IMPORTANCE Data on BNT162b2 messenger RNA (mRNA) vaccine (Pfizer-BioNTech) effectiveness and safety in pregnancy are currently lacking because pregnant women were excluded from the phase 3 trial.OBJECTIVE To assess the association between receipt of BNT162b2 mRNA vaccine and risk of SARS-CoV-2 infection among pregnant women. DESIGN, SETTING, AND PARTICIPANTSThis was a retrospective cohort study within the pregnancy registry of a large state-mandated health care organization in Israel. Pregnant women vaccinated with a first dose from December 19, 2020, through February 28, 2021, were 1:1 matched to unvaccinated women by age, gestational age, residential area, population subgroup, parity, and influenza immunization status. Follow-up ended on April 11, 2021.EXPOSURES Exposure was defined by receipt of the BNT162b2 mRNA vaccine. To maintain comparability, nonexposed women who were subsequently vaccinated were censored 10 days after their exposure, along with their matched pair. MAIN OUTCOMES AND MEASURESThe primary outcome was polymerase chain reaction-validated SARS-CoV-2 infection at 28 days or more after the first vaccine dose. RESULTSThe cohort included 7530 vaccinated and 7530 matched unvaccinated women, 46% and 33% in the second and third trimester, respectively, with a mean age of 31.1 years (SD, 4.9 years). The median follow-up for the primary outcome was 37 days (interquartile range, 21-54 days; range, 0-70). There were 118 SARS-CoV-2 infections in the vaccinated group and 202 in the unvaccinated group. Among infected women, 88 of 105 (83.8%) were symptomatic in the vaccinated group vs 149 of 179 (83.2%) in the unvaccinated group (P Ն .99). During 28 to 70 days of follow-up, there were 10 infections in the vaccinated group and 46 in the unvaccinated group. The hazards of infection were 0.33% vs 1.64% in the vaccinated and unvaccinated groups, respectively, representing an absolute difference of 1.31% (95% CI, 0.89%-1.74%), with an adjusted hazard ratio of 0.22 (95% CI, 0.11-0.43). Vaccine-related adverse events were reported by 68 patients; none was severe. The most commonly reported symptoms were headache (n = 10, 0.1%), general weakness (n = 8, 0.1%), nonspecified pain (n = 6, <0.1%), and stomachache (n = 5, <0.1%). CONCLUSIONS AND RELEVANCEIn this retrospective cohort study of pregnant women, BNT162b2 mRNA vaccination compared with no vaccination was associated with a significantly lower risk of SARS-CoV-2 infection. Interpretation of study findings is limited by the observational design.
We are concerned with the detection of associations between random vectors of any dimension. Few tests of independence exist that are consistent against all dependent alternatives. We propose a powerful test that is applicable in all dimensions and is consistent against all alternatives. The test has a simple form and is easy to implement. We demonstrate its good power properties in simulations and on examples.
Bacterial and viral infections are often clinically indistinguishable, leading to inappropriate patient management and antibiotic misuse. Bacterial-induced host proteins such as procalcitonin, C-reactive protein (CRP), and Interleukin-6, are routinely used to support diagnosis of infection. However, their performance is negatively affected by inter-patient variability, including time from symptom onset, clinical syndrome, and pathogens. Our aim was to identify novel viral-induced host proteins that can complement bacterial-induced proteins to increase diagnostic accuracy. Initially, we conducted a bioinformatic screen to identify putative circulating host immune response proteins. The resulting 600 candidates were then quantitatively screened for diagnostic potential using blood samples from 1002 prospectively recruited patients with suspected acute infectious disease and controls with no apparent infection. For each patient, three independent physicians assigned a diagnosis based on comprehensive clinical and laboratory investigation including PCR for 21 pathogens yielding 319 bacterial, 334 viral, 112 control and 98 indeterminate diagnoses; 139 patients were excluded based on predetermined criteria. The best performing host-protein was TNF-related apoptosis-inducing ligand (TRAIL) (area under the curve [AUC] of 0.89; 95% confidence interval [CI], 0.86 to 0.91), which was consistently up-regulated in viral infected patients. We further developed a multi-protein signature using logistic-regression on half of the patients and validated it on the remaining half. The signature with the highest precision included both viral- and bacterial-induced proteins: TRAIL, Interferon gamma-induced protein-10, and CRP (AUC of 0.94; 95% CI, 0.92 to 0.96). The signature was superior to any of the individual proteins (P<0.001), as well as routinely used clinical parameters and their combinations (P<0.001). It remained robust across different physiological systems, times from symptom onset, and pathogens (AUCs 0.87-1.0). The accurate differential diagnosis provided by this novel combination of viral- and bacterial-induced proteins has the potential to improve management of patients with acute infections and reduce antibiotic misuse.
A n effective and safe vaccination campaign is urgently needed to halt the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, COVID-19. The BNT162b2 vaccine, developed by BioNTech in cooperation with Pfizer, is a lipid nucleoside-modified RNA encoding the SARS-CoV-2 full-length spike protein 1 . Results from a phase 3 randomized placebo-controlled trial demonstrated that a two-dose regimen in a 21-d interval conferred 95% protection against laboratory-confirmed COVID-19 infection in individuals 16 years of age or older 2 . On 11 December 2020, the Food and Drug Administration issued an Emergency Use Authorization for emergency use of the vaccine for the prevention of COVID-19 (ref. 3 ), and, after that, an emergency use of the vaccine was also issued by the Israeli Ministry of Health (MOH).On 20 December 2020, Israel launched a national COVID-19 vaccination campaign 4 , in which BNT162b2 vaccines were administered. The Israeli health system comprises four health maintenance organizations (HMOs), and vaccinations were widely available, according to a prioritization schedule determined by the Israeli MOH. During the early phases of the distribution process, individuals considered as being at high risk for COVID-19 were prioritized for vaccination, including individuals older than 60 years, nursing home residents, healthcare workers and individuals with severe comorbidities. The vaccination campaign was further expanded for individuals aged 55 years and older 5 and 40 years 6 and older on 12 January 2021 and 19 January 2021, respectively. On 21 January, individuals aged 16-18 years were also prioritized for vaccination. On 28 January, the vaccination campaign expanded to those aged 35 and older 7 . On 4 February, all individuals aged 16 years and older were eligible to receive the vaccine. However, the HMOs were still instructed to focus their efforts on those aged 50 years and older 8 .
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