EMA gives green light to HIPRA's COVID-19 vaccine as a booster

The CMCiB participated in the demonstration of the vaccine's effectiveness in its preclinical phase

Friday, 31 March 2023

Image source: EMA

A booster dose of the 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 vaccine against COVID-19 to be licensed in the European Union

HIPRA has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorisation in the European Union of BIMERVAX®, the vaccine against COVID-19 developed by the biotech pharmaceutical company. It is a new generation vaccine to confer protection against COVID-19, developed 100% in the European Union and designed using recombinant protein technology. It is 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 adjuvanted recombinant protein vaccine licensed in the European Union against the virus.

The Comparative Medicine and Bioimage Centre of Catalonia (CMCiB) participated in the demonstration of the efficacy of the vaccine in its preclinical phase, carrying out studies with the different variants of the virus and with mice as animal models in the high-security level 3 facilities. The centre has a team specialised in working under high-risk biosafety conditions with a comparative model. The procedure was approved by the Animal Experimentation Ethics Committee and the Biosafety Committee of CMCiB, and followed the strictest animal welfare criteria.

The EMA's positive opinion comes after concluding that it has sufficient robust data on the quality, immunogenicity and safety of the vaccine. In Phase IIb and III studies, it has been shown to be a safe, low reactogenic vaccine with a broad capacity to neutralise the main SARS-CoV-2 variants, including the Omicron variants. In the comparative study versus the mRNA vaccine required by the EMA, it is shown that, 6 months after receiving the booster dose, people vaccinated with the HIPRA vaccine have higher levels of neutralising antibodies against all variants studied, suggesting longer-lasting protection. In the same comparative study, it is shown to have less reactogenicity than the mRNA vaccine.

The vaccine is stored at a refrigerated temperature between 2°C and 8°C, facilitating logistics and distribution. It is a "ready-to-use" vaccine, i.e. it is not necessary to reconstitute it before use, thus facilitating the task of healthcare personnel.

Due to its characteristics and results demonstrated in clinical trials, according to HIPRA, the vaccine fits the current needs considering the evolution of the pandemic. In the possible situation of a new variant with a different mutation that would require adapting the vaccine, the recombinant protein platform has a great versatility to be updated in a very short time and allows including 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 vaccination programmes, whether they are periodic reminder vaccination plans or for the control of a possible resurgence of the pandemic". On the other hand, "BIMERVAX® is based on a widely used and well-known technology in the manufacture of vaccines, such as hepatitis and influenza, among others".

HIPRA's COVID-19 vaccine is the first vaccine for human health to be designed and developed in Spain, an aspect that marks a turning point in the history of Spanish medicine and highlights the country's talent and technology. Having the structures and capacities from the most basic research, development and even production of vaccines in the country is a key factor in guaranteeing a rapid response in the event of future health emergencies and reinforces European strategic autonomy in the field of health.

Project developments

In May 2020, the company's R&D team started designing its first COVID-19 vaccine based on the Wuhan strain and, shortly thereafter, given the emergence of the first variants of the virus, decided to adapt the antigen composition and start designing the current adjuvanted vaccine based on the Beta and Alpha variants. After conducting pre-clinical studies and demonstrating the safety and efficacy of the vaccine at the pre-clinical level, clinical trials started 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) under which 13 European Union (EU) member states have the option to purchase up to 250 million doses of the vaccine. Unlike other COVID-19 vaccines, which were eligible under the EU's Advanced Purchase Agreement (APA) programmes during the health emergency, there is no purchase obligation or advance payment under the JPA.

Finally, on 30 March, the vaccine received a positive opinion from the EMA.

In recent months, contacts have also been established with the authorities of different countries outside the EU that 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 organisations that have coordinated vaccine donations at the international level, with the aim of making the vaccine part of the vaccination plans in these territories and contribute to the global control of COVID-19.

In addition, within the framework of the European RBDCOV project led by HIPRA and involving hospitals, research centres and organisations from different European countries, the vaccine is being studied as a booster dose for immunocompromised individuals and studies will soon be initiated in children and adolescents under 16 years of age.

Reference study

Barreiro A, Prenafeta A, Bech-Sabat G, Roca M, Perozo Mur E, March R, González-González L, Madrenas L, Corominas J, Fernández A, Moros A, Cañete M, Molas M, Pentinat-Pelegrin T, Panosa C, Moreno A, Puigvert Molas E, Pol Vilarrassa E, Palmada J, Garriga C, Prat Cabañas T, Iglesias-Fernández J, Vergara-Alert J, Lorca-Oró C, Roca N, Fernández-Bastit L, Rodon J, Pérez M, Segalés J, Pradenas E, Marfil S, Trinité B, Ortiz R, Clotet B, Blanco J, Díaz Pedroza J, Ampudia Carrasco R, Rosales Salgado Y, Loubat-Casanovas J, Capdevila Larripa S, Prado JG, Barretina J, Sisteré-Oró M, Cebollada Rica P, Meyerhans A, Ferrer L. Preclinical evaluation of a COVID-19 vaccine candidate based on a recombinant RBD fusion heterodimer of SARS-CoV-2. iScience. 2023 Mar 17;26(3):106126. DOI: 10.1016/j.isci.2023.106126. PMID: 36748086; PMCID: PMC9893798.