Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine.
Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine.
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DOI：
10.1056/nejmoa2200674
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发表时间：
2022-05-19
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在2019冠状病毒病（Covid-19）大流行期间，BNT 162 b2疫苗（辉瑞-BioNTech）的主动免疫是预防严重急性呼吸系统综合征冠状病毒2（SARS-CoV-2）感染的关键缓解工具。鉴于有报告称，初次接种两剂疫苗后6个月保护力减弱，因此需要关于在16岁或以上人群中接种第三剂（加强剂）疫苗的安全性和有效性的数据。在这项正在进行的安慰剂对照、随机、3期试验中，我们将至少6个月前接受过两次30 μg剂量BNT 162 b2疫苗的参与者分配为注射第三次BNT 162 b2疫苗或安慰剂。我们从第三剂疫苗接种后7天开始评估疫苗的安全性和有效性。共有5081名参与者接受了第三次BNT 162 b2剂量，5044名接受了安慰剂。疫苗组第2剂和第3剂之间的中位间隔为10.8个月，安慰剂组为10.7个月;中位随访时间为2.5个月。第三次给药后的局部和全身反应原性事件通常为低级别。未发现新的安全性信号，未报告心肌炎或心包炎病例。在没有既往SARS-CoV-2感染证据但可进行评估的受试者中，在疫苗组6名受试者和安慰剂组123名受试者中观察到在第3次接种后至少7天发生的Covid-19，这对应于95.3%的相对疫苗有效性（95%置信区间，89.5至98.3）。与两剂BNT 162 b2疫苗相比，在第二剂疫苗接种后中位10.8个月接种第三剂BNT 162 b2疫苗，在中位2.5个月的随访期间，对Covid-19的有效率为95.3%。（由BioNTech和Pfizer资助; C4591031 ClinicalTrials.gov编号，NCT 04955626。）
Active immunization with the BNT162b2 vaccine (Pfizer–BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the coronavirus disease 2019 (Covid-19) pandemic. In light of reports of waning protection occurring 6 months after the primary two-dose vaccine series, data are needed on the safety and efficacy of offering a third (booster) dose in persons 16 years of age or older. In this ongoing, placebo-controlled, randomized, phase 3 trial, we assigned participants who had received two 30-μg doses of the BNT162b2 vaccine at least 6 months earlier to be injected with a third dose of the BNT162b2 vaccine or with placebo. We assessed vaccine safety and efficacy against Covid-19 starting 7 days after the third dose. A total of 5081 participants received a third BNT162b2 dose and 5044 received placebo. The median interval between dose 2 and dose 3 was 10.8 months in the vaccine group and 10.7 months in the placebo group; the median follow-up was 2.5 months. Local and systemic reactogenicity events from the third dose were generally of low grade. No new safety signals were identified, and no cases of myocarditis or pericarditis were reported. Among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated, Covid-19 with onset at least 7 days after dose 3 was observed in 6 participants in the vaccine group and in 123 participants in the placebo group, which corresponded to a relative vaccine efficacy of 95.3% (95% confidence interval, 89.5 to 98.3). A third dose of the BNT162b2 vaccine administered a median of 10.8 months after the second dose provided 95.3% efficacy against Covid-19 as compared with two doses of the BNT162b2 vaccine during a median follow-up of 2.5 months. (Funded by BioNTech and Pfizer; C4591031 ClinicalTrials.gov number, NCT04955626.)