Malawi launches twice-yearly HIV jab

Malawi yesterday launched Lenacapavir, a twice-yearly injectable HIV prevention medicine amid reflections on whether the country can sustainably finance emerging technologies in the face of waning donor support.

Pharmacy and Medicines Regulatory Authority (PMRA) and National Aids Commission (NAC) formally confirmed the registration of the injection yesterday, describing it as a strategic addition to a prevention portfolio already under pressure from rising demand and constrained resources.

A fallen tree blocks the road in Manyowe, Blantyre.

Approved by PMRA on November 28, the drug is administered as a six-monthly subcutaneous injection after an initial phase of one dose plus oral tablets taken on the first two days.

Said PMRA director-general Mphatso Kawaye: “The expedited registration of Lenacapavir showcases PMRA’s unwavering commitment to fast-tracking access to high-quality, safe and efficacious medicines.”

NAC chief executive officer Dr Beatrice Matanje said the twice-yearly dose offers a new level of convenience and adherence support, particularly for people at substantial risk of HIV infection.

“The development marks a major breakthrough in HIV prevention. Its twice-yearly administration significantly reduces dosing burden and minimises the frequency of facility visits,” she said.

But civil society has cautioned that science alone will not guarantee impact unless long-term financing is secured.

Network of Journalists Living with HIV executive director David Kamkwamba suggested that Malawi must confront the sustainability challenge head-on amid withdraw by some financiers.

Health rights activist Maziko Matemba welcomed the development, noting that it comes at a time when new HIV infections among men and young people continue despite progress towards the UNAids 95-95-95 targets.

Malawi currently offers daily oral pre-exposure prophylaxis (PrEP) and recently added Cabotegravir, another injectable PrEP administered every two months but limited to Lilongwe and Blantyre.

The product approval in the country follows a review of an application through a collaborative procedure with the European Medicines Agency and the World Health Organisation.

Manuf ac t u red by Gi l ead Sciences Ireland UC, Lenacapavir is recommended for adults and adolescents weighing at least 35 kilogrammes.