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Bimervax isthe first bivalent recombinant protein vaccine against SARS-CoV-2 to be authorised in EU. (Photo: Hipra).

European Union gives the green light to the Hipra COVID-19 vaccine

Hipra’s vaccine against COVID-19, Bimervax, has already been marketed in the European Union, after receiving a positive opinion from the European Medicines Agency (EMA) and obtaining it the authorization from the European Commission. The team from the company’s R&D center at the Barcelona Science Park -where part of the research for the design, generation and characterization of new vaccine antigens is carried out–has actively participated in the project.

After the EMA Committee for Medicinal Products for Human Use (CHMP) gave its positive opinion for marketing authorisation in the European Union of Bimervax, the European Commission has also given its approval on the same day, 30 March. Therefore, Hipra’s vaccine against COVID-19 now has the green light to be marketed in the European Union.

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 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 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.

» For further information: EMA website [+] and Hipra website [+]