A booster dose of bivalent recombinant protein vaccine provides long-lasting immunisation in people over 16 years of age
The vaccine has been shown to be less reactogenic than mRNA vaccines
It is the first bivalent recombinant protein COVID-19 vaccine to be authorised in the European Union
HIPRA has received the positive opinion of the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for marketing authorisation in the European Union of BIMERVAX®, the COVID-19 vaccine developed by the biotechnological pharmaceutical company. It is a next-generation vaccine to provide protection against COVID-19, developed 100% in the European Union and designed using recombinant protein technology. It consists of a bivalent adjuvanted vaccine containing a recombinant protein based on the Beta and Alpha variants of SARS-CoV-2 and is indicated as a booster dose for people over 16 years of age1, 2, 3. It is the first bivalent recombinant protein vaccine against the virus to be authorised in the European Union.
The positive opinion of the EMA comes after concluding that sufficient robust data on vaccine quality, immunogenicity and safety are available. Phase IIb and III studies have shown that this is a safe, non-reactogenic vaccine with a broad ability to neutralise major SARS-CoV-2 variants, including Omicron variants. The comparative study versus the mRNA vaccine required by the EMA shows that, at six months after receiving the booster dose, people vaccinated with the HIPRA vaccine have higher levels of neutralising antibodies against all variants studied, suggesting more lasting protection. In the same comparative study, it is shown to have less reactogenicity than the mRNA vaccine1, 2, 3.
The vaccine is stored at refrigerated temperature between 2 and 8ºC, facilitating storage and distribution. This is a “ready-to-use” vaccine, i.e. it does not need to be reconstituted before use, thus making it easier for healthcare personnel.
Due to its characteristics and results demonstrated in clinical trials, according to HIPRA, the vaccine fits with current needs taking into account the course of the pandemic. Given the potential for a new variant with a different mutation that required adaptation of the vaccine, the recombinant protein platform offers great versatility for updating in a very short time and allows for the inclusion of more than one variant in a single active substance, which to date is not feasible with other vaccine designs approved in the European Union.
HIPRA believes that “it is positive that health systems around the world have a catalogue of vaccines of different technologies because it is a key aspect in the implementation of vaccine programmes, whether they are periodic plans for booster vaccination or for the control of a possible pandemic flare-up.” Furthermore, “BIMERVAX® is based on a widely-used technology known in the manufacture of vaccines, such as hepatitis and influenza, among others.”
The HIPRA COVID-19 vaccine is the first human health vaccine to be designed and developed in Spain, which marks a watershed moment in the history of Spanish medicine and underlines the talent and technology that the country possesses. Having the structures and capabilities ranging from the most basic research and development to the production of vaccines in the country is a key factor in being able to guarantee a rapid response in the event of future health emergencies and reinforces the strategic autonomy of Europe in the field of health.
Project Evolution
In May 2020, the company’s R&D team began designing its first COVID-19 vaccine based on the Wuhan strain and soon after, given the emergence of the first virus variants, decided to adapt the antigen composition and begin designing the current adjuvanted vaccine based on the Beta and Alpha variants. After conducting the pre-clinical studies and demonstrating the safety and efficacy of the vaccine pre-clinically, the clinical trials began in August 2021 and in March 2022 the European Medicines Agency initiated the rolling review process.
In August 2022, the company signed a Joint Procurement Agreement (JPA) whereby 13 member states of the European Union (EU) have the option to purchase up to 250 million doses of the vaccine. Unlike other COVID-19 vaccines, which during the health emergency situation could be accommodated under the EU’s Advance Purchase Agreement (APA) programmes, there is no obligation to purchase or pay in advance with the JPA.
Lastly, today as of 30 March, the vaccine has received positive feedback from the EMA.
In recent months, there have also been contacts with authorities from different countries outside the EU who have shown interest in the vaccine. Now that the vaccine is available in the European Union, work will be done to reach agreements with these countries, as well as with the agencies that have coordinated vaccine donations internationally with the goal of making the vaccine part of vaccination plans in these territories and that can contribute to global control of COVID-19.
