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Privacy Policy

VBI Vaccines Inc. (“VBI”) offers online resources in order to provide health, medical, and product-related information, as well as corporate and financial news, employment and other information related to VBI’s business. In addition, some of VBI’s online resources allow qualified professionals to place orders for our vaccine, apply for grants, or contribute to research studies.  In order to better serve and communicate with you, VBI, to the extent necessary, collects Personal Information (as defined below).

VBI respects the privacy of visitors to this website and this Privacy Policy (“Policy”) explains if on the occasion VBI collects Personal Information, how VBI collects, uses, and discloses your Personal Information and answers specific questions that you may have regarding privacy and security.  Respect for the privacy of Personal Information about you is very important to VBI.  VBI’s web sites and other online resources that display this Policy are committed to collecting, maintaining, and securing Personal Information about you in accordance with applicable law and this policy.

This Policy applies to information VBI collects from or about you online from our online resources that display a link to this policy (such as VBI owned and controlled websites, social media or live chat) and communications by phone, fax, e-mail or post.  VBI may also collect Personal Information about you through specific forms submitted by you on a website that is owned or controlled by VBI.  This Policy also does not apply to third-party online resources to which our web sites may link, where we do not control the content or the privacy practices of such resources.

1. Types of Personal Information VBI May Collect

Personal Information as used in this Policy applies to any information relating to an identifiable natural person who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person or as otherwise defined in applicable law.

2. How does VBI Collect Personal Information

VBI collects Personal Information through VBI owned and operated websites, online resources and other communications which includes phone, fax and/or email.

VBI utilizes the following methods to collect Personal Information:

a) Information that you provide- In most cases, VBI collects Personal Information from you that you voluntarily provide to VBI. VBI collects Personal Information and other data that you provide when you interact with VBI, such as such as registering on our websites, using any interactive features or applications, signing up to receive a newsletter or a rebate, participating in a savings program, making a direct purchase, calling or emailing us to ask questions, and contacting VBI to report information.

This Personal Information may include, but not be limited to, contact information (such as your name, postal address, e-mail address, telephone number, user ID and password), date of birth, professional credentials, experiences, activities, skills, preferences, hobbies and interests.

Furthermore, VBI may collect health information from you in response to a quality, medical or adverse event resulting from the use of a VBI product that you provide by responding to our questions through your use of VBI’s website, safety information mailbox or safety hotline tools that VBI provides.

Some of VBI’s websites enable users to place orders for VBI products.  These web sites may use external accredited third parties.

b) Information that VBI collects from your computer or electronic device- If you interact with VBI online, VBI uses cookies and other technological tools to collect data about your computer and your use of our website and applications.  This information may include your Internet Protocol (IP) address, Internet Service Provider (ISP), domain name, browser type, date and time of your request and information provided by tracking technologies, such as cookies, single-pixel tags, local share objects (Flash), local storage, Etags and scripts.  If you use a mobile device to access VBI’s websites or online resources or to download our mobile apps, VBI may collect information about your device, such as your device ID and device type, as well as usage information about your device and your use of our mobile web sites and other mobile resources.   For more information about cookies and other technologies, please see the “Cookies and Other Data Collection Technologies” below.

c) Information from public or third-party information sources- VBI may collect Personal Information about health care professionals who register on VBI web sites from public or third-party information sources to verify their professional credentials and identity. VBI may collect additional data from other sources, such as public records, and/or third-party data suppliers who enhance our files, and/or from social media sites such as Facebook or social networking; communities, forums, and message boards; blogging, microblogging, and vlogging; wikis; social bookmarking; and podcasts.

