VIDPREVTYN BETA Solution and emulsion for emulsion for injection Ref.[50347] 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

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. However, 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, safety and immunogenicity of the vaccine have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The immune response of VidPrevtyn Beta may be lower in immunosuppressed 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 VidPrevtyn Beta may not protect all vaccine recipients.

Excipients

Sodium

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

Potassium

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

No interaction studies have been performed.

Concomitant administration of VidPrevtyn Beta with other vaccines has not been studied.

Pregnancy

There is limited experience with use of VidPrevtyn Beta 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 VidPrevtyn Beta during pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.

Breast-feeding

It is unknown whether VidPrevtyn Beta is excreted in human milk.

No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to VidPrevtyn Beta is negligible.

Fertility

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

VidPrevtyn Beta 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 safety of VidPrevtyn Beta administered as a first booster in individuals previously vaccinated with a primary series of mRNA-based, adenovirus-vectored or protein-based COVID-19 vaccines was evaluated in an ongoing phase 3 clinical study. This study involved 705 participants 18 years of age and older who received the vaccine 4 to 10 months after receiving primary vaccination. Due to the size of the safety database for VidPrevtyn Beta, uncommon adverse reactions (≥1/1,000 to <1/100) may not be detected. The median duration of safety follow-up was 145 days, with 610 (86.5%) participants completing more than 2 months safety follow-up after booster injection.

The most common adverse reactions with VidPrevtyn Beta were injection site pain (76.2%), headache (41.4%), myalgia (37.8%), malaise (33.0%), arthralgia (28.7%), and chills (19.9%).

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.

Supportive safety data were collected in 7093 participants 18 years of age and older having received primary or booster vaccine formulation containing the same Beta antigen (Monovalent (B.1.351)/bivalent (B.1.351 + D614)) and AS03 adjuvant. In general, the safety profile based on these supportive data is in accordance with the most common adverse reactions detected based on the VidPrevtyn Beta safety database (N=705). The majority of these participants received primary immunisation with bivalent (B.1.351 + D614) vaccine.

Tabulated list of adverse reactions

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

Within each System Organ Class, adverse reactions are presented in order of decreasing frequency and then by decreasing seriousness (Table 1).

Table 1. Adverse reactions:

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.

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