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250 Million Contagious Worldwide: VBI Vaccines (NASDAQ:VBIV) Advances to Phase III Trial for Hep B



This article is published in collaboration with Scutify, where you can find real-time markets and stock commentary from Robert Marcin, Cody Willard and others. Download the Scutify iOS App, the Scutify Android App or visit

Hepatitis B has become a major global health concern. The disease, incorrectly assumed to be near-eliminated in the developed world, has been making a serious resurgence. A worsening migrant crisis and an aging population are bringing hepatitis B back to Europe, and healthcare workers are struggling to cope with the fallout. Globally, two billion people have been infected with Hepatitis B, and up to 250 million people are currently contagious.

In the midst of all this, one company is attempting to advance a third-generation hepatitis B vaccine are delivered. If the company is successful, it may be on the cusp of one of the major medical breakthroughs of the 21st century.

The name of the company is VBI Vaccines (NASDAQ: VBIV). Recently, the company has made significant advancements in its pursuit of a global Phase III clinical trial for its hepatitis B vaccine that promises to increase vaccination rates for populations who do not respond well to existing second-generation vaccines. The medication it's testing is known as Sci-B-Vac. Sci-B-Vac has been safely administered to over 300,000 patients abroad and is already approved for use in Israel and 14 other countries. Now, VBI Vaccines is ready to bring it to the North American and European Union markets in a big way. There are positive announcements revealed this month that the FDA could be reviewing initial Phase III clinical trial data from Sci-B-Vac as early as next year.

The Situation: Why There's a Need For a New Vaccine

Hepatitis B is an infectious disease that affects the liver. It can cause sickness, vomiting, yellow skin, tiredness and abdominal pain. Most people with HBV are asymptomatic for 30 to 90 days. About 15-25% with the disease die from it, because it can lead to cirrhosis and liver cancer.

Hepatitis B vaccines have existed for many years. Initially, they were developed directly from the blood of people infected with the disease. Later, when the HIV epidemic became a major concern, public health authorities demanded a new, safer form of the vaccine. Eventually, a doctor found a vaccine after synthesizing hepatitis B antibodies (surface proteins that the immune system uses to fight viruses) from yeast. This method of creating hepatitis B vaccines is still in use today.

Today's second-generation hepatitis B vaccines work well for about 90% of patients. However, the medication needs to be administered at a young age. If immunization is delayed until old age, the success rate can drop below 40%. This is a serious concern. As populations age worldwide, more and more people become unreceptive to hepatitis B vaccines.

The concern over aging populations is especially felt in Europe, which has the most rapidly aging population in the world. Europe experienced a record number of refugees and asylum-seekers last year, mainly from the Middle East and North Africa. In many of these regions, hepatitis B vaccination is not routine. The disease can thus be spread from new arrivals to healthcare workers, who may contract it themselves or spread it to their elderly patients. Since elderly people are more susceptible to illness, and not receptive to hepatitis B vaccination, this puts them especially at risk.

For these patients, existing vaccines are simply not a reliable option. VBI Vaccines hopes to create better solutions for them, in the form of 'third-generation' vaccines that give these patients the peace of mind they need.

VBI Vaccines Reaches an Important Milestone with the FDA

VBI recently reached a major milestone on its mission to advance its next generation hepatitis B vaccine. On June 19th, the company announced that it had completed a pre-Investigational New Drug meeting with the FDA. The meeting was conducted to discuss the Phase III clinical program for Sci-B-Vac, its third-generation hepatitis B vaccine.

Sci-B-Vac is already approved for use in 15 countries. Now the company is aiming to get its flagship product approved across the EU and Europe. The recent meeting marks significant progress in the process. The company's management can now confirm that further clinical studies will not be needed to support its Phase III clinical program.

In a recent statement, VBI's President and CEO Jeff Baxter said, "The successful completion of our pre-IND meeting with the FDA is a significant milestone in the development of Sci-B-Vac. Following similar positive discussions with the European Medicines Agency and Health Canada, we now have a strong indication from all three regulatory agencies that Sci-B-Vac is Phase III-ready in the U.S., Europe, and Canada."

This is a strong indication that VBI Vaccines' management is confident about the future and the prospects of its lead product.

About Sci-B-Vac

Sci-B-Vac is VBI Vaccines' biggest-selling product and main research focus. The drug is notable for targeting all three surface antigens of the hepatitis B virus, in contrast to other medications that target just one. This is a very important point, because targeting more antigens may increase the efficacy of treatment.

Currently, there are several branded hepatitis B vaccines available to consumers. These brands, like Recombivax HB, Engerix-B, and Elovac B, are all derived from the same second-generation structure and have the same action. All of them target the S surface antigen of the hepatitis B virus.

Sci-B-Vac is unique in targeting all 3 antigens of the virus: S, pre-S1, and pre-S2. This provides a higher level of overall immunization by giving the immune system more ways to combat the disease. With second-generation vaccines, the body learns to fight only the S antigen. With third-generation vaccines like Sci-B-Vac, the body is trained to fight several antigens at once, possibly increasing treatment efficacy.

VBI Vaccines Added To Russell 2000 and Russell 3000 Indices

VBI Vaccines hit yet another major milestone on June 26th, when the company announced it had been added to the Russell 2000 and Russell 3000 indices. According to CEO Jeff Baxter, this addition is an important milestone for the company. He said that, among other things, it "validates the growing shareholder value we are building within VBI," adding that "the Russell Indexes are closely followed by the investment community and we believe inclusion in these indexes will bring increased exposure and visibility for VBI."

The Russell indices, while not as famous as the Dow or Standard & Poor indices, are still among the most important in the world. The Russell 3000 Index, in particular, is significant for measuring the performance of the largest 3,000 companies in the U.S. This is a much larger number of companies than represented on the S&P 500, yet smaller than the Dow.

VBI Vaccines' addition to the Russell 2000 and 3000 indices shows that the company continues to grow and expand its products for use around the world.

VBI Vaccines is hoping to become an industry leader with its third-generation hepatitis B vaccine. In the long term, the company is also aiming to become a leading provider of vaccines for other health conditions, including cytomegalovirus and glioblastoma multiforme.

This article was written by Luke Douglas for on .

This article published in collaboration with Scutify, the best app for traders and investors. Download the Scutify iOS App, the Scutify Android App or visit

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