Green light for the clinical trial of the covid vaccine from the Catalan company Hipra

The investigation into the first COVID-19 vaccine developed entirely in Spain continues to advance. The Girona-based pharmaceutical company Hipra has just received authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) to carry out the clinical trial of the vaccine, a key step for its future commercialization. It thus becomes the first Spanish company to do so, after the temporary halt of trials with volunteers for the vaccine developed by CSIC researcher Mariano Esteban.

The company, located in Amer, will test the PHH-1V vaccine with volunteers aged between 18 and 39, who will receive two doses 21 days apart. In collaboration with Hospital Clínic de Barcelona and Josep Trueta de Girona, the safety and tolerability of this drug will be evaluated, as well as its efficacy against the coronavirus. Its optimal dose will also have to be determined, varying the inoculated amount among the different participants. Throughout the trial, all volunteers will be closely monitored, and all adverse reactions and infections will be identified.

Hipra's vaccine is based on two recombinant proteins from the alpha (British) and beta (South African) variants, capable of generating an immune response against one of the SARS-COV-2 proteins. This system is similar to that used for the Novavax and Sanofi/GSK vaccines, which are already in the process of evaluation by the European Medicines Agency (EMA) and, unlike Hipra's, are based on the original variant (the Chinese).

The company is convinced that recombinant protein technology will be very effective in the fight against the pandemic and that it will be an additional solution to contribute to global vaccination and the annual revaccination process that will come. In animal vaccines, the company manufactures 24 billion doses of this type each year.

If all the necessary steps to validate the vaccine are successfully completed, the Catalan pharmaceutical company expects to produce between 600 and 900 million doses in 2022, a figure that was originally estimated to be 400 million. Manufacturing would begin this very month of October and, once European approval is obtained, it would be commercialized starting early next year.

More than 50 years of experience

The Amer multinational is considered the sixth largest producer of animal vaccines in the world. The company is characterized by a verticalized structure that controls the entire value and production chain. This organization, added to the experience accumulated over 50 years, has allowed it to fully develop a vaccine against covid and to do so more quickly than other existing projects in Spain.

The company led by David Nogareda claims to be the laboratory that has launched the most innovative and technological vaccines in the last ten years in animal health, with a total of 22. Beyond the vaccine against covid that it will now begin to test on people, Hipra is carrying out research in collaboration with Hospital Clínic de Barcelona to develop a second vaccine to combat the coronavirus. In this case, it is based on the virus's mRNA.

The Amer multinational is considered the sixth largest producer of animal vaccines in the world and has a verticalized structure that controls the entire value and production chain

Since 2019, the company has been promoting the Hipra Campus project, in Aiguaviva (Girona), which foresees the expansion of its current facilities into a new complex that will house different production and research units, as well as new business areas of the company. It will do so on an area of 114,000 square meters that will be added to the 56,000 square meters of the Amer factory. The project will involve an investment of 472 million euros until 2026 and the direct creation of 580 jobs.