Comirnaty

Pharmaceutical Form: (See Table 1.)

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Each dose contains COVID-19 mRNA vaccine embedded in lipid nanoparticles.
COMIRNATY is highly purified single-stranded, 5'-capped messenger ribonucleic acid (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2. (See Table 2.)

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Excipients/Inactive Ingredients: ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159), 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC), Cholesterol, Tromethamine (Tris base), Tris (hydroxymethyl) aminoethane hydrochloride (Tris HCl), Sucrose, Water for injection.

Pharmacotherapeutic group: vaccines, viral vaccines. ATC code: J07BN01.
Pharmacology: Pharmacodynamics: Mechanism of action: The nucleoside-modified messenger RNA in COMIRNATY is formulated in lipid nanoparticles, which enable delivery of the non-replicating RNA into host cells to direct transient expression of the SARS-CoV-2 S antigen. The mRNA codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. The vaccine elicits both neutralising antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19.
Efficacy and immunogenicity: Immunogenicity data supporting the use of a single dose of COMIRNATY in seropositive, vaccine-naïve individuals: In a subset of Study 7 (Study BNT162-17) in participants 18 through 85 years of age, immunogenicity of a single 30 micrograms dose of a Pfizer-BioNTech bivalent COVID-19 vaccine containing equal quantities of modRNA encoding the viral spike (S) glycoprotein for the Alpha and Delta SARS-CoV-2 variants (hereafter referred to as the bivalent Alpha and Delta vaccine which is not authorised or approved) was assessed in COVID-19 vaccine-naïve participants with prior SARS-CoV-2 infection (n=262) compared to participants without prior SARS-CoV-2 infection who received 2 doses of COMIRNATY (Original) in Study 2 (n=275). The immunogenicity of the bivalent Alpha and Delta vaccine is relevant to COMIRNATY (2023-2024 formula) because these vaccines are manufactured using the same process with differences only in the encoded spike proteins.
A primary immunogenicity objective of the study was to assess non-inferiority with respect to level of 50% neutralising titre (NT50) and to the seroresponse rate to the reference strain immune response induced by a single dose of the bivalent Alpha and Delta vaccine in COVID-19 vaccine-naïve participants with evidence of prior infection relative to the response in participants without evidence of SARS-CoV-2 infection who received 2 doses of COMIRNATY (Original).
Non-inferiority of the reference strain immune response with respect to level of NT50 was met, as the lower bound of the 2-sided 95% CI for GMR was >0.67. The GMT was higher after a single dose of bivalent Alpha and Delta vaccine in COVID-19 vaccine-naïve participants with evidence of prior SARS-CoV-2 infection (Table 3).
Non-inferiority of the seroresponse rate to the reference strain was not met, as the lower bound of the 2-sided 95% CIs for the difference in seroresponse rate of reference strain was -10.04%, below the non-inferiority margin of -10% (Table 4).
The immune responses to the Alpha, Delta and Omicron BA.5 variants in vaccine-naïve participants with evidence of prior SARS-CoV-2 infection after 1 dose of the bivalent Alpha and Delta vaccine, in vaccine-naïve participants without evidence of SARS-CoV-2 infection after 2 doses of the bivalent Alpha and Delta vaccine, and in participants who had previously received 2 doses of COMIRNATY (Original) without evidence of SARS-CoV-2 infection and received 1 dose of the bivalent Alpha and Delta vaccine are provided in Table 5. (See Tables 3, 4 and 5.)

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Study 2 is a multicentre, multinational, Phase 1/2/3 randomised, placebo-controlled, observer-blind dose-finding, vaccine candidate selection and efficacy study in participants 12 years of age and older. Randomisation was stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the ≥56-year stratum. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 6 weeks before enrolment, were included as were participants with known stable infection with HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV).
Efficacy in participants 16 years of age and older - after 2 doses: In the Phase 2/3 portion of Study 2, based on data accrued through 14 November 2020, approximately 44,000 participants were randomised equally and were to receive 2 doses of COMIRNATY (Original) or placebo. The efficacy analyses included participants that received their second vaccination within 19 to 42 days after their first vaccination. The majority (93.1%) of vaccine recipients received the second dose 19 days to 23 days after Dose 1. Participants are planned to be followed for up to 24 months after Dose 2, for assessments of safety and efficacy against COVID-19. In the clinical study, participants were required to observe a minimum interval of 14 days before and after administration of an influenza vaccine in order to receive either placebo or COMIRNATY. In the clinical study, participants were required to observe a minimum interval of 60 days before or after receipt of blood/plasma products or immunoglobulins within through conclusion of the study in order to receive either placebo or COMIRNATY.
The population for the analysis of the primary efficacy endpoint included 36,621 participants 12 years of age and older [18,242 in the COMIRNATY (Original) group and 18,379 in the placebo group] who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. In addition, 134 participants were between the ages of 16 through 17 years of age (66 in the COMIRNATY (Original) group and 68 in the placebo group) and 1,616 participants 75 years of age and older (804 in the COMIRNATY (Original) group and 812 in the placebo group). (See Table 6.)

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At the time of the primary efficacy analysis, participants had been followed for symptomatic COVID-19 for in total 2,214 person-years for the COMIRNATY (Original) and in total 2,222 person-years in the placebo group.
There were no meaningful clinical differences in overall vaccine efficacy in participants who were at risk of severe COVID-19 including those with 1 or more comorbidities that increase the risk of severe COVID-19 [e.g., asthma, body mass index (BMI) ≥30 kg/m², chronic pulmonary disease, diabetes mellitus, hypertension].
The vaccine efficacy information is presented in Table 7. (See Table 7.)

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Efficacy of COMIRNATY in preventing first COVID-19 occurrence from 7 days after Dose 2 compared to placebo was 94.6% (95% confidence interval of 89.6% to 97.6%) in participants 16 years of age and older with or without evidence of prior infection with SARS-CoV-2.
Additionally, subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across genders, ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19.
Updated efficacy analyses were performed with additional confirmed COVID-19 cases accrued during blinded placebo-controlled follow-up through 13 March 2021, representing up to 6 months of follow-up after Dose 2 for participants in the efficacy population.
The updated vaccine efficacy information is presented in Table 8. (See Table 8.)

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The updated subgroup analyses of vaccine efficacy by demographic characteristics are presented in Table 9 and Table 10. (See Tables 9 and 10.)

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The updated subgroup analyses of vaccine efficacy by risk status in participants are presented in Table 11 and Table 12. (See Tables 11 and 12.)

