Spikevax (previously COVID-19 Vaccine Moderna)

HOS-100073 · has-adverse-reaction-information · PDF-Seite 32

Summary of the safety profile Adults 32 The safety of Spikevax (original) was evaluated in a Phase 3 randomised, placebo-controlled, observer-blind clinical study conducted in the United States involving 30 351 participants 18 years of age and older who received at least one dose of Spikevax (original) (n=15 185) or placebo (n=15 166) (NCT04470427). At the time of vaccination, the mean age of the population was 52 years (range 18-95); 22 831 (75.2%) of participants were 18 to 64 years of age and 7 520 (24.8%) of participants were 65 years of age and older. The most frequently reported adverse reactions were pain at the injection site (92%), fatigue (70%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23%), axillary swelling/tenderness (19.8%), fever (15.5%), injection site swelling (14.7%) and redness (10%). Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age. Overall, there was a higher incidence of some adverse reactions in younger age groups: the incidence of axillary swelling/tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting and fever was higher in adults aged 18 to < 65 years than in those aged 65 years and above. Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1. Adolescents 12 through 17 years of age Safety data for Spikevax (original) in adolescents were collected in a Phase 2/3 randomised, placebo-controlled, observer-blind clinical study with multiple parts conducted in the United States. The first portion of the study involved 3 726 participants 12 through 17 years of age who received at least one dose of Spikevax (original) (n=2 486) or placebo (n=1 240) (NCT04649151). Demographic characteristics were similar among participants who received Spikevax (original) and those who received placebo. The most frequent adverse reactions in adolescents 12 to 17 years of age were injection site pain (97%), headache (78%), fatigue (75%), myalgia (54%), chills (49%), axillary swelling/tenderness (35%), arthralgia (35%), nausea/vomiting (29%), injection site swelling (28%), injection site erythema (26%), and fever (14%). This study transitioned to an open-label Phase 2/3 study in which 1 346 participants 12 years through 17 years of age received

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100079 · has-adverse-reaction-information · PDF-Seite 57

Summary of the safety profile Adults 57 The safety of Spikevax (original) was evaluated in a Phase 3 randomised, placebo-controlled, observer-blind clinical study conducted in the United States involving 30 351 participants 18 years of age and older who received at least one dose of Spikevax (original) (n=15 185) or placebo (n=15 166) (NCT04470427). At the time of vaccination, the mean age of the population was 52 years (range 18-95); 22 831 (75.2%) of participants were 18 to 64 years of age and 7 520 (24.8%) of participants were 65 years of age and older. The most frequently reported adverse reactions were pain at the injection site (92%), fatigue (70%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23%), axillary swelling/tenderness (19.8%), fever (15.5%), injection site swelling (14.7%) and redness (10%). Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age. Overall, there was a higher incidence of some adverse reactions in younger age groups: the incidence of axillary swelling/tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting and fever was higher in adults aged 18 to < 65 years than in those aged 65 years and above. Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1. Adolescents 12 through 17 years of age Safety data for Spikevax (original) in adolescents were collected in a Phase 2/3 randomised, placebo-controlled, observer-blind clinical study with multiple parts conducted in the United States. The first portion of the study involved 3 726 participants 12 through 17 years of age who received at least one dose of Spikevax (original) (n=2 486) or placebo (n=1 240) (NCT04649151). Demographic characteristics were similar among participants who received Spikevax (original) and those who received placebo. The most frequent adverse reactions in adolescents 12 to 17 years of age were injection site pain (97%), headache (78%), fatigue (75%), myalgia (54%), chills (49%), axillary swelling/tenderness (35%), arthralgia (35%), nausea/vomiting (29%), injection site swelling (28%), injection site erythema (26%), and fever (14%). This study transitioned to an open-label Phase 2/3 study in which 1 346 participants 12 years through 17 years of age received

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100067 · has-adverse-reaction-information · PDF-Seite 6

Summary of the safety profile Adults 6 The safety of Spikevax (original) was evaluated in a Phase 3 randomised, placebo-controlled, observer-blind clinical study conducted in the United States involving 30 351 participants 18 years of age and older who received at least one dose of Spikevax (original) (n=15 185) or placebo (n=15 166) (NCT04470427). At the time of vaccination, the mean age of the population was 52 years (range 18-95); 22 831 (75.2%) of participants were 18 to 64 years of age and 7 520 (24.8%) of participants were 65 years of age and older. The most frequently reported adverse reactions were pain at the injection site (92%), fatigue (70%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23%), axillary swelling/tenderness (19.8%), fever (15.5%), injection site swelling (14.7%) and redness (10%). Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age. Overall, there was a higher incidence of some adverse reactions in younger age groups: the incidence of axillary swelling/tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting and fever was higher in adults aged 18 to < 65 years than in those aged 65 years and above. Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1. Adolescents 12 through 17 years of age Safety data for Spikevax (original) in adolescents were collected in a Phase 2/3 randomised, placebo-controlled, observer-blind clinical study with multiple parts conducted in the United States. The first portion of the study involved 3 726 participants 12 through 17 years of age who received at least one dose of Spikevax (original) (n=2 486) or placebo (n=1 240) (NCT04649151). Demographic characteristics were similar among participants who received Spikevax (original) and those who received placebo. The most frequent adverse reactions in adolescents 12 to 17 years of age were injection site pain (97%), headache (78%), fatigue (75%), myalgia (54%), chills (49%), axillary swelling/tenderness (35%), arthralgia (35%), nausea/vomiting (29%), injection site swelling (28%), injection site erythema (26%), and fever (14%). This study transitioned to an open-label Phase 2/3 study in which 1 346 participants 12 years through 17 years of age received a

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100069 · has-contraindication-information · PDF-Seite 30

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

HOS-100063 · has-contraindication-information · PDF-Seite 4

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

HOS-100075 · has-contraindication-information · PDF-Seite 55

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

HOS-100062 · has-indication-information · PDF-Seite 3

Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recommendations.

