Table 2.
Published studies on COVID-19 vaccine-associated PFP.
| Ref | Country/data source | Study design | Vaccine and sample size | FP in vaccine groups | Controls and sample size | FP in control groups | Main results |
|---|---|---|---|---|---|---|---|
| Disproportionality analyses | |||||||
| [34] | US/Vaccine Adverse Event Reporting System | Disproportionality analysis | BNT162b2 | 405 |
Any other vaccinesa |
NR |
ROR (95%CI): BNT162b2: 1.84 (1.65-2.06)b |
| mRNA-1273 | 512 | mRNA-1273: 1.54 (1.39-1.70) | |||||
| Influenza vaccines | 462 | Influenza: 2.04 (1.76-2.36) | |||||
| [35] | WHO Vigibase | Disproportionality analysis | mRNA vaccines: 133,883c | 844d | Influenza vaccine: 314,980e | 5734 | IC f: -1.26 (-1.36 to -1.17) b |
| Other viral vaccines e: 1,265,182 | 2087 | ICf: 0.09 (-0.01 to 0.19) b | |||||
| Cohort studies | |||||||
| [36] | Israel/Clalit Health Service | Observational cohort study comparing the incidence of AE within 42 days of vaccination to unvaccinated patients matched 1:1 on sociodemographic and clinical variable g | BNT162b2: 884,828 | 81 | Unvaccinated patients: 884,828 | 59 | Risk ratio (95%CI): 1.32 (0.92-1.86) |
| [37] | US/Vaccine Safety Datalink | Self-controlled case series comparing the incidence of AE during a risk interval of 1 to 21 days after either mRNA vaccine dose 1 or 2 versus 22-42 days after the most recent mRNA vaccine dose h | BNT162b2/mRNA-1273: 660,766 person-years |
535 | BNT162b2/mRNA-1273: 364,988 person-years |
301 | Adjusted rate ratio (95%CI): 1.00 (0.86-1.17) |
| [38] | US/Mayo Clinic Health Systems (curation methods of Electronic health records) | Retrospective cohort study comparing the incidence rate of AE within 7 days after the 1st or 2nd mRNA vaccine dose to that of unvaccinated patients propensity matched 1:1 according to demographic, geographic and clinical features | Number of person-days: BNT162b2: |
Number of person-days (unvaccinated) | Incidence rate ratio (95%CI) | ||
| Dose 1: 361,554 | 4 | 359,560 | 10 | Dose 1: 0.4 (0.091-1.4) | |||
| Dose 2: 273,167 | 4 | 263,612 | 7 | Dose 2: 0.55 (0.12-2.2) | |||
| mRNA-1273: | |||||||
| Dose 1: 114,992 | 1 | 114,637 | 4 | Dose 1: 0.25 (0.0051-2.5) | |||
| Dose 2: 82,941 | 1 | 79,822 | 3 | Dose 2: 0.32 (0.0061-1.4) | |||
| [39] | Israel/Meuhedet Health Maintenance Organization | Historical cohort study comparing the number of cases of FP in vaccinated and unvaccinated patients matched 1:1 according to sex, age, comorbidities and population sectori | BNT162b2: | Unvaccinated | Relative risk (95%CI) | ||
| Dose 1: 233,159 | 23 | 233,159 | 24 | Dose 1: 0.96 (0.54 -1.70) | |||
| Dose 2: 131,033 | 8 | 131,033 | 12 | Dose 2: not significant (calculation not provided) | |||
| [40] | UK/Linkage of the national database of Covid-19 vaccination to national databases for mortality, hospital admissions and SARS-CoV-2 infection | Self-controlled case series comparing the incidence rate ratio of neurological AE in a risk interval of 1 to 28 days after either the first dose of mRNA vaccine or ChadOx1nCov-19 and in SARS-CoV-2-positive patients relative to baseline period (≥ 29 days before or after exposure) |
BNT162b2: 12,134,782 |
247 |
Incidence rate ratio (95%CI) within 1-28 days after exposure 1.06 (0.9-1.26) |
||
| Ch adOx1nCov-19: 20,417,752 | 430 | 1.07 (0.94-1.21)j | |||||
| SARS-Cov-2 infection: 2,005,280 | 77 | 1.34 (0.91-1.97)k | |||||
| Case control studies | |||||||
| [41] | Israel Emergency department of the Shamir Medical Center | Case control study comparing the rate of exposure to BNT162b2 within the previous 30 days in 37 patients admitted for a new onset of FP to that of 74 patients admitted for any other reasons and matched (1:2) on age, sex and admission date |
BNT162b2: 65 |
21 |
