Intended for US Healthcare Professionals only.
Indication and Usage
JYNNEOS is approved for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
Important Safety Information
Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of JYNNEOS. Anyone who has experienced a severe allergic reaction following a previous dose of JYNNEOS or following exposure to any component of JYNNEOS may be at increased risk for severe allergic reactions.
Syncope (fainting) has been reported following vaccination with JYNNEOS. Procedures should be in place to avoid injury from fainting.
Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to JYNNEOS.
Vaccination with JYNNEOS may not protect all recipients.
In smallpox vaccine-naïve healthy adults, the most common (>10%) solicited injection site reactions were pain (84.9%), redness (60.8%), swelling (51.6%), induration (45.4%), and itching (43.1%); the most common solicited systemic adverse reactions were muscle pain (42.8%), headache (34.8%), fatigue (30.4%), nausea (17.3%) and chills (10.4%).
In healthy adults previously vaccinated with a smallpox vaccine, the most common (>10%) solicited injection site reactions were redness (80.9%), pain (79.5%), induration (70.4%), swelling (67.2%), and itching (32.0%); the most common solicited systemic adverse reactions were fatigue (33.5%), headache (27.6%), and muscle pain (21.5%).
The frequencies of solicited local and systemic adverse reactions among adults with HIV infection and adults with atopic dermatitis were generally similar to those observed in healthy adults.
Across all studies, a causal relationship to JYNNEOS could not be excluded for 4 serious adverse events (SAEs), all non-fatal, which included Crohn’s disease, sarcoidosis, extraocular muscle paresis and throat tightness.
Cardiac adverse events of special interest (AESIs) considered causally related to study vaccination were reported in 0.08% of subjects who received JYNNEOS and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST segment elevation, electrocardiogram T wave abnormal, and palpitations. None of the cardiac AESIs considered causally related to study vaccination were considered serious.
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.
These Terms and Conditions govern the VIVOTIF® Dose Replacement Program (the “Program”) operated by Emergent Travel Health (“Emergent”).
Program Participation Eligibility:
The Program will be available, subject to these Terms and Conditions, to health care practitioners (“Program Participants”) who (i) have purchased VIVOTIF either directly from Emergent or from a third party who purchased the product from Emergent, (ii) have patients who have improperly administered and/or stored VIVOTIF (as determined by Emergent in its sole discretion) and who the Program Participants have directed to restart taking VIVOTIF and (iii) comply with these Terms and Conditions. Emergent has the sole authority to determine eligibility for participation in the Program.
Product Eligibility:
The Program is available for doses of VIVOTIF which have been improperly administered or stored by patients of Program Participants so long as the patients have been directed by the Program Participant to restart taking VIVOTIF. In order to receive credit or replacement product for VIVOTIF, Program Participants must contact Emergent Medical Information at medicalinformation@ebsi.com or 1-800-533-5899 to determine the viability of the improperly administered or stored doses of VIVOTIF.
For the avoidance of doubt, the Program is not available for, and no credit or replacement product will be issued in respect of, (i) any product for which a patient has not been directed to restart taking VIVOTIF, (ii) any lost or misplaced product or any product for which a patient has experienced an adverse reaction or side effect but which has not been improperly administered or stored, (iii) any product (whether administered or unused) for which reimbursement has been or will be requested or collected or (iv) any product damaged as a result of unforeseen power outages, natural disasters or other emergency situations.
Program Participants may request credit or replacement product for VIVOTIF satisfying the criteria set forth herein for up to five units of VIVOTIF (each unit contains four doses) during each calendar year. Emergent has the sole authority to determine product eligibility for the Program.
Enrollment and Requests for Credit or Replacement Product:
Program Participants are required to enroll in the Program and request a credit or product replacement from Emergent by fully and accurately completing the Program Administration Form available on the Product Replacement Program section of our site and by submitting the completed and signed form to Emergent Customer Care via facsimile at 800-392-9490, e-mail at customercare@ebsi.com, or online at the Product Replacement Program section of our site.
