VBI Vaccines Inc. (NASDAQ:VBIV) has submitted a Marketing Authorization Application (MAA) for its 3-antigen prophylactic hepatitis B vaccine candidate to the European Medicines Agency. The company is seeking approval for the vaccine candidate to prevent infections caused by hepatitis B virus subtypes.
VBI bringing hepatitis B vaccine to European patients
Jeff Baxter, the company’s CEO, stated that they believe the 3-antigen prophylactic hepatitis B vaccine has the potential of being a vital intervention in preventing hepatitis B infections. He said that the MAA submission is a massive milestone for the company and the potential vaccine candidate. Baxter said that the company is committed to working with the EMA on the 3-antigen prophylactic vaccine candidate’s regulatory process to offer access to European patients.
Hepatitis B is one of the most infectious disease threats globally, with over 290 million individuals infected worldwide. Interestingly HBV infection is among the leading causes of liver diseases, and it is difficult-to-treat with currently available treatments, with most patients ending up with liver cancers. Around 780,000 people die annually due to chronic HBV-related complications such as hepatocellular carcinoma d liver decompensation.
Biologics License Application for 3-antigen hepatitis B vaccine
As part of the company’s global commercialization strategy, VBI Vaccines recently submitted a Biologics License Application to the FDA to approve the 3-antigen prophylactic hepatitis B vaccine. Baxter said the completion of the BLA is a huge milestone as the company works to avail the vaccine candidate to adult patients in the US. He said that hepatitis B infection in the US is a public health threat, and in recent years there has been an increase in the rate of acute infections. There are approximately 2.2 million severely-infected individuals in the US. Baxter said that they are looking forward to collaborating with the FDA on the regulatory review process as the company seeks marketing approval in the US.
VBI Vaccines is also planning to submit a regulatory review application to the UK Medicines and health products, Regulatory agency, and Health Canada in Q1 2021.