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Privacy Policy

This privacy policy explains how Bavarian Nordic A/S (“Bavarian Nordic”, “us”, “we”, or “our”) collects and handles your personal information when you access and use our website(s) (“Site”).

The Privacy Policy is intended to meet our duties of Transparency under applicable data protection legislation, in particular the “General Data Protection Regulation”, Regulation (EU) 2016/679 or “GDPR” and the Swiss Data Protection Act or “FDPA”.

1. DATA CONTROLLER

The legal entity responsible for the processing of your personal information is:

Bavarian Nordic A/S
CVR: 16271187
Philip Heymans Alle 3
DK-2900 Hellerup
Denmark

If you have inquiries and/or questions to our processing of your personal information, please contact us at data.request@bavarian-nordic.com

2. CATEGORIES OF PERSONAL INFORMATION

All the personal information we collect, both from you and from any third parties about you, is outlined in the table below:

Category of personal
information collected		What this means
Contact DataYour email address and any other information you provide in any email you send us.
Technical DataInternet protocol (IP) address, your login data (where applicable), browser type and version, time zone setting and location, browser plug-in types and versions, operating system and platform and other technology on the devices you use to access this website or use our services.

Aggregated data

We also collect, use and share “Aggregated Data” such as statistical or demographic data for any purpose. Aggregated Data may be derived from your personal information, but once in aggregated form it will not constitute personal information for the purposes of the GDPR and the FDPA as this data does not directly or indirectly reveal your identity. However, if we combine or connect Aggregated Data with your personal information so that it can directly or indirectly identify you, we treat the combined data as personal information which will be used in accordance with this Privacy Policy.

No Special Categories of Personal Data

We do not collect any “Special Categories of Personal Data” about you (this includes details about your race or ethnicity, religious or philosophical beliefs, sex life, sexual orientation, political opinions, trade union membership, social security number, information about your health and genetic and biometric data). Nor do we collect any information about criminal convictions and offences.

Please do not provide us with any such data types.

3. USE OF PERSONAL INFORMATION

We will only use your personal information for the purposes for which we collected it as listed below, unless we reasonably consider that we need to use it for another reason and that reason is compatible with the original purpose.

If we need to use your personal information for an unrelated purpose, we will update this Privacy Policy and we will explain the legal basis which allows us to do so.

4. LEGAL BASIS

In respect of each of the purposes for which we use your personal information, the GDPR requires us to ensure that we have a “legal basis” for that use. Most commonly, we will rely on one of the following legal bases:

Generally, we do not rely on your Consent as a legal basis for using your personal information.

We have set out below, in a table format, the legal bases we rely on in respect of the relevant purposes for which we use your personal information.

PurposeCategory(ies) of personal information involvedWhy we do thisOur legal basis for this use of this data
Troubleshooting and SecurityContact Data
Technical Data		To track issues that might be occurring on our systems.
To keep our website, our services and associated systems operational and secure.		Legitimate Interests. It is in our legitimate interests that we are able to monitor and ensure the proper operation of our Site and associated systems and services.
We have a legitimate interest in ensuring the ongoing security and proper operation of our services, website and associated IT services and networks.
Compliance with LawContact Data
Technical Data		We may process your personal information (including sharing it with competent authorities or regulators, and/or our advisers, see Section 5 below) where necessary to comply with legal and regulatory requirements, and protect against fraud, illegal activity, and claims and other liabilities.Compliance with Law.

5. SHARING OF YOUR PERSONAL INFORMATION

We may share your personal information on a strict need-to-know basis with the following recipients:

RecipientsCategory(ies) of personal information involvedWhy we share itLocation(s)
Our AffiliatesContact DataOur affiliates help us provide our service and help manage our customer relationships (including providing customer support, customer liaison etc.).Within Europe (incl. Switzerland)
The United States
Service Providers (as listed in Annex A)Contact Data
Identity Data		Our service providers provide us with IT and system administration services.Within Europe (incl. Switzerland)
Canada
The United States
Professional advisersContact DataOur lawyers, bankers, auditors and insurers and other advisers who provide consultancy, banking, legal, insurance and accounting services.Within Europe (incl. Switzerland)
The United States
Regulators and other authoritiesContact DataAuthorities may require reporting of processing activities in certain circumstancesWithin Europe (incl. Switzerland)
The United States

6. TRANSFERS TO COUNTRIES OUTSIDE THE EU/EEA AND SWITZERLAND

As the clear main rule, your personal information will only be processed and stored in Denmark and Germany.

