De Wereldgezondheidsorganisatie (WHO) werd op 31 december 2019 op de hoogte gebracht van het bestaan ​​van dit nieuwe virus, nadat in Wuhan (de Volksrepubliek China) een uitbraak van gevallen van "virale longontsteking" was vastgesteld¹. Het aantal bevestigde gevallen steeg plotseling met duizenden nieuwe gevallen die dagelijks werden gediagnosticeerd in de maand januari, in de aanloop naar 30 januari 2020 toen de uitbraak van COVID-19 door de WHO werd uitgeroepen tot een noodsituatie voor de volksgezondheid van internationale betekenis. Op 11 maart 2020 verklaarde de WHO de status van COVID-19 officieel als een wereldwijde pandemie³.

De meerderheid van de geïnfecteerde mensen ervaart een milde of matige luchtwegaandoening en herstelt zonder speciale behandeling. Maar sommigen worden ernstig ziek en hebben medische behandeling nodig. Ouderen en mensen met onderliggende gezondheidsproblemen – zoals hart- en vaatziekten, diabetes, chronische luchtwegaandoeningen of kanker – hebben een grotere kans om de ernstige ziekte te ontwikkelen⁴. 

COVID-19 verspreidt zich wanneer een geïnfecteerde persoon kleine ademhalingsdeeltjes en druppeltjes uitademt die het virus bevatten. Deze ademhalingsdeeltjes en druppels kunnen door andere mensen worden ingeademd of kunnen op hun ogen, neus of mond terechtkomen. In sommige omstandigheden kunnen ze de oppervlakken besmetten die anderen aanraken. Iedereen die besmet is met COVID-19 kan de ziekte verspreiden, ook als ze zelf geen symptomen vertonen⁵.

Inzet van HIPRA met betrekking tot COVID-19

HIPRA, met meer dan 50 jaar ervaring in vaccinontwikkeling ten behoeve van het bestrijden van overdraagbare ziekten, is een bedrijf dat zich inzet voor gezondheid, mensen, maatschappij en vooruitgang. Om deze reden, gezien de uitzonderlijke situatie, koos HIPRA er vanaf het begin voor om zijn knowhow bij te dragen in de strijd tegen de pandemie met de ontwikkeling van een recombinant eiwitvaccin tegen SARS-COV-2 (EMA-handelsvergunning op 31 maart 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

Bibliografische referenties:

^{1. Wereldgezondheidsorganisatie. Basisinformatie over COVID-19. [Internet] Beschikbaar op: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-covid-19 (Laatste bezoek: 8 maart 2023)}

^{2. “Informatie voor het publiek. Vragen en antwoorden over het nieuwe COVID-19-coronavirus [Internet]”. Beschikbaar op: https://www.sanidad.gob.es/en/profesionales/saludPublica/ccayes/alertasActual/nCov/ciudadania.htm (Laatste bezoek: 8 maart 2023)}

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

^{4. Wereldgezondheidsorganisatie. Coronavirus. [Internet] Beschikbaar op: https://www.who.int/health-topics/coronavirus#tab=tab_1 (Laatste bezoek: 8 maart 2023)}

^{5. Centres for Disease Control and Prevention (Centra voor ziektebestrijding en -preventie). [Internet]. Beschikbaar op: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html (Laatste bezoek: maart 2023)}

^{6. Wereldgezondheidsorganisatie. Vragen en antwoorden over de verspreiding van COVID-19. [Internet] Beschikbaar op:  https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-covid-19-how-is-it-transmitted (Laatste bezoek: maart 2023)}