The country's top drug regulator has cleared a mpox vaccine developed by Chinese drugmaker Sinopharm for clinical trial on Monday, which could be the nation's first experimental dose to battle the deadly disease, according to the company.
The domestic vaccine candidate, created by the Shanghai Institute of Biological Products and administered by Sinopharm, is expected to play an important role in preventing and controlling mpox infections, the company said in a statement released on Monday afternoon.
In China, a vaccine candidate typically goes through three phases of clinical trials before gaining market approval. The process can take years, even decades, but the National Medical Products Administration, China's top drug regulator, has launched a number of accelerated or streamlined channels to facilitate applications of novel drugs and vaccines or those in urgent need.
According to the company, the new vaccine is a replication-deficient vaccine based on a strain called MVA. The description is the same as Jynneos, the world's first mpox vaccine approved by the Food and Drug Administration in the United States in 2019.
The company said that it has accumulated rich data on the vaccine's safety and efficacy through preclinical studies and production methods for the vaccine that are deemed reliable and stable.
"In nonhuman primate models, the vaccine can generate good immune protection against the mpox virus," it said.
There is currently no approved mpox vaccine in China. Globally, a few vaccines have been approved in the United States, Canada, the European Union, Japan and Russia.
The World Health Organization said on Aug 14 that the mpox outbreak in Africa constitutes a public health emergency of international concern — its highest form of alert.
Previously, in July 2022, the WHO declared a global emergency but then lifted it in May last year because of a sustained decline in international cases.
So far, more than 120 countries and regions across the world have reported more than 100,000 confirmed infections and 226 related deaths.
China classified mpox as a Class B infectious disease — on par with COVID-19 and HIV/AIDS — in September last year.
The nation reported the first imported case in September 2022 and the first domestic case in June last year.
By the end of July, the nation had reported 2,567 confirmed cases.