Unvaccinated: 46 |
16 |
Adjusted OR (95%CI): 0.84 (0.37-1.90) |
| [42] | Hong Kong/Hospital Authority electronic health record system | Nested case control study comparing the rate of exposure to BNT162b2 within the previous 42 days in 298 patients admitted for a new onset of FP to that of 1,181 controls admitted for any other reason during the same period and matched (1:4) by age, sex, admission setting, and date of hospital attendance |
BNT162b2: 45 |
14 |
Unvaccinated: 1181 |
256 |
Adjusted OR (95%CI) - BNT162b2: 1.76 (0.89-3.48) |
| CoronaVac®: 81 | 28 | - CoronaVac®: 2.39 (1·42-4.02) | |||||
| Observed-to-expected analyses | |||||||
| Hong Kong/Adverse events reported in the online Vaccine Adverse Event Reporting System | Comparison of the reported incidence rate of FP within 42 days of the first dose of CoronaVac® or BNT162b2 to the background incidence rate of FP in the same area for the same study period in 2020 |
BNT162b2 : 537,235 |
16 |
NA l |
NA l |
Age-standardized rate ratio (95% CI): BNT162b: 1.66 (0.95-2.91) |
|
| CoronaVac® : 451,939 | 18 |
CoronaVac®: 2.64 (1.67-4.17) |
|||||
| [43] | Israel Database of Clalit Health Services (CHS) | Comparison of the observed number of cases of FP within 21 or 30 days after the first or second dose in patients with a previous history of FP to the background rate of FP estimated from the CHS data in 2019 during the same period | BNT162b2 | Expected number | SIR (95% CI) | ||
| - Dose 1: 2,594,990 | 132 | 97.1 | - 1.36 (1.14-1.61)m | ||||
| - Dose 2: 2,434,674 | 152 | 130.5 | - 1.16 (0.99-1.36) | ||||
| Previous history of FP | |||||||
| - Dose 1: 7,567 | 4 | 3.5 | - 1.15 (0.36-2.76) | ||||
| - Dose 2: 7,045 | 10 | 4.7 | - 2.15 (1.09-3.83) | ||||
AE: adverse effects; CI: confidence interval; COVID-19: coronavirus disease 2019, FP: facial paralysis, IC: information component; NR: not reported; OR: odds ratio; ROR: reporting odds ratio; SIR: standardized incidence ratio.
The study involved a total of 303,589 reports of AE following the use of any vaccine but the total number of AE for each vaccine was not provided
Results were adjusted based on sex and age
Total number of AE reported with BNT162b2 and 1273mRNA vaccines in Vigibase.
Of the 844 cases of FP, 749 were reported with BNT162b2 and 95 with mRNA-1273 vaccines.
Total number of AE with other viral vaccines or influenza vaccines alone.
IC: Information Component. A disproportionality signal is significant if the lower boundary of the 95% credibility interval of the IC025 is >0.
Patients with a previous PCR-positive test for SARS-Cov-2 or with a previous history of FP were excluded.
A total of 6.2 million individuals were administered BNT162b2 (3,539,611 first and 3,214,737 second doses) or mRNA-1273 (2,636,202 first and 2,454,578second doses) vaccines.
Patients with a COVID-19 infection at any time before or after the vaccine were excluded.
For the ChadOx1nCov-19 vaccine, there was a significant increased risk only for the 15–21 day period after the first dose (IRR, 1.29; 95% CI: 1.08–1.56).
For patients with a positive SARS-CoV-2 test, there was an increased risk at day 0 (IRR, 33.23; 95% CI: 22.57–48.94), days 1–7 (IRR, 5.84; 95% CI: 4.09–8.33) and days 8–14 (IRR, 2.17; 95% CI: 1.30–3.63).
The crude expected number of cases of FP was not provided. The age-standardized incidence rate per 100,000 person-years (95%CI) was 42.8 (19.4–66.1) for BNT162b2 and 66.9 (37.2–96.6) for CoronaVac® with a background incidence calculated for the same study period for each vaccination program of 25.7 (22.7–28.8) to 25.3 (22.6–28.1), respectively.
The highest SIR was 2.51 (95%CI: 1.65–3.68) and observed in females older than 64 years, only after the first dose. The SIR did not significantly increased in males whatever the dose.