HOS-100068 · has-indication-information · PDF-Seite 29

Spikevax LP.8.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recommendations.

HOS-100074 · has-indication-information · PDF-Seite 54

Spikevax XFG is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recommendations.

HOS-100077 · has-interaction-information · PDF-Seite 57

Spikevax (including variant formulations) can be concomitantly administered with influenza vaccines (standard and high-dose) and with herpes zoster (shingles) subunit vaccine. Different injectable vaccines should be given at different injection sites.

HOS-100071 · has-interaction-information · PDF-Seite 32

Spikevax (including variant formulations) can be concomitantly administered with influenza vaccines (standard and high-dose) and with herpes zoster (shingles) subunit vaccine. Different injectable vaccines should be given at different injection sites.

HOS-100065 · has-interaction-information · PDF-Seite 6

Spikevax (including variant formulations) can be concomitantly administered with influenza vaccines (standard and high-dose) and with herpes zoster (shingles) subunit vaccine. Different injectable vaccines should be given at different injection sites.

HOS-100072 · has-pregnancy-information · PDF-Seite 32

Pregnancy A large amount of observational data from pregnant women vaccinated with Spikevax has not shown an increase in adverse pregnancy outcomes. Since differences between products are confined to the spike protein sequence, and there are no clinically meaningful differences in reactogenicity, SARS-CoV-2 LP.8.1 mRNA can be used during pregnancy. Breast-feeding No data are available yet regarding the use of SARS-CoV-2 LP.8.1 mRNA during breastfeeding. However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to the vaccine is negligible. Observational data from women who were breastfeeding after vaccination with Spikevax (original) have not shown a risk for adverse effects in breastfed newborns/infants. SARS-CoV-2 LP.8.1 mRNA can be used during breastfeeding. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

HOS-100078 · has-pregnancy-information · PDF-Seite 57

Pregnancy A large amount of observational data from pregnant women vaccinated with Spikevax has not shown an increase in adverse pregnancy outcomes. Since differences between products are confined to the spike protein sequence, and there are no clinically meaningful differences in reactogenicity, SARS-CoV-2 XFG mRNA can be used during pregnancy. Breast-feeding No data are available yet regarding the use of SARS-CoV-2 XFG mRNA during breastfeeding. However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to the vaccine is negligible. Observational data from women who were breastfeeding after vaccination with Spikevax (original) have not shown a risk for adverse effects in breastfed newborns/infants. SARS-CoV-2 XFG mRNA can be used during breastfeeding. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

HOS-100066 · has-pregnancy-information · PDF-Seite 6

Pregnancy A large amount of observational data from pregnant women vaccinated with Spikevax has not shown an increase in adverse pregnancy outcomes. Since differences between products are confined to the spike protein sequence, and there are no clinically meaningful differences in reactogenicity, SARS-CoV-2 JN.1 mRNA can be used during pregnancy. Breast-feeding No data are available yet regarding the use of SARS-CoV-2 JN.1 mRNA during breastfeeding. However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to the vaccine is negligible. Observational data from women who were breastfeeding after vaccination with Spikevax (original) have not shown a risk for adverse effects in breastfed newborns/infants. SARS-CoV-2 JN.1 mRNA can be used during breastfeeding. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

HOS-100070 · has-warning-information · PDF-Seite 30

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. 30 Hypersensitivity and anaphylaxis Anaphylaxis has been reported in individuals who have received Spikevax. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. Subsequent doses of Spikevax LP.8.1 should not be given to those who have experienced anaphylaxis to a prior dose of any Spikevax vaccine. Myocarditis and pericarditis There is an increased risk for myocarditis and pericarditis following vaccination with Spikevax. These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been observed more often in younger males, and more often after the second dose compared to the first dose (see section 4.8). Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. 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

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100064 · has-warning-information · PDF-Seite 4

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. 4 Hypersensitivity and anaphylaxis Anaphylaxis has been reported in individuals who have received Spikevax. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. Subsequent doses of Spikevax JN.1 should not be given to those who have experienced anaphylaxis to a prior dose of any Spikevax vaccine. Myocarditis and pericarditis There is an increased risk for myocarditis and pericarditis following vaccination with Spikevax. These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been observed more often in younger males, and more often after the second dose compared to the first dose (see section 4.8). Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. 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

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100076 · has-warning-information · PDF-Seite 55

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. 55 Hypersensitivity and anaphylaxis Anaphylaxis has been reported in individuals who have received Spikevax. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. Subsequent doses of Spikevax XFG should not be given to those who have experienced anaphylaxis to a prior dose of any Spikevax vaccine. Myocarditis and pericarditis There is an increased risk for myocarditis and pericarditis following vaccination with Spikevax. These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been observed more often in younger males, and more often after the second dose compared to the first dose (see section 4.8). Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. 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

Auszug; vollständigen Abschnitt im Original lesen.