If it becomes necessary to transfer all or some of your personal information to countries outside the EU/EEA and Switzerland, we will only transfer the personal information after having provided one of the following safeguards:

7. RETENTION OF YOUR PERSONAL INFORMATION

It is our policy not to keep personal information for longer than necessary, unless a longer retention period is required by applicable law.

Your personal information will be deleted in accordance with the Bavarian Nordic Personal Data Retention Procedure.

For further information, please contact us as provided for in Section 1

8. HOW WE KEEP YOUR PERSONAL INFORMATION SECURE

We have put in place appropriate security measures to prevent your personal information from being accidentally lost, used or accessed in an unauthorized way, altered or disclosed.

We limit access to your personal information to those employees and other staff who have a business need to have such access. All such people are subject to a contractual duty of confidentiality.

We have put in place procedures to deal with any actual or suspected personal information breach. In the event of any such breach, we have systems in place to work with applicable regulators. In addition, in certain circumstances (e.g., where we are legally required to do so) we may notify you of breaches affecting your personal information.

9. YOUR RIGHTS

By law, you have the following rights to:

How to exercise your rights

If you want to exercise any of the rights described above, please contact us as provided for in Section 1.

Typically, you will not have to pay a fee to access your personal information (or to exercise any of the other rights). However, except in relation to your right to withdraw your consent, we may charge a reasonable fee if your request is clearly unfounded, repetitive or excessive, or, we may refuse to comply with your request in these circumstances.

We may need to request specific information from you to help us confirm your identity and ensure your right to access your personal information (or to exercise any of your other rights). This is a security measure to ensure that personal information is not disclosed to any person who has no right to receive it. We may also contact you to ask you for further information in relation to your request to speed up our response.

We try to respond to all legitimate requests within thirty (30) days. Occasionally it may take us longer than a month if your request is particularly complex or you have made a number of requests. In this case, we will notify you and keep you updated.

Complaints

If you would like to make a complaint regarding this Privacy Policy or our practices in relation to your personal information, please contact us as provided for in Section 1. We will reply to your complaint as soon as we can.

If you feel that your complaint has not been adequately resolved, please note that the GDPR gives you the right to contact your local data protection supervisory authority, as listed here. The data protection supervisory authority for Switzerland is the Office of the Federal Data Protection and Information Commissioner.

10. OBLIGATION TO PROVIDE PERSONAL INFORMATION AND CONSEQUENCES FOR FAILING TO DO SO

Where we need to process your personal information either to comply with law, or to perform the terms of a contract we have with you and you fail to provide that data when requested, we may not be able to perform the contract we have or are trying to enter into with you (for example, to provide you with the functionalities of the Site).

11. AUTOMATED DECISION-MAKING

Your personal information will not be used for automated decision-making, including profiling.

12. THIRD-PARTY LINKS

This Site may include links to third-party websites, plug-ins and applications. Clicking on those links or enabling those connections may allow third parties to collect or share your personal information. We do not control these third-party websites and are not responsible for their privacy statements. When you leave our Site, we encourage you to read the privacy policy of every site you visit.

13. OUR POLICY ON CHILDREN

This Site is not intended for children below 16 and we do not knowingly collect data relating to such children.

14. CHANGES TO THIS PRIVACY POLICY

Changes to this privacy policy will be posted on our webpage here: www.bavarian-nordic.com/privacy. We encourage you to visit our webpage regularly to keep yourselves updated on any such changes.

