BIMERVAX® LP.8.1 is the last updated COVID-19 vaccine developed by HIPRA to prevent the disease in adults over 12 years of age. The vaccine is authorized as a booster dose regardless of prior COVID-19 vaccination status. The vaccine is based on a recombinant protein, specifically the receptor binding domain (RBD) of the SARS-COV-2 spike protein, presented as a homodimer and combined with a Squalen-based adjuvant that amplifies the body’s immunogenic response. 

This updated formulation is specifically adapted to target the LP.8.1 variant following official recommendation on COVID-19 vaccines adaptation from WHO and EMA and contributes to maintaining protection against emerging sublineages, such as NB.1.8.1 and XFG, thanks to the cross-protection generated by the vaccine.

The COVID-19 HIPRA’s vaccine is given as an injection, usually in the muscle of the upper arm. For more information about using it, see the package leaflet or consult a healthcare professional.

BIMERVAX® LP.8.1 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 defences — 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.

The benefits of this vaccine were assessed over its clinical development which encompass 10 clinical trials (5 randomised doble-blind trials and 5 single arm), mainly on healthy adults, but it has been studied also on elderly, in co-administration with adjuvated seasonal flu vaccine, on participant with an immunocompromised condition and on adolescents. All clinical data have shown: 

- Good safety profile with less reactogenicity when compared to an mRNA-based vaccine comparator.^1,2

- Strong humoral and cellular immune response^1-4 and long-lasting humoral response that has shown non-inferior or even superior to an mRNA-based vaccine comparator.^2-4

- Broad SARS-CoV-2 variant cross-reactivity with the parent vaccine (BIMERVAX®) and its first adaptations, BIMERVAX® XBB.1.16 and now with BIMERVAX® LP.8.1. They have shown significative humoral response against all variant tested.^1-6 

Moreover, the vaccine has been developed using well-known and widely used components and technologies. Subunit vaccines based on recombinant proteins can be produced on low-cost expression platforms and scaled up with high yields, making them easier to produce and distribute globally and its stability at +2ºC - +8ºC makes easy its storage and logistics for distributors and supply chain with the impact that may have on carbon foodprint and healthcare system sustainability and health care burden of COVID-19 vaccination programs.^7,8

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® and its adaptations should be given under close supervision with appropriate medical treatment available.

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

On October 2024 a marketing authorisation of BIMERVAX® XBB.1.16, HIPRA’s COVID Vaccine first adaptation against Omicron XBB.1.16 variant, was granted by the EU based on immunobridging clinical trial, which compared the immune response induced by this new adaptation against the EU authorised mRNA vaccine Comirnaty® XBB.1.5. The study showed Bimervax XBB.1.16 also causes the production of antibodies against SARS-CoV-2 that can protect against the XBB.1.16 strain, which was circulating at the time of the study. At the time of approval, more recent strains were in circulation. However, the agency considered the data provided for the evaluation of Bimervax XBB.1.16 useful for the development and evaluation of future adapted Bimervax vaccines and have proved the capacity of HIPRA’s platform to adapt its COVID-19 vaccine to a future SARS-CoV-2 variants following recommended by WHO and EMA guidelines. 

On September 22nd 2025, HIPRA obtained marketing authorisation from the European Commission for the BIMERVAX® LP.8.1 vaccine. The approval comes after having demonstrated that BIMERVAX® LP.8.1 generates good immunity against Omicron LP.8.1 SARS-CoV-2 variant.