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Cookies Policy

VBI Vaccines Inc. (“VBI”) uses cookies to improve the experience for visitors to our websites, and has published this, Cookie Policy.  It explains what cookies are and how we use them on our websites.

1. What are Cookies?

When you visit our website or use our mobile applications, we collect certain data by automated means, using technologies such as cookies, pixel tags, email analytics, actiondata, browser analysis tools, server logs and web beacons.

For example, when you visit our website, we may place cookies on your computer. Cookies are small text files that websites send to your computer or other Internet-connected device to uniquely identify your browser or to store data or settings in your browser. Cookies allow us to recognize you when you return. They also help us provide a customized experience and enable us to detect certain kinds of fraud.  Cookies cannot be executed as code or used to deliver viruses and they cannot enable us to access your hard drive. We cannot read any information on your hard drive even if we store cookies there.

2. What are the different purposes of Cookies?

The data generated through cookies on VBI websites can be used for various purposes including the following:

Strictly necessary

These cookies are essential in order to enable you to move around the website and use its features, such as accessing secure areas of the website and saving items to a shopping basket.

VBI is required by law to obtain your consent for all types of cookies that we place other than those that are “strictly necessary”.

Performance

These cookies collect information about how visitors use a website, for instance which pages visitors go to most often and if they receive error messages. They are used to improve how a website works in future versions.

Functionality

These cookies allow the website to remember choices you make such as user name, language or region you are in and provide a more enhanced personal experience.

Targeting or advertising

These cookies are used to deliver content more relevant to you and your interests.

VBI has relationships with third party advertising companies such as Google to place advertisements on some of our websites which may include this website and other websites, and to perform tracking and reporting functions for this website and other websites. These third-party advertising companies may place cookies on your computer when you visit our website or other websites so that they can display targeted advertisements to you. These third-party advertising companies do not collect Personal Information in this process, and we do not give any Personal Information to them as part of this process. However, this Policy does not cover the collection methods or use of the data collected by these vendors. For more information about third party advertising, please visit the Network Advertising Initiative (NAI) at www.networkadvertising.org.

This site may contain links or references to other websites. Please be aware that we do not control the cookies / tracking technologies of other websites and this Cookie Policy does not apply to those websites.

3. How do we use the information?

We collect many different types of data from cookies and other technologies. For example, we may collect data about the device you use to access our website, your operating system type, browser type, domain, and other system settings, as well as the language your system uses and the country and time zone where your device is located and the date and time you visit our sites and the pages you visit. Our server logs also record the IP address of the device you use to connect to the Internet. An IP address is a unique identifier that devices use to identify and communicate with each other on the Internet. We may also collect data about the website you were visiting before you came to VBI and the website you visit after you leave our site.

In many cases, the data we collect using cookies and other tools is only used in a non-identifiable way, without any reference to Personal Information. For example, we use data we collect about all website users to optimize our websites and to understand website traffic patterns.

4. How to manage your Cookies

You can learn more about how to manage your cookies by visiting the Help function of your browser, the settings of your mobile device or you can visit www.aboutcookies.org which provides detailed information on managing cookies on popular browsers.  Please be aware that parts of our websites may not function correctly if you disable cookies.

5. Changes to This Cookie Policy

If this Cookie Policy changes, the revised policy will be posted on this site.

6. How to Contact Us

Please contact us if you have any questions or comments about our privacy practices, your privacy choices, or this Cookie Policy. You can always reach us online at www.vbivaccines.com/contact or by emailing VBI at privacy@vbivaccines.com. You may contact us to update or correct much of your Personal Information that you provided to VBI, or to opt out from our mailings and other services and communications that you may have signed up for.

If you choose to contact us via mail at the address below, please provide your name, address, email address, and information about the communication that you do not want to receive.

VBI Vaccines Inc.
Attn: Privacy Officer
160 Second Street, Floor 3
Cambridge, MA 02142

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Indication & Important Safety Info
INDICATION

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

IMPORTANT SAFETY INFORMATION

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

INDICATION

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

IMPORTANT SAFETY INFORMATION

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact medinfo@vbivaccines.com or call 1-888-421-8808 (toll-free).

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov

Please see Full Prescribing Information.

THIS LINK WILL TAKE YOU TO A SITE MAINTAINED BY A THIRD PARTY WHO IS SOLELY RESPONSIBLE FOR ITS CONTENTS

VBI Vaccines provides this link as a service to website visitors. VBI Vaccines is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.

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ENROLLMENT2

Demographic and baseline characteristics were similar in both vaccine groups.

CONSTANT STUDY DESIGN3

STUDY OBJECTIVES

The primary objective was to demonstrate consistency of immune response as measured by geometric mean concentration of antibodies across three consecutively manufactured lots of PreHevbrio 10 μg. The secondary objective was to demonstrate non-inferiority of SPR (% of subjects achieving anti-HBs titers ≥10 mIU/mL) of PreHevbrio (pooled) compared to Engerix-B at Day 196.

ENROLLMENT3

Demographic and baseline characteristics were similar in both vaccine groups.

PROTECT STUDY DESIGN3

STUDY OBJECTIVES

The two co-primary objectives of comparing SPR (% of subjects achieving anti-HBs titers ≥10 mIU/mL) at 4 weeks after receiving the third dose of PreHevbrio or Engerix-B were non-inferiority in adults ≥18 years of age and superiority in adults ≥45 years of age for PreHevbrio 10 μg compared to Engerix-B 20 μg. Key secondary endpoints included SPRs for PreHevbrio at days 56 and 168 and for Engerix-B at day 196; local and systemic solicited adverse events; and unsolicited adverse events. Key exploratory endpoints included SPRs for both study groups at days 0, 28, 56, 168, and 336; geometric mean concentration of anti-HBs antibody titers; and the proportion of participants having anti-HBs titers ≥100 mIU/mL at days 28, 56, 168, 196, and 336.