Fosun mRNA COVID-19 vaccine s Phase II trials in China
Fosun mRNA COVID-19 vaccine s Phase II trials in China, recruiting 960 healthy volunteers. On November 25, Fosun Pharma and German biotechnology company BioNTech jointly announced that its preferred novel coronavirus mRNA vaccine BNT162b2 will be conducting Phase II clinical trials in Taizhou and Lianshui, Jiangsu, China.
The clinical trial is in charge of the Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Public Health Research Institute). The trial site is located in Taizhou China Medical City Vaccine Engineering Center and Lianshui County CDC, Taizhou People’s Hospital, Lianshui County People’s Hospital and other units jointly participated . It is planned to recruit 960 healthy subjects online, aged 18 to 85 years old, to evaluate the safety and immunogenicity of the candidate vaccine to support the future application of the vaccine in China.
Dr. Ugur Sahin, the co-founder and CEO of Bytech, said: “Our common goal is to quickly design and develop safe and effective vaccines to achieve global supply. The clinical trials and research carried out in China are not only bye An important part of the global research and development of Entaico’s COVID-19 vaccine also marks an important step in bringing the vaccine to the Chinese people.”
According to the ongoing Phase III clinical study of the vaccine, BNT162b2 has reached all major efficacy endpoints, and its effectiveness in preventing the new coronavirus has reached 95%.
At present, sufficient safety data has been collected for the vaccine. Byentico and Pfizer have submitted an emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA) on November 20. In addition, BNT162b2 is currently It is undergoing regulatory review by European, British and Canadian regulatory agencies.
Sain said in an exclusive interview with a reporter from China Business News last month that although many Chinese companies are producing vaccines, the size of China’s population determines that the market for vaccines is very large. “If everyone is vaccinated, it may require a supply of about 2 billion doses of vaccine.” He said, “This means that China still has a huge opportunity.”
If the COVID-19 nucleic acid vaccine is successfully marketed, it will become the first commercialized product of Bytech. “I think the COVID-19 virus will have a profound impact on humans in the next ten years, until the immunized population reaches 90%, which will bring us very large long-term benefits.” Sain said, “The vaccine business will continue. Yes, the market potential is huge, which will encourage us to grow faster.”
According to the plan, Biotech will produce 100 million doses of the COVID-19 vaccine this year, and it will produce 1.3 billion doses of vaccine in 2021. In order to increase vaccine production capacity, Biotech also recently acquired Novartis’ biopharmaceutical production plant in Marburg, Germany.
“We have already started producing vaccines in Germany and the United States. We currently have hundreds of thousands of vaccines in stock and have the capacity to produce hundreds of millions of doses. Once approved by the regulatory agency, we can immediately ship them.” Tell the first financial reporter. But he emphasized that before the vaccine is finally available, it has to go through many steps of testing.
Sain also revealed that the vaccine will be provided to China in steps. “In the first step, we will export vaccines from Germany to China in batches, that is, export vaccines filled in Germany; in the second step, we may consider filling vaccines in China through our partner Fosun Pharma or producing vaccines locally. But these are all under discussion.” He said. However, he refused to provide information on the quantity of the first batch of vaccines exported to China