Real-world safety data for the Pfizer BNT162b2 SARS-CoV-2 vaccine: historical cohort study

Abstract

Objective The Pfizer BNT162b2 vaccine showed a reassuring safety profile in clinical trials, but real-world data are scarce. Bell’s palsy, herpes-zoster, Guillain-Barré syndrome (GBS) and other neurological complaints in proximity to vaccination have received special public attention. We compared their rates among vaccinated and unvaccinated individuals. Methods Individuals ≥16 years vaccinated with at least one dose of BNT162b2 were eligible for this historical-cohort study in a health maintenance organization insuring 1.2 million citizens. Each vaccinee was matched to a non-vaccinated control by sex, age, population sector (general Jewish, Arab, ultra-orthodox Jewish) and comorbidities. Diagnosis of Covid-19 before or after vaccination was an exclusion criterion. The outcome was a diagnosis of: Bell’s palsy, GBS, herpes-zoster, or symptoms of numbness or tingling, coded in the visit diagnosis field using ICD-9 codes. Diagnoses of Bell’s palsy and GBS were verified by individual file review. Results Of 406,148 individuals vaccinated during the study period, 394,609 (97.2%) were eligible (11,539 excluded). 233,159 (59.1%) were matched with unvaccinated controls. Mean follow was 43±15.14 days. In vaccinated and unvaccinated individuals there were 23 versus 24 cases of Bell’s palsy (RR 0.96, CI 0.54-1.70), 1 versus 0 cases of GBS, 151 versus 141 cases of herpes-zoster (RR 1.07, CI 0.85-1.35), and 605 versus 497 cases of numbness or tingling (RR 1.22, CI 1.08-1.37), respectively. Conclusions No association was found between vaccination, Bell’s palsy, herpes-zoster or GBS. Symptoms of numbness or tingling were more common among vaccinees. This study adds reassuring data regarding the safety of the BNT162b2 vaccine.

Sub-acute Onset of Guillain-Barré Syndrome Post-mRNA-1273 Vaccination: a Case Report

“…A recent Image 2 Sagittal T2 of cervical (a), thoracic (b), and lumbar (c) spines showing normal appearance of spinal cord, conus medullaris, and cauda equina large population-level study assessing the safety of BNT162b2 (another mRNA vaccine) found no association with Bell's palsy, herpes zoster, or GBS. [13] Furthermore, it is important to realize there are several reported cases of neurological complications such as transverse myelitis and GBS after COVID-19 infection. [14][15][16] After reviewing the occurrences of GBS, the Advisory Committee on Immunization Practices of the United States in July 2021 determined that the benefits of COVID-19 vaccination in preventing COVID-19 morbidity and mortality outweigh the risks for these rare serious adverse events [https:// www.…”

Rapid evaluation of the safety of COVID-19 vaccines: how well have we done?

“…The only outcome showing an association with vaccination in the study by Shasha et al ( 1 ) was an excess of reports of numbness and tingling in BNT162b2 vaccinees mainly involving the face. This finding is difficult to interpret and warrants further investigation.…”

“…Safety signals can be generated from pre-licensure trials or during vaccine implementation from reports of unexpected or rare clinical events that occur in temporal association with vaccination. The accompanying paper in this edition by Shasha et al ( 1 ) provides a nice “real-world” example of this process. The authors used electronic records from the Meuhedet Health Maintenance Organisation (HMO) in Israel to investigate various safety signals raised for the BNT162b2 mRNA vaccine from pre-licensure trials and post-marketing case reports.…”

“…Evidence on the risk of Guillain Barré syndrome (GBS) after the BNT162b2 vaccine from the study by Shasha et al ( 1 ) was inconclusive as it was inadequately powered to exclude an elevated risk and GBS was not included as an outcome in the other Israeli study using the Clalit HMO database. ( 3 ).…”

A Comparative Analysis of COVID-19 Vaccines Based on over 580,000 Cases from the Vaccination Adverse Event Reporting System

“…A number of papers have examined the onset of adverse events, such as those described above, after COVID-19 vaccination. However, these recent studies have either (i) been limited to the reporting of incidence rates and otherwise lacking statistical analyses [ 18 , 19 ], (ii) unable to reach strong conclusions because of sparse data [ 20 , 21 ], or (iii) been unable to find statistically significant deviations in the occurrences of the adverse conditions described above [ 22 , 23 ]. To address these limitations, we have examined the number of cases of CVST, GBS, myocarditis or pericarditis after vaccination with either the Pfizer/BioNTech, Moderna, or J&J vaccines; in particular, we used the Vaccine Adverse Event Reporting System (VAERS), and the statistical properties of the occurrences of these post-vaccination side effects were quantified using odds ratios (ORs).…”