Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups

美国食品和药物管理局授权莫德纳和辉瑞-生物技术公司二价新冠肺炎疫苗作为年轻群体的强化剂量：冠状病毒（新冠肺炎）更新：

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.

今天，美国食品药品监督管理局修改了现代新冠肺炎疫苗二价和辉瑞-生物技术公司新冠肺炎疫苗二价的紧急使用授权，以授权它们作为较年轻年龄组的单一强化剂量使用。辉瑞-生物技术公司新冠肺炎疫苗二价授权在五岁以下儿童完成初级或强化疫苗接种后至少两个月使用。现代新冠肺炎疫苗，二价，授权在六岁以下儿童完成初级或强化疫苗接种后至少两个月内给药。

These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.

这话疫苗中的mRNA是一段特定的遗传物质，指导体内细胞制造原始病毒株和奥密克戎变种血统BA.4和BA.5的独特“尖峰”蛋白。Ba.4和Ba.5的尖峰蛋白完全相同。这些双价新冠肺炎疫苗包括原始菌株的一种mRNA成分，以提供对新冠肺炎有广泛保护作用的免疫反应，以及奥密克戎变异体BA.4和BA.5谱系之间的一种共同mRNA成分，以提供对奥密克戎变异体引起的新冠肺炎的更好保护。

“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D. “While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible.”

“由于儿童已经亲自回到学校，人们正在恢复大流行前的行为和活动，接触导致新冠肺炎的病毒的风险有可能增加。新冠肺炎病毒在儿童中的严重程度往往低于成人，但随着新冠肺炎病毒的各种浪潮的发生接种疫苗仍然是预防新冠肺炎严重后果的最有效措施，包括住院和死亡，“彼得·马克斯医学博士说“虽然在很大程度上，，更多的儿童患上了这种疾病并住院治疗。我们鼓励父母考虑为儿童接种初级疫苗，并在符合条件时使用更新的加强剂量进行后续治疗。“儿童也可能会经历长期的影响，即使是在最初的轻微疾病之后。

With today’s authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. Both the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine continue to be authorized for primary series administration in individuals six months of age and older.

现代新冠肺炎疫苗和辉瑞-生物技术公司新冠肺炎疫苗继续被授权在6个月及以上的个人中进行初级系列管理。随着今天的授权，单价辉瑞-生物技术公司新冠肺炎疫苗不再被授权为5至11岁个人的强化剂量。

For each of the bivalent COVID-19 vaccines authorized today, the FDA relied on immune response and safety data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. In addition, the FDA has evaluated and considered immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups. These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups.

对于今天授权的每一种二价新冠肺炎疫苗，美国食品和药物管理局都依赖于免疫反应和安全性数据，这些数据是它以前从成人临床研究中评估的，该研究中增加了一种二价新冠肺炎疫苗的剂量，该疫苗含有新型冠状病毒原始菌株的一种成分和奥密克戎血统BA.1的一种成分。此外，美国食品和药物管理局已经评估和考虑了单价mRNA新冠肺炎疫苗临床研究的免疫反应和安全性数据，包括作为儿科年龄组的强化剂量。这些数据和单价mRNA新冠肺炎疫苗的现实经验已经给包括幼儿在内的数百万人接种，支持二价新冠肺炎疫苗在年轻群体中的EUA。美国食品和药物管理局认为这些数据与含有奥密克戎变异体BA.4和BA.5谱系成分的疫苗相关并支持。

What You Need to Know: Authorization of Moderna COVID-19 Vaccine, Bivalent

你需要知道的：莫德纳新冠肺炎疫苗授权，二价

The data supporting FDA’s authorization of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for both the 6 years through 11 years age group and 12 through 17 years age group is based on the FDA’s previous analysis of immune response and safety data from a clinical study in adults 18 years of age and older who received a booster dose of Moderna’s investigational bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of Omicron lineage BA.1.

这些数据来自一项临床研究，该研究对18岁及以上的成年人进行了分析，这些成年人接受了强化剂量的莫德纳研究性二价新冠肺炎疫苗，该疫苗包含新型冠状病毒原始菌株的一个成分和奥密克戎血统BA.1的一个成分。支持美国食品和药物管理局授权6岁至11岁年龄组和12岁至17岁年龄组的单一强化剂量的莫德纳新冠肺炎疫苗（二价）的数据是基于美国食品和药物管理局以前对免疫反应和安全性数据的分析，

For the 12 through 17 years age group, the authorization is also based on the effectiveness of a single booster dose of the monovalent Moderna COVID-19 Vaccine in this age group. The FDA’s analysis included a comparison of the immune response among approximately 250 clinical trial participants in this age group who received a single booster dose of Moderna COVID-19 Vaccine at least five months after completion of a two-dose primary series of the vaccine to the immune responses among approximately 300 clinical trial participants 18 through 25 years of age who had received a two-dose primary series of Moderna COVID-19 Vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. The immune response to the booster dose of Moderna COVID-19 Vaccine in the 12 through 17 years age group was comparable to the immune response to the two-dose primary series in the adult participants.

