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Meta-Analysis
. 2022 Dec 6;17(12):e0278624.
doi: 10.1371/journal.pone.0278624. eCollection 2022.

Effectiveness of Pfizer-BioNTech COVID-19 vaccine as evidence for policy action: A rapid systematic review and meta-analysis of non-randomized studies

Megan Wallace  1 , Jennifer P Collins  1 , Heidi Moline  1   2 , Ian D Plumb  1 , Monica Godfrey  1 , Rebecca L Morgan  3 , Doug Campos-Outcalt  4 , Sara E Oliver  1 , Kathleen Dooling  1 , Julia W Gargano  1
Affiliations
Meta-Analysis

Effectiveness of Pfizer-BioNTech COVID-19 vaccine as evidence for policy action: A rapid systematic review and meta-analysis of non-randomized studies

Megan Wallace et al. PLoS One. .

Abstract

In December 2020, an interim recommendation for the use of Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years was made under Food and Drug Administration's Emergency Use Authorization. In preparation for Biologics License Application approval, we conducted a systematic review and meta-analysis to inform the U.S. Centers for Disease Control and Prevention's Advisory Committee for Immunization Practice's (ACIP) decision-making for a standard recommendation. We conducted a rapid systematic review and meta-analysis of Pfizer-BioNTech vaccine effectiveness (VE) against symptomatic COVID-19, hospitalization due to COVID-19, death due to COVID-19, and asymptomatic SARS-CoV-2 infection. We identified studies through August 20, 2021 from an ongoing systematic review conducted by the International Vaccine Access Center and the World Health Organization. We evaluated each study for risk of bias using the Newcastle-Ottawa Scale. Pooled estimates were calculated using meta-analysis. The body of evidence for each outcome was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. We identified 80 articles, selected 35 for full-text review, and included 26. The pooled VE of Pfizer-BioNTech COVID-19 vaccine was 92.4% (95% CI: 87.5%-95.3%) against symptomatic COVID-19 with moderate evidence certainty (eight studies), 94.3% (95% CI: 87.9%-97.3%) against hospitalization due to COVID-19 with moderate certainty (eight studies), 96.1% (95% CI: 91.5%-98.2%) against death due to COVID-19 with moderate certainty (four studies), and 89.3% (88.4%-90.1%) against asymptomatic SARS-CoV-2 infection with very low certainty (two studies). The Pfizer-BioNTech COVID-19 vaccine demonstrated high effectiveness in all pre-specified outcomes and extended knowledge of the vaccine's benefits to outcomes and populations not informed by the RCTs. Use of an existing systematic review facilitated a rapid meta-analysis to inform an ACIP policy decision. This approach can be utilized as additional COVID-19 vaccines are considered for standard recommendations by ACIP.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Evidence retrieval and article selection.
Fig 2
Fig 2
Forest plots showing individual-study and pooled vaccine effectiveness estimates against (A) symptomatic PCR-confirmed COVID-19; (B) hospitalization due to COVID-19; (C) death due to COVID-19; and (D) asymptomatic SARS-CoV-2 infection. Pooled vaccine effectiveness estimates were derived from random effects meta-analyses (A-C) or fixed effects meta-analysis (D). Values for pooled effectiveness estimates and heterogeneity are shown in supplementary tables.
Fig 3
Fig 3
Forest plots showing primary pooled vaccine effectiveness estimates and estimates from sensitivity analyses for (A) symptomatic PCR-confirmed COVID-19; (B) hospitalization due to COVID-19; (C) death due to COVID-19; and (D) asymptomatic SARS-CoV-2 infection. Pooled vaccine effectiveness estimates were derived from random effects meta-analyses (A-C) or fixed effects meta-analysis (D). Values for pooled effectiveness estimates and heterogeneity are shown in supplementary tables. 1Three studies provided a Delta-specific estimates [29, 31, 40] and one provided an estimate for the Delta-dominant period [33].
See this image and copyright information in PMC

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