3. Why does VBI collect, use and disclose Personal Information?

a) Generally- VBI collects Personal Information online as necessary to enable individuals to register for, customize, and personalize certain of VBI’s online resources and communications. VBI uses Personal Information collected online to provide products, features and other resources that individuals have requested (e.g., educational literature and related information about our business and products, e-mail programs, tools, and surveys). We analyze Personal Information collected online to identify and offer additional services and promotions that we believe you might find interesting. We evaluate use of some online resources and communications with non-identifiable or aggregate information only. We also may use Personal Information to audit our online resources for compliance, authorized access, and security.

b) Pharmacovigilance- VBI is under a legal obligation under applicable pharmacovigilance and product safety and quality legislation in regions where its products are approved for marketing to collect certain Personal Information after the occurrence of a product safety or adverse event pertaining to its products.

By way of example, VBI complies with, including but not limited to, the obligations promulgated in the Good Pharmacovigilance Practices (“GVP”),  to collect specific Personal Information relating to the safety of its product for reasons of public interest in the area of public health or depending on applicable jurisdiction based on your consent.  In doing so, legal obligations require VBI to take “detailed records” of every adverse event referred to VBI to evaluate the event.  In doing so, VBI may collect the following Personal Information: name or initials; contact details for follow up purposes (when relevant); age (date of birth, if provided); gender; weight and height; details of the product you were using, dosage information, details of other medicines you were taking, treatment received etc.  Furthermore, some of this information is considered by law to be “sensitive Personal Information” which may include any information about your health.

c) Quality and Medical Inquiry-VBI may collect Personal Information to the extent necessary to meet quality control requirements and medical inquiry requests as relates to its products. This type of collection is due to applicable legal obligations imposed on VBI in regions where VBI’s products received marketing approval. Your Personal Information will be collected either in accordance with this legal obligation or based on your consent which would be obtained at the time of collection.

The Personal Information VBI may collect about you when you are the subject of a quality complaint report is: name and contact details; health related details depending on the nature of the complaint or details on the relevant product and events.  Further, the Personal Information VBI may collect about you in response to a medical inquiry may be your name and contact details and details of your inquiry that you provided.

4. How VBI Uses Personal Information

a) Generally- VBI may use your Personal Information for its business purposes, such as:

  • To respond to your requests for information, products, services;
  • To provide you with marketing communications and offers for products and services;
  • If you have a business or professional relationship with VBI, to develop our business relationship with you;
  • For our research and development efforts;
  • To monitor and analyze our respective business operations and website and other applications usage;
  • To anonymize data so that it is no longer Personal Information.

For other everyday business purposes, such as payment processing and financial account management, product development, contract management, website administration, analytics, fraud prevention, corporate governance, reporting, and legal compliance.

b) Legal and regulatory purposes- As part of meeting our pharmacovigilance and other legal and regulatory obligations, VBI may share Personal Information to: investigate the adverse event, quality complaint or medical inquiries; contact you for further information about the adverse event, quality complaint or medical inquiries you reported; collate the information about the adverse event, quality complaint or medical inquiry with information about other adverse events, quality complaint or medical inquiries received by VBI to perform tests to confirm the safety of a batch; and provide mandatory reports to applicable national and/or regional authorities so that they can perform test to confirm the safety of a batch.

Personal Information will be held in conformance to VBI’s retention policies and local legal frameworks. If you have any questions regarding VBI’s retention policies, please email privacy@vbivaccines.com.

5. When and Why Personal Information Is Disclosed by VBI

VBI does not sell, share, or otherwise distribute your Personal Information with third parties for their marketing purposes. VBI will share your Personal Information only in compliance with applicable laws and regulations. For example, we may share your Personal Information as follows:

  • We may share your Personal Information with your consent or as you direct.
  • VBI may share Personal Information with its affiliated companies, with other pharmaceutical companies who are our co-marketing, co-distribution, or other license partners, where pharmacovigilance, quality or medical information obligations for a product require such exchange of information.
  • VBI may share information with national and/or regional authorities pursuant to regulatory or legal obligations. VBI is unable to control national or regional authorities’ use of any information and your options for correction/deletion of information may not be available but please note that in these circumstances, in these cases, VBI does not share any information that directly identifies any individual.
  • We may also disclose your Personal Information when requested under legal process or otherwise required by law, such as in response to a subpoena, including to law enforcement agencies and courts in countries where we operate.

