The World Health Organization (WHO) was notified of the existence of this new virus on 31 December 2019, once an outbreak in cases of “viral pneumonia” was declared in Wuhan (The People’s Republic of China)¹. The number of confirmed cases rose suddenly with thousands of new cases diagnosed on a daily basis during the month of January, leading up to 30 January 2020 when the outbreak of COVID-19 was declared by the WHO as a public health emergency of international significance. It was on 11 March 2020 when the WHO officially declared the status of COVID-19 as a global pandemic³.

The majority of infected people experience a mild or moderate respiratory disease, and recover without needing any special treatment. However, some become severely ill and need medical attention. Elderly people and those with underlying health conditions – such as cardiovascular diseases, diabetes, chronic respiratory diseases or cancer – have a higher probability of developing the severe illness⁴. 

COVID-19 spreads when an infected person exhales tiny respiratory particles and droplets that contain the virus. These respiratory particles and droplets can be inhaled by other people or may land on their eyes, nose or mouth. In some circumstances, they can contaminate the surfaces that others touch. Anyone who is infected with COVID-19 can spread the disease, even if they themselves do not present any symptoms⁵.

Commitment of HIPRA towards COVID-19

HIPRA, with more than 50 years of experience fighting communicable diseases through vaccine development, is a company committed to health, people, society and progress. For this reason, faced with an exceptional situation, HIPRA opted from the beginning to contribute its know-how in the fight against the pandemic with the development of a recombinant protein vaccine against SARS-COV-2 (EMA Marketing Authorization on March 31th 2023).

The project has been supported by the Center for Technological Development and Innovation (CDTI) and the National Recovery, Transformation and Resilience Plan - "Next Generation EU" funds.

- 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

Bibliographic references:

^{1. World Health Organization. Basic information about COVID-19. [Internet] Available at: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-covid-19 (Last visited: 8 March 2023)}

^{2. “Information for the public. Questions and Answers about the new COVID-19 Coronavirus [Internet]”. Available at: https://www.sanidad.gob.es/en/profesionales/saludPublica/ccayes/alertasActual/nCov/ciudadania.htm (Last visited: 8 March 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. World Health Organization. Coronavirus. [Internet] Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 (Last visited: 8 March 2023)}

^{5. Centres for Disease Control and Prevention. [Internet]. Available at: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html (Last visited: March 2023)}

^{6. World Health Organization. Questions and answers about the spread of COVID-19. [Internet] Available at:  https://www.who.int/news-room/questions-and-answers/item/coronavirus-disease-covid-19-how-is-it-transmitted (Last visited: March 2023)}

^{7. EMEA. BIMERVAX EPAR-Product information 2023. Available from: https://www.ema.europa.eu/en/documents/product-information/bimervax-epar-product-information_en.pdf.} 

^{8. Corominas J, Garriga C, Prenafeta A, Moros A, Canete M, Barreiro A, et al. Safety and immunogenicity of the protein-based PHH-1V compared to BNT162b2 as a heterologous SARS-CoV-2 booster vaccine in adults vaccinated against COVID-19: a multicentre, randomised, double-blind, non-inferiority phase IIb trial. Lancet Reg Health. 2023; doi https://doi.org/10.1016/j.lanepe.2023.100613} 

^{9. Barreiro A, Prenafeta A, Moros A, Madrenas L, Cañete M, Corominas J, et al. Humoral immune response against SARS-CoV-2 variants (Omicron BA.1, BA.4/5, Beta and Delta) of PHH-1V booster vaccine in subjects previously vaccinated with a mRNA vaccine. Results of a randomised controlled trial up to 6 months. Poster in: 17th Vaccine Congress. Glasgow; 24-27 sept 2023. https://seq.es/wp-content/uploads/2023/06/cambra12jun2023.pdf} 

^{10. Prenafeta A, Moros A, Barreiro A, Madrenas L, Cañete M, Corominas J, et al. Humoral response of Bimervax (PHH-1V, HIPRA) heterologous booster against SARS-CoV-2 in subjects with different prime-vaccination regimes. Results of a phase 3 clinical trial. Poster 106 in: 2023 ISV Annual Congress. Lausanne; 22-24 oct 2023. https://pubmed.ncbi.nlm.nih.gov/37131861/}