China’s drug regulator clears mpox vaccine; to undergo clinical trial

In China, a vaccine candidate typically goes through three phases of clinical trials before gaining market approval (representational image)

China’s top drug regulator has cleared a mpox vaccine developed by local drug firm Sinopharm for clinical trials which could be the country’s first experimental dose to battle the deadly disease.

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.

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.

In China, a vaccine candidate typically goes through three phases of clinical trials before gaining market approval.

The process can take years, even decades. However, 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, state-run China Daily reported on Tuesday.

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 World Health Organisation said on August 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 reported its 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, according to the China Daily report.