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Efficacy against severe COVID-19 - after 2 doses: Updated efficacy analyses of secondary efficacy endpoints supported benefit of COMIRNATY in preventing severe COVID-19. Vaccine efficacy against severe COVID-19 is presented only for participants with or without prior SARS-CoV-2 infection (Table 13) as the COVID-19 case counts in participants without prior SARS-CoV-2 infection were the same as those in participants with or without prior SARS-CoV-2 infection in both the COMIRNATY (Original) and placebo groups. (See Table 13.)

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Efficacy and immunogenicity in adolescents 12 through 15 years of age - after 2 doses: In an analysis of Study 2 in adolescents 12 through 15 years of age without evidence of prior infection, there were no cases in 1005 participants who received the vaccine and 16 cases out of 978 who received placebo. The point estimate for efficacy is 100% (95% confidence interval 75.3, 100.0). In participants with or without evidence of prior infection there were 0 cases in the 1119 who received vaccine and 18 cases in 1110 participants who received placebo. This also indicates the point estimate for efficacy is 100% (95% confidence interval 78.1, 100.0).
In Study 2, an analysis of SARS-CoV-2 neutralising titres 1 month after Dose 2 was conducted in a randomly selected subset of participants who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2, comparing the response in adolescents 12 through 15 years of age (n = 190) to participants 16 through 25 years of age (n = 170).
The ratio of the geometric mean titres (GMT) in the 12 through 15 years of age group to the 16 through 25 years of age group was 1.76, with a 2-sided 95% CI of 1.47 to 2.10. Therefore, the 1.5-fold non-inferiority criterion was met as the lower bound of the 2-sided 95% CI for the geometric mean ratio [GMR] was >0.67.
An updated efficacy analysis of Study 2 has been performed in approximately 2,260 adolescents 12 through 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cut-off date of September 2, 2021, representing up to 6 months of follow-up after Dose 2 for participants in the efficacy population.
The updated vaccine efficacy information in adolescents 12 through 15 years of age is presented in Table 14. (See Table 14.)

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Efficacy in children 5 through <12 years of age - after 2 doses: An initial descriptive efficacy analysis of Study 3 has been performed in 1,968 children 5 through <12 years of age without evidence of infection prior to 7 days after Dose 2. This analysis evaluated confirmed symptomatic COVID-19 cases accrued up to a data cut-off date of 8 October 2021.
Table 15 presents the specific demographic characteristics in participants who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. (See Table 15.)

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The initial descriptive vaccine efficacy results in children 5 through <12 years of age without evidence of prior SARS-CoV-2 infection are presented in Table 16. None of the cases accrued met criteria for severe COVID-19 or multisystem inflammatory syndrome in children (MIS-C). No cases of COVID-19 were observed in either the vaccine group or the placebo group in participants with evidence of prior SARS-CoV-2 infection. (See Table 16.)

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Prespecified hypothesis-driven efficacy analysis was performed with additional confirmed COVID-19 cases accrued during blinded placebo-controlled follow-up, representing up to 6 months after Dose 2 in the efficacy population.
In the efficacy analysis of Study 3 in children 5 to 11 years of age without evidence of prior infection, there were 10 cases out of 2,703 participants who received the vaccine and 42 cases out of 1,348 participants who received placebo. The point estimate for efficacy is 88.2% (95% CI: 76.2, 94.7). In participants with or without evidence of prior infection there were 12 cases in the 3,018 who received vaccine and 42 cases in 1,511 participants who received placebo. The point estimate for efficacy is 85.7% (95% CI: 72.4, 93.2).
Immunogenicity in children 5 through <12 years of age - after 2 doses: Study 3 is a Phase 1/2/3 study comprised of an open-label vaccine dose finding portion (Phase 1) and a multicentre, multinational, randomised, saline placebo-controlled, observer-blind efficacy portion (Phase 2/3) that has enrolled participants 5 through <12 years of age.
In Study 3, an analysis of SARS-CoV-2 NT50 1 month after Dose 2 in a randomly selected subset of participants demonstrated effectiveness by immunobridging of immune responses comparing children 5 through <12 years of age in the Phase 2/3 part of Study 3 to participants 16 through 25 years of age in the Phase 2/3 part of Study 2 who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2, meeting the prespecified immunobridging criteria for both the GMR and the seroresponse difference with seroresponse defined as achieving at least 4-fold rise in SARS-CoV-2 NT50 from baseline (before Dose 1).
The ratio of the SARS-CoV-2 NT50 in children 5 through <12 years of age to that of young adults 16 through 25 years of age was 1.04 (2-sided 95% CI: 0.93, 1.18), as presented in Table 17. (See Table 17.)

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Among participants without prior evidence of SARS-CoV-2 infection up to 1 month after Dose 2, 99.2% of children 5 through <12 years of age and 99.2% of participants 16 through 25 years of age had a seroresponse from before vaccination to 1 month after Dose 2. The difference in proportions of participants who had seroresponse between the 2 age groups (children - young adult) was 0.0% (2-sided 95% CI: -2.0%, 2.2%), as presented in Table 18. ( See Table 18.)

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Efficacy and immunogenicity in individuals 6 months through <5 years of age - 3-dose primary course: Effectiveness in individuals 6 months through 4 years of age is based on a comparison of efficacy against symptomatic COVID-19 comparing to placebo and immune responses in this age group to individuals 16 through 25 years of age.
Efficacy in participants 6 months through 4 years of age - after 3 doses: The efficacy analysis of Study 3 was performed across the combined population of participants 6 months through 4 years of age based on cases confirmed among 873 participants in the COMIRNATY (Original) group and 381 participants in the placebo group (2:1 randomisation ratio) who received all 3 doses of study intervention during the blinded follow-up period when the Omicron variant of SARS-CoV-2 (BA.2) was the predominant variant in circulation (data cut-off date of 17 June 2022).
Table 19 presents the specific demographic characteristics in participants 6 months through 4 years of age who received 3 doses of COMIRNATY (Original) (3 micrograms modRNA) or placebo. (See Table 19.)

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The vaccine efficacy results after Dose 3 in participants 6 months through 4 years of age are presented in Table 20. (See Table 20.)

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Analysis of COVID-19 cases that excluded those involving coinfection with other respiratory pathogens did not meaningfully impact the estimated vaccine efficacy in this population.
Among participants 2 through 4 years of age, severe COVID-19 criteria (as described in the protocol, based on FDA definition and modified for children) were fulfilled for 9 cases [6 COMIRNATY (Original) and 3 placebo] of which 5 of the 6 cases in the COMIRNATY (Original) group fulfilled a single criterion of increased heart rate or respiratory rate and all 3 cases in the placebo group fulfilled a single criterion of increased heart rate or decreased peripheral oxygen saturation. None of the cases accrued met criteria for multisystem inflammatory syndrome in children (MIS-C).
Among participants 6 months through 23 months of age, severe COVID-19 criteria were fulfilled for 3 cases [2 COMIRNATY (Original) and 1 placebo] of which 1 of the 2 cases in the COMIRNATY (Original) group fulfilled a single criterion of increased heart rate (152 bpm) and 1 case in the placebo group fulfilled a single criterion of increased heart rate (172 bpm). None of the cases accrued met criteria for MIS-C.
Immunogenicity in participants 2 through 4 years of age - after 3 doses: Immunogenicity analyses have been performed in the immunobridging subset of 143 Study 3 participants 2 through 4 years of age without evidence of infection up to 1 month after Dose 3 based on a data cut-off date of 29 April 2022.
Table 21 presents the specific demographic characteristics in the studied evaluable immunogenicity population. (See Table 21.)

