Asked specifically about restrictions on HIV prevention programs, Vought said: "We believe that many of these nonprofits are not geared toward the viewpoints of the administration." His office did not respond to a request for further details. Reuters spoke to four PrEP users in Nigeria, all gay or bisexual men, who have tested positive for HIV since January when they stopped being able to obtain more pills, after practicing unsafe sex. Hearty Empowerment and Rights (HER) Initiative, a community-based organisation in southeastern Nigeria, worked with other groups that provide HIV/AIDS services to confirm the men's diagnosis and help secure treatment for them, said executive director Festus Alex Chinaza. In Asaba, the capital of Nigeria's Delta state, Echezona, a 30-year-old gay man who took PrEP pills daily for more than three years, is struggling to come to terms with his HIV-positive test result, which he received in early May. He regrets that he had unprotected sex. "I just pray and wish that Trump actually changes his policy and everything comes back to normal so that the spread and transmission of the virus would be reduced," said Echezona, who asked to be identified only by his first name for fear of stigma. Like the other three men, he described being told by staff at community-based clinics that PrEP was only available to pregnant and lactating women, in line with the Trump administration guidelines. Nigeria has an adult HIV prevalence rate of 1.3% and an estimated 2 million people living with HIV, the fourth-highest total globally, according to UNAIDS. But for so-called key populations, the rates are much higher: 25% for men who have sex with men, according to a survey completed in 2021. The Nigerian health ministry did not respond to a request for comment on the effects of the Trump administration's cuts to HIV prevention services. South Africa – which has an estimated 7.7 million people living with HIV, according to UNAIDS, the highest number in the world - pays for its own PrEP pills. But some clinics where so-called key populations obtained them relied on PEPFAR grants and have been forced to close in recent months. PrEP is also available for free at public health centers, but gay men and sex workers often avoid such facilities, fearing discrimination and harassment, nine activists said. Francois Venter, executive director of the Ezintsha medical research center at the University of the Witwatersrand in Johannesburg, said PrEP distribution from public sector clinics in the city had shown almost no increase since the Trump cuts. Foster Mohale, spokesperson for South Africa's health ministry, said the ministry was "not aware" of reports that key populations were avoiding health facilities due to stigma. "We have sensitized health officials across the country to create (a) conducive environment for all healthcare seekers/clients to access the service without feeling judged or discriminated against," he said.