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Persons who have previously experienced a severe allergic reaction to any ingredient contained within the ERVEBO vaccine should not be vaccinated. ERVEBO contains recombinant human serum albumin derived from rice. Individuals who have previously experienced an allergic reaction to rice protein should not be vaccinated.
Public health officials report that there is insufficient human data from clinical trials to determine the risk of ERVEBO vaccination during pregnancy. Vaccination of pregnant women should take into consideration the risk of disease and the potential for adverse events associated with vaccination. Additionally, data is absent on the effect of ERVEBO vaccination on human milk, its presence in human milk, and the impact on the breastfed baby. Breastfeeding women who are contemplating ERVEBO vaccination should consider disease risk as well as the potential for vaccine-related adverse events.
Data is also insufficient to assess the safety and efficacy of ERVEBO vaccination on persons with immunodeficient conditions. Limited information is available on the use of the vaccine in persons with stable HIV disease.
ERVEBO is a replication-competent, live attenuated virus vaccine. Vaccinated individuals may be capable of transmitting the vaccine virus on to close contacts. Vaccine virus RNA has been detected in the urine of vaccinated individuals as long as seven days post-vaccination, and in the saliva and blood for as long as 2 weeks. Additionally, the vaccine virus has been detected in skin vesicles and synovial fluid for as long as 20 days after vaccination. To prevent the risk of vaccine-virus transmission, vaccine recipients should:
- Avoid sharing personal items such as toothbrushes, drinking from the same cup, sharing razors, or open mouth kissing for at least two weeks after vaccination. If an individual develops oral lesions post-vaccination, these activities should be avoided until healed
- Refrain from donating blood for at least 6 weeks post-vaccination
- Use an effective prophylaxis during sexual interactions for at least 2 months post-vaccination
- Avoid any activities that expose a high-risk person to blood and body fluids for at least 6 weeks. High-risk persons include children under 12 months of age, pregnant and breastfeeding women, and immunocompromised individuals.
- Avoid exposing livestock to blood and body fluids
- Cover any vesicular or maculopapular rash with a bandage until healed. Any contaminated bandages should be placed in a sealed plastic bag prior to disposal and hands should be washed with soap and water.