LILONGWE, Malawi — Malawi has taken a historic step in the fight against HIV by becoming the fourth African country to approve lenacapavir, the world’s first twice-yearly injectable drug for HIV prevention. On Thursday, the Pharmacy and Medicines Regulatory Authority (PMRA) officially authorised the medicine after an expedited 46-day review, making Malawi one of the earliest adopters globally of this long-acting pre-exposure prophylaxis (PrEP).
Developed by Gilead Sciences, lenacapavir is administered as a single subcutaneous injection every six months. In landmark clinical trials — PURPOSE 1 among cisgender women in South Africa and Uganda, and PURPOSE 2 among diverse populations in multiple countries — the drug demonstrated unprecedented efficacy: 100 % protection in women and girls and a 96 % reduction in HIV acquisition among men and gender-diverse individuals compared with daily oral Truvada. Side effects were mostly mild injection-site reactions.
Dr Beatrice Matanje, executive director of the National AIDS Commission (NAC), described the approval as a “great milestone” and a “major breakthrough” for Malawi. “A twice-yearly injection significantly reduces the burden of daily pill-taking and frequent clinic visits. This has the potential to transform preventive outcomes, especially for young women and girls who bear the heaviest burden of new infections,” she said.
PMRA Director General Mphatso Kawaye called the fast-tracked decision a “deliberate strategy to accelerate access to life-saving innovations.” The review was conducted in close collaboration with the European Medicines Agency (EMA) and the World Health Organization (WHO) under a reliance-based regulatory pathway that allows African regulators to leverage assessments already completed by stringent authorities.
Malawi now joins South Africa (approved October 2025), Zambia (November 2025) and Zimbabwe (November 2025) as the only African nations to have authorised the drug so far. Several others, including Botswana, including Botswana, Kenya, and Nigeria, are in advanced stages of review.
The approval comes at a critical time. Malawi has one of the highest HIV burdens in the world: approximately 950,000 adults and children are living with the virus, and women and adolescent girls account for more than 70 % of new infections. While the country has achieved the UNAIDS 95-95-95 treatment targets ahead of schedule, prevention coverage remains low, with only about one in four people at substantial risk currently using oral PrEP.
The Global Fund to Fight AIDS, Tuberculosis and Malaria has already committed funding and technical support for Malawi’s rollout. The first consignments of lenacapavir are expected to reach the continent before the end of 2025, with Malawi among the priority countries. Gilead has signed voluntary licensing agreements with six generic manufacturers to supply the drug at not-for-profit prices — estimated at around US$40 per person per year — to 120 low- and lower-middle-income countries, covering nearly 70 % of people living with HIV worldwide.
Health workers and activists welcomed the news with cautious optimism. “For many young women in rural areas, remembering a daily pill or getting to a clinic every month is a real challenge,” said Thoko Banda, a community health advocate in Blantyre. “Six months of protection from just one jab could be life-changing.”
The National AIDS Commission says it will prioritise adolescent girls and young women, female sex workers, men who have sex with men, and fishing communities along Lake Malawi for the initial rollout. Training of healthcare providers is scheduled to begin early next year, with pilot implementation planned in Lilongwe, Blantyre, and Mzuzu.
While supply volumes will be limited in 2026, advocates hope the arrival of generic versions from 2027 onward will allow rapid scale-up. UNAIDS and WHO have both described lenacapavir as a potential “game-changer” in the global effort to end AIDS as a public health threat by 2030.
For Malawi — a country that has lost generations to the epidemic — the approval of this twice-yearly injection offers renewed hope that the tide can finally turn.
