Girona-based pharmaceutical Hipra's vaccine presents "good results" against Omicron variant
The company expects to start phase 3 of the clinical trial in the middle of this month
GironaPharmaceutical company Hipra, based in Girona