China's National Medical Products Administration has granted clearance for Sinopharm's mpox vaccine candidate to proceed with clinical trials. This marks a significant advancement in China's efforts to combat the infectious disease, as it is the first domestically developed mpox vaccine to reach this stage. The vaccine candidate, developed by the Shanghai Institute of Biological Products, a subsidiary of Sinopharm, is expected to play a crucial role in preventing and controlling mpox infections within the country.
Vaccine Design and Preclinical Data
The Sinopharm vaccine is a replication-deficient vaccine based on the Modified Vaccinia Ankara (MVA) strain. This design mirrors that of Jynneos, the first mpox vaccine approved by the U.S. Food and Drug Administration in 2019. Preclinical studies conducted by Sinopharm have demonstrated promising safety and efficacy data. According to the company, the vaccine has shown the ability to generate strong immune protection against the mpox virus in non-human primate models, suggesting its potential to prevent infection and disease progression in humans.
Regulatory Context and Clinical Trial Process
In China, vaccines typically undergo three phases of clinical trials before they can be considered for market approval. While this process can often take several years, the National Medical Products Administration has implemented accelerated pathways to expedite the review and approval of novel drugs and vaccines, particularly those addressing urgent medical needs. The clearance of Sinopharm's mpox vaccine for clinical trials reflects the urgency with which Chinese authorities are addressing the potential threat of mpox.
Mpox Outbreak and Global Response
The World Health Organization (WHO) has declared the mpox outbreak in Africa a Public Health Emergency of International Concern. Globally, over 120 countries and regions have reported more than 100,000 confirmed infections and 226 related deaths. China classified mpox as a Class B infectious disease in September of last year and has reported 2,567 confirmed cases as of the end of July. The development of a domestic vaccine is therefore a key priority for public health officials.
Addressing an Unmet Need
Currently, there are no approved mpox vaccines available in China. While several vaccines have been approved in other countries, including the United States, Canada, the European Union, Japan, and Russia, access to these vaccines may be limited. The Sinopharm vaccine, if successful in clinical trials, could provide a critical tool for preventing and controlling mpox infections in China and potentially contribute to global efforts to combat the disease.