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SARS-CoV-2 NT50 were compared between an immunogenicity subset of Phase 2/3 participants 2 through 4 years of age from Study 3 at 1 month after the 3-dose primary course and a randomly selected subset from Study 2 (Phase 2/3) participants 16 through 25 years of age at 1 month after the 2-dose primary course, using a microneutralisation assay against the reference strain (USA_WA1/2020). The primary immunobridging analyses compared the geometric mean titres (using a GMR) and the seroresponse (defined as achieving at least 4-fold rise in SARS-CoV-2 NT50 from before Dose 1) rates in the evaluable immunogenicity population of participants without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 3 in participants 2 through 4 years of age and up to 1 month after Dose 2 in participants 16 through 25 years of age. The prespecified immunobridging criteria were met for both the GMR and the seroresponse difference (see Table 22 and Table 23, respectively).

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Using a non-validated fluorescence focus reduction neutralisation test assay against the Omicron variant of SARS-CoV-2 (BA.1), the NT50 GMT at 1 month after Dose 3 among a subset of 34 study participants without evidence of prior SARS-CoV-2 infection (82.5 [2-sided 95% CI: 55.4, 122.9]) was increased compared to the NT50 GMT before Dose 3 (14.0 [2-sided 95% CI: 10.6, 18.5]).
An additional descriptive immunogenicity analysis was performed for participants 2 through 4 years of age who received a 3-dose course of COMIRNATY (Original) in Study 3 (Phase 2/3), compared with a subset of participants 18 through 50 years of age in Study C4591017 (Phase 3) who had received a 2-dose primary course followed by a booster dose of COMIRNATY (Original) 30 micrograms. The comparator group (participants 18 through 50 years of age) in this analysis had a similar interval between COMIRNATY (Original) Dose 2 and Dose 3 (median 13.0 weeks) as the participants 2 to 4 years of age (median 10.6 weeks). Among 34 participants 2 through 4 years of age without evidence of prior SARS-CoV-2 infection who received 3 doses of COMIRNATY (Original) 3 micrograms, neutralising GMTs were 114.3 at 1-month post-Dose 3. Among 27 participants 18 through 50 years of age without evidence of prior SARS-CoV-2 infection who received 3 doses of COMIRNATY (Original) 30 micrograms, Omicron neutralising GMTs were 164.2 at 1-month post Dose 3.
Immunogenicity in participants 6 through 23 months of age - after 3 doses: Immunogenicity analyses have been performed in the immunobridging subset of 82 Study 3 participants 6 through 23 months of age without evidence of infection up to 1 month after Dose 3 based on a data cut-off date of 29 April 2022.
Table 24 presents the specific demographic characteristics in the studied evaluable immunogenicity population. (See Table 24.)

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SARS-CoV-2 NT50 1 month after the vaccination course were compared between an immunogenicity subset of Phase 2/3 participants 6 through 23 months of age from Study 3 and a randomly selected subset from Study 2 (Phase 2/3) participants 16 through 25 years of age, using a microneutralisation assay against the reference strain (USA_WA1/2020). The primary immunobridging analyses compared the geometric mean titres (using a GMR) and the seroresponse (defined as achieving at least 4-fold rise in SARS-CoV-2 NT50 from before Dose 1) rates in the evaluable immunogenicity population of participants without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 3 in participants 6 through 23 months of age and up to 1 month after Dose 2 in participants 16 through 25 years of age. The prespecified immunobridging criteria were met for both the GMR and the seroresponse difference (see Table 25 and Table 26, respectively).

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Using a non-validated fluorescence focus reduction neutralisation test assay against the Omicron variant of SARS-CoV-2 (BA.1), the NT50 GMT at 1 month after Dose 3 among a subset of 32 study participants without evidence of prior SARS-CoV-2 infection (127.5 [2-sided 95% CI: 90.2, 180.1]) was increased compared to the NT50 GMT before Dose 3 (16.3 [2-sided 95% CI: 12.8, 20.8]).
An additional descriptive immunogenicity analysis was performed for participants 6 through 23 months of age who received a 3-dose course of COMIRNATY (Original) in Study 3 (Phase 2/3), compared with a subset of participants 18 through 50 years of age in Phase 3 Study C4591017 who had received a 2-dose primary course followed by a booster dose of COMIRNATY (Original) 30 micrograms. The comparator group (participants 18 through 50 years of age) in this analysis had a similar interval between COMIRNATY (Original) Dose 2 and Dose 3 (median 13.0 weeks) as the participants 6 through 23 months of age (median 12.9 weeks). Among 32 participants 6 through 23 months of age without evidence of prior SARS-CoV-2 infection who received 3 doses of COMIRNATY (Original) 3 micrograms, Omicron neutralising GMTs were 128.8 at 1-month post-Dose 3. Among 27 participants 18 through 50 years of age without evidence of prior SARS-CoV-2 infection who received 3 doses of COMIRNATY (Original) 30 micrograms, Omicron neutralising GMTs were 164.2 at 1-month post-Dose 3.
Immunogenicity in participants 18 years of age and older - after booster dose: Effectiveness of a booster dose of COMIRNATY (Original) was demonstrated by evaluating non-inferiority immune responses of SARS-CoV-2 NT50 1 month after a booster dose. In Study 2, an analysis of SARS-CoV-2 NT50 demonstrated non-inferior immune responses 1 month after a booster dose compared to 1 month after Dose 2 in participants at least 18 through 55 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after the booster dose, based on prespecified non-inferiority criteria for both GMR and difference in seroresponse rates. Seroresponse for a participant was defined as achieving a ≥4-fold rise from baseline (before Dose 1) in NT50 (Table 27 and Table 28).
The SARS-CoV-2 NT50 GMR of 1 month after the booster dose to 1 month after Dose 2 was 3.26 (2-sided 97.5% CI: 2.76, 3.86), which met the non-inferiority criteria for GMR (lower bound of the 2-sided 97.5% CI >0.67 and point estimate of the GMR ≥0.8).
A high proportion of participants (99.5%) had seroresponse 1 month after Dose 3 compared with 95.0% 1 month after Dose 2. The difference in proportions of participants with a seroresponse 1 month after the booster dose (Dose 3) and 1 month after Dose 2 (Dose 3 minus Dose 2) was 1.5% (2-sided 97.5% CI: 1.0%, 7.9%), which met the 10% non-inferiority criterion (i.e., lower bound of the 2-sided 97.5% CI >-10%). (See Tables 27 and 28.)

