继中国武汉宣布爆发“病毒性肺炎”疫情后，世界卫生组织 (WHO) 于 2019 年 12 月 31 日被告知这一新型病毒的存在¹。确认病例数陡然上升，当年 1 月，每天都有数千个新的确诊病例。WHO 因此于 2020 年 1 月 30 日宣布，COVID-19 的爆发成为具有国际影响的公共卫生紧急事件。2020 年 3 月 11 日，WHO 正式宣布将 COVID-19 定性为一种全球性流行病³。

大多数感染者都伴有轻微或中度的呼吸系统疾病症状，但无需特别治疗即可痊愈。然而，一些病例病情严重，需要专门治疗。老年人和那些有基础疾病的患者——例如心血管疾病、糖尿病、慢性呼吸道疾病或癌症——发展为重症的几率更高⁴。 

当感染者通过呼吸系统呼出含有病毒的微粒和飞沫时，COVID-19 就会借机传播。这些呼出的微粒和飞沫可被他人吸入，也可能附着在他们的眼睛、鼻子或嘴巴上。在某些情况下，它们可能会污染物体表面，而这些表面会被其他人触碰。感染 COVID-19 的任何人都有可能成为疾病的传播者，即使他们自己没有任何症状也是如此⁵。

HIPRA 关于 COVID-19 的承诺

HIPRA 是一家致力于健康、人、社会和进步的公司，拥有 50 多年通过疫苗开发抗击传染性疾病的经验。正由于此，面对这一非常时期，HIPRA 从一开始就选择贡献自己的专业技术，针对 SARS-COV-2 开发了一种重组蛋白疫苗，以此帮助抗击新冠疫情（2023 年 3 月 31 日获得 EMA 上市许可)。

- What is BIMERVAX® and what is it used for? 

BIMERVAX® is the vaccine developed by HIPRA to prevent COVID-19 in adults over 16 years of age. The vaccine is authorized as a booster dose for those who have already been immunized at least 6 months after a previous mRNA COVID-19 vaccine. The vaccine is based on a recombinant protein. Specifically, the vaccine is based on the receptor binding domain (RBD) of the virus surface, which is added to an adjuvant that amplifies the body's immunogenic response. 

- How is it used? 

The COVID-19 HIPRA’s vaccine is given as an injection, usually in the muscle of the upper arm. It is given as a booster at least 6 months after a previous mRNA COVID-19 vaccine. For more information about using it, see the package leaflet or consult a healthcare professional. 

- How does it work? 

BIMERVAX® works by preparing the body to defend itself against COVID-19. The vaccine contains a protein produced in the laboratory that consists of part of the SARS-CoV-2 spike protein from the virus. It also contains an ‘adjuvant’, a substance to help strengthen the immune response to the vaccine. When a person is given the vaccine, their immune system will identify the combined protein as foreign and produce natural defenses — antibodies and T cells — against it. If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognize the spike protein on the virus and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells. 

- What benefits of BIMERVAX® have been shown in studies? 

The benefits of this vaccine were assessed in an immunobridging study, which compared the immune response induced by this new vaccine with that induced by the authorised mRNA vaccine Comirnaty, which targets the original (Wuhan) SARS-CoV-2 spike protein. The study involved 765 adults who had previously completed primary vaccination with 2 doses of Comirnaty and who were subsequently given a booster dose of either BIMERVAX® or Comirnaty. Although BIMERVAX® triggered the production of lower levels of antibodies against the original strain of SARS-CoV-2 than Comirnaty, it led to higher levels of antibodies against the Beta and Omicron variants and comparable levels against the Delta variant. Supportive data were provided from an ongoing study that included 36 adolescents aged 16 to 17 years old, with immune response data available for 11 of them. This study found that BIMERVAX® given as a booster produced an adequate immune response in these adolescents, with antibody production comparable to that seen in adults who received BIMERVAX®.

 - What are the risks associated with BIMERVAX®? 

The most common side effects (which may affect more than 1 in 10 people) are pain at the injection site, headache, tiredness and muscle pain. Lymphadenopathy (enlarged lymph nodes), diarrhoea, vomiting, nausea (feeling sick), fever, pain in the armpits and reddening, hardness or swelling at the injection site may affect less than 1 in 10 people. Other less frequent adverse effects may affect less than 1 in 100 people are listed in the SmPC. Allergic reactions may occur. As for all vaccines, BIMERVAX® should be given under close supervision with appropriate medical treatment available. 

- Why is BIMERVAX® authorized in the European Union?

 Based on data comparing the immune response triggered by BIMERVAX® with that triggered by an authorised mRNA COVID-19 vaccine, EMA concluded that BIMERVAX® is expected to be at least as effective as the comparator at restoring protection against COVID-19 in people aged 16 years and older. The safety profile of BIMERVAX® is comparable to that of other COVID-19 vaccines. The most common side effects seen with BIMERVAX® were usually mild to moderate and cleared within a few days after vaccination. EMA therefore decided that BIMERVAX®’s benefits are greater than its risks and that it can be recommended for authorisation in the EU. BIMERVAX® received a marketing authorisation valid throughout the EU on 30 March 2023. Further information on HIPRA’s COVID-19 vaccine can be found on the European Medicines Agency website: ema.europa.eu/medicines/human/EPAR/bimervax

参考文献：

^{1. World Health Organization. Basic information about COVID-19.[Internet]（世界卫生组织。关于 COVID-19 的基本信息。） 网址：https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-covid-19（上次访问：2023 年 3 月 8 日）}

^{2. “Information for the public. Questions and Answers about the new COVID-19 Coronavirus[Internet]”.（公开信息。关于新型 COVID-19 冠状病毒的问答。） 网址：https://www.sanidad.gob.es/en/profesionales/saludPublica/ccayes/alertasActual/nCov/ciudadania.htm（上次访问：2023 年 3 月 8 日）}

^{3. Hu B, Guo H, Zhou P, Shi ZL. Characteristics of SARS-CoV-2 and COVID-19.（Hu B、Guo H、Zhou P、Shi ZL。SARS-CoV-2 和 COVID-19 的特点。） Nat Rev Microbiol.（《自然综述：微生物学》） 2021;19(3):141-154.}

^{4. World Health Organization. Coronavirus. [Internet]（世界卫生组织。冠状病毒。） 网址：https://www.who.int/health-topics/coronavirus#tab=tab_1（上次访问：2023 年 3 月 8 日）}

^{5. Centres for Disease Control and Prevention.[Internet]（美国疾病控制和预防中心。） 网址：https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html（上次访问：2023 年 3 月）}

^{6. World Health Organization. Questions and answers about the spread of COVID-19.[Internet]（世界卫生组织。关于 COVID-19 传播的问答。） 网址： https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-covid-19-how-is-it-transmitted（上次访问：2023 年 3 月）}