Bimervax · 4.4 Special warnings and precautions for use · 3

HOS-100512 · has-adverse-reaction-information · PDF-Seite 33

Summary of the safety profile BIMERVAX (original, heterodimer B.1.351 and B.1.1.7 strains) Individuals 18 years of age and older The most common adverse reactions reported after a booster dose with BIMERVAX in adult individuals who received a primary series with mRNA COVID-19 vaccine, were injection site pain (82.9%), headache (30.9%), fatigue (31.1%) and myalgia (20.7%). 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. The most common adverse reactions reported after an additional booster dose of BIMERVAX as a fourth dose were injection site pain (79.9%), headache (25.0%) and fatigue (25.0%). 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. Adolescents 12 through 17 years of age The most common adverse reactions reported after a booster dose of BIMERVAX in adolescents were injection site pain (77.5%), headache (28.3%), fatigue (29.3%) and malaise (22.5%). The median duration of local and systemic adverse reactions was 1 to 3 days. Most adverse reactions occurred within 2 days following vaccination and were mild to moderate in severity. BIMERVAX XBB.1.16 (Omicron XBB.1.16-adapted BIMERVAX) The safety of BIMERVAX XBB.1.16 is inferred from the safety data of the BIMERVAX (original, heterodimer B.1.351 and B.1.1.7 strains) vaccine and the safety data from the clinical trial of the adapted BIMERVAX XBB.1.16 vaccine. The overall safety profile for the BIMERVAX XBB.1.16 booster dose was similar to that seen after the BIMERVAX (original, heterodimer B.1.351 and B.1.1.7 strains) booster dose. The most common adverse reactions reported were injection site pain (68.11%), headache (23.42%), fatigue (19.60%) and myalgia (13.62%). Most adverse reactions were mild to moderate in severity. No new adverse reactions were identified for the BIMERVAX XBB.1.16 booster dose. BIMERVAX LP.8.1 (Omicron LP.8.1-adapted BIMERVAX) The safety of BIMERVAX LP.8.1 is inferred from safety data of BIMERVAX (original, heterodimer B.1.351 and B.1.1.7 strains) vaccine and from the Omicron XBB.1.16-adapted BIMERVAX vaccine. Tabulated list of adverse reactions The safety profile presented below is based on pooled safety data generated in two phase 2b and phase 3 clinical trials with a total of 3 156 individuals 18 year

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HOS-100500 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Individuals 18 years of age and older The most common adverse reactions reported after a booster dose with BIMERVAX in adult individuals who received a primary series with mRNA COVID-19 vaccine, were injection site pain (82.9%), headache (30.9%), fatigue (31.1%) and myalgia (20.7%). 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. The most common adverse reactions reported after an additional booster dose of BIMERVAX as a fourth dose were injection site pain (79.9%), headache (25.0%) and fatigue (25.0%). 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. Adolescents 12 through 17 years of age The most common adverse reactions reported after a booster dose of BIMERVAX in adolescents were injection site pain (77.5%), headache (28.3%), fatigue (29.3%) and malaise (22.5%). The median duration of local and systemic adverse reactions was 1 to 3 days. Most adverse reactions occurred within 2 days following vaccination and were mild to moderate in severity. Tabulated list of adverse reactions The safety profile presented below is based on pooled safety data generated in two phase 2b and phase 3 clinical trials with a total of 3 156 individuals 18 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 12 months for a 99.4% of the individuals, and 6 months for a 0.6% of the individuals. The safety of an additional booster dose of BIMERVAX as a fourth dose was assessed in 288 individuals, 18 years of age and older, who had completed either 3 doses of COVID-19 mRNA vaccine (tozinameran) or 2 doses of COVID-19 mRNA vaccine (tozinameran) and 1 dose of BIMERVAX, and received an additional booster dose with BIMERVAX between 6 and 12 months after the third previous dose. The safety of a booster dose of BIMERVAX in adolescents aged 12 through 17 years is based on safety data from the phase 3 clinical trial and the ongoing phase 2b clinical trial. A total of 276 participants, with and without medical history of prior SARS-CoV-2 infection, received a booster dose of BIMERVAX at least 3 months after the last dose of the primary series. Adverse reactions observed dur

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HOS-100506 · has-adverse-reaction-information · PDF-Seite 19

