First malaria drug for newborns and young infants expected to be approved in Africa within weeks
The drug, known as Coartem Baby or Riamet Baby in some countries, has been approved by Swiss authorities for use in babies weighing between 2 kilograms (4 pounds, 6 ounces) and 5 kilograms (11 pounds) and is formulated to be easy for them to take, Novartis said.
Coartem Baby already has approval in the West African nation of Ghana and Novartis said it now expects eight African countries to grant their own approvals within 90 days. The countries – Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda – also participated in the assessment of the drug.
Vas Narasimhan, chief executive of Novartis, said in a news release that this first clinically proven malaria treatment for newborns and young babies ensures 'even the smallest and most vulnerable can finally receive the care they deserve.'
Until now, the smallest babies have been treated for malaria, a potentially deadly disease spread by mosquitoes, with medications designed for older children. Novartis, the Swiss pharmaceutical corporation behind the newly approved drug, says this can expose newborns to the risk of overdose and toxicity.
'Most clinical trials have historically excluded babies under six months old,' Novartis spokesman Ruairidh Villar told CNN.
There were 263 million cases of malaria and 597,000 deaths in 2023 – nearly all of them in Africa, according to World Health Organization data. Children under the age of 5 accounted for about three in four malaria deaths in the region.
The medicine was developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV), a Switzerland-based not-for-profit organization.
Novartis told CNN that it plans to 'roll out the medicine in the coming weeks on a largely not-for-profit basis.'
'Malaria is one of the world's deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated,' said Martin Fitchet, chief executive of MMV.
'The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.'
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The $400 million that the United States Congress removed from a list of programmes from which the Trump administration wants to cut funds, doesn't cancel the cuts to global HIV and TB programmes made in February. HIV projects that have closed in South Africa, which were formerly funded by the US government, won't restart as a result of this decision. The 'limited Pepfar waiver' that President Donald Trump announced in February remains in place. The $400 million that the United States (US) Congress removed from a list of programmes from which the Trump administration will now take back previously approved but unspent funds doesn't mean that the cuts to global HIV and TB programmes in February, including those in South Africa, are now reversed. HIV projects that have closed in South Africa, which were formerly funded by the US government, won't restart as a result of this decision. In fact, quite the opposite. The 'limited Pepfar (President's Emergency Plan for Aids Relief) waiver' that US President Donald Trump announced in February remains in place. That means no HIV-prevention activities, unless they intend to stop pregnant and breastfeeding women from infecting their babies, can be paid for with US government money, and projects that make it easier for teen girls and young women in Africa, trans people, sex workers, injecting drug users and gay and bisexual men - groups of people that have a higher chance of getting HIV than the general population - cannot be funded. READ | 'Systemic shock': SA's HIV viral load testing fell 21% in wake of Pepfar cuts - UNAIDS Without a proper explanation for it, the $400 million seems to be a random amount that Trump's administration picked to take back from Pepfar, a US government programme which funds Aids projects in poorer countries with high HIV infection rates, such as South Africa. The amount is about 8.5% of Pepfar's $4.725-billion budget for this financial year and was part of a larger $9.4-billion 'rescissions package' - that has now been reduced to $9 billion and passed as the HR4 Rescissions Act of 2025. Rescissions happen when the presidential administration wants to cancel funding that was approved by Congress and use it for something else. What the decision to remove the $400 million from the package does, however, mean is that activism could finally be starting to pay off. Activists have had hundreds of meetings with US senators and Congress committee chairs. There have been 'Save Pepfar' social media campaigns, and plenty of media coverage about the devastating consequences of the funding cuts. READ | Motsoaledi urges unity, assures HIV/Aids programme stability amid US Pepfar funding pullout Tens of modelling studies have also projected what could happen if the lost funds are not replaced. Opposition from within Trump's Republican Party against nonevidence-based cuts to a programme that has, for two decades, been supported by both the Democrats and Republicans and has saved over 25 million lives, is now at last emerging. 'It's a small win within the bigger context, but nonetheless, a huge win for advocacy, and a reminder that activism is powerful and alive, and making an impact,' Jirair Ratevosian, a former head of staff at Pepfar and fellow at Duke University's Global Health Institute, told Bhekisisa at last week's Conference on HIV Science in Kigali. Around $8 billion of the money was for foreign aid and development programmes, including global health, and just over $1 billion for public broadcast stations that the Trump administration has accused of being biased because they're too liberal. Marko Milivojevic/Pixnio via Bhekisisa But the Rescissions Act is, in itself, bad news. 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Three months later, in June, he decided he wanted to change some of that and submitted a $9.4-billion rescission request, which the House of Representatives (it has five more Republican than Democrat members) passed on 12 June. When it was the Senate's turn to vote on this, some Republican senators weren't happy with the $400-million Pepfar cut, signalling they wouldn't sign off on the deal unless the Pepfar part was removed. Because there was a danger of them swinging the vote, the Republicans removed the $400 million from the Rescissions Bill and got the House to pass that too. All that's left is for Trump to now sign the Act. 2. What was the $400 million that was removed from the Rescissions Act for? In short, no one really knows, because the Trump administration hasn't said what it was for - or what it plans to do with it. But what we do know is that the US law that governs rescissions, the Impoundment Control Act, says that the president can only request that Congress takes back funding that it previously approved, if the money has not yet been obligated - that means funds hadn't yet been given to a particular recipient, for instance, an HIV project in South Africa. We also know that the $400-million was part of the financial budget for 2025, says Warren, but because the law gives Pepfar permission to spend money over five years, that money doesn't have to be legally spent until 2029. 3. What will the $400 million now be used for? Again, no one knows. We don't even know if it will be used, because over the past few months, the Trump administration's main strategy has 'simply been to illegally impound funds - by announcing a 'funding freeze' or 'programmatic review' with no public notice at all - and force those harmed by the impoundments to pursue relief in court', the Centre on Budget and Policy Priorities explains in an analysis. But we do know what the money can't be used for. Unless the rules of Trump's 'limited waiver' are changed, Pepfar funds can mostly not be spent on any of the evidence-based strategies it paid for before Trump was elected in January. Pepfar used to focus on groups of people and areas where people have the highest chance of getting infected with HIV - that way, the programme got the biggest bang for its buck. In South Africa, for instance, Pepfar worked in the 27 districts with the highest infection rates and groups known as 'key populations' - sex workers, gay and bisexual men, trans people, injecting drug users and African women between the ages of 15 and 24 - that are much more likely to get newly infected with HIV than other South Africans. Now those projects, which studies show stopped many new infections, have been closed down and the Trump administration says it's not prepared to buy HIV prevention medicine for any group other than pregnant and breastfeeding women. 'It used to be all about evidence,' Warren says. 'Now it's all about ideology.' 4. What do scientists and activists want the $400 million to be used for? Ratevosian says this moment should be used to gain Republican support to change the waiver rules, so that Pepfar money can cover more of the populations and services needed for HIV prevention. Lenacapavir, a pricey twice-a-year anti-HIV jab, which scientists believe could help to stop HIV in its tracks if it's rolled out properly, could be used to convince Republican Congress members, says Ratevosian. 'Pepfar has long wanted to get countries to transition to taking more ownership [read: Pay more] for their HIV responses. So now activists are arguing: 'Preventing more new infections with the jab, will make it easier for countries to take ownership because the pandemic will be easier to manage.'' In December, Pepfar said it would join another organisation, the Global Fund for HIV, TB and Malaria to buy enough lenacapavir for two million people over three years. But in July, the Global Fund had to go ahead with the deal by itself, because Pepfar seemed to no longer be on board. 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