HIPRA receives approval for its BIMERVAX® COVID-19 Vaccine, a stepping stone for the work of the RBDCOV project

RBDCOV has already conducted clinical trials in immunocompromised individuals and will soon initiate trials in paediatric participants.

The approval of BIMERVAX® represents a major milestone for the RBDCOV project. 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 will also be initiated shortly. In May 2022 RBDCOV initiated the first Phase IIb clinical trial of HIPRA’s COVID-19 vaccine in people with immunocompromised conditions. The next step will involve starting clinical trials in paediatrics.

HIPRA has received approval 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 age. It is the first bivalent recombinant protein vaccine against the virus to be authorised in the European Union.

The vaccine was approved this March and now can be marketed in the European Union, after having received a positive opinion from the European Medicines Agency and marketing authorization from the European Commission. 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, low-reactogenic vaccine with a broad ability to neutralise major SARS-CoV-2 variants, including Omicron variants. The comparative study versus an 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 vaccine.

Characteristics of HIPRA’s vaccine

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-known technology used 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.

The HIPRA vaccine is 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.

More about the RBDCOV project

RBDCOV is one of 11 selected projects supporting clinical trials for a new vaccine that can go beyond Europe’s borders and create links with other European initiatives to effectively respond to the coronavirus crisis and strengthen existing research infrastructures. The European Commission has selected 11 projects in total involving 312 research teams from 40 countries. These projects fall under the Horizon Europe Framework Programme (2021-2027), Europe’s largest research and innovation programme, and one of its priorities is to support urgent research on coronavirus and its variants.

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