Verdenssundhedsorganisationen (WHO) blev underrettet om eksistensen af denne nye virus den 31. december 2019, da et udbrud af tilfælde af "viral lungebetændelse" blev erklæret i Wuhan (Folkerepublikken Kina)¹. Antallet af bekræftede tilfælde steg pludseligt med tusindvis af nye tilfælde diagnosticeret på daglig basis i løbet af januar måned, frem til 30. januar 2020, hvor Verdenssundhedsorganisationen (WHO) erklærede udbruddet af COVID-19 for en folkesundhedsmæssig krisesituation af international betydning. Det var den 11. marts 2020, hvor WHO officielt erklærede COVID-19 for en global pandemi³.

Størstedelen af de smittede oplever en mild eller moderat luftvejssygdom, og kommer sig uden at have behov for særlig behandling. Nogle bliver dog alvorligt syge og har brug for lægehjælp. Ældre og personer med underliggende helbredsproblemer – såsom hjerte-kar-sygdomme, diabetes, kroniske luftvejssygdomme eller kræft – har større sandsynlighed for at udvikle den alvorlige sygdom⁴. 

COVID-19 spreder sig, når en smittet person udånder små luftvejspartikler og dråber, der indeholder virussen. Disse respiratoriske partikler og dråber kan indåndes af andre mennesker eller kan lande på deres øjne, næse eller mund. I nogle tilfælde kan de forurene de overflader, som andre rører ved. Alle, der smittes med COVID-19, kan sprede sygdommen, selvom de ikke selv udviser symptomer⁵.

HIPRA’s forpligtelse med hensyn til COVID-19

Med mere end 50 års erfaring i bekæmpelse af smitsomme sygdomme gennem vaccineudvikling, er HIPRA en virksomhed, der er engageret i sundhed, mennesker, samfund og fremskridt. Af denne årsag, og i lyset af en usædvanlig situation, valgte HIPRA fra begyndelsen at bidrage med sin knowhow i kampen mod pandemien med udviklingen af en rekombinant proteinvaccine mod SARS-COV-2 (EMA-markedsføringstilladelse den 31. marts 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

Bibliografiske referencer:

^{1. Verdenssundhedsorganisationen. Grundlæggende oplysninger om COVID-19. [Internet] Tilgængelig på: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-covid-19 (Sidst besøgt: 8. marts 2023)}

^{2. "Information til offentligheden. Spørgsmål og svar om den nye COVID-19 coronavirus [Internet]”. Tilgængelig på: https://www.sanidad.gob.es/en/profesionales/saludPublica/ccayes/alertasActual/nCov/ciudadania.htm (Sidst besøgt: 8. marts 2023)}

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

^{4. Verdenssundhedsorganisationen. Coronavirus. [Internet] Tilgængelig på: https://www.who.int/health-topics/coronavirus#tab=tab_1 (Sidst besøgt: 8. marts 2023)}

^{5. Centres for Disease Control and Prevention. [Internet]. Tilgængelig på: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html (Sidst besøgt: 8. marts 2023)}

^{6. Verdenssundhedsorganisationen. Spørgsmål og svar om spredningen af COVID-19. [Internet] Tilgængelig på:  https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-covid-19-how-is-it-transmitted (Sidst besøgt: 8. marts 2023)}