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Relative vaccine efficacy in participants 16 years of age and older - after booster dose: An interim efficacy analysis of Study 4, a placebo-controlled booster study, was performed in approximately 10,000 participants 16 years of age and older who were recruited from Study 2, evaluated confirmed COVID-19 cases accrued from at least 7 days after booster vaccination up to a data cut-off date of 08 February 2022 (a period when Delta and then Omicron was the predominant variant), which represents a median of 2.8 months (range 0.3 to 7.5 months) post-booster follow-up. Vaccine efficacy of the COMIRNATY (Original) booster dose after the primary series relative to the placebo booster group who only received the primary series dose was assessed. The relative vaccine efficacy information for participants 16 years of age and older is presented in Table 29. (See Table 29.)

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Immunogenicity in children 5 through <12 years of age - after booster dose: Effectiveness of a booster dose of COMIRNATY (Original) was based on an assessment of NT50 against the reference strain of SARS-CoV-2 (USA_WA1/2020). Analyses of NT50 1 month after the booster dose compared to before the booster dose (Dose 3) demonstrated a substantial increase in GMTs in individuals 5 through <12 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after the booster dose. This analysis is summarised in Table 30. (See Table 30.)

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Immunogenicity in children 5 through <12 years of age on the Omicron variant - after booster dose: The neutralising GMTs against both the Omicron variant and reference strain were substantially increased after booster vaccination compared with after the 2-dose primary series. At 1-month post-Dose 2, the observed neutralising GMTs for the Omicron variant and reference strain were 27.6 and 323.8, respectively. At 1-month post-Dose 3, the observed neutralising GMTs for the Omicron variant and reference strain were 614.4 and 1702.8, respectively (see Table 31).
For the Omicron variant, neutralising titres after booster vaccination (1-month post-Dose 3) increased 22-fold over those after the 2-dose primary series (1-month post-Dose 2). For the reference strain, the increase after the booster relative to the primary series was 5.3-fold. (See Table 31.)

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Immunogenicity with concomitant vaccine administration - COMIRNATY 30 micrograms: Concomitant administration with seasonal influenza vaccine: In Study 8 (C4591030), a Phase 3 multicentre, randomised, observer-blind study, 1,134 participants 18 through 64 years of age who had received 3 doses of COMIRNATY (Original) at least 3 months prior were randomised in a 1:1 ratio to receive either COMIRNATY (Original) co-administered with a seasonal inactivated influenza vaccine (SIIV), quadrivalent (Afluria Quad) followed 1 month later by placebo (Group 1, n=568) or an inactivated influenza vaccine with placebo followed 1 month later with COMIRNATY (Original) (Group 2, n=566).
The immune responses to COMIRNATY (Original) and SIIV were similar after COMIRNATY (Original) administered concomitantly with SIIV compared with those elicited by either vaccine administered alone. The non-inferiority criterion was achieved for both full-length S-binding immunoglobulin G (IgG) and all 4 influenza strain-specific haemagglutination inhibition (HAI) titres.
The immunogenicity results are presented in Table 32 and Table 33. (See Tables 32 and 33.)

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Concomitant administration with pneumococcal conjugate vaccine: In Study 11 (B7471026), a double-blind, randomised descriptive study, participants 65 years of age and older who had received 2 doses of COMIRNATY (Original) at least 6 months earlier, were randomised in a 1:1:1 ratio to receive either 20vPnC concomitantly administered with a booster dose of COMIRNATY (Original) (n=190), or 20vPnC vaccine administered alone (n=191), or a booster dose of COMIRNATY (Original) administered alone (n=189).
Immune responses to both vaccines were observed after concomitant administration of 20vPnC vaccine and COMIRNATY (Original). Opsonophagocytic activity (OPA) GMTs for the 20 pneumococcal serotypes were similar to 20vPnC vaccine administered alone and IgG GMCs for the full-length S−binding protein were similar to COMIRNATY (Original) administered alone. A post-hoc analysis found the immune responses to all 20 serotypes elicited by 20vPnC vaccine when concomitantly administered with COMIRNATY (Original) would have met conventional 2-fold non-inferiority criteria compared to 20vPnC vaccine alone, and the full-length S-binding IgG GMC elicited by COMIRNATY (Original) would have met conventional 1.5-fold non-inferiority criteria compared to COMIRNATY (Original) alone.
Concomitant administration with an RSV vaccine or with an RSV vaccine and a high dose influenza vaccine: In Study 12 (C5481001) a Phase 1/2, randomised, multicentre, parallel group, observer-blinded study 1,083 participants 65 years of age and older who had previously received at least 3 prior doses of an mRNA COVID-19 vaccine, had not previously received any RSV vaccine, or an influenza vaccine in the ≤120 days prior to enrolment, were randomised in 1 of 2 enrolment strata.
The first stratum of approximately 750 participants were randomised 1:1 to evaluate the safety, tolerability, and immunogenicity of admixed COMIRNATY (Bivalent BA.4/BA.5) and RSV (bivalent, recombinant) vaccine concomitantly administered with high dose quadrivalent flu vaccine or placebo in the opposite arm, compared to the individual vaccines.
In the second stratum (total participants n=316) participants were randomised 1:1 to receive COMIRNATY (Bivalent BA.4/BA.5) with concomitantly administered RSV (bivalent, recombinant) vaccine (in one arm) with either placebo or high dose quadrivalent flu vaccine (opposite arm). The study objectives included assessing the impact on the immune response of COMIRNATY (Bivalent BA.4/BA.5) concomitantly administered with RSV (bivalent, recombinant) vaccine, the immune response of concomitant use of RSV (bivalent, recombinant) vaccine, COMIRNATY (Bivalent BA.4/BA.5), and high dose quadrivalent flu vaccine.
When COMIRNATY (Bivalent BA.4/BA.5) was concomitantly administered with RSV (bivalent, recombinant) vaccine immunologic non-inferiority was demonstrated for COMIRNATY (Bivalent BA.4/BA.5) and RSV (bivalent, recombinant) vaccine compared to individual administration. The lower limit of the 2 sided 97.5% CI for the GMR for RSV A, RSV B, both SARS-CoV-2 Omicron BA.4/BA.5 strain and SARS-COV-2 Wuhan-Hu 1 strain (wildtype) reference strain neutralising titres (NTs) all met the predefined 2-fold non-inferiority criterion.
When COMIRNATY (Bivalent BA.4/BA.5) and RSV (bivalent, recombinant) vaccine were concomitantly administered with high dose quadrivalent flu vaccine, immunologic non-inferiority was demonstrated for COMIRNATY (Bivalent BA.4/BA.5), RSV (bivalent, recombinant) vaccine and high dose quadrivalent flu vaccine group compared to each individual administration. The lower limit of the 2 sided 97.5% CI for the GMR for RSV A, RSV B, both SARS-CoV-2 Omicron BA.4/BA.5 strain and SARS-COV-2 Wuhan-Hu 1 strain (wildtype) reference strain NTs, and each of the 4 strain specific HAI titres all met the predefined 2-fold non-inferiority criterion.
Pharmacokinetics: Not applicable.
Toxicology: Preclinical safety data: Non-clinical data with COMIRNATY (Original) reveal no special hazard for humans based on conventional studies of repeat dose toxicity and reproductive and developmental toxicity.
General toxicity: Rats intramuscularly administered COMIRNATY (receiving 3 full human doses once weekly, generating relatively higher levels in rats due to body weight differences) demonstrated some injection site oedema and erythema and increases in white blood cells (including basophils and eosinophils) consistent with an inflammatory response as well as vacuolation of portal hepatocytes without evidence of liver injury. All effects were reversible.
Genotoxicity/Carcinogenicity: Neither genotoxicity nor carcinogenicity studies were performed. The components of the vaccine (lipids and mRNA) are not expected to have genotoxic potential.
Reproductive toxicity: Reproductive and developmental toxicity were investigated in rats in a combined fertility and developmental toxicity study where female rats were intramuscularly administered COMIRNATY prior to mating and during gestation (receiving 4 full human doses that generate relatively higher levels in rat due to body weight differences, spanning between pre-mating day 21 and gestational day 20). SARS-CoV-2 neutralising antibody responses were present in maternal animals from prior to mating to the end of the study on postnatal day 21 as well as in foetuses and offspring. There were no vaccine-related effects on female fertility, pregnancy, or embryo-foetal or offspring development. No COMIRNATY data are available on vaccine placental transfer or excretion in milk.

