MVABEA Suspension for injection Ref.[50431] Active ingredients: Ebola vaccine

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Hypersensitivity

Close observation is recommended following vaccination for the early signs of anaphylaxis or anaphylactoid reactions. As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine. Individuals should be observed by a healthcare professional for at least 15 minutes after vaccination.

Anxiety-related reactions

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.

Thrombocytopenia and coagulation disorders

The vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder because bleeding or bruising may occur following an intramuscular administration in these individuals.

Concurrent illness

Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection, unless the benefit of immediate vaccination outweighs the potential risks. The presence of a minor infection and/or low-grade fever should not delay vaccination.

Immunocompromised individuals

Safety and immunogenicity of the Zabdeno, Mvabea vaccine regimen has not been assessed in immunocompromised individuals, including those receiving immunosuppressive therapy.

Immunocompromised individuals may not respond as well as immunocompetent individuals to the Zabdeno, Mvabea vaccine regimen.

Level of protection

The exact level of protection afforded by the vaccine regimen is unknown.

In the absence of field efficacy data, the protective effect of the vaccine regimen in humans was inferred by the bridging of immunogenicity in humans to immunogenicity and efficacy data obtained in non-human primates (immunobridging) (see section 5.1).

If only one of the vaccines, Zabdeno or Mvabea, is received, the efficacy is expected to be reduced as compared to the 2-dose vaccine regimen.

The vaccine regimen might not protect all individuals against Ebola virus (Zaire ebolavirus species) disease, and does not replace precautions to avoid exposure to Ebola virus. Vaccinated individuals should adhere to local guidelines and recommendations to prevent or treat exposure to Ebola virus.

The Zabdeno, Mvabea vaccine regimen should not be initiated for post-exposure prophylaxis against Ebola virus.

Duration of protection

The duration of protection is unknown. A booster dose of Zabdeno administered at various intervals after completion of a primary series with Zabdeno and Mvabea has been shown to elicit an anamnestic response (see section 5.1). As a precautionary measure, a Zabdeno booster vaccination should be considered for individuals at imminent risk of exposure to Ebola virus, for example healthcare professionals and those living in or visiting areas with an ongoing Ebola virus disease outbreak, who completed the 2-dose primary vaccination regimen more than 4 months ago (see sections 4.2 and 5.1).

Protection against Filovirus disease

The vaccine regimen is not intended to prevent diseases caused by Filoviruses other than Zaire ebolavirus species.

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, and is considered to be essentially sodium-free.

The safety, immunogenicity and efficacy of co-administration of Mvabea with other vaccines have not been evaluated, and therefore, co-administration is not recommended.

If Mvabea must be given at the same time as another injectable vaccine(s), then the vaccine(s) should always be administered at different injection sites. Do not mix Mvabea with any other vaccine in the same syringe or vial.

Pregnancy

There are no data from the use of Mvabea in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Zabdeno and Mvabea vaccine regimens elicited detectable Ebola virus (EBOV) GP-specific maternal antibody titres that were transferred to the foetuses (see section 5.3).

As a precautionary measure, it is preferable to avoid vaccination with Mvabea during pregnancy. Nevertheless, considering the severity of Ebola virus disease, vaccination should not be withheld when there is a clear risk of exposure to Ebola infection.

Breast-feeding

It is not known whether Mvabea is excreted in human milk.

A risk to the newborns/infants from breast-feeding by vaccinated mothers cannot be excluded.

As a precautionary measure, it is preferable to avoid vaccination with Mvabea during breast-feeding. Nevertheless, considering the severity of Ebola virus disease, vaccination should not be withheld when there is a clear risk of exposure to Ebola infection.

Fertility

No data are available on fertility in humans. A reproductive toxicity study in animals with Zabdeno and Mvabea vaccine regimens did not reveal any evidence of impaired female fertility. General toxicity studies have not revealed any effects on male sex organs that would impair male fertility (see section 5.3).

Mvabea has no known effect on the ability to drive and use machines.

Summary of the safety profile

The most common local adverse reactions reported in adults who received Mvabea were pain (45%), warmth (20%) and swelling (10%) at the injection site. The most common systemic adverse reactions were fatigue (30%), myalgia (26%) and arthralgia (16%). Most adverse reactions occurred within 7 days following vaccination and were mild to moderate in severity and of short duration (2-3 days).

The most common local adverse reaction reported in children 1 to 17 years of age who received Mvabea was pain (21%) at the injection site. The most common systemic adverse reaction was fatigue (11%). Most adverse reactions occurred within 7 days following vaccination. Most adverse reactions were mild to moderate in severity and of short duration (1-3 days).

Pyrexia was reported more frequently for younger children 1 to 3 years of age (8%) and 4 to 11 years of age (4%) compared to adolescents 12 to 17 years of age (2%) and adults (4%). The frequency of pyrexia in younger children was less than that observed in the placebo control group.

The safety profile of Mvabea in children 1 to 17 years of age was generally similar to that observed in adults.

Tabulated list of adverse reactions

Adverse reactions observed during clinical studies are listed below by the following frequency categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Adults

Table 1 shows the adverse reactions reported from clinical trials in adults.

Table 1. Adverse Reactions Reported in Adults Following Vaccination with Mvabea:

Children 1 to 17 years of age

Table 2 shows the adverse reactions reported from clinical trials in children 1 to 17 years of age.

Table 2. Adverse Reactions Reported in Children 1 to 17 Years of Age Following Vaccination with Mvabea:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

In the absence of compatibility studies, Mvabea must not be mixed with other medicinal products.