BIMERVAX Emulsion for injection Ref.[50884] Active ingredients: SARS-CoV-2 spike glycoprotein (B.1 strains)

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 and anaphylaxis

Events of anaphylaxis have been reported with COVID-19 vaccines. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.

Close observation for at least 15 minutes is recommended following 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.

Concurrent illness

Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.

Thrombocytopenia and coagulation disorders

As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia), because bleeding or bruising may occur following an intramuscular administration in these individuals.

Immunocompromised individuals

The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of BIMERVAX may be lower in immunocompromised individuals.

Duration of protection

The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.

Limitations of vaccine effectiveness

As with any vaccine, vaccination with BIMERVAX may not protect all vaccine recipients.

Excipients

Potassium

This vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially ‘potassium-free’.

Sodium

This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

No interaction studies have been performed.

Concomitant administration of BIMERVAX with other vaccines has not been studied.

Pregnancy

There is no experience with the use of BIMERVAX in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition, or post-natal development (see section 5.3).

Administration of BIMERVAX during pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.

Breast-feeding

It is unknown whether BIMERVAX is excreted in human milk. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to BIMERVAX is negligible.

Fertility

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3.

BIMERVAX has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.

Summary of the safety profile

The most common adverse reactions reported were injection site pain (82.2%), headache (30.2%), fatigue (30.9%) and myalgia (20.2%). The median duration of local and systemic adverse reactions was 1 to 3 days. Most adverse reactions occurred within 3 days following vaccination and were mild to moderate in severity.

Tabulated list of adverse reactions

The safety profile presented below is based on interim pooled safety data generated in two phase 2b and phase 3 clinical trials with a total of 3 192 individuals 16 years of age and older, that received one booster dose of BIMERVAX at least 3 months after a previous COVID-19 vaccine. The median duration of the safety follow-up was 5 months for a 84% of the individuals, and 7.5 months for a 16% of the individuals.

Adverse reactions observed during clinical trials are listed below according to the following frequency categories: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10 000 to <1/1000), very rare (<1/10 000) and not known (cannot be estimated from the available data).

Table 1. Adverse reactions:

^a This term also included events reported as lymphadenitis
^b This term also included events reported as upper and lower abdominal pain
^c Based on a single event during clinical trials

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 and include batch/Lot number if available.

This medicinal product must not be mixed with other medicinal products or diluted.