Malawi fast-tracks breakthrough HIV prevention jab, becoming regional pioneer

The country’s approval of twice-yearly lenacapavir positions Malawi among the world’s earliest adopters of cutting-edge HIV prevention tools.

By Collins Mtika

Malawi has approved lenacapavir, a novel long-acting injectable for HIV prevention, becoming the fourth African nation to authorize the medicine and signaling growing continental momentum toward next-generation prevention options.

The Pharmacy and Medicines Regulatory Authority (PMRA) issued the approval on November 28 following a swift 46-day expedited review, placing Malawi among the world’s earliest adopters of the drug.

Lenacapavir, developed by Gilead Sciences Ireland UC, is administered through a single subcutaneous injection every six months and is intended for HIV-negative individuals at substantial risk of acquiring the virus.

It is the first twice-yearly HIV prevention method ever to reach regulatory approval in low-income settings.

Global clinical trials have demonstrated unprecedented results.

In a Phase 3 trial involving women in sub-Saharan Africa, traditionally the demographic with the highest infection burden, the drug achieved 100% protection, with no recorded HIV infections among participants receiving lenacapavir.

Another study involving men who have sex with men reported 99.9% effectiveness, with only two infections among 2,179 participants, both occurring before full drug exposure.

Such results have led experts to describe lenacapavir as the most promising biomedical HIV prevention tool since pre-exposure prophylaxis (PrEP) was introduced a decade ago.

Malawi’s approval comes as the country continues to battle one of the highest HIV prevalence rates in the world. About 946,000 Malawians are living with HIV, representing an 8.9% adult prevalence.

While Malawi has made major gains, over 97.9% of people aware of their status are on antiretroviral therapy with suppressed viral loads; new infections remain stubbornly high at 2.3 per 1,000 adults annually.

Young women aged 15–24 remain disproportionately affected, with infection rates twice those of their male peers.

Gender inequality, limited access to youth-friendly health services, and inconsistent adherence to daily prevention pills continue to drive new cases.

“This approval represents a major breakthrough in HIV prevention,” said Dr Beatrice Matanje, CEO of Malawi’s National AIDS Commission.

“A twice-yearly injection significantly reduces the burden of adherence and clinic visits, and this has the potential to transform prevention outcomes, especially for young women.”

PMRA Director General Mphatso Kawaye described the rapid regulatory review as a deliberate strategy to accelerate access to lifesaving innovations:

“The expedited registration of lenacapavir showcases PMRA’s unwavering commitment to fast-tracking high-quality, safe, and effective medicines for Malawians.”

The approval was facilitated through a collaborative registration pathway involving the European Medicines Agency (EMA) and the World Health Organization (WHO), which has been instrumental in accelerating regulatory decisions across southern Africa.

South Africa approved lenacapavir in October, followed by Zambia and Zimbabwe in November, and additional African regulators are expected to follow in 2025.

The Global Fund has committed to supporting country adoption, with first consignments expected to arrive in Africa by the end of the year and broader programmatic introduction targeted for early 2026.

Generic manufacturers have pledged to supply the injection for about US$40 per person per year by 2027, a pricing milestone seen as crucial for broad uptake in low-income countries.

Malawi currently provides daily oral PrEP in all 28 districts and has recently begun rolling out cabotegravir, another long-acting injectable administered every two months.

Cabotegravir is currently being piloted in four districts, with an expansion to 11 more planned in 2026.

Health authorities say lenacapavir will be introduced through a phased approach, with implementation guidelines to be announced.

The long-acting profile is expected to resonate strongly with many potential users. More than 75% of trial participants preferred the twice-yearly injection over daily pills, citing convenience, discretion, and a stronger sense of protection.

For Malawi, where distance to health facilities, stigma, and adherence challenges consistently hinder prevention efforts, the introduction of lenacapavir could mark a turning point.

With women and young people driving new infections, the drug’s extended protection window may offer the most practical tool yet to curb transmission.

As global health leaders look toward ending AIDS as a public health threat by 2030, Malawi’s early adoption of innovative tools places it among the countries redefining what is possible in the HIV response.