COMIRNATY is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 6 months of age and older.
The use of this vaccine should be in accordance with official recommendations.

Posology: (See Table 34.)

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A booster may be administered at least 3 months after completion of primary series and in accordance with official recommendations.
Individuals who have partially completed the primary series with a COVID-19 vaccine: Individuals 6 months through <12 years of age who have partially completed the primary series should complete the primary series with an age-appropriate dose of the most current COMIRNATY presentation available. Refer to Table 34 for the age-appropriate primary series dosing.
Individuals 12 years of age and older who have partially completed the primary series should receive a single dose of the most current COMIRNATY presentation available.
Individuals who have previously completed a primary series with a COVID-19 vaccine: Individuals 6 months of age and older who have previously completed a primary series should receive a single dose with the most current COMIRNATY presentation at least 3 months after the previous dose.
Individuals may not be protected until 7 days after they have completed their dosing recommendations as noted in Table 34 (see Pharmacology: Pharmacodynamics under Actions).
Additional booster doses in individuals 12 years of age and older: Any subsequent doses of COMIRNATY may be administered at least 3 months after a previous dose of COMIRNATY and in accordance with official recommendations.
Interchangeability with other COVID-19 vaccines: The interchangeability of COMIRNATY with other COVID-19 vaccines has not been established.
Paediatric population: The safety and efficacy of COMIRNATY in paediatric participants aged less than 6 months have not yet been established. Limited data are available.
Elderly population: No dosage adjustment is required in elderly individuals ≥65 years of age. The safety of a booster dose of COMIRNATY in individuals 65 years of age and older is based on safety data in 12 booster dose recipients 65 through 85 years of age in Study 2, 306 booster dose recipients 18 through 55 years of age in Study 2, and 1,175 booster dose recipients 65 years of age and older in Study 4. The effectiveness of a booster dose of COMIRNATY in individuals 65 years of age and older is based on effectiveness data in 306 booster dose recipients 18 through 55 years of age in Study 2, and an efficacy analysis from participants 16 years of age and older in 9,945 participants in Study 4.
Method of administration: Administer COMIRNATY intramuscularly. Do not administer intravascularly, subcutaneously, or intradermally.
In individuals 6 months to <12 months of age: administer COMIRNATY in the anterolateral aspect of the thigh.
In individuals 1 year to <5 years of age: administer COMIRNATY in the anterolateral aspect of the thigh or the deltoid muscle.
In individuals 5 years of age and older: administer COMIRNATY in the deltoid muscle.
For detailed instructions on the handling, dilution, and dose preparation of the vaccine before administration, see Special precautions for disposal and other handling under Cautions for Usage.

In clinical trials, participants who received up to 2 times the recommended dose of COMIRNATY did not have an increase in reactogenicity or adverse events.
In post-authorisation experience, there have been reports of higher than recommended doses of COMIRNATY. In general, adverse events reported with overdoses have been similar to the known adverse reaction profile of COMIRNATY.
In the event of overdose, monitoring of vital functions and individualised symptomatic treatment is recommended.

Hypersensitivity to the active substance or to any of the excipients listed under Description.

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. 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 30 minutes is recommended following vaccination. Subsequent dose(s) of the vaccine should not be given to those who have experienced anaphylaxis to the earlier dose of COMIRNATY.
Myocarditis and pericarditis: Postmarketing data demonstrate increased risks of myocarditis and pericarditis. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often, but not exclusively in younger males. There have been reports in females. Based on accumulating data, the reporting rates of myocarditis and pericarditis after primary series in children ages 5 through <12 years are lower than in ages 12 through 17 years. Rates of myocarditis and pericarditis in booster doses do not appear to be higher than after the second dose in the primary series. Although some cases required intensive care support and fatal cases have been observed, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae.
Local cases of myocarditis with severe outcomes have been rarely reported with strenuous physical activity following vaccination. Vaccine recipients should be advised to seek medical attention promptly if they develop chest pain, shortness of breath or abnormal heartbeats. Non-specific symptoms of myocarditis and pericarditis also include fatigue, nausea and vomiting, abdominal pain, dizziness or syncope, oedema and cough. Refer to the national vaccination guidances for local recommendations.
Anxiety-related reactions: Some individuals may have stress-related responses associated with the process of vaccination itself. Stress-related responses are temporary and resolve on their own. They may include dizziness, fainting, palpitations, increases in heart rate, alterations in blood pressure, feeling short of breath, tingling sensations, sweating and/or anxiety. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation and precautions should be in place to avoid injury from fainting.
Concurrent illness: Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection.
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 has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY may be lower in immunosuppressed individuals. Additional doses may be administered to individuals who are severely immunocompromised in accordance with national recommendations.
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 COMIRNATY may not protect all vaccine recipients.
Effects on ability to drive and use machines: COMIRNATY has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under Adverse Reactions may temporarily affect the ability to drive or use machines.