Issuance of Credit or Product Replacement:
Emergent will determine, in its sole discretion, whether any submitted request complies with these Terms and Conditions, whether to accept or reject any submitted request and whether to issue a credit or product replacement. Credits will only be available for Program Participants who have purchased VIVOTIF directly from Emergent. For all other Program Participants, only product replacement will be available under the Program. In the event Emergent elects to accept a request and issue a credit, such credit will be equal to the lesser of (i) the net purchase price paid to Emergent by the Program Participant for the doses of VIVOTIF described in the Program Administration Form and (ii) the purchase price established by Emergent for VIVOTIF purchases by the Program Participant and in effect as of the date of the credit request. Such credit will apply solely to future purchases of VIVOTIF or other products from Emergent. In the event Emergent elects to accept a request and provide replacement product, it will deliver the replacement product to the Program Participant (at Emergent’s cost and expense).
Recordkeeping:
Each Program Participant will be obligated to maintain accurate books and records supporting any credit or product replacement request made under the Program for a period of five years following the later of (i) the date of the last request submitted hereunder by such Program Participant and (ii) the termination date of the Program. Emergent or its agent may, during normal working hours and with reasonable advance notice, inspect, audit and reproduce such books and records (x) to validate any request made hereunder and/or any representation made on any Program Administration Form by such Program Participant, or (y) as otherwise requested by governmental authorities or required by applicable law or regulation.
Warranty and Disclaimer:
TO THE MAXIMUM EXTEND PERMITTED BY LAW, EMERGENT PROVIDES THE PROGRAM “AS IS” WITH NO WARRANTIES OF ANY KIND AND EXPRESSLY DISCLAIMS ANY WARRANTY, EXPRESS OR IMPLIED, REGARDING THE PROGRAM, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.
Limitation of Liability:
UNDER NO CIRCUMSTANCES WILL EMERGENT OR ITS AFFILIATES OR THEIR RESPECTIVE SHAREHOLDERS, AGENTS, EMPLOYEES, MANAGERS, OFFICERS OR DIRECTORS BE LIABLE FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES ARISING OUT OF OR IN CONNECTION WITH PARTICIPATION IN THE PROGRAM, WHETHER OR NOT Emergent HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
Sole Remedy:
Any Program Participant who is dissatisfied with the Program or these Terms and Conditions will have as the sole and exclusive remedy the discontinuation of participation in the Program.
Indemnification:
Each Program Participant agrees to indemnify, defend and hold harmless Emergent and its affiliates and their respective shareholders, agents, employees, managers, officers and directors from and against any and all claims, actions, causes of action, liabilities, losses and expenses (including reasonable attorneys’ fees) arising from (i) the Program Participant’s participation in the Program, (ii) the Program Participant’s violation of these Terms and Conditions and (iii) any violation or failure by the Program Participant to comply with all applicable laws and regulations relating to the Program.
Termination:
Emergent reserves the right to terminate or suspend the Program or to remove a Program Participant from the Program, in each case for any reason without notice in its sole discretion. No requests for credit or product replacement will be accepted after termination of the Program or removal of a Program Participant from the Program, regardless of whether the applicable VIVOTIF purchase or request was made prior to such termination or removal.
Amendments:
Emergent reserves the right to amend these Terms and Conditions at any time in its sole discretion.
Governing Law:
These Terms and Conditions will be governed by the laws of the State of Delaware without regard to conflicts of laws principles. Any dispute arising hereunder will be subject to final and binding arbitration in San Mateo County, California before the American Arbitration Association under its then applicable rules for commercial disputes. Each Program Participant and Emergent waive any rights to have any dispute resolved in a court of law by a judge or jury.
Interpretation:
Emergent has the sole authority to interpret these Terms and Conditions and to determine eligibility for participation in the Program and compliance with these Terms and Conditions.
Program Assistance:
For questions or additional information regarding the Program, please visit the Product Replacement Program section of our site or contact Emergent Customer Care at 1-800-533-5899.
