Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies’ Omicron KP.2-adapted monovalent COVID-19 vaccine (COMIRNATY ® KP.2) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The European Commission will review the CHMP’s recommendation and is expected to make a final decision soon. Following the EC decision, Pfizer and BioNTech’s Omicron KP.2-adapted COVID-19 vaccine will ship to European Union (EU) member states that have specifically ordered this formulation.

辉瑞公司 （纽约证券交易所代码：PFE，“辉瑞”）和 BioNTech SE （纳斯达克股票代码：BNTX，“BioNTech”）今天宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）已建议授权两家公司的 Omicron KP.2 改良单价 COVID-19 疫苗（COMIRNATY ® KP.2）进行主动免疫，以预防 6 个月及以上人群中由 SARS-CoV-2 引起的 COVID-19。欧盟委员会将审查 CHMP 的建议，并预计将很快做出最终决定。根据欧盟委员会的决定，辉瑞和 BioNTech 的 Omicron KP.2 改良 COVID-19 疫苗将运往专门订购此剂型的欧盟 (EU) 成员国。

The CHMP recommendation dated September 19, 2024 is based on the non-clinical and manufacturing data of the Omicron KP.2-adapted vaccine and the clinical and real-world evidence supporting the safety and efficacy of prior formulas of the COVID-19 vaccines by Pfizer and BioNTech. The non-clinical data showed that the KP.2-adapted vaccine generates a substantially improved response against multiple currently circulating Omicron JN.1 sublineages, including KP.2, LB.1, KP.3 and KP.3.1.1, compared with the companies’ Omicron XBB.1.5-adapted COVID-19 vaccine.

CHMP 于 2024 年 9 月 19 日提出的建议基于 Omicron KP.2 适应型疫苗的非临床和制造数据，以及支持辉瑞和 BioNTech 先前新冠疫苗配方安全性和有效性的临床和现实世界证据。非临床数据显示，与这两家公司的 Omicron XBB.1.5 适应型新冠疫苗相比，KP.2 适应型疫苗对目前流行的多种 Omicron JN.1 亚系（包括 KP.2、LB.1、KP.3 和 KP.3.1.1）产生了显著改善的反应 。

In July 2024, the EC granted marketing authorization for Pfizer and BioNTech’s Omicron JN.1-adapted COVID-19 vaccine. This authorization was based on evidence showing that the JN.1-adapted COVID-19 vaccine generates a substantially improved response against multiple Omicron JN.1 sublineages, including KP.2, LB.1, KP.3 and KP.3.1.1, as compared with the companies’ Omicron XBB.1.5-adapted COVID-19 vaccine.

2024 年 7 月，欧盟委员会批准辉​​瑞和 BioNTech 的 Omicron JN.1 适应型 COVID-19 疫苗上市。该授权基于证据表明，与这两家公司的 Omicron XBB.1.5 适应型 COVID-19 疫苗相比，JN.1 适应型 COVID-19 疫苗对多个 Omicron JN.1 亚系（包括 KP.2、LB.1、KP.3 和 KP.3.1.1）产生了显著改善的反应。

Pending authorization of the Omicron KP.2-adapted vaccine by the EC, both the Omicron KP.2-adapted vaccine and the Omicron JN.1-adapted vaccine will be available across the EU, though availability will vary based on individual country government requests and national recommendations.

等待欧盟委员会授权 Omicron KP.2 适应疫苗后，Omicron KP.2 适应疫苗和 Omicron JN.1 适应疫苗将在整个欧盟范围内上市，但供应情况将根据各个国家政府的要求和国家建议而有所不同。

In the United States, the U.S. Food and Drug Administration approved the companies’ Omicron KP.2-adapted COVID-19 vaccine for individuals 12 years of age and older and granted emergency use authorization for individuals 6 months through 11 years of age on August 22, 2024. Pfizer and BioNTech will continue to monitor the evolving epidemiology of COVID-19 and remain prepared to develop modified vaccine formulas, as the data support and as regulatory agencies recommend.

在美国，美国食品药品监督管理局于2024年8月22日批准了这两家公司的Omicron KP.2改良型新冠疫苗，用于12岁及以上的人群，并授予了针对6个月至11岁人群的紧急使用授权。辉瑞和BioNTech将继续监测新冠疫情的不断发展的流行病学，并根据数据支持和监管机构的建议，随时准备开发改良的疫苗配方。

The COVID-19 vaccines (COMIRNATY ® ) by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY ® and its adapted vaccines in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

辉瑞与 BioNTech 联合研发的新冠肺炎疫苗（COMIRNATY ® ）基于 BioNTech 专有的 mRNA 技术，由两家公司共同开发。BioNTech 是 COMIRNATY ® 及其改良疫苗在美国、欧盟、英国和其他国家/地区的上市许可持有人，也是美国（与辉瑞联合）和其他国家/地区的紧急使用授权或等效授权持有人。