Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY ® (COVID-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies’ Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine. This season’s vaccine is for use as a single dose for most individuals 5 years of age and older. Individuals 5 years of age and older with certain kinds of immunocompromise previously vaccinated with Pfizer and BioNTech COVID-19 vaccines or children under the age of 5 who have not already completed a three-dose series with previous formulas of a COVID-19 vaccine may be eligible to receive additional doses.

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，美国食品药品监督管理局（“FDA”）已批准针对12岁及以上个人的补充生物制品许可申请（COMIRNATY® （ COVID-19疫苗，mRNA），并授予针对6个月至11岁个人的紧急使用授权（辉瑞-BioNTech COVID-19疫苗）两家公司的Omicron KP.2改编的2024-2025配方COVID-19疫苗。本季疫苗供大多数5岁及以上人士单剂使用。曾接种过辉瑞和BioNTech COVID-19疫苗且患有某些免疫功能低下的5岁及以上人士或曾接种过辉瑞和BioNTech COVID-19疫苗的5岁以下儿童尚未完成之前接种的三剂 COVID-19 疫苗的人可能有资格接种额外剂量。

The KP.2 adaptation is based on guidance from the FDA, which stated that KP.2 is the preferred strain of the JN.1 lineage for COVID-19 vaccines for use in the U.S. during the 2024-2025 fall and winter season, if feasible. 1 Staying up to date on vaccinations in line with the Centers for Disease Control and Prevention (“CDC”) recommendations remains important, particularly in light of COVID-19 cases on the rise again. 2 This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals, and clinics across the U.S. beginning in the coming days.

KP.2 的改良版基于 FDA 的指导，FDA 指出，如果可行的话，KP.2 是 JN.1 谱系中用于美国 2024-2025 年秋冬季 COVID-19 疫苗的首选菌株。1 按照 美国疾病控制和预防中心 (CDC) 的建议及时接种疫苗仍然很重要，尤其是在 COVID-19 病例再次上升的情况下。 本季的辉瑞和 BioNTech COVID-19 疫苗将立即开始发货，并将在未来几天开始在美国各地的药店、医院和诊所发售。

The approval is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and effectiveness of the COVID-19 vaccines by Pfizer and BioNTech. The application also included manufacturing and non-clinical data showing that the KP.2-adapted vaccine generates a substantially improved response against currently circulating Omicron JN.1 sublineages, including KP.2, KP.3 and LB.1, compared with the companies’ Omicron XBB.1.5 adapted COVID-19 vaccine

此次批准是基于辉瑞和 BioNTech 之前大量临床、非临床和现实世界证据，这些证据支持辉瑞和 BioNTech 的 COVID-19 疫苗的安全性和有效性。该申请还包含制造和非临床数据，表明与这两家公司的 Omicron XBB.1.5 适应型 COVID-19 疫苗相比，KP.2 适应型疫苗对目前流行的 Omicron JN.1 亚系（包括 KP.2、KP.3 和 LB.1）的反应显著改善 。

The COVID-19 vaccines 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 (COMIRNATY ® (COVID-19 Vaccine, mRNA); COMIRNATY ® Original/Omicron BA.1; COMIRNATY ® Original/Omicron BA.4-5; COMIRNATY ® Omicron XBB.1.5; COMIRNATY ® JN.1; COMIRNATY ® KP.2) 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 联合研发的新冠疫苗基于 BioNTech 专有的 mRNA 技术，由两家公司共同开发。BioNTech 是美国、欧盟、英国和其他国家/地区的 COMIRNATY ® 及其改良疫苗（COMIRNATY ® （新冠疫苗，mRNA）；COMIRNATY ® Original/Omicron BA.1；COMIRNATY ® Original/Omicron BA.4-5；COMIRNATY ® Omicron XBB.1.5；COMIRNATY ® JN.1；COMIRNATY ® KP.2）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。