Dengvaxia Special Precautions

Protection: As with any vaccine, vaccination with Dengvaxia may not protect 100% of vaccinated individuals. It is recommended to continue personal protection measures against mosquito bites after vaccination.
As a precaution, healthcare professionals should follow-up and appropriately manage any vaccines with signs and symptoms of dengue fever, with particular attention to dengue warning signs (e.g., high fever, severe abdominal pain or tenderness, persistent vomiting, mucosal bleeding, somnolence and hyperactivity according to WHO guidelines 2009).
Special patient groups: Individuals who have not been previously infected by dengue virus or for whom this information is unknown.
Individuals who have not been previously infected by the dengue virus should not be vaccinated because an increased risk of hospitalization for dengue and clinically severe dengue (predominantly grade 1 or 2 Dengue Hemorrhagic Fever [WHO 1997]) has been observed in not previously infected, vaccinated individuals during the long-term follow up of clinical trials (see Adverse Reactions).
In the absence of documented prior dengue virus infection, previous infection must be confirmed by a test before vaccination (see Screening under Dosage & Administration). To avoid vaccination of false positives, only test methods with adequate performance in terms of specificity and cross-reactivity based on the local disease epidemiology should be used.
Altered immune status: For patients receiving treatment with high doses of systemic corticosteroids given for 2 weeks or more (daily receipt of prednisone or equivalent 20 mg or 2 mg/kg body weight is considered as a substantially immunosuppressive dose), it is advisable to wait until immune function has recovered, i.e., for at least 4 weeks after stopping treatment, before administering Dengvaxia.
Travelers: Vaccination is not recommended for individuals, living in non-endemic areas, who have not been in potential contact with dengue virus and who only occasionally travel to endemic areas.
Precautions for administration: Dengvaxia must not be administered by intravascular injection under any circumstances.
Precautions related to serious and severe adverse events: In individuals who have a history of serious or severe reactions within 48 hours after a prior administration of Dengvaxia or of a vaccine containing similar components, the risks and benefits of administering Dengvaxia must be carefully considered.
Before administering any biological, the person responsible for administration must take all precautions to prevent allergic or other reactions. As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following administration of the vaccine.
Epinephrine (1:1000) and other appropriate agents used to control immediate allergic reactions must be available to treat unexpected events such as anaphylaxis.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to injection with a needle. Procedures should be in place to prevent injury from falling and to manage syncopal reactions.
Effects on ability to drive and use machines: No studies have been performed on the effects of Dengvaxia on the ability to drive, to use machines or to perform other hazardous tasks.