Summary of the safety profile BIMERVAX (original, heterodimer B.1.351 and B.1.1.7 strains) Individuals 18 years of age and older The most common adverse reactions reported after a booster dose with BIMERVAX in adult individuals who received a primary series with mRNA COVID-19 vaccine, were injection site pain (82.9%), headache (30.9%), fatigue (31.1%) and myalgia (20.7%). 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. The most common adverse reactions reported after an additional booster dose of BIMERVAX as a fourth dose were injection site pain (79.9%), headache (25.0%) and fatigue (25.0%). 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. Adolescents 12 through 17 years of age The most common adverse reactions reported after a booster dose of BIMERVAX in adolescents were injection site pain (77.5%), headache (28.3%), fatigue (29.3%) and malaise (22.5%). The median duration of local and systemic adverse reactions was 1 to 3 days. Most adverse reactions occurred within 2 days following vaccination and were mild to moderate in severity. BIMERVAX XBB.1.16 (Omicron XBB.1.16-adapted BIMERVAX) The safety of BIMERVAX XBB.1.16 is inferred from the safety data of the BIMERVAX (original, heterodimer B.1.351 and B.1.1.7 strains) vaccine and the safety data from the clinical trial of the adapted BIMERVAX XBB.1.16 vaccine. The overall safety profile for the BIMERVAX XBB.1.16 booster dose was similar to that seen after the BIMERVAX (original, heterodimer B.1.351 and B.1.1.7 strains) booster dose. The most common adverse reactions reported were injection site pain (68.11%), headache (23.42%), fatigue (19.60%) and myalgia (13.62%). Most adverse reactions were mild to moderate in severity. No new adverse reactions were identified for the BIMERVAX XBB.1.16 booster dose. Tabulated list of adverse reactions The safety profile presented below is based on pooled safety data generated in two phase 2b and phase 3 clinical trials with a total of 3 156 individuals 18 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 12 months for a 99.4% of the individuals, and 6 months for a 0.6% of the in

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HOS-100518 · has-adverse-reaction-information · PDF-Seite 48

Summary of the safety profile BIMERVAX (original, heterodimer B.1.351 and B.1.1.7 strains) Individuals 18 years of age and older The most common adverse reactions reported after a booster dose with BIMERVAX in adult individuals who received a primary series with mRNA COVID-19 vaccine, were injection site pain (82.9%), headache (30.9%), fatigue (31.1%) and myalgia (20.7%). 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. The most common adverse reactions reported after an additional booster dose of BIMERVAX as a fourth dose were injection site pain (79.9%), headache (25.0%) and fatigue (25.0%). 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. Adolescents 12 through 17 years of age The most common adverse reactions reported after a booster dose of BIMERVAX in adolescents were injection site pain (77.5%), headache (28.3%), fatigue (29.3%) and malaise (22.5%). The median duration of local and systemic adverse reactions was 1 to 3 days. Most adverse reactions occurred within 2 days following vaccination and were mild to moderate in severity. BIMERVAX XBB.1.16 (Omicron XBB.1.16-adapted BIMERVAX) The safety of BIMERVAX XBB.1.16 is inferred from the safety data of the BIMERVAX (original, heterodimer B.1.351 and B.1.1.7 strains) vaccine and the safety data from the clinical trial of the adapted BIMERVAX XBB.1.16 vaccine. The overall safety profile for the BIMERVAX XBB.1.16 booster dose was similar to that seen after the BIMERVAX (original, heterodimer B.1.351 and B.1.1.7 strains) booster dose. The most common adverse reactions reported were injection site pain (68.11%), headache (23.42%), fatigue (19.60%) and myalgia (13.62%). Most adverse reactions were mild to moderate in severity. No new adverse reactions were identified for the BIMERVAX XBB.1.16 booster dose. BIMERVAX XFG.1.1 (Omicron XFG.1.1-adapted BIMERVAX) The safety of BIMERVAX XFG.1.1 is inferred from safety data of BIMERVAX (original, heterodimer B.1.351 and B.1.1.7 strains) vaccine and from the Omicron XBB.1.16-adapted BIMERVAX vaccine. Tabulated list of adverse reactions The safety profile presented below is based on pooled safety data generated in two phase 2b and phase 3 clinical trials with a total of 3 156 individuals 18 y

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HOS-100508 · has-contraindication-information · PDF-Seite 31

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100502 · has-contraindication-information · PDF-Seite 17

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100514 · has-contraindication-information · PDF-Seite 46

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100496 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100507 · has-indication-information · PDF-Seite 30

BIMERVAX LP.8.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.

