세계보건기구(WHO)는 중국의 우한에서 “바이러스성 폐렴” 사례가 발생했음이 공표된 후인 2019년 12월 31일 이 신종 바이러스의 존재를 통보받았습니다¹. WHO가 코로나-19의 발생을 국제적으로 중요한 공중 보건 비상사태로 공표하는 2020년 1월 30일까지 1월 한 달 동안 매일 수천 명의 신규 감염이 진단되면서 확인된 감염 사례의 숫자가 갑작스럽게 늘어났습니다. WHO가 코로나-19를 공식적으로 글로벌 대유행으로 공표한 것은 2020년 3월 11일이었습니다³.

감염된 대부분의 사람들은 경증 또는 중간 중증도의 호흡기 질환을 경험하고, 특별한 치료 필요 없이 회복합니다. 그러나, 일부 사람들은 중증을 앓게 되고 치료를 필요로 합니다. 노인 및 기저 질환(예, 심혈관 질환, 당뇨병, 만성 호흡기 질환 또는 암)을 앓고 있는 사람들은 중증으로 발전할 가능성이 더 높습니다⁴. 

코로나-19는 감염된 사람이 바이러스가 포함되어 있는 호흡기 미세입자 및 비말을 내쉬면서 확산됩니다. 이 호흡기 입자 및 비말은 타인이 흡입하거나 눈, 코 또는 입에 떨어질 수 있습니다. 일부 상황에서 이로 인해 다른 사람들이 만지는 표면이 오염될 수 있습니다. 코로나-19에 감염된 사람은 누구든지 질병을 퍼트릴 수 있으며, 증상이 나타나지 않는 경우일지라도 그럴 수 있습니다⁵.

코로나-19에 관한 HIPRA의 약속

HIPRA는 백신 개발을 통해 전염병과 싸워 온 50년 이상의 경험을 바탕으로 건강, 사람, 사회 및 발전에 전념하는 기업입니다. 이와 같은 이유로, 예외적인 상황에 직면했기 때문에, HIPRA는 대유행의 초기부터 SARS-COV-2에 대한 재조합 단백질 백신을 개발하여 대유행과의 싸움을 위해 회사의 노하우를 기여하기로 선택하였습니다 (2023년 3월 31일 EMA 마케팅 승인).

- 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

서지 참조:

^{1. 세계보건기구(WHO). Basic information about COVID-19(코로나-19에 관한 기본 정보). [Internet] https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-covid-19에서 보실 수 있습니다 (마지막 방문: 2023년 3월 8일)}

^{2. “Information for the public. Questions and Answers about the new COVID-19 Coronavirus [Internet]”(대중을 위한 정보. 새로운 코로나-19 코로나바이러스에 관한 질의 응답). https://www.sanidad.gob.es/en/profesionales/saludPublica/ccayes/alertasActual/nCov/ciudadania.htm에서 보실 수 있습니다(마지막 방문: 2023년 3월 8일).}

^{3. Hu B, Guo H, Zhou P, Shi ZL. Characteristics of SARS-CoV-2 and COVID-19(SARS-CoV-2 및 코로나-19의 특징). Nat Rev Microbiol. 2021;19(3):141-154.}

^{4. 세계보건기구(WHO). Coronavirus(코로나바이러스). [Internet] https://www.who.int/health-topics/coronavirus#tab=tab_1에서 보실 수 있습니다(마지막 방문: 2023년 3월 8일).}

^{5. Centres for Disease Control and Prevention(질병통제예방센터). [Internet]. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html에서 보실 수 있습니다 (마지막 방문: 2023년 3월).}

^{6. 세계보건기구(WHO). Questions and answers about the spread of COVID-19(코로나-19 확산에 관한 질의 응답). [Internet]  https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-covid-19-how-is-it-transmitted에서 보실 수 있습니다(마지막 방문: 2023년 3월).}