China's Drug Regulator Approves Mpox Vaccine for Clinical Trials

China's leading drug regulator has approved a new mpox vaccine developed by Sinopharm for clinical trials. This marks a crucial step toward developing the country’s first vaccine against the mpox virus. The vaccine candidate, created by the Shanghai Institute of Biological Products, is designed to play a key role in preventing and controlling mpox infections across the country.

This newly approved vaccine is expected to undergo multiple phases of clinical trials before gaining market approval, a process that could take several years. However, the Chinese government has implemented streamlined processes for fast-tracking the development of essential vaccines, especially those that are needed urgently.

Highlights:

• Vaccine Technology: The new mpox vaccine is based on a replication-deficient MVA strain, similar to the Jynneos vaccine approved in the U.S.
• Urgent Need: While other countries like the U.S., Japan, and Russia have approved mpox vaccines, China currently lacks an approved option.
• Global Impact: As of July 2023, over 100,000 cases of mpox have been reported globally, with 226 related deaths.
• Public Health Emergency: The World Health Organization continues to classify mpox as a Public Health Emergency of International Concern due to its spread in certain regions of Africa.

This new vaccine development comes at a crucial time for China, as the nation continues to report cases of mpox. With over 2,500 confirmed cases by the end of July 2023, the need for an effective mpox vaccine has become urgent. The vaccine’s successful approval could mark the beginning of a larger global response to the mpox virus.

This advancement will be closely monitored as clinical trials progress, and the world will look to China as it navigates its efforts to control the mpox outbreak.