2019 年 12 月 31 日，在武漢（中華人民共和國）宣佈爆發「病毒性肺炎」疫情後，世界衛生組織 (WHO) 獲悉存在這種新型病毒¹。確診病例數量突然新增，1 月份每日診斷數千例新增病例，直至 2020 年 1 月 30 日，WHO 宣佈 COVID-19 的爆發為具有國際意義的突發公共衛生事件。2020 年 3 月 11 日，WHO 正式宣佈 COVID-19 疫情為全球性大流行疾病³。

大多數感染者都患有輕度或中度呼吸道疾病，無需任何特殊治療即可康復。然而，有些患者病情嚴重，需要醫療護理。老年人和那些有基礎疾病（如心血管疾病、糖尿病、慢性呼吸道疾病或癌症）的患者發展為嚴重疾病的可能性更大⁴。 

COVID-19 透過感染者呼出含有病毒的微小呼吸道微粒和飛沫進行傳播。這些呼吸道微粒和飛沫可被其他人吸入，也可能落在他們的眼睛、鼻子或嘴巴上。在某些情况下，它們會感染其他人接觸的表面。任何感染 COVID-19 的人都可能傳播該疾病，即使他們自身沒有任何症狀⁵。

HIPRA 關於 COVID-19 的承諾

HIPRA 擁有超過 50 年透過疫苗開發對抗傳染病的經驗，是一家致力於健康、人類、社會和進步的公司。因此，面對特殊情况，HIPRA 從一開始就選擇透過開發針對 SARS-COV-2 的重組蛋白疫苗，為抗擊疫情貢獻自己的專業知識 （歐洲藥品局 (EMA) 核准藥物於一個、數個或所有歐盟成員國 (EU Member States) 上市的授權日期為 2023 年 3 月 31 日）。 

- 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

參考文獻：

^{1. 世界衛生組織。COVID-19 的基本資訊。[Internet]網址：https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-covid-19（上次瀏覽時間：2023 年 3 月 8 日）}

^{2. 「公眾資訊。關於新型 COVID-19 冠狀病毒的問答[Internet]」。網址：https://www.sanidad.gob.es/en/profesionales/saludPublica/ccayes/alertasActual/nCov/ciudadania.htm（上次瀏覽時間：2023 年 3 月 8 日）}

^{3. Hu B、Guo H、Zhou P、Shi ZL。SARS-CoV-2 和 COVID-19 的特性。Nat Rev Microbiol。2021;19(3):141-154。}

^{4. 世界衛生組織。冠狀病毒。[Internet]網址：https://www.who.int/health-topics/coronavirus#tab=tab_1（上次瀏覽時間：2023 年 3 月 8 日）}

^{5. Centres for Disease Control and Prevention (疾病控制和預防中心)。[Internet]。網址：https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html（上次瀏覽時間：2023 年 3 月）}

^{6. 世界衛生組織。關於 COVID-19 傳播的問答。[Internet]網址：https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-covid-19-how-is-it-transmitted（上次瀏覽時間：2023 年 3 月）}