Insight 数据库/医药资讯/FDA 授予两款新冠 Omicron 二价疫苗紧急使用授权，无人体数据支持

FDA 授予两款新冠 Omicron 二价疫苗紧急使用授权，无人体数据支持

2022-09-01 19:56:55本文来源: Insight数据库

8 月 31 日，美国 FDA 宣布，来自辉瑞/BioNTech 和 Moderna 的两款针对新冠原始毒株和奥密克戎变种 BA.4/BA.5 的二价 mRNA 疫苗加强针获得该机构紧急使用授权（EUA）。其中前者被授权用于 12 岁以上人群，后者被授权用于 18 岁及以上人群。

来自：FDA 官网

值得关注的是，本次许可并未经过人体试验的支持，而仅基于新疫苗的临床前数据。具体而言，FDA 作出决策的数据基础包括来自于另一款二价 COVID-19 疫苗加强剂量的临床研究免疫原性及安全性数据，该疫苗含有 SARS-CoV-2 原始毒株 + Omicron BA.1 的成分，FDA 认为这些数据与本次批准的含 Omicron BA.4/BA.5 成分的二价疫苗相关且能够支持这些批准。并且，当前 mRNA 疫苗也已经用于数百万人，这也有助于帮助该机构评估并决策。

实际上，辉瑞在此前 Q2 季度会上就已经宣布了这方面计划。该公司表示，目前新冠各流行变异株出现的时间间隔越来越短，而正常疫苗的研发周期通常包括 3 个月的临床前研究、8 个月的临床阶段研究，不足以对疫情作出足够迅速的响应。而 mRNA 技术平台已经在实践中拥有了广泛的临床证据，可能支持未来以临床前免疫原性数据/CMC 申报 EUA。昨晚的结果也代表了 FDA 对此种策略的认可。

顺应新冠病毒演变趋势的 mRNA 疫苗研发

来自：辉瑞 2022Q2 季报

基于临床前数据的批准并非是本次新冠疫情下的首创，每年流感疫苗的批准策略也近乎于此。FDA 认为，长期使用同一种工艺的疫苗在毒株每个周期的演变当中不需要新的人体数据支持，他们拥有丰富的经验，并征求了外部专家的意见，采取了相应措施来保证新疫苗符合严格的安全性、有效性和生产质量标准。

不过，这次批准仍旧引起了一些公众争议和质疑。两家公司也计划通过后续临床试验继续证实新获批疫苗相较于现有疫苗的有效性和安全性。

附：FDA 此次批准的依据（来自 FDA 官方新闻稿，原始链接附于文末）

1、支持 Moderna 新二价疫苗批准的数据

To evaluate the effectiveness of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older, the FDA analyzed immune response data among approximately 600 individuals 18 years of age and older who had previously received a two-dose primary series and one booster dose of monovalent Moderna COVID-19 Vaccine. These participants received a second booster dose of either the monovalent Moderna COVID-19 Vaccine or Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1) at least 3 months after the first booster dose. After 28 days, the immune response against BA.1 of the participants who received the bivalent vaccine was better than the immune response of those who had received the monovalent Moderna COVID-19 Vaccine.

The safety of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older is supported by safety data from a clinical study which evaluated a booster dose of Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1), safety data from clinical trials which evaluated primary and booster vaccination with the monovalent Moderna COVID-19 Vaccine, and postmarketing safety data with the monovalent Moderna COVID-19 Vaccine.

The safety data accrued with the bivalent vaccine (original and omicron BA.1) and with the monovalent Moderna COVID-19 Vaccine are relevant to the Moderna COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

The clinical study that evaluated the safety of a booster dose of the bivalent vaccine (original and omicron BA.1) included approximately 800 participants 18 years of age and older who had previously received a two dose primary series and one booster dose of the monovalent Moderna COVID-19 Vaccine, and then at least 3 months later, received a second booster dose with either the monovalent Moderna COVID-19 Vaccine or Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1).

Among the study participants who received the bivalent vaccine, the most commonly reported side effects included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, swelling of the lymph nodes in the same arm of the injection, nausea/vomiting and fever.

2、支持辉瑞/BioNTech 二价疫苗批准的依据

To evaluate the effectiveness of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older, the FDA analyzed immune response data among approximately 600 adults greater than 55 years of age who had previously received a 2-dose primary series and one booster dose with the monovalent Pfizer-BioNTech COVID-19 Vaccine. These participants received a second booster dose of either the monovalent Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original and omicron BA.1) 4.7 to 13.1 months after the first booster dose. After one month, the immune response against BA.1 of the participants who received the bivalent vaccine was better than the immune response of those who had received the monovalent Pfizer-BioNTech COVID-19 Vaccine.

The safety of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older is based on safety data from a clinical study which evaluated a booster dose of Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original and omicron BA.1), safety data from clinical trials which evaluated primary and booster vaccination with the monovalent Pfizer-BioNTech COVID-19 Vaccine, and postmarketing safety data with the monovalent Pfizer-BioNTech COVID-19 Vaccine.

The safety data accrued with the bivalent vaccine (original and omicron BA.1) and with the monovalent Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID 19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

The clinical study that evaluated the safety of a booster dose of the bivalent vaccine (original and omicron BA.1) included approximately 600 participants greater than 55 years of age who had previously received a 2-dose primary series, one booster dose of the monovalent Pfizer-BioNTech COVID-19 Vaccine, and then 4.7 to 13.1 months later, received a second booster dose of either the monovalent Pfizer-BioNTech COVID-19 Vaccine or Pfizer-BioNTech’s investigational bivalent COVID-19 vaccine (original and omicron BA.1). Among the study participants who received the bivalent vaccine, the most commonly reported side effects included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, joint pain, and fever.

来源：FDA News Release - Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose

链接：https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use

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