Beijing (Agencies): China’s first domestically developed monkeypox vaccine has officially entered phase I clinical trials, with recruitment underway for volunteers in Zhengzhou, capital of Henan Province, according to a statement by the Shanghai Institute of Biological Products Co. (SIBP) under the China National Pharmaceutical Group Corp (Sinopharm).
The vaccine, which is based on a Modified Vaccinia Virus Ankara (MVA) platform, is a live attenuated vaccine designed to offer protection against the monkeypox virus, a zoonotic disease known for symptoms similar to smallpox but generally milder and with a lower mortality rate.
The Henan Infectious Diseases Hospital is conducting the phase I trials, with plans to recruit 120 volunteers aged 18 and above. These include 60 healthy individuals, 30 men who have sex with men (MSM), and 30 people living with HIV — groups considered to be at higher risk of monkeypox infection based on WHO guidance.
Eligible participants must meet strict criteria, including a body temperature below 37.3°C on the day of enrollment. Individuals previously vaccinated against smallpox must have been born before 1980. Female participants of childbearing age and all male participants are required to use contraception and refrain from conceiving for at least six months. The application deadline is August 21, 2025.
The vaccine received clinical trial approval from the National Medical Products Administration (NMPA) on September 9, 2024, making it the first monkeypox vaccine in China to reach this stage, according to Chinese media outlet The Paper.
Monkeypox, caused by the monkeypox virus, spreads through direct contact, respiratory droplets, contaminated objects, sexual transmission, and mother-to-child transmission. Symptoms typically appear after a one- to five-day prodromal phase, including fever, swollen lymph nodes, headaches, and body aches.
Preclinical trials of the Chinese MVA-based vaccine demonstrated strong immune protection in non-human primates and were found to be safe and effective, experts from SIBP stated. The vaccine utilizes a mature cell factory production method, ensuring consistent quality and stable manufacturing.
Currently, no monkeypox vaccine has been approved for general use in China. In contrast, the United States has two monkeypox vaccines approved by the FDA — JYNNEOS, a non-replicating live virus vaccine, and ACAM2000, a replicating vaccine not suitable for all populations due to potential adverse effects. JYNNEOS is also marketed as Imvanex in the UK and Europe, and Imvamune in Canada.
The launch of clinical trials for a homegrown vaccine marks a significant step in China’s public health preparedness and response capabilities, especially as global attention remains focused on preventing future outbreaks of monkeypox and other zoonotic diseases.