12至17岁年龄组对强化剂量现代新冠肺炎疫苗的免疫反应与成人参与者对两剂初级系列的免疫反应相当。对于12至17岁的年龄组，授权也是基于单价现代新冠肺炎疫苗在该年龄组的单次强化剂量的有效性。美国食品和药物管理局的分析包括将该年龄组中大约250名临床试验参与者的免疫反应与大约300名18至25岁的临床试验参与者的免疫反应进行比较，这些参与者在完成两剂初级系列疫苗后至少五个月接受了单剂强化剂量的现代新冠肺炎疫苗，他们在以前的一项研究中接受了两剂初级系列现代新冠肺炎疫苗，该研究确定该疫苗在预防新冠肺炎方面有效。

For the 6 years through 11 years age group, the authorization is also based on the effectiveness of a single booster dose of the monovalent Moderna COVID-19 Vaccine in this age group. The FDA’s analysis included a comparison of the immune response among approximately 100 clinical trial participants 6 years through 11 years of age who received a single booster dose of Moderna COVID-19 Vaccine at least six months after completion of a two-dose primary series of the vaccine to the immune responses among approximately 300 clinical trial participants 18 through 25 years of age who had received a two-dose primary series of Moderna COVID-19 Vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. The immune response to the booster dose of Moderna COVID-19 Vaccine in the 6 years through 11 years age group was comparable to the immune response to the two-dose primary series in the adult participants.

6岁至11岁年龄组对强化剂量现代新冠肺炎疫苗的免疫反应与成人参与者对两剂初级系列的免疫反应相当。对于6至11岁年龄组，授权也是基于单价现代新冠肺炎疫苗在该年龄组的单次强化剂量的有效性。美国食品和药物管理局的分析包括将大约100名6岁至11岁的临床试验参与者的免疫反应与大约300名18岁至25岁的临床试验参与者的免疫反应进行比较，这些参与者在完成两剂初级系列疫苗后至少6个月接受了单剂强化剂量的现代新冠肺炎疫苗，此前的一项研究确定该疫苗在预防新冠肺炎方面有效。

The safety of a single booster dose of monovalent Moderna COVID-19 Vaccine was evaluated in approximately 1,300 participants 12 through 17 years of age who received a booster dose of monovalent Moderna COVID-19 Vaccine at least five months after the second dose of the primary series, and approximately 1,300 participants 6 years through 11 years of age who received a booster dose of monovalent Moderna COVID-19 Vaccine at least six months after the second dose of the primary series. The most commonly reported side effects after a booster dose of the monovalent Moderna COVID-19 Vaccine in the clinical trial participants for both age groups were pain, redness and swelling at the injection site, tiredness, headache, muscle pain, chills, joint pain, underarm swollen lymph nodes in the same arm as the injection, nausea/vomiting and fever.

在两个年龄组的临床试验参与者中，加强剂量单价现代新冠肺炎疫苗后，最常见的副作用是注射部位疼痛、红肿、疲劳、头痛、肌肉疼痛、寒战、关节痛、注射时同一手臂的腋下淋巴结肿大、恶心/呕吐和发烧。在大约1300名12岁至17岁的参与者中评估了单次强化剂量单价现代新冠肺炎疫苗的安全性，他们在初级系列第二剂后至少5个月接受了强化剂量单价现代新冠肺炎疫苗，以及大约1300名6岁至11岁的参与者在初级系列第二剂后至少6个月接受了强化剂量单价现代新冠肺炎疫苗。

Individuals who receive the bivalent vaccine may experience similar side effects reported by individuals who received the monovalent Moderna COVID-19 Vaccine.

接受二价疫苗的个人可能会经历接受单价现代新冠肺炎疫苗的个人报告的类似副作用。

The data for the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

单价现代新冠肺炎疫苗的数据与二价现代新冠肺炎疫苗相关，因为这些疫苗是使用相同的工艺制造的。

What You Need to Know: Authorization of Pfizer-BioNTech COVID-19 Vaccine, Bivalent

你需要知道的：辉瑞-生物技术公司新冠肺炎疫苗授权，二价

The data supporting the authorization of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 5 through 11 years of age is based in part on the FDA’s previous analysis of immune response and safety data from a clinical study in adults greater than 55 years of age who received a booster dose of a Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of Omicron lineage BA.1. In addition, the authorization is based on the FDA’s previous analysis of safety and effectiveness data of a booster dose of monovalent Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age.

此外，该授权是基于美国食品和药物管理局此前对5至11岁儿童强化剂量单价辉瑞-生物技术公司新冠肺炎疫苗安全性和有效性数据的分析。支持为5岁至11岁的个体授权单次强化剂量的辉瑞-生物技术公司新冠肺炎二价疫苗的数据部分基于美国食品和药物管理局此前对免疫反应和安全性数据的分析，这些数据来自一项临床研究，该研究针对55岁以上的成年人，他们接受了强化剂量的辉瑞-生物技术公司的研究性二价新冠肺炎疫苗，该疫苗包含新型冠状病毒原始菌株的一个成分和奥密克戎血统BA.1的一个成分。

Individuals who receive Pfizer-BioNTech COVID-19 Vaccine, Bivalent may experience similar side effects reported by individuals who received the monovalent Pfizer-BioNTech COVID-19 Vaccine.

生物技术公司新冠肺炎疫苗的个人报告的类似副作用。接受辉瑞-生物技术公司新冠肺炎疫苗的个人可能会经历接受单价辉瑞-

The fact sheets for both of the bivalent COVID-19 vaccines for recipients and caregivers and for healthcare providers include information about potential side effects, as well as the risks of myocarditis and pericarditis.

为接受者和护理人员以及医疗保健提供者提供的两种双价新冠肺炎疫苗的概况介绍包括关于潜在副作用以及心肌炎和心包炎风险的信息。

The amendments to the EUAs were issued to Moderna TX Inc. and Pfizer Inc.

EUAs的修正案已发布给莫德纳德克萨斯公司和辉瑞公司。

Moderna COVID-19 Vaccine

现代新冠肺炎疫苗

Pfizer-BioNTech COVID-19 Vaccine

辉瑞-生物技术公司研发的新冠肺炎疫苗

COVID-19 Bivalent Vaccine Boosters

新冠病毒二价疫苗助推器

COVID-19 Vaccines

新冠肺炎疫苗

Emergency Use Authorization for Vaccines Explained

解释疫苗紧急授权使用

###

###