The FDA’s decision is based on positive results from two Phase III trials, the PROTECT and CONSTANT, on the drug’s efficacy.
The U.S. Food and Drug Administration has approved VBI Vaccines’ candidate drug PreHevbrio to prevent infection among patients diagnosed with the hepatitis B virus.
PreHevbrio is a recombinant hepatitis B vaccine that contains three surface antigens: S, pre-S1, and pre-S2. It is indicated for adults ages 18 years and up and is already commercially available in Israel under the brand name Sci-B-Vac.
The FDA’s decision is based on positive results from two Phase III trials on the efficacy of the drug. Both the PROTECT and CONSTANT clinical studies compared PreHevbrio to the single-antigen HBV vaccine Engerix-B. The PROTECT trial observed PreHevbrio to have a higher rate of seroprotection at 91.4% versus Engerix-B, which logged only 76.5% among all participants aged 18 years and older. In the 45 years old and above age group, PreHevbrio remained superior, logging 89.4% versus 73.1% for Engerix-B.
Some adverse reactions were seen, but most were generally resolved without any interventions within one or two days. The side effects included fatigue, myalgia, and pain and tenderness on the injection site. The two studies are published in The Journal of the American Medical Association Network Open (October 2021) and The Lancet Infectious Diseases (May 2021)
With the FDA’s green light, VBI expects to roll out PreHevbrio in the U.S. by the first quarter of 2022. Its partner Syneos Health will help ensure that it is commercially available in the country. The European Medicines Agency (EMA) is also reviewing the vaccine’s marketing authorization application, with regulatory conditions expected to be completed next year.
“This is a substantial achievement that demonstrates the VBI team’s ability to progress vaccine candidates from the clinic through to approval. This approval, however, is just the first step in our mission to provide broad access to our vaccine and to help strengthen the public health effort to put an end to adult HBV infections,” commented Jeff Baxter, the president and chief executive officer of VBI, in a statement.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend HBV vaccinations to all adults on November 3. This move was welcomed by concerned organizations across the board.
“As we work to implement the ACIP’s new universal hepatitis B vaccine recommendation for all adults ages 19-59, as voted on in November, we benefit from having more tools, including this newly approved 3-antigen hepatitis B vaccine,” Chari Cohen, DrPH, MPH, the senior vice president of the Hepatitis B Foundation, in the same statement.
Hepatitis B is a viral illness that attacks the liver, although it can be prevented through vaccines. As of 2019, the World Health Organization estimates that around 296 million people are living with chronic hepa-B infection, with 1.5 million new cases added annually. Most of the deaths associated with the virus were from primary liver cancer and cirrhosis.