Please note that we may also disclose data about you that is not personally identifiable. For example, we may publish reports that contain aggregate and statistical data about our customers. These reports do not contain any data that would enable the recipient to contact, locate, or identify you.

6. Who will have access to your Personal Information

Personal information about you will be accessible to VBI including its subsidiaries, divisions and groups worldwide, and to individuals and organizations that use Personal Information solely for and at the direction of VBI (e.g., employees, agents, vendors or service providers). Uses and disclosures of Personal Information by external individuals and organizations acting on VBI’s behalf are governed by agreements, with requisite terms and conditions, that require Personal Information to be protected appropriately. Personal Information about you will only be used and disclosed by VBI and individuals and organizations working on our behalf, in a manner consistent with this Policy, other applicable privacy notices, data, with accessed controls as needed and as explicitly permitted or required by applicable laws, rules and regulations.

7. Cookies and Other Data Collection Technologies

If you have questions about the use of cookies on our websites, please consult our Cookies Policy here.

8. Social Media Plug-ins

This website uses social medial plugins (e.g., the Facebook “Like” button, “Share to Twitter” button) to enable you to easily share information with others. When you visit our corporate social media profile, the operator of the social plugin can place a cookie on your computer, enabling that operator to recognize individuals who have previously visited our site. If you are logged into the social media website (e.g., Facebook, Twitter) while browsing on our corporate social media profile, the social plugins allow that social media website to share data about your activities on our social media profile with other users of their social media website. For example, Facebook Social Plugins allows Facebook to show your Likes and comments on our pages to your Facebook friends. Facebook Social Plugins also allows you to see your friends’ Facebook activity on our corporate social media profile. VBI does not control any of the content from the social media plugins. For more information about social plugins from other social media websites you should refer to those sites’ privacy and data sharing statements.

9. Do-Not Track Signals and Similar Mechanisms

Some web browsers may transmit “do-not-track” signals to websites with which the browser communicates. Websites linked to this Policy may not respond to these “do-not-track” signals.

10. Your Choices

You can always limit the data you provide to VBI, but if you choose not to provide certain requested information, you may be unable to access some of the services, offers, and content on our websites.   You can also limit the communications that VBI may send to you by following a simple opt-out process. Simply follow the instructions in our advertisement/promotional emails to opt-out of receiving future marketing communications.

You can manage cookie preferences and opt-out of having cookies and other data collection technologies used by adjusting the settings on your browser. All browsers are different, so visit the “Help” section of your browser to learn about cookie preferences and other privacy settings that may be available.

You can opt-out of being targeted by those third-party advertising companies that are NAI members online at www.networkadvertising.org.

11. Access and Correction

VBI takes reasonable measures to maintain updated and accurate Personal Information and we respect your right to access and correct your Personal Information. You may update your Personal Information at any time by contacting us online at www.vbivaccines.com/contact or privacy@vbivaccines.com. You can also write us at the address in the “How to Contact Us” section below. If you send us a letter, please provide your name, email address, and detailed information about the change(s) you would like to make.

12. Data Security

VBI has implemented a data security program that contains administrative, technical and physical controls that are designed to reasonably safeguard your Personal Information from unlawful use and unauthorized disclosure. However, no system is completely secure or error-free. We do not, and cannot, guarantee the complete security of your personal information.

13. Disclosure to Subsequent Owner or Operator

If all or part of VBI is sold or merged into another entity, Personal Information collected from you in accordance with this Policy may be transferred to a third party in the event of a sale, assignment, transfer, or acquisition of VBI.  VBI would require the purchase, assignee or transferee to treat that Personal Information in accordance with applicable data protection laws.

14. Consent to Processing in the United States and Elsewhere

This site is owned and operated by VBI in the United States, but the data you provide will be accessible to our product co-promotion and co-marketing partners, affiliates, vendors, and suppliers in other countries. Furthermore, if you are visiting this site from another country other than the United States, your communication with us will necessarily result in the transfer of data across international boundaries. The level of legal protection for Personal Information is not the same in all countries. However, we will take the security measures described in this Policy in an effort to keep your data secure. By using this site, you consent to the collection, storage, and processing of your data in the United States and in any country to which we may transfer your data in the course of our business operations.

