National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
PLoS One. 2022 Dec 6;17(12):e0278624. doi: 10.1371/journal.pone.0278624. eCollection 2022.
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.
2020 年 12 月，根据食品和药物管理局的紧急使用授权，辉瑞-生物技术公司的 COVID-19 疫苗在 16 岁及以上人群中的使用获得了临时推荐。为了准备获得生物制品许可申请的批准，我们进行了一项系统评价和荟萃分析，为美国疾病控制与预防中心的免疫实践咨询委员会（ACIP）的标准建议决策提供信息。我们对辉瑞-生物技术公司 COVID-19 疫苗对有症状的 COVID-19、因 COVID-19 住院、因 COVID-19 死亡和无症状的 SARS-CoV-2 感染的有效性进行了快速系统评价和荟萃分析。我们通过国际疫苗获取中心和世界卫生组织正在进行的系统评价，于 2021 年 8 月 20 日之前确定了研究。我们使用纽卡斯尔-渥太华量表评估了每一项研究的偏倚风险。使用荟萃分析计算了汇总估计值。使用推荐评估、制定和评价（GRADE）方法评估了每个结果的证据质量。我们确定了 80 篇文章，选择了 35 篇进行全文审查，并纳入了 26 篇。辉瑞-生物技术公司 COVID-19 疫苗对有症状的 COVID-19 的总体疫苗有效性为 92.4%（95%CI：87.5%-95.3%），证据质量为中度（八项研究），对因 COVID-19 住院的总体疫苗有效性为 94.3%（95%CI：87.9%-97.3%），证据质量为中度（八项研究），对因 COVID-19 死亡的总体疫苗有效性为 96.1%（95%CI：91.5%-98.2%），证据质量为中度（四项研究），对无症状的 SARS-CoV-2 感染的总体疫苗有效性为 89.3%（88.4%-90.1%），证据质量为极低（两项研究）。辉瑞-生物技术公司的 COVID-19 疫苗在所有预先指定的结果中均表现出高度有效性，并扩展了疫苗对 RCT 未涵盖的结果和人群的益处的认识。利用现有的系统评价促进了快速的荟萃分析，为 ACIP 的政策决策提供了信息。随着更多的 COVID-19 疫苗被考虑作为 ACIP 的标准推荐，这种方法可以被利用。
