VBI Vaccines Inc. (VBIV) has seen a decrease of 8.02% in the premarket. However, the last trading session closed at $2.37 with a decrease of 4.44%.
New Drug Submission – Latest Updates
On 9th December 2021, VBIV announced that they have filed a new drug submission for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate. This regulatory filing for clearance in Canada is another milestone in the drive to broaden access to the 3-antigen HBV vaccine candidate in more countries.
Moreover, the company is dedicated to collaborating with Health Canada throughout their consideration of this submission because they believe that the vaccine candidate appears to be a useful new tool for healthcare practitioners in the fight over adult hepatitis B.
FDA Approval of PreHevbrio – What’s happening?
On 1st December 2021, VBIV reported that the Hepatitis B Vaccine named PreHevbrio has been licensed by the United States Food and Drug Administration (FDA) for the prevention of infection caused by all known subtypes of the hepatitis B virus (HBV) in adults aged 18 and above. Moreover, PreHevbrio, the only licensed 3-antigen HBV vaccine for adults in the United States, contains the S, pre-S2, and pre-S1 HBV surface antigens.
VBIV is pleased to report that PreHevbrio, VBI’s first FDA-licensed vaccine, has been authorized. This is a significant accomplishment that highlights the VBI team’s capacity to advance vaccine candidates from clinic to approval. However, receiving FDA clearance is only the first step in the aim to enable widespread access to vaccines and to support the public health drive to eradicate adult HBV infections.
Moreover, the executives would like to express their gratitude to the trial participants, clinical site investigators, the workers, and everyone else who helped the company reach this goal. Last but not the least, PreHevbrio is expected to be available in the United States in the first quarter of 2022, because VBI has been working with Syneos Health to assure commercial preparedness for the past two years.