15. Privacy Statements of Third Parties

This Policy only addresses the use and disclosure of Personal Information by VBI. VBI may provide links to outside websites or advertisements for third parties that have their own privacy statements and data collection, use and disclosure practices. VBI’s independent dealers, suppliers and business partners have their own privacy statements, too. We encourage you to familiarize yourself with the privacy statements provided by all third parties prior to providing them with data or taking advantage of an offer or promotion.

16. Children’s Privacy

In general, VBI’s websites and online resources are not directed at children and most of the online resources are designed for individuals who are 18 years of age or older. Where requests for information about a VBI product are permitted by law, individuals requesting information about a VBI product that is indicated for use in children must be 18 years of age or older.

VBI websites and online resources are not intended to and VBI does not knowingly collect Personal Information from children under 13 years of age.  If you believe your child is using our website or online resources, please contact us at privacy@vbivaccines.com so we can investigate and delete any inappropriate data.

17. Forums, Product Reviews and Other Public Areas

VBI websites may contain forums and other areas where you can publicly post product reviews, communicate with others, and submit media content. Prior to posting in these areas, please read our Terms of Use carefully. You have no privacy rights in public postings. All the data you post will be accessible to anyone with Internet access, and any Personal Information you include in your posting may be read, collected, and used by others. For example, if you post your email address along with a product review, you may receive unsolicited messages. Please use caution when posting any Personal Information.

18. Changes to this Policy

VBI will only use Personal Information in the manner described in this Policy in effect when the data was collected from you. However, VBI reserves the right to change the terms of this Policy at any time by posting revisions to our site. If VBI makes any material changes to this Policy, we will either notify you or place a prominent notice on our website. If at any point, we decided to use Personal Information in a manner different from that stated at the time it was collected, you will be given a choice to allow or disallow any additional uses or disclosures of your Personal Information , beyond that which was stated in this Policy at the time your data was collected.

Any portions of this Policy are void to the extent they are prohibited by applicable law.

If you have questions about this Policy or wish to contact VBI with any other privacy related questions, please reach out by emailing privacy@vbivaccines.com.

19. How to Contact Us and Your Rights

Please contact us if you have any questions or comments about our privacy practices, your privacy choices, or this 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

In addition, you may contact us at www.vbivaccines.com/contact or by emailing privacy@vbivaccines.com at any time to request access to the Personal Information we hold about you, to correct any mistakes or to request deletion of the same or withdraw your consent to certain types of processing of your Personal Information. If such a request places VBI or its affiliates in breach of its obligations under applicable laws, regulations or codes of practice, then VBI may not be able to comply with your request. However, you may be able to request that we block the use of your Personal Information for further processing. You may also have a right to data portability to another data controller under certain circumstances.

20. CCPA Privacy Notice (Notice for California Consumers)

Why?

The California Consumer Privacy Act of 2018 (CCPA) gives California residents the right to know what Personal Information VBI Vaccines Inc. (“VBI,” “we,” “us,” or “our”) collects about them, including whether it is being sold or disclosed to third parties.

In this Notice, “Personal Information” (or “PI”) means any information that identifies, relates to, describes, or is capable of being associated with you or your household, whether directly or indirectly.

The CCPA also grants certain rights to California residents, including the right to delete their Personal Information (subject to certain exceptions) and the right to prevent VBI from selling their Personal Information. Companies are also prohibited from retaliating or discriminating against consumers for exercising their rights under the CCPA.

All companies need to collect and share consumers’ Personal Information for everyday business purposes, marketing, and maintenance of the safety, security, and integrity of their websites and other assets, among other reasons. This Notice provides the information required under the CCPA and applies to both VBI’s online and offline activities.

What?

