Posted by Michael Wonder on 01 Dec 2020
VBI Vaccines announces submission of biologics license application to FDA for 3 antigen prophylactic hepatitis B vaccine
1 December 2020 - VBI Vaccines today announced the submission of a biologics license application to the U.S. FDA seeking approval of the Company’s 3 antigen prophylactic hepatitis B vaccine candidate, for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults.
VBI previously announced the submission of the marketing authorisation application to the EMA on 23 November 2020, and the Company expects to submit regulatory approval applications to the United Kingdom Medicines and Healthcare products, Regulatory Agency and to Health Canada by the end of the first quarter of 2021.
