| 国家免疫规划技术工作组流感疫苗工作组.中国流感疫苗预防接种技术指南（2021-2022）[J].Chinese journal of Epidemiology,2021,42(10):1722-1749 |
| 中国流感疫苗预防接种技术指南（2021-2022） |
| Technical guidelines for seasonal influenza vaccination in China (2021-2022) |
| Received:September 13, 2021 |
| DOI：10.3760/cma.j.cn112338-20210913-00732 |
| KeyWord: 流感 疾病负担 疫苗 预防接种 技术指南 |
| English Key Word: Influenza Disease burden Vaccine Vaccination Technical guidelines |
| FundProject:国家自然科学基金（91846302）；公共卫生应急反应机制运行项目（131031001000200001）；支持新疫苗纳入国家免疫规划的机制以及国家免疫规划专家委员会技术工作组能力建设（OPP1193638） |
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| Abstract: |
| 流感是由流感病毒引起的一种急性呼吸道传染病，严重危害人群健康。流感病毒其抗原性易变，传播迅速，每年可引起季节性流行，在学校、托幼机构和养老院等人群聚集的场所可发生暴发疫情。每年流感季节性流行在全球可导致300万~500万重症病例，29万~65万呼吸道疾病相关死亡。孕妇、婴幼儿、老年人和慢性基础疾病患者等高危人群，罹患流感后出现严重疾病和死亡的风险较高。尤其是2021年全球新型冠状病毒肺炎（新冠）疫情严重流行态势仍将持续，今冬明春可能会出现新冠疫情与流感等呼吸道传染病叠加流行的风险。而接种流感疫苗是预防流感的最有效手段，可以减少流感相关疾病带来的危害及对医疗资源的占用。我国现已批准上市的流感疫苗有三价灭活流感疫苗（IIV3）、四价灭活流感疫苗（IIV4）和三价减毒活流感疫苗（LAIV3），IIV3包括裂解疫苗和亚单位疫苗，IIV4为裂解疫苗，LAIV为减毒疫苗。流感疫苗在我国大多数地区属于非免疫规划类疫苗，实行自愿、自费接种。2018-2020年，中国CDC均印发了当年度的《中国流感疫苗预防接种技术指南》。一年来，新的研究证据在国内外发表，为更好地指导我国流感预防控制和疫苗应用工作，国家免疫规划技术工作组流感疫苗工作组综合国内外最新研究进展，在2020年版指南的基础上进行了更新和修订，形成了《中国流感疫苗预防接种技术指南（2021-2022）》。本指南更新的内容主要包括：第一，增加了新的研究证据，尤其是我国的研究结果，包括流感疾病负担、疫苗效果、疫苗安全性监测、疫苗预防接种成本效果等；第二，更新了一年来国家卫生健康委员会流感防控有关政策和措施；第三，更新了我国2021-2022年度国内批准上市及批签发的流感疫苗种类；第四，更新了本年度三价和四价流感疫苗组分；第五，更新了2021-2022年度的流感疫苗接种建议。本指南建议：原则上，接种服务单位应为≥6月龄所有愿意接种流感疫苗且无禁忌证的人提供接种服务。流感疫苗与新冠疫苗的接种间隔应>14 d。对可接种不同类型、厂家疫苗产品的人群，可由受种者自愿选择接种任一种流感疫苗，无优先推荐。结合今年新冠疫情形势，为尽可能降低流感的危害和对新冠疫情防控的影响，推荐按照优先顺序对重点和高风险人群进行接种：①医务人员，包括临床救治人员、公共卫生人员、卫生检疫人员等；②大型活动参加人员和保障人员；③养老机构、长期护理机构、福利院等人群聚集场所脆弱人群及员工；④重点场所人群，如托幼机构、中小学校的教师和学生，监所机构的在押人员及工作人员等；⑤其他流感高风险人群，包括≥60岁的居家老年人、6月龄~5岁儿童、慢性病患者、<6月龄婴儿的家庭成员和看护人员以及孕妇或准备在流感季节妊娠的女性。首次接种或既往接种<2剂次流感疫苗的6月龄~8岁儿童应接种2剂次，间隔≥4周，对IIV或LAIV均建议上述原则；2020-2021年度或以前接种过≥2剂次流感疫苗的儿童，建议接种1剂次；≥9岁儿童和成年人仅需接种1剂次。建议各地在疫苗供应到位后尽快安排接种工作，最好在10月底前完成免疫接种；对10月底前未接种的对象，接种单位在整个流行季节都可以提供接种服务。孕妇在孕期的任一阶段均可接种IIV。本指南适用于从事流感防控相关的各级疾病预防控制机构工作人员，预防接种点的接种人员，各级医疗机构儿科、内科、感染科等医务人员，以及各级妇幼保健机构的专业人员。根据国内外研究进展，本指南今后亦将定期更新、完善。 |
| English Abstract: |
| Influenza is a respiratory infectious disease that can seriously affect human health. Influenza virus has frequent antigenic drifts that can facilitate escape from pre-existing population immunity and lead to rapid and widespread transmission. Seasonal influenza is characterized by annual epidemics and outbreaks in places of public gathering such as schools, kindergartens, and nursing homes. According to the World Health Organization (WHO), seasonal influenza causes 3 to 5 million severe cases and 290 000 to 650 000 deaths globally each year. Pregnant women, young children, the elderly, and persons with chronic medical conditions are at highest risk for severe illness and death from influenza virus infection. With the ongoing COVID-19 pandemic, SARS-CoV-2 may co-circulate with influenza and other respiratory viruses in the upcoming winter-spring influenza season. Seasonal influenza vaccination is the most effective way to prevent influenza virus infection and complications from influenza. China has several licensed influenza vaccines-trivalent inactivated influenza vaccines (IIV3), which include split-virus influenza vaccine and subunit vaccine; quadrivalent split-virus inactivated influenza vaccine (IIV4); and trivalent live attenuated influenza vaccine (LAIV3). With the exception of a few major cities, influenza vaccine is a non-program vaccine, which means that influenza vaccination is not included in China's Expanded Program on Immunization, and recipients must pay for influenza vaccine and its administration. China CDC has issued "Technical Guidelines for Seasonal Influenza Vaccination in China" every year from 2018 to 2020. This past year, there have been scientific and programmatic advances in prevention and control of seasonal influenza. To strengthen technical guidance for