Chinese monkeypox vaccine gets green light for clinical trials

A domestic monkeypox vaccine candidate developed by Chinese drugmaker Sinopharm received clearance from the top drug regulator for clinical trials on Monday, representing the nation's first experimental dose to win the trial approval, said the company.

The vaccine candidate is created by Shanghai Institute of Biological Products administered by Sinopharm and is expected to play an important role in preventing and controlling monkeypox infections, said the company 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 and 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 drug is a replication-deficient vaccine based on a strain called MVA. The description is the same as Jynneos, the world's first monkeypox vaccine approved by the Food and Drug Administration in the United States in 2019.

The company said it has accumulated rich data on the vaccine's safety and efficacy through preclinical studies and production methods for the vaccine are deemed reliable and stable.

"In nonhuman primate models, the vaccine can generate good immune protection against monkeypox virus," it said.

There is currently no approved monkeypox 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 monkeypox 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 in May 2023 because of a sustained decline in international cases.

So far, more than 120 countries and regions across the world have reported over 100,000 confirmed infections and 226 related deaths.

China classified monkeypox as a Class B infectious disease — on par with COVID-19 and AIDS — in September of last year.

The nation reported the first imported case in September 2022 and the first domestic case in June 2023.

As of the end of July, China reported 2,567 confirmed cases.