China has begun the Phase I clinical trials for its first monkeypox vaccine. The vaccine, developed by the Shanghai Institute of Biological Products (SIBP), has gained approval from the National Medical Products Administration. It aims to offer protection against the monkeypox virus, which has been a growing concern globally.
The vaccine is a live attenuated version, based on the Modified Vaccinia Virus Ankara (MVA) platform. It has been specifically developed for monkeypox, a viral zoonotic disease similar to smallpox. This virus spreads through various channels, including direct contact, respiratory droplets, contaminated objects, sexual contact, and from mother to child.
The Phase I trials are taking place at the Henan Infection Diseases Hospital in Zhengzhou, the capital of Henan Province. The research team will enroll 120 volunteers aged 18 and above. The selected volunteers will consist of healthy individuals, men who have sex with men, and people living with HIV. Recruitment will focus on those who meet specific health criteria, including a body temperature below 37.3°C on the day of enrollment.
The trial will also require participants to meet specific demographic and health-related criteria. For example, participants who were vaccinated against smallpox must have been born before 1980. Women of childbearing age and male participants must agree to use effective contraception for the duration of the study.
While this is China’s first monkeypox vaccine to enter clinical trials, the development has come after global concerns about the virus. The World Health Organization (WHO) has issued interim guidance on monkeypox vaccination, recommending the vaccine for close contacts of monkeypox patients and other high-risk groups. These high-risk groups include healthcare workers, researchers, and men who have sex with men.
The vaccine’s safety and efficacy have been demonstrated through extensive preclinical trials. It has shown promising results in non-human primates, where it provided strong immune protection against the virus. This data is crucial for its potential future use in preventing outbreaks of monkeypox in humans.
Experts have highlighted that the MVA-based vaccine is produced using a mature cell factory manufacturing process. This ensures stable production and consistent quality control. These features make the vaccine highly reliable for future mass production and distribution if it proves successful in human trials.
Monkeypox, a virus similar to smallpox but with milder symptoms, has been recognized for its ability to cause severe illness, particularly in immunocompromised individuals. The mortality rate for monkeypox ranges from 1% to 10%. However, the symptoms, such as swollen lymph nodes, fever, and sore throat, often resemble those of other viral infections.
Currently, there are no approved monkeypox vaccines in China. However, there are two vaccines approved by the US Food and Drug Administration (FDA) to combat monkeypox. These are JYNNEOS and ACAM2000. JYNNEOS is a non-replicating orthopoxvirus vaccine, while ACAM2000 is a live, replicating vaccinia virus vaccine. Despite their availability, these vaccines are not suitable for all populations due to potential adverse reactions.
China’s approval of the first monkeypox vaccine for clinical trials could play a pivotal role in controlling future outbreaks. The vaccine’s potential efficacy could make it a critical tool in the global fight against monkeypox, especially in regions that have not yet seen widespread access to vaccines like JYNNEOS and ACAM2000.
As the clinical trials progress, the world will be watching closely to determine whether this new vaccine will be effective in preventing the spread of monkeypox. With the rising concern over emerging diseases, the development of new vaccines like China’s monkeypox vaccine represents a significant step in global health preparedness.
This vaccine development is another example of China’s growing role in global public health and vaccine production. As more data becomes available, experts will assess its potential impact in both China and globally. If successful, it could pave the way for more advanced vaccines for emerging diseases.