Pregnancy: There are limited amount of clinical study data from the use of COMIRNATY (Original) 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 Pharmacology: Toxicology: Preclinical safety data under Actions). Administration of COMIRNATY in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
No clinical study data are available regarding the use of variant-adapted COMIRNATY during pregnancy.
Breast-feeding: It is unknown whether COMIRNATY is excreted in human milk.
No clinical study data are available regarding the use of variant-adapted COMIRNATY during breast-feeding.
Fertility: It is unknown whether COMIRNATY has an impact on fertility. Animal studies conducted with COMIRNATY (Original) do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).

Summary of safety profile: The safety of COMIRNATY (Original) was evaluated in participants 5 years of age and older in 3 clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America. Study BNT162-01 (Study 1) enrolled 60 participants, 18 through 55 years of age and 36 participants, 56 through 85 years of age. Study C4591001 (Study 2) enrolled approximately 46,000 participants, 12 years of age or older. Study C4591007 (Study 3) enrolled approximately 4,600 participants 5 through <12 years of age. Study 3 also enrolled approximately 3,600 participants 2 through 4 years of age and 2,200 participants 6 months through 23 months of age.
Additionally, 306 existing Phase 3 participants at least 18 through 55 years of age received a booster dose of COMIRNATY (Original) approximately 6 months after the second dose in the non-placebo-controlled booster dose portion of Study 2. The overall safety profile for the booster dose was similar to that seen after 2 doses.
In Study C4591031 (Study 4), a placebo-controlled booster study, 5,081 participants 16 years of age and older were recruited from Study 2 to receive a booster dose of COMIRNATY (Original) at least 6 months after the second dose. The overall safety profile for the booster dose was similar to that seen after 2 doses.
In a subset of Study 3 (Phase 2/3), 2,408 participants 5 through <12 years of age received a booster dose of COMIRNATY (Original) at least 5 months after completing the primary series. The overall safety profile of COMIRNATY (Original) for the booster dose was similar to that seen after the primary series.
Participants 16 years of age and older - after 2 doses: In Study 2, a total of 22,026 participants 16 years of age or older received at least 1 dose of COMIRNATY (Original) and a total of 22,021 participants 16 years of age or older received placebo (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively). A total of 20,519 participants 16 years of age or older received 2 doses of COMIRNATY.
The most frequent adverse reactions in participants 16 years of age and older that received 2 doses were injection site pain (>80%), fatigue (>60%), headache (>50%), myalgia (>40%), chills (>30%), arthralgia (>20%), pyrexia and injection site swelling (>10%) and 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.
The safety profile in 545 participants 16 years of age and older receiving COMIRNATY (Original), that were seropositive for SARS-CoV-2 at baseline, was similar to that seen in the general population.
Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. The safety profile of the participants receiving COMIRNATY (Original) (n = 100) in the individuals with stable HIV infection was similar to that seen in the general population.
Adolescents 12 through 15 years of age - after 2 doses: In an analysis of long-term safety follow-up in Study 2, 2,260 adolescents [1,131 COMIRNATY (Original); 1,129 placebo] were 12 through 15 years of age. Of these, 1,559 adolescents [786 COMIRNATY (Original) and 773 placebo] were followed for ≥4 months after the second dose.
The most frequent adverse reactions in adolescents 12 through 15 years of age that received 2 doses were injection site pain (>90%), fatigue and headache (>70%), myalgia and chills (>40%), arthralgia and pyrexia (>20%).
In adolescents 12 through 15 years of age, psychiatric-related serious adverse events were numerically higher in the vaccine group, 4 recipients (3 [0.3%] with depression and 1 [0.1%] with suicidal ideation) and none in the placebo group. The events in the vaccine group were confounded by prior medical history as all 4 participants had concurrent psychiatric illness including depression prior to vaccination. Currently available information is insufficient to determine a causal relationship with the vaccine.
Children 5 through <12 years of age - after 2 doses: In an analysis of Study 3 (Phase 2/3), 4,647 participants [3,109 COMIRNATY (Original) 10 micrograms; 1,538 placebo] were 5 through <12 years of age. Of these, 2,206 [1,481 COMIRNATY (Original) 10 micrograms; 725 placebo] participants have been followed for ≥4 months after the second dose in the placebo-controlled blinded follow-up period. The safety evaluation in Study 3 is ongoing.
The most frequent adverse reactions in children 5 through <12 years of age that received 2 doses included injection site pain (>80%), fatigue (>50%), headache (>30%), injection site redness and swelling (≥20%), myalgia, chills and diarrhoea (>10%).
Children 2 through 4 years of age - after 3 doses: In an analysis of Study 3 (Phase 2/3), 3,541 individuals [2,368 COMIRNATY (Original) 3 micrograms and 1,173 placebo] were 2 through 4 years age. Based on data in the blinded placebo-controlled follow-up period up to the cut-off date of 28 February 2023, 1,268 individuals 2 through 4 years of age who received a 3-dose primary course [863 COMIRNATY (Original) 3 micrograms; 405 placebo] have been followed a median of 2.2 months after the third dose.
The most frequent adverse reactions in children 2 through 4 years of age that received any primary series dose included pain at injection site and fatigue (>40%), injection site redness and fever (>10%).
Children 6 through 23 months of age - after 3 doses: In an analysis of Study 3 (Phase 2/3), 2,176 individuals [1,458 COMIRNATY (Original) 3 micrograms and 718 placebo] were 6 through 23 months of age. Based on data in the blinded placebo-controlled follow-up period up to the cut-off date of 28 February 2023, 720 individuals 6 through 23 months of age who received a 3-dose primary course [483 COMIRNATY (Original) 3 micrograms; 237 placebo] have been followed for a median of 1.7 months after the third dose.
The most frequent adverse reactions in children 6 through 23 months of age that received any primary series dose included irritability (>60%), decrease appetite (>30%), tenderness at the injection site (>20%), injection site redness and fever (>10%).
Participants 12 years of age and older - after booster dose: A subset from Study 2 (Phase 2/3) participants of 306 adults at least 18 through 55 years of age who completed the primary COMIRNATY (Original) 2-dose course, received a booster dose of COMIRNATY (Original) approximately 6 months (range 4.8 to 8.0 months) after receiving Dose 2. Of these, 301 participants have been followed for ≥4 months after the booster dose of COMIRNATY (Original).
The most frequent adverse reactions in participants 18 through 55 years of age were injection site pain (>80%), fatigue (>60%), headache (>40%), myalgia (>30%), chills and arthralgia (>20%).
In Study 4, a placebo-controlled booster study, participants 16 years of age and older recruited from Study 2 received a booster dose of COMIRNATY (Original) (5,081 participants), or placebo (5,044 participants) at least 6 months after the second dose of COMIRNATY (Original). Overall, participants who received a booster dose, had a median follow-up time of 2.8 months (range 0.3 to 7.5 months) after the booster dose in the blinded placebo-controlled follow-up period to the cut-off date (08 February 2022). Of these, 1,281 participants [895 COMIRNATY (Original); 386 placebo] were followed for ≥4 months after the booster dose of COMIRNATY (Original). The overall safety profile for the booster dose was similar to that seen after 2 doses.
In another subset from Study 2, 825 adolescents 12 to 15 years of age who completed the COMIRNATY (Original) 2-dose course, received a booster dose of COMIRNATY (Original) approximately 11.2 months (range 6.3 to 20.1 months) after receiving Dose 2. Overall, participants who received a booster dose, had a median follow-up time of 9.5 months (range 1.5 to 10.7 months) based on data up to the cut-off date (3 November 2022). No new adverse reactions of COMIRNATY (Original) were identified.
Children 5 through <12 years of age - after booster dose: In a subset from Study 3, a total of 2,408 children 5 through <12 years of age received a booster dose of COMIRNATY (Original) 10 micrograms at least 5 months (range 5.3 to 19.4 months) after completing the primary series. The analysis of the Study 3 (Phase 2/3) subset is based on data up to the cut-off date of 28 February 2023 (median follow-up time of 6.4 months).
The most frequent adverse reactions in participants 5 through <12 years of age were injection site pain (>60%), fatigue (>30%), headache (>20%), myalgia, chills, injection site redness, and swelling (>10%).
Tabulated list of adverse reactions from clinical studies and post-authorisation experience: Adverse reactions observed during clinical studies are listed as follows according to the following frequency categories: 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). (See Tables 35, 36, 37 and 38.)

