L’Organizzazione mondiale della sanità (OMS) è stata informata dell’esistenza di questo nuovo virus il 31 dicembre 2019, dopo che a Wuhan (Repubblica Popolare Cinese) è stato rilevato un focolaio di casi di “polmonite virale”¹. Il numero di casi confermati è aumentato improvvisamente, arrivando a migliaia di nuovi casi al giorno nel mese di gennaio, fino al 30 gennaio 2020 quando l'epidemia di COVID-19 è stata dichiarata dall’OMS un’emergenza sanitaria pubblica di rilevanza internazionale. Era l’11 marzo 2020 quando l’OMS dichiarò ufficialmente lo stato di pandemia globale da COVID-19³.

La maggior parte delle persone infette sperimenta una malattia respiratoria lieve o moderata e guarisce senza bisogno di cure speciali. Tuttavia, alcune si ammalano gravemente e necessitano di cure mediche. Le persone anziane e quelle affette da patologie preesistenti, come malattie cardiovascolari, diabete, malattie respiratorie croniche o cancro hanno una maggiore probabilità di sviluppare la malattia grave⁴. 

Il COVID-19 si diffonde quando una persona infetta espira minuscole particelle d’aria e goccioline che contengono il virus. Queste particelle e goccioline espirate possono essere inalate da altre persone o possono depositarsi su occhi, naso o bocca. In alcune circostanze, possono contaminare le superfici toccate da altri. Chiunque sia stato infettato dal COVID-19 può diffondere la malattia, pur non presentando alcun sintomo⁵.

Impegno di HIPRA sul COVID-19

HIPRA, con oltre 50 anni di esperienza nella lotta contro le malattie trasmissibili attraverso lo sviluppo di vaccini, è un’azienda impegnata a favore della salute, delle persone, della società e del progresso. Per questo motivo, di fronte a una situazione eccezionale, HIPRA ha scelto fin dall’inizio di contribuire con il proprio know-how alla lotta contro la pandemia, attraverso lo sviluppo di un vaccino proteico ricombinante contro il SARS-COV-2 (Autorizzazione all’immissione in commercio dell’EMA del 31 marzo 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

Bibliografia:

^{1. Organizzazione mondiale della sanità. Informazioni di base sul COVID-19. [Internet] Disponibili sul sito https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-covid-19 (ultima visita: 8 marzo 2023)}

^{2. “Informazioni per il pubblico. Domande e risposte sul nuovo coronavirus COVID-19[Internet]”. Disponibili su https://www.sanidad.gob.es/en/profesionales/saludPublica/ccayes/alertasActual/nCov/ciudadania.htm (utima visita: 8 marzo 2023)}

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

^{4. Organizzazione mondiale della sanità. Coronavirus. [Internet] Disponibili su https://www.who.int/health-topics/coronavirus#tab=tab_1 (ultima visita: 8 marzo 2023)}

^{5. Centres for Disease Control and Prevention (Centri per la prevenzione e il controllo delle malattie). [Internet]. Disponibili su: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html (ultima visita: marzo 2023)}

^{6. Organizzazione mondiale della sanità. Domande e risposte sulla diffusione del COVID-19. [Internet] Disponibili su  https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-covid-19-how-is-it-transmitted (ultima visita: marzo 2023)}