Ebola vaccine

Ebola vaccine consists of a live, attenuated recombinant vesicular stomatitis virus-based vector expressing the envelope glycoprotein gene of Zaire Ebola virus (rVSV∆G-ZEBOV-GP). Immunisation of subjects with the vaccine results in an immune response and protection from Zaire Ebola Virus Disease (EVD). The relative contributions of innate, humoral and cell-mediated immunity to protection from Zaire Ebola virus are unknown.

Not applicable.

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and toxicity to reproduction and development.

When ebola vaccine was administered to female rats, antibodies against the vaccine virus were detected in foetuses and offspring, likely due to trans-placental transfer during gestation and with the acquisition of maternal antibodies during lactation, respectively.

Ebola vaccine administered to female rats had no effects on mating performance, fertility, or embryonic/foetal development.

Ebola vaccine administered to female rats had no effects on development or behaviour of the offspring.

Environmental Risk Assessment (ERA)

The vaccine virus is a Genetically Modified Organism (GMO). An ERA was conducted to determine the potential impact of this vaccine on human health and the environment. Because this vaccine is based on VSV, a known pathogen in livestock (e.g. horses, cattle, pigs), the risk assessment included species that are relevant for the wild type (wt) VSV backbone of this vaccine.

In a biodistribution study conducted in non-human primates, vaccine virus RNA was detected in lymphoid organs up to 112 days post-vaccination. However, infectious virus was detected at Day 1 and persistent infectious virus was not detected at any subsequent timepoints measured (Days 56, 84 and 112).

Based on limited shedding in adults, the results of a toxicity study in non-human primates, and lack of horizontal transmission in pigs, the overall risk of ebola vaccine to human health and the environment is considered negligible. However, as a precaution, vaccinees should attempt to avoid exposure of livestock to blood and bodily fluids for at least 6 weeks following vaccination to avoid the theoretical risk of spread of the vaccine virus. People who develop vesicular rash after receiving the vaccine should cover the vesicles until they heal. Cover the vaccination site or any vesicles with an adequate bandage (e.g. any adhesive bandage or gauze and tape) that provides a physical barrier to protect against direct contact with vesicle fluid. The bandage may be removed when there is no visible fluid leakage. To avoid unintended exposure to livestock, ensure medical waste and other cleaning materials do not come in contact with livestock.