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Safety with concomitant vaccine administration - COMIRNATY 30 micrograms: Concomitant administration with seasonal influenza vaccine: In Study 8 (C4591030), a Phase 3 study, participants 18 through 64 years of age who received COMIRNATY (Original) co-administered with seasonal inactivated influenza vaccine (SIIV), quadrivalent followed 1 month later by placebo (n=564), were compared to participants who received an inactivated influenza vaccine with placebo followed 1 month later by COMIRNATY (Original) alone (n=564). Reactogenicity events were reported more frequently by participants who received COMIRNATY (Original) co-administered with SIIV, quadrivalent, compared to participants who received COMIRNATY (Original) alone, but overall the reactogenicity events were mostly mild to moderate in severity. The most common adverse reactions reported in the co-administration group versus COMIRNATY (Original) alone were injection site pain (86.2% versus 84.4%, respectively), fatigue (64.0% versus 50.8%, respectively) and headache (47.2% versus 37.8%, respectively).
Concomitant administration with pneumococcal conjugate vaccine: In Study 11 (B7471026), a Phase 3 study, participants 65 years of age and older who received a booster dose of COMIRNATY (Original) co-administered with 20-valent pneumococcal conjugate vaccine (20vPnC [Prevenar 20]) (n=187), the overall safety profile was similar with COMIRNATY (Original) given alone (n=185). Overall, reactogenicity events were mostly mild to moderate in severity. The most common adverse reactions reported in the co-administration group versus COMIRNATY (Original) alone were injection site pain (72.4% versus 67.6%, respectively), fatigue (54.1% versus 54.6%, respectively), and myalgia (32.4% versus 31.9%, respectively).
Concomitant administration with an RSV vaccine or with an RSV vaccine and a high dose influenza vaccine: In Study 12 (C5481001), a Phase 1/2 study, participants 65 years of age and older who received COMIRNATY (Bivalent BA.4/BA.5) and RSV (bivalent, recombinant [ABRYSVO]) vaccine co-administered in one arm plus high dose quadrivalent influenza vaccine (QIV [Fluzone HD]) (n=158) or placebo (n=157) in the opposite arm were compared to participants who received the individual vaccines given with placebo. The overall safety profile was similar with COMIRNATY (Bivalent BA.4/BA.5) given alone (n=150).
Overall, reactogenicity events reported for the concomitantly administered vaccines were mostly mild to moderate in severity. The most common reported adverse reactions in the COMIRNATY (Bivalent BA.4/BA.5) administered concomitantly with RSV vaccine group, COMIRNATY (Bivalent BA.4/BA.5) administered concomitantly with both RSV vaccine and high dose quadrivalent influenza vaccine group, and COMIRNATY (Bivalent BA.4/BA.5) alone were injection site pain (56.7%, 53.8%, and 62.7%, respectively) and fatigue (38.9%, 46.8%, and 35.3%, respectively).
Other reporting instructions: Vaccination providers may report all other adverse events, to the extent feasible, to Pfizer Singapore using the contact information as follows.
Email: SGP.AEReporting@pfizer.com.
Fax number: 8001012817 (local toll free).
Telephone number: +65 6403 8888.
Adverse event reporting to HSA: Healthcare professionals are required to report any suspected serious adverse events observed with the use of COMIRNATY to HSA as soon as possible. All fatal and life-threatening events are to be reported as soon as possible, within 24 hours. Report the adverse events to the Vigilance and Compliance Branch at Tel: 6866 1111, or report online at https://www.hsa.gov.sg/adverse-events.

Do not mix COMIRNATY with other vaccines or products in the same syringe.
COMIRNATY 30 micrograms may be administered concomitantly with seasonal influenza vaccine (see Pharmacology: Pharmacodynamics under Actions). Different injectable vaccines should be given at different injection sites.
In individuals 18 years of age and older, COMIRNATY 30 micrograms may be administered concomitantly with a pneumococcal conjugate vaccine (PCV) (see Pharmacology: Pharmacodynamics under Actions).
In individuals 60 years of age and older, COMIRNATY 30 micrograms may be administered concomitantly with an unadjuvanted recombinant protein respiratory syncytial virus (RSV) vaccine (see Pharmacology: Pharmacodynamics under Actions).
In individuals 65 years of age and older, COMIRNATY 30 micrograms may be administered concomitantly with an unadjuvanted recombinant protein RSV vaccine and a high dose influenza vaccine (see Pharmacology: Pharmacodynamics under Actions).