Annex A

Service Providers with whom we share personal information

RecipientsCategory(ies) of personal information involvedWhy we share itLocation(s)
Netlify Inc.Identity Data
Contact Data		If you send us contact and identity data or any other data via the contact form on http://cdmo.bavarian-nordic.com such data will be transferred to us via Netlify who hosts that websiteEurope
Media Mechanics Inc.Identity Data
Contact Data		If you visit our website www.loweringtherisk.com we share information with Media Mechanics to enable them to provide us with that website solution.Canada
Google Inc.Identity Data
Contact Data
Professional Data		Google Inc. hosts our website www.loweringtherisk.com on a server in the U.S.The United States

Important Safety Information

  • People with a history of severe allergic reaction (e.g., anaphylaxis) to RabAvert or any of its ingredients should not receive RabAvert…

Indication

RabAvert is a vaccine approved for all age groups to help prevent rabies infection both before and after a suspected exposure.

…for protection before a potential exposure (PrEP) to the rabies virus. They should receive a different rabies vaccine if a suitable product is available. However, because rabies is almost always fatal if left untreated, the protection provided with RabAvert after a potential exposure (PEP) to the rabies virus outweighs the risks associated with a severe allergic reaction.

  • The ingredients of RabAvert, which could in rare cases, cause allergic reactions in some people, include egg and chicken proteins, processed bovine (cow) gelatin and trace amounts of neomycin, chlortetracycline, and amphotericin B. Let your healthcare professional know if you have had any issues, including allergic reactions, with any of these ingredients or with vaccines in general.
  • Severe, potentially life-threatening allergic reaction, swelling of the brain and spinal cord; loss of movement or sensation due to nerve damage, such as inflammation of the brain or temporary loss of movement; Guillain-Barré Syndrome; inflammation of spinal cord; inflamed nerves of the eye; and multiple sclerosis have in very rare cases been reported.
  • RabAvert should be injected into muscle only. RabAvert injected into a vein may cause a reaction throughout the body, including shock.
  • Fainting can occur when injectable vaccines are used, including RabAvert. Your healthcare provider should put procedures in place to avoid falling injury and to restore blood flow to the brain after fainting.
  • Patients with a weakened immune system due to illness or the use of certain medications or treatments (such as radiation therapy, antimalarials, and corticosteroids) may have issues developing immunity. If such a patient is receiving RabAvert, then the healthcare professional may measure immune response through blood testing. Vaccination with RabAvert for protection before a potential exposure (PrEP) to the rabies virus should be delayed in anyone who is sick or recovering from an illness.
  • RabAvert contains albumin which is a protein found in human blood that carries an extremely remote risk for transmission of viral diseases, including Creutzfeldt-Jakob disease (CJD), a rare brain disorder. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
  • Persons who have not been previously vaccinated against rabies will receive Human Rabies Immune Globulin (HRIG). HRIG should not be administered to persons who have been previously vaccinated as it may counteract the effect of the rabies vaccine. Let your healthcare provider know if you were previously vaccinated for rabies as you may not need HRIG.
  • Only use RabAvert while pregnant or breastfeeding if clearly needed. RabAvert was not studied in pregnant or lactating women so it is not known if RabAvert can cause any harm to the fetus, have any effect on ability to get pregnant, or whether it is passed through breast milk to infants (but many drugs are excreted in human milk).
  • There is no information on how RabAvert works when given at the same time as other vaccines.  
  • The most common side effects in clinical trials were reactions at the injection site, such as reddening, hardening, and pain; flu-like symptoms, such as lack of energy, tiredness, fever, headache, muscle pain, and feeling of discomfort; joint pain; dizziness; swelling of lymph nodes; upset stomach; and rash.
  • Vaccination before a potential exposure (PrEP) to the rabies virus does not remove the need for additional therapy after a suspected or known rabies exposure.
  • Seek the advice of a healthcare professional to help assess your specific level of risk if you are traveling to areas of high risk of rabies exposure; in frequent contact with the rabies virus or rabid animals, such as on the job; and/or are active outdoors and could encounter animals with rabies in the wild.
  • If you are exposed to a potentially rabid animal, seek medical attention right away before you have symptoms. Once symptoms are present, the rabies infection has spread through the body and survival is unlikely.

Uses for RabAvert

RabAvert is a vaccine approved for all age groups to help prevent rabies infection both before and after a suspected exposure. 

Patients should always ask their healthcare professionals for medical advice about the appropriate use of vaccines and adverse events. To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by either
visiting www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.

Please see full Prescribing Information