10-9-2024 (BEIJING) Sinopharm, a leading Chinese drugmaker, has received the green light from the country’s top drug regulator to commence clinical trials for its domestically developed mpox vaccine candidate. This milestone marks the first such approval for an experimental mpox vaccine in China, signalling a major step forward in the nation’s efforts to combat the global health threat.
The vaccine, developed by the Shanghai Institute of Biological Products under Sinopharm’s umbrella, is poised to play a crucial role in the prevention and control of mpox infections, according to a statement released by the company on Monday afternoon. This announcement comes at a time when the global health community continues to grapple with the ongoing mpox outbreak.
Sinopharm’s vaccine candidate is described as a replication-deficient vaccine based on the MVA strain, sharing similarities with Jynneos, the world’s first monkeypox vaccine approved by the US Food and Drug Administration in 2019. The company reports that extensive preclinical studies have yielded promising data on the vaccine’s safety and efficacy, with production methods deemed reliable and stable.
“In nonhuman primate models, the vaccine has demonstrated the ability to generate robust immune protection against the monkeypox virus,” the company stated, underlining the potential of this new candidate.
The approval for clinical trials represents a significant milestone in China’s vaccine development landscape. Typically, vaccine candidates in China undergo three phases of clinical trials before obtaining market approval, a process that can span years or even decades. However, the National Medical Products Administration has implemented accelerated channels to expedite the development of novel drugs and vaccines, particularly those addressing urgent public health needs.
Currently, China has no approved mpox vaccine, while several have been authorised in countries including the United States, Canada, European Union member states, Japan, and Russia. This development positions China to potentially join the ranks of nations with domestically produced mpox vaccines.
The timing of this announcement is particularly pertinent given the World Health Organization’s recent declaration on 14 August that the monkeypox outbreak in Africa constitutes a public health emergency of international concern – its highest form of alert. This follows a previous global emergency declaration in July 2022, which was lifted in May 2023 due to a sustained decline in international cases.
To date, over 120 countries and regions worldwide have reported more than 100,000 confirmed mpox infections and 226 related deaths. In response to the global situation, China classified mpox as a Class B infectious disease – on par with COVID-19 and AIDS – in September last year.
China reported its first imported mpox case in September 2022, followed by the first domestic case in June 2023. By the end of July, the country had recorded 2,567 confirmed cases, underscoring the need for effective preventive measures and treatments.