HOS-100513 · has-indication-information · PDF-Seite 45

BIMERVAX XFG.1.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.

HOS-100495 · has-indication-information · PDF-Seite 2

BIMERVAX is indicated as a booster for active immunisation to prevent COVID-19 in individuals 12 years of age and older who have previously received a mRNA COVID-19 vaccine (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recommendations.

HOS-100501 · has-indication-information · PDF-Seite 16

BIMERVAX XBB.1.16 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations.

HOS-100510 · has-interaction-information · PDF-Seite 32

No interaction studies have been performed. Concomitant administration of BIMERVAX LP.8.1 with other vaccines has not been studied.

HOS-100516 · has-interaction-information · PDF-Seite 47

No interaction studies have been performed. Concomitant administration of BIMERVAX XFG.1.1 with other vaccines has not been studied.

HOS-100504 · has-interaction-information · PDF-Seite 18

No interaction studies have been performed. Concomitant administration of BIMERVAX XBB.1.16 with other vaccines has not been studied.

HOS-100498 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed. Concomitant administration of BIMERVAX with other vaccines has not been studied.

HOS-100499 · has-pregnancy-information · PDF-Seite 4

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 breast- feeding woman to BIMERVAX is negligible. 4 Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3.

HOS-100517 · has-pregnancy-information · PDF-Seite 47

Pregnancy There is no experience with the use of BIMERVAX XFG.1.1 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 XFG.1.1 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 XFG.1.1 is excreted in human milk. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast- feeding woman to BIMERVAX XFG.1.1 is negligible. 47 Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3.

HOS-100505 · has-pregnancy-information · PDF-Seite 18

Pregnancy There is no experience with the use of BIMERVAX XBB.1.16 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 XBB.1.16 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 XBB.1.16 is excreted in human milk. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast- feeding woman to BIMERVAX XBB.1.16 is negligible. 18 Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3.

HOS-100511 · has-pregnancy-information · PDF-Seite 32

Pregnancy There is no experience with the use of BIMERVAX LP.8.1 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 LP.8.1 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 LP.8.1 is excreted in human milk. No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast- feeding woman to BIMERVAX LP.8.1 is negligible. 32 Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, see section 5.3.

HOS-100503 · has-warning-information · PDF-Seite 17

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. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of BIMERVAX. 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 17 haemophilia), because bleeding or bruising may occur following an intramuscular administration in these individuals. Immunocompromised individuals There are limited data available on immunogenicity and safety of the vaccine when administered to immunocompromised individuals, including those receiving immunosuppressant therapy (see section 5.1). The efficacy of BIMERVAX XBB.1.16 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 XBB.1.16 may not protect all vaccine recipients. Excipients with known effect 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’. Polysorbate 80 This vaccine contains 1.18 mg of polysorb

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HOS-100515 · has-warning-information · PDF-Seite 46

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. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of BIMERVAX. 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 46 haemophilia), because bleeding or bruising may occur following an intramuscular administration in these individuals. Immunocompromised individuals There are limited data available on immunogenicity and safety of the vaccine when administered to immunocompromised individuals, including those receiving immunosuppressant therapy (see section 5.1). The efficacy of BIMERVAX XFG.1.1 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 XFG.1.1 may not protect all vaccine recipients. Excipients with known effect 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’. Polysorbate 80 This vaccine contains 1.18 mg of polysorbate

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HOS-100497 · has-warning-information · PDF-Seite 3

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. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of BIMERVAX. 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 3 haemophilia), because bleeding or bruising may occur following an intramuscular administration in these individuals. Immunocompromised individuals There are limited data available on immunogenicity and safety of the vaccine when administered to immunocompromised individuals, including those receiving immunosuppressant therapy (see section 5.1). 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 with known effect 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’. Polysorbate 80 This vaccine contains 1.18 mg of polysorbate 80 in each dose.

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HOS-100509 · has-warning-information · PDF-Seite 31

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. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of BIMERVAX. 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 31 haemophilia), because bleeding or bruising may occur following an intramuscular administration in these individuals. Immunocompromised individuals There are limited data available on immunogenicity and safety of the vaccine when administered to immunocompromised individuals, including those receiving immunosuppressant therapy (see section 5.1). The efficacy of BIMERVAX LP.8.1 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 LP.8.1 may not protect all vaccine recipients. Excipients with known effect 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’. Polysorbate 80 This vaccine contains 1.18 mg of polysorbate 8

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