prevention and control of influenza and facilitate operational research on influenza vaccination, the National Immunization Advisory Committee (NIAC) Influenza Vaccination Technical Working Group (TWG) updated the 2020-2021 technical guidelines into the "Technical Guidelines for Seasonal Influenza Vaccination in China (2021-2022)." The new version has updates in five key areas:(1) new research evidence, especially from studies in China, on disease burden, vaccine effectiveness, vaccine-avoidable disease burden, vaccine safety monitoring, and cost-effectiveness and cost-benefit analyses, (2) policies and measures for influenza prevention and control that were issued by National Health Commission (NHC) in the past year, (3) licensure of a new seasonal influenza vaccine in time for the 2021-2022 season, (4) composition of the northern hemisphere trivalent and quadrivalent influenza vaccines for the 2021-2022 season, and (5) recommendations for influenza vaccination during the 2021-2022 influenza season. The recommendations specify that immunization clinics should provide influenza vaccine to all persons aged 6 months and above who are willing to be vaccinated and do not have contraindications; the interval between receipt of influenza vaccine and COVID-19 vaccine should at least 14 days; and there is no preference for one influenza vaccine over another for persons for whom more than one licensed, recommended, and appropriate vaccine is available. Considering the global COVID-19 pandemic and the need to decrease risk of influenza virus infection and minimize potential impact on COVID-19 prevention and control, we recommend the following target population priorities in preparation for the 2021-2022 influenza season:(1) healthcare workers, including clinical doctors and nurses, public health professionals, and quarantine professionals, (2) volunteers and staff who provide service and support for large events, (3) people living in nursing homes or welfare homes and staff who take care of vulnerable, at-risk individuals, (4) people who work in high population density settings, including teachers and students in kindergartens, primary, and secondary schools and prisoners and prison staff, and (5) people with high risk of complications from influenza, including adults ≥ 60 years of age, children 6-59 months of age, persons with certain chronic conditions, family members and caregivers of infants <6 months of age, and pregnant women and women who plan to become pregnant during the influenza season. Children 6 months through 8 years of age who have never received influenza vaccine or who have received only one lifetime dose require 2 doses of influenza vaccine that are administered at least 4 weeks apart. This recommendation applies to both IIV and LAIV. If children received 2 doses of influenza vaccine in the 2020-2021 influenza season or received more than 2 doses of influenza vaccine in prior influenza seasons, 1 dose of influenza vaccine is recommended. People more than 9 years old require only 1 dose of influenza vaccine. People should receive influenza vaccination by the end of October, and influenza vaccine should be offered as soon as it is available. For people unable to be vaccinated before the end of October, influenza vaccine will continue to be offered throughout the season. Influenza vaccine is recommended for pregnant women during any trimester of pregnancy. These guidelines are intended for use by staff of CDCs at all levels who work on influenza control and prevention; immunization clinic staff members; healthcare workers from departments of pediatrics, internal medicine, and infectious diseases; and staff of maternity and child care institutions at all levels. The guidelines will be periodically updated as new evidence becomes available. |
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