L’Organisation mondiale de la santé (OMS) a été avertie de l’existence de ce nouveau virus le 31 décembre 2019, lorsqu’une épidémie de « pneumonie virale » fut déclarée à Wuhan (République populaire de Chine)¹. Le nombre de cas confirmés a augmenté en flèche avec des milliers de nouveaux cas par jour en janvier, et l’épidémie de Covid-19 a été déclarée comme une urgence de santé publique de portée internationale par l’OMS le 30 janvier 2020. Le 11 mars 2020, l’OMS a officiellement déclaré que la Covid-19 était une pandémie mondiale³.

La plupart des personnes infectées présentent une affection respiratoire légère à modérée et guérissent sans traitement particulier. Cependant, certaines personnes deviennent gravement malades et ont besoin d’une prise en charge médicale. Les personnes âgées et présentant un terrain à risque (maladies cardiovasculaires, diabète, maladies respiratoires chroniques ou cancer) risquent davantage de développer une forme grave de la maladie⁴. 

La Covid-19 se transmet lorsqu’une personne infectée exhale de minuscules particules et gouttelettes contenant le virus. Ces particules et gouttelettes respiratoires peuvent être inhalées par d’autres personnes ou se loger dans leurs yeux, leur nez ou leur bouche. Dans certaines circonstances, elles peuvent contaminer les surfaces en contact avec les mains. Toute personne infectée par la Covid-19 peut transmettre la maladie, même si elle ne présente aucun symptôme⁵.

Engagement d’HIPRA en ce qui concerne la Covid-19

Forte de plus de 50 ans d’expérience dans la lutte contre les maladies transmissibles par le biais du développement de vaccins, HIPRA est une entreprise qui s’engage en faveur de la santé, de la population, de la société et du progrès. C’est pourquoi, face à cette situation exceptionnelle, HIPRA a choisi dès le début de mettre son savoir-faire au service de la lutte contre la pandémie avec le développement d’un vaccin à protéine recombinante contre la SARS-COV-2 (Autorisation de mise sur le marché de l’EMA le 31 mars 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

Bibliographie :

^{1. Organisation mondiale de la santé. Maladie à coronavirus 2019 (COVID-19) : ce qu'il faut savoir. [Internet] Consultable à l’adresse : https://www.who.int/fr/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-covid-19 (Dernière visite : 8 mars 2023)}

^{2. « Information publique. Questions et réponses sur le nouveau coronavirus Covid-19[Internet] ». Consultable à l’adresse : https://www.sanidad.gob.es/en/profesionales/saludPublica/ccayes/alertasActual/nCov/ciudadania.htm (Dernière visite : 8 mars 2023)}

^{3. Hu B, Guo H, Zhou P, Shi ZL. Caractéristiques de la SARS-CoV-2 et de la Covid-19. Nat Rev Microbiol. 2021;19(3):141-154.}

^{4. Organisation mondiale de la santé. Coronavirus. [Internet] Consultable à l’adresse : https://www.who.int/health-topics/coronavirus#tab=tab_1 (Dernière visite : 8 mars 2023)}

^{5. Centres pour le contrôle et la prévention des maladies. [Internet]. Consultable à l’adresse : https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html (Dernière visite : Mars 2023)}

^{6. Organisation mondiale de la santé. Maladie à coronavirus 2019 (COVID-19) : comment se transmet la COVID-19 ? [Internet] Consultable à l’adresse :  https://www.who.int/fr/news-room/questions-and-answers/item/coronavirus-disease-covid-19-how-is-it-transmitted (Dernière visite : mars 2023)}