Die Weltgesundheitsorganisation (WHO) wurde am 31. Dezember 2019 über die Existenz dieses neuen Virus informiert, nachdem in Wuhan (Volksrepublik China) ein Ausbruch von Fällen „viraler Lungenentzündungen“ gemeldet worden war¹. Die Zahl der bestätigten Fälle stieg im Laufe des Monats Januar schlagartig an, wobei täglich Tausende neuer Fälle diagnostiziert wurden, bis zum 30. Januar 2020, als der COVID-19-Ausbruch von der WHO zu einer gesundheitlichen Notlage internationaler Tragweite erklärt wurde. Am 11. März 2020 erklärte die WHO COVID-19 offiziell zur globalen Pandemie³.

Die meisten Infizierten leiden an einer leichten oder mittelschweren Atemwegserkrankung und genesen, ohne dass eine besondere Behandlung erforderlich ist. Einige Menschen erkranken jedoch schwer und benötigen medizinische Behandlung. Ältere Menschen und Menschen mit Vorerkrankungen (wie Herz-Kreislauf-Erkrankungen, Diabetes, chronischen Atemwegserkrankungen oder Krebs) entwickeln mit höherer Wahrscheinlichkeit eine schwere Erkrankung⁴. 

COVID-19 wird übertragen, wenn eine infizierte Person kleinste Atemwegspartikel und Tröpfchen ausatmet, die das Virus enthalten. Diese Atemwegspartikel und Tröpfchen können von anderen Menschen eingeatmet werden oder auf deren Augen, Nase oder Mund gelangen. In manchen Fällen können sie auch die Oberflächen kontaminieren, die andere Menschen berühren. Jede Person, die mit COVID-19 infiziert wurde, kann die Krankheit verbreiten, auch wenn sie selbst keine Symptome zeigt⁵.

Verpflichtung von HIPRA in Bezug auf COVID-19

HIPRA, mit mehr als 50 Jahren Erfahrung in der Bekämpfung übertragbarer Krankheiten durch die Entwicklung von Impfstoffen, ist ein Unternehmen, das sich für Gesundheit, Menschen, Gesellschaft und Fortschritt engagiert. Aus diesem Grund hat sich HIPRA angesichts der Ausnahmesituation von Beginn an dafür entschieden, das Know-how des Unternehmens in die Bekämpfung der Pandemie einzubringen und einen rekombinanten Proteinimpfstoff gegen SARS-COV-2 zu entwickeln (EMA-Marktzulassung am 31. März 2023).

- 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

Bibliographische Referenzen:

^{1. Weltgesundheitsorganisation. Grundlegende Informationen über COVID-19. [Internet] Verfügbar unter: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-covid-19 (Zuletzt besucht: 8. März 2023)}

^{2. „Informationen für die Öffentlichkeit. Fragen und Antworten zum neuen Coronavirus COVID-19 [Internet]“. Verfügbar unter: https://www.sanidad.gob.es/en/profesionales/saludPublica/ccayes/alertasActual/nCov/ciudadania.htm (Zuletzt besucht: 8. März 2023)}

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

^{4. Weltgesundheitsorganisation. Coronavirus. [Internet] Verfügbar unter: https://www.who.int/health-topics/coronavirus#tab=tab_1 (Zuletzt besucht: 8. März 2023)}

^{5. Centres for Disease Control and Prevention. [Internet]. Verfügbar unter: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html (Zuletzt besucht: März 2023)}

^{6. Weltgesundheitsorganisation. Fragen und Antworten über die Verbreitung von COVID-19. [Internet] Verfügbar unter:  https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-covid-19-how-is-it-transmitted (Zuletzt besucht: März 2023)}