Zimbabwe Approves Twice‑Yearly HIV Injection After Record 23‑Day Review
Zimbabwe has fast-tracked approval of lenacapavir, a groundbreaking HIV prevention injection taken just twice a year.
The Medicines Control Authority of Zimbabwe (MCAZ) cleared the drug in a record 23 days, marking a major step in the country’s fight against HIV.
The treatment, submitted by Gilead on October 29, is intended for HIV-negative adults and adolescents weighing at least 35 kilogrammes who face high risk of infection.
Health officials and experts say the twice-yearly shot provides a crucial alternative to daily oral PrEP, which many users struggle to maintain.
The dosing schedule starts with one injection and oral tablets on days one and two.
After that, patients receive a subcutaneous shot every six months.
MCAZ stressed that lenacapavir must be used alongside safer sex practices, including condom use and behavioural risk reduction, to ensure full protection.
According to SundayMail, the authority said the expedited clearance reflects the urgent need for new prevention tools.
MCAZ director-general Richard Rukwata said the swift authorization highlights the regulator’s commitment to expanding access to reliable health products.
“The rapid approval of Lenacapavir reflects MCAZ’s dedication to accelerating access to trusted, high-quality health products. This milestone brings new hope for HIV prevention and reinforces our commitment to safeguarding public health,” he said.
Public health experts believe lenacapavir could sharply reduce new HIV infections if widely adopted, giving Zimbabwe a powerful new tool in its fight to end the epidemic.