The types of Personal Information we collect and disclose depends on your relationship and interaction with VBI. Please review the information above to learn about our data collection and disclosure practices generally. The information below describes the categories of personal information we have collected in the preceding 12 months, along with the categories of sources from which the personal information was collected, the purpose for collecting or selling the personal information, the categories of third parties with whom we share the personal information, and if we sell the information, the categories of third parties to whom we sell it.

In addition to the purposes for collecting and sharing Personal Information described in the information above VBI may collect and disclose any and all Personal Information to our service providers and corporate affiliates (but only as necessary or appropriate to perform legitimate business purposes). We also collect and disclose any and all Personal Information as necessary to: comply with laws and regulations; monitor, investigate potential breaches of, and enforce compliance with VBI’s policies and procedures and legal and regulatory requirements; comply with civil, criminal, judicial, or regulatory inquiries, investigations, subpoenas, or summons; and exercise or defend the legal rights of VBI and its employees, affiliates, customers, contractors, and agents. We will not collect additional categories of Personal Information nor use the Personal Information collected for additional purposes without providing you notice.

Your Rights

If you are a California resident, you have the following rights under the CCPA with respect to your Personal Information, subject to certain exceptions and exemptions:

  • Right to Notice: Before or at the time we collect Personal Information from you, you have the right to receive notice of the Personal Information to be collected and the purposes for which we use it. This Notice is intended to satisfy this requirement. You also have the right to request that we disclose to you the categories of Personal Information we have collected about you in the preceding 12 months, along with the categories of sources from which the Personal Information was collected, the purpose for collecting or selling the Personal Information, the categories of third parties with whom we shared the Personal Information, and the categories of third parties to whom we sold the Personal Information, if any.
  • Right of Access: You have the right to request that we disclose or provide you with access to the specific pieces of Personal Information we have collected about you in the preceding 12 months.
  • Right to Deletion: You have the right to request that we delete the Personal Information we collect from you. However, in certain situations we are not required to delete your Personal Information, such as when the information is necessary in order to complete the transaction for which the Personal Information was collected, to provide a good or service requested by you, to comply with a legal obligation, to engage in research, to secure our websites or other online services, or to otherwise use your Personal Information internally in a lawful manner that is compatible with the context in which you provided the information.
  • Right to Opt Out of the Sale of Personal Information: VBI does not sell your Personal Information. VBI does not sell the Personal Information of minors under 16 years of age without affirmative authorization.
  • Right Not to Be Subject to Discrimination: You have the right to be free from discrimination or retaliation for exercising any of your rights under the CCPA as described above.

VERIFICATION: We value the security and confidentiality of your Personal Information. Therefore, if you exercise your right to notice, right of access, or right to deletion, we must first verify your identify to make sure that you are the person about whom we have collected Personal Information. We will verify every request carefully.

  • Along with your request, we will ask that you provide us with a scanned copy of a government-issued ID and/or use a multi-factor authentication process to confirm your identity.
  • When all of your household members jointly submit a request, we will ask that each of you provide us a scanned copy of a government-issued ID and/or use a multi-factor authentication process to confirm your identities.

You may also authorize someone else to submit these requests on your behalf. To do so, you may designate directly with us another person who may act on your behalf by providing us with a notarized copy of power of attorney, or ask the authorized agent to provide us with a copy of your written permission and a scanned copy of their own government-issued ID.

Financial Incentives

You have the right to be free from discrimination or retaliation for exercising any of your rights under the CCPA. We may, however, charge a different price or rate, or provide a different level or quality of goods or services to you, if that difference is reasonably related to the value provided to VBI by your Personal Information. Further, we may offer you financial incentives in return for your Personal Information. Should we offer such programs, we will provide you with additional information at the time you enroll.

Contact Us

Call (617) 830-3031 or email us at privacy@vbivaccines.com to contact us with questions regarding this Notice. California residents who are unable to review or access this Notice due to a disability may email us at privacy@vbivaccines.com  to request access to this Notice in an alternative format.

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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.

Read more

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.