Ebola vaccine wins approval from regulators
China’s top food and drug authority announced on Friday that it has approved the country’s first vaccine for Ebola virus disease.
This makes China the third country, after the United States and Russia, with vaccines available for use to combat the deadly infectious disease, the China Food and Drug Administration said.
The vaccine, named recombinant Ebola virus disease vaccine (Adenovirus type 5 vector), is available in powder, and, compared with liquid vaccines in the other two countries, is more stable. This highlights its advantages in transportation and use in tropical areas such as Africa, it said.
The most serious outbreak of the disease, which hit West Africa in 2014, caused at least 11,300 deaths, according to the administration.
The CFDA approved the application for registration of the new drug on Thursday. The drug was jointly developed by the Academy of Military Medical Sciences in Beijing and CanSinoBio, a Chinese company in human vaccine development and production, according to the CFDA.
The CFDA approved the application for clinical tests of the drug in February 2015, and received an application for registration for production of the drug in April, it said.
The vaccine improves China’s ability to prevent and control major public health threats and provides a new means for China to handle global disease epidemics effectively, it said.
“It will promote research and development of vaccines for major infectious diseases in China,” the CFDA said. “It demonstrates a major advance in China’s ability in the technological innovation of biomedicine.”
CanSinoBio could not be reached by phone for comment on Friday.
Li Lanjuan, a member of the Chinese Academy of Engineering and a professor in infectious diseases at Zhejiang University, said the approval of the vaccine shows China has greatly increased its ability for research and development of vaccines.
“Clinical tests conducted on Africans in China showed the vaccine was safe and effective,” said Li, who led the clinical tests at Zhejiang University in 2015.
It will promote research and development of vaccines for major infectious diseases in China.” China Food and Drug Administration
Clinical tests for the vaccine also were completed on 120 Chinese in Taizhou, Jiangsu province, in February 2015.
Efforts to develop the Ebola vaccine started at the Academy of Military Medical Sciences more than seven years ago and the process accelerated with the outbreak of the disease in West Africa in 2014, according to a previous report by the news website caixin.com.
The Ebola virus is transmitted to people from wild animals and spreads in the human population through human-to-human transmission. Mortality among those infected could reach 90 percent, according to the World Health Organization.
There is yet no proven treatment available for the disease, but a range of potential treatments, including blood products, immunotherapies and drug therapies, are being evaluated, it said.