Furthermore, within the framework of the European RBDCOV project led by HIPRA, which consists of hospitals, research centres and entities from different European countries, the vaccine is being studied as a booster dose for immunocompromised people, and studies in children and adolescents under 16 years of age will also be initiated shortly.
Thank you to all collaborators, research sites, hospitals and volunteers
If the vaccine is a reality, it is thanks to the knowledge, effort and perseverance of the HIPRA team and the teams of all the research sites, institutions, public and private hospitals that have collaborated: Hospital Universitari de Girona Doctor Josep Trueta (Girona, Cataluña), Hospital Vall d’Hebron Barcelona Hospital Campus (Barcelona, Cataluña), Hospital Germans Trias i Pujol (Badalona, Cataluña), Hospital de Mollet (Mollet del Vallès, Cataluña), CAP La Florida (Santa Perpètua de Mogoda, Cataluña), Hospital Universitario La Paz (Madrid, Comunidad de Madrid), Hospital Clínic de Barcelona (Barcelona, Cataluña), Hospital Clínico Universitario de Valencia (Valencia, Comunidad Valenciana), Hospital Universitario Regional de Málaga (Málaga, Andalucía), Hospital Universitario Príncipe de Asturias (Alcalá de Henares), Hospital Universitario de Cruces (Barakaldo, País Vasco), Hospital General Universitario Gregorio Marañón (Madrid, Comunidad de Madrid), HM Nou Delfos (Barcelona, Cataluña), Hospital HM Montepríncipe (Boadilla del Monte, Comunidad de Madrid), Hospital Universitario HM Sanchinarro, Hospital HM Puerta del Sur (Móstoles, Comunidad de Madrid), Hospital Quirónsalud Barcelona (Barcelona, Cataluña), Hospital Universitario Quirónsalud Madrid (Pozuelo de Alarcón, Comunidad de Madrid), Hospital ASST Grande Ospedale Metropolitano Niguarda (Milán, Italia), Hospital HM Rosaleda (Santiago de Compostela, Galicia), Hospital HM Modelo (A Coruña, Galicia), IDIBGI Institut d'Investigació Biomèdica de Girona (Girona, Cataluña), IDIBAPS Instituto de Investigaciones Biomédicas August Pi i Sunyer (Barcelona, Cataluña), Vall d'Hebron Institut de Recerca (Barcelona, Cataluña), Instituto de Salud Carlos III (Madrid, Comunidad de Madrid), Universitat Pompeu Fabra (Barcelona, Cataluña), CMCiB (Centre de Medicina Comparativa i Bioimatge) de l’IGTP (Institut de recerca Germans Trias i Pujol) (Badalona, Cataluña), Nostrum Biodiscovery (Barcelona, Cataluña), Institut de Recerca i Tecnologia Agroalimentàries – Centre de Recerca en Sanitat Animal (IRTA-CReSA) (Bellaterra, Cataluña) y el Institut de Recerca de la Sida IrsiCaixa (Badalona, Cataluña). IrsiCaixa, as a benchmark virology and immunology centre, has also contributed to the project by carrying out a technology transfer to the HIPRA team to enable the monitoring of new COVID-19 variants. The project has also been supported by several private companies specialising in research.
The HIPRA vaccine is also a reality thanks to the thousands of people who, through their voluntary efforts, have helped make this project possible by participating in the vaccine clinical trials conducted in Spain, Italy and Vietnam. Volunteers have become a key figure in any medical research and even more so in this case, taking into account the global impact COVID-19 has had.
1. BIMERVAX® Summary of Product Characteristics
2. Corominas J, Garriga C, Prenafeta A, Moros A, Cañete 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. Medrxiv. doi: https://doi.org/10.1101/2022.07.05.22277210
3. 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;In Press.