COMIRNATY (Tozinameran) (1) If the Booster Vaccination Was Conducted, up to the Day Before Booster. vs COMIRNATY (Tozinameran) (2) If the Booster Vaccination Was Conducted, After the Booster.: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00825 | 0.00691 | 0.00986 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0035 | 0.00264 | 0.00464 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00475 | 0.00299 | 0.00657 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 2.36 | 1.69 | 3.29 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 2.37 | 1.69 | 3.31 | log | ClinicalTrials.gov | |
Number needed to harm, for one more participant with a serious adverse event on COMIRNATY (Tozinameran) (1) If the Booster Vaccination Was Conducted, up to the Day Before Booster. than on COMIRNATY (Tozinameran) (2) If the Booster Vaccination Was Conducted, After the Booster. | 211 | 152 | 335 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | COMIRNATY (Tozinameran) (1) If the Booster Vaccination Was Conducted, up to the Day Before Booster. | The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product.~If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed.~If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination.~This study only collected serious adverse events. | 120 | 14,537 | EG000 | ClinicalTrials.gov |
| Group 2 | COMIRNATY (Tozinameran) (2) If the Booster Vaccination Was Conducted, After the Booster. | Same as the left. | 48 | 13,695 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation) | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Drug Use Investigation of COMIRNATY Intramuscular Injection | ClinicalTrials.gov |
| NCT number | NCT04815031 | ClinicalTrials.gov |
| Phases | ClinicalTrials.gov | |
| Conditions | COVID-19 | ClinicalTrials.gov |
| Interventions | BNT162b2 | ClinicalTrials.gov |
| Lead sponsor | Pfizer | ClinicalTrials.gov |
| Results first posted | 2024-10-30 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04815031?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.