The vaccine scheme is as follows: (1) Ad26.ZEBOV is used as the first immunization vaccine, which is based on Jansen's AdVac technology. (2) about 8 weeks later, MVA-BN-Filo was used as the second immunization vaccine, which was based on Bavarian Nordic's MVA-BN technology. Two MAA samples were supported by data from phase I, phase II and III clinical studies, which evaluated the safety and immunogenicity of the vaccine regimen in adults and children, as well as preclinical research and immune bridge analysis data. So far More than 6500 volunteers in the United States, Europe and Africa participated in more than 10 clinical studies on the Jansen vaccine.
Since the first outbreak, Ebola has claimed thousands of lives, and the world has finally had a licensed Ebola vaccine. On Nov. 11, Mershadong's Ervebo (V920) approved a conditional listing by European regulators, making it the first approved Ebola vaccine in the world.
Mershadong has also submitted an application to (FDA), the Food and Drug Administration, and FDA has granted Ervebo the qualification for identification and priority review of breakthrough therapy, and is expected to make a final decision on the vaccine's listing license in March 2020. On the other hand, Johnson's Yang Sen Pharmacy also announced that it had submitted two marketing authorization applications to EMA for approval of its research Ebola vaccine program for the prevention of Ebola virus disease caused by the Zairian Ebola virus strain. Two applications for (EVD), have been submitted in parallel to support each of the two immunization programs (Ad26.ZEBOV). , MVA-BN-Filo. In September, the CHMP granted the application for accelerated evaluation. Who Director-General Gebryessus said the approval was a "historic step" in ensuring access to vaccines for those most in need. "five years ago, we didn't have an Ebola vaccine, and we didn't have a cure for Ebola,"he said in a statement. Now that Ebola has a qualified vaccine and experimental treatment, we can prevent and treat the disease."
（Picture Source:Sogou）
V920 is a live attenuated vaccine with replication ability, which can express ZEBOV glycoprotein by reverse genetic technique using vesicular stomatitis virus Indiana strain ZEBOV as vector. Originally developed by (PHAC), the Canadian Public Health Agency, it was licensed to NewLink Genetics in 2010. At the end of 2014, when the Ebola epidemic peaked in western Africa, Mershadong was from NewLink. The company signed a global exclusive licensing agreement to obtain the Ebola vaccine.
Ervebo (V920) can be used for active immunization of people over 18 years of age to prevent Ebola hemorrhagic fever caused by Ebola virus in Zaire. The approval is valid in 28 EU member states, as well as in Iceland, Liechtenstein and Norway, members of the European Economic area. Ervebo is the first Ebola vaccine currently approved by the European Union. Before it was approved, because of the severity of the epidemic, Mershadong had responded to the request of the World Health Organization ((WHO)) by providing a large number of research preparations and injecting them in the Congo, which has claimed nearly 2200 lives.
It is reported that, in addition to Ervebo, other Ebola virus vaccines under development, including virus vector vaccine, protein vaccine, DNA vaccine, have entered the clinical trial stage. Among them, the recombinant virus vector Ebola vaccine has a good prospect. The innovative recombinant vaccine product "Recombinant Ebola virus Disease Vaccine (adenoviral Vector)", which was independently developed by China and has completely independent intellectual property rights, was approved by the State Administration of Food and Drug Administration on October 19, 2017. Other recombinant viral vector Ebola vaccines currently developed include non-replicative human adenoviral vector Ebola vaccine (Ad26-ZEBOV), replication deficient chimpanzee type 3 adenoviral vector Ebola vaccine (ChAd3-EBO-Z), replication defective human adenoviral vector Ebola vaccine (Ad5-EBOV), Ebola virus disease combined vector vaccine (GamEvac-Combi).
Roger Perlmutter, president of Mershadong Research Laboratory, said the company's current "top priority" is to prepare for planning to produce Ervebo. Now that the vaccine has been approved by European regulators, Mershadong will begin production at a German factory and is expected to begin shipping in the third quarter of 2020. "CHMP's recommendation represents an important step towards Ervebo's goal of protecting people who may be affected by Ebola," said Dr. Roger M. Perlmutter, president of the Mershadong Research Laboratory. "Thank you very much to the World Health Organization and With the help of many other Governments and non-governmental organizations, their tireless efforts have contributed to the development of the Ebola virus vaccine. Our current priority is to obtain the regulatory approval of the Erveo German manufacturer for subsequent production and supply and to support the global public health goals. "
Ebola was discovered as early as 1976 and is now the second most popular virus in the world. Ebola is a strong infectious disease virus, mainly transmitted through body fluids, can cause fatal viral hemorrhagic fever. According to data provided by the World Health Organization, the mortality rate of patients infected with Ebola virus is as high as 25% to 90%. The main causes of death are stroke, myocardial infarction, hypovolemic shock or multiple organ failure. The outbreak in the Democratic Republic of the Congo since the second half of last year has killed more than 2000 people. Before that, medical researchers had invested a lot of energy in the development of Ebola vaccine, but most of them stayed. In the clinical trial phase.
