During the approval process of Dynavax, there were some issues with the approval process. On August 4th of this year, the FDA committee recommended Heplisav-B with a 12:1 vote. At the same time, the FDA requested Dynaax to provide more information on its listing plan, which resulted in Dynaax's stock price falling by 11%. The FDA is very confident in the effectiveness of Heplisav-B, but there are some concerns about the safety of the vaccine. Regulatory analysis found that the causes of deaths and heart disease events that occurred after receiving the vaccine were not explained.

Professor William Schaffnerhi, Preventive Medicine: "The approval of Heplisavb-B will bring competition to the existing hepatitis B B vaccine Engerix-B. I believe that Heplisavb-B of Dynavax will eventually defeat Engerix-B of GSK plc. First, Heplisavb-B can be treated twice in a month, while Engerix-B needs to complete three injections in six months. Therefore, the compliance of patients with Heplisavb-B is better than Engerix-B. Second, in a comparison with Engerix-B In the study, Heplisavb-B has a better therapeutic effect

In September of this year, the CEO of the company, Eddie Gray, stated that the adult vaccine market is a key focus area for Dynavax, and the success of our star vaccine Heplisavb-B is a recognition of our work.