On April 22, local time, immunotherapy company BioNTech and pharmaceutical giant Pfizer announced that the German regulatory agency, the German Federal Institute for Vaccine and Biomedicine (Paul Ehrlich Institute) has approved the BioNTech BNT162 vaccine to prevent new coronary pneumonia Phase 1/2 clinical trial of the project.
BNT162 was jointly developed by BioNTech and Pfizer. As part of the global plan, Fosun Pharma and BioNtech will also conduct clinical trials of the new crown vaccine in China after obtaining regulatory approval.
On April 23, Guo Guangchang, chairman of Fosun International, confirmed the news on his official account. Guo Guangchang said: “This epidemic is a great test for humanity in the past 100 years. At present, vaccines may be the ultimate weapon to end this epidemic. As a community of human destiny, we should promote together through global cooperation Rapid development and production of vaccines. “
The trial of BNT162 is the first clinical trial of a new coronary pneumonia vaccine in Germany, and it is expected that it will soon be approved by US regulatory authorities. And carry out experiments in the United States.
According to Pfizer ’s official website, the four candidate vaccines approved this time are the first of BioNTech ’s key projects focused on new coronary pneumonia, LightSpeed, each Vaccines represent different mRNA types and target antigens. The dose upgrade part of the Phase 1/2 clinical trial will include approximately 200 healthy subjects between the ages of 18 and 55, with doses ranging from 1 microgram to 100 micrograms, designed to determine the optimal dose for further research and to assess the safety of the vaccine And immunogenicity. Subjects with a higher risk of severe infection with new coronary pneumonia will be included in the second phase of the study.
“We are pleased to have completed the preclinical study in Germany and obtained this important regulatory approval to initiate this first human trial. From the start of the project, The speed of regulatory approval and the initiation of human trials indicate that everyone involved is actively working, “said Ugur Sahin, Co-founder and CEO of BioNTech.
“The cooperation between Pfizer and BioNTech has mobilized resources at an extraordinary speed to face this global challenge.” Chairman and CEO of Pfizer Albert Bourla said, “Now the work in Germany can be started, we look forward to and actively prepare for this uniquePotential clinical research projects will be launched in the United States in the near future. “