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: Handling instructions: COMIRNATY should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.
Vials: Handling instructions prior to use: Frozen vials must be completely thawed prior to use. Frozen vials should be transferred to 2°C to 8°C to thaw. Thaw times for 10-vial packs are noted in table as follows. (See Table 39.)

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Upon moving frozen vaccine to 2°C to 8°C storage, update the expiry date on the carton. The updated expiry date should reflect 10 weeks from the date of transfer to refrigerated conditions (2°C to 8°C) and not exceeding the expiry date (EXP).
Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30°C for immediate use.
If the vaccine is received at 2°C to 8°C it should continue to be stored at 2°C to 8°C. Check that the carton has been previously updated to reflect the 10-week refrigerated expiry date.
Unopened vials can be stored for up to 12 hours at temperatures up to 30°C. Total storage time between 8°C to 30°C, inclusive of storage before and after puncture, should not exceed 24 hours.
Preparation for administration: Vial verification: Prior to administration, check the name and strength of the vaccine on the vial label and the colour of the vial cap and vial label border to ensure it is the intended presentation. Check whether the vial is a single dose vial or a multidose vial and check if the vial requires dilution.
COMIRNATY (Omicron JN.1) (Do Not Dilute) (For 12 Years of Age and Older) (Vials with Grey Cap); COMIRNATY (Omicron JN.1) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap): Instructions applicable to both single dose and multidose vials: Check appearance of vaccine prior to mixing and administration.
Grey cap vials: Prior to mixing, the vaccine is a while to off-white dispersion and may contain white to off-white opaque amorphous particles.
Blue cap vials: Prior to mixing, the vaccine is a clear to slightly opalescent dispersion and may contain white to off-white opaque amorphous particles
Gently invert the vial 10 times. Do not shake.
Do not use the vaccine if particulates or discolouration are present after mixing.
Preparation of individual doses: Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
Withdraw a 0.3 mL single dose.
For Dark Grey or Dark Blue cap multidose vials (6 doses per vial): After first puncture, record appropriate date and time on the vial and store at 2°C to 30°C for up to 12 hours. Do not re-freeze.
Each dose must contain 0.3 mL of vaccine. Low dead-volume syringes and/or needles should be used in order to extract all doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres.
If the amount of vaccine remaining in the vial cannot provide a full dose, discard the vial and any excess volume.
COMIRNATY (Omicron JN.1) (Dilute Before Use) (For Age 6 Months to <5 Years) (Vials with Yellow Cap): Prior to dilution: After the thawed vial has reached room temperature, gently invert it 10 times prior to dilution. Do not shake.
Check appearance of vaccine.
Yellow cap vials: Prior to dilution, the vaccine is a clear to slightly opalescent dispersion and may contain white to off-white opaque amorphous particles.
Dilution instructions: Thawed vaccine must be diluted in its original vial with sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques. Volume of sodium chloride 9 mg/mL (0.9%) required are noted as follows: Yellow cap vials: 1.1 mL of sodium chloride 9 mg/mL.
Equalise vial pressure before removing the needle from the vial stopper by withdrawing air into the empty diluent syringe. Volume of air required are noted as follows: Yellow cap vials: 1.1 mL of air.
Gently invert the diluted dispersion 10 times. Do not shake.
Check appearance of vaccine after dilution.
Yellow cap vials: After mixing, the vaccine should present as a clear to slightly opalescent dispersion with no particulates visible. Do not use the vaccine if particulates or discolouration are present.
After dilution, mark vial with appropriate date/time, store at 2°C to 30°C and use within 12 hours. Do not re-freeze
Preparation of individual doses: Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab.
Withdraw a single dose.
Yellow cap vials (3 doses per vial): Each dose must contain 0.3 mL of vaccine. Standard syringes can be used.
If the amount of vaccine remaining in the vial cannot provide a full dose, discard the vial and any excess volume.
Pre-filled syringes: Preparation and administration of individual doses of the refrigerated storage only, glass pre-filled syringes: Prior to use, the pre-filled syringes can be stored for up to 12 hours at temperatures between 8°C to 30°C and can be handled in room light conditions.
Do not shake.
Remove tip cap by slowly turning the cap counterclockwise while holding the luer lock.
Attach a needle appropriate for intramuscular injection and administer the entire volume.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Shelf life: Vials: Shelf life of frozen vials: COMIRNATY may be received frozen at -90°C to -60°C. Frozen vaccine can be stored either at -90°C to -60°C or 2°C to 8°C upon receipt.
If COMIRNATY is received frozen at -90°C to -60°C the frozen vials can continue to be stored at -90°C to -60°C according to the table as follows. (See Table 40.)

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Thawing frozen vials: Frozen (-90°C to -60°C) vials can be thawed at either 2°C to 8°C or at temperatures up to 30°C (see Special precautions for disposal and other handling under Cautions for Usage for more detailed thawing instructions).
Once thawed, the vaccine should not be re-frozen.
Shelf life of refrigerated vials: Frozen vials may be transferred to refrigerated storage (2°C to 8°C) upon receipt. Once moved to refrigerated storage, unopened vials may be stored for a single period of up to 10 weeks, not exceeding the original expiry date (EXP).
Upon moving the product to 2°C to 8°C storage, the original expiry date on the outer carton should be crossed out and updated expiry date must be written (10 weeks from the date the vials were removed from frozen storage). The vaccine should be used or discarded by the updated expiry date.
If the vaccine is received refrigerated (2°C to 8°C) it should be stored at 2°C to 8°C. Check that the expiry date on the outer carton has been updated to reflect the refrigerated expiry date and that the original expiry date has been crossed out.
Storage of thawed, opened (punctured or diluted) vials: Once a vial has been punctured or diluted (dilution with sodium chloride 9 mg/mL 0.9% solution for injection) chemical and physical in-use stability has been demonstrated for 12 hours at 2°C to 30°C.
From a microbiological point of view, unless the method of opening precludes the risks of microbial contamination, the product should be used immediately after the first puncture of single dose vials and within 12 hours after puncture or dilution of multidose vials. If not used within the recommended duration, in-use storage times and conditions are the responsibility of the user.
Pre-filled syringes: Shelf life of unopened glass pre-filled syringes: 12 months when stored at 2°C to 8°C.
Verify the storage conditions on the pre-filled syringe label and apply the applicable storage conditions for that presentation.
COMIRNATY glass pre-filled syringes should not be frozen.
Syringes may be stored at temperatures between 8°C and 30°C for up to 12 hours.
Special precautions for storage: Store COMIRNATY in the original package in order to protect from light.
During use, thawed vials and pre-filled syringes can be handled in room light conditions. Avoid exposure to direct sunlight and ultraviolet light.

Vaccines, Antisera & Immunologicals

J07BN01 - covid-19, RNA-based vaccine ; Belongs to the class of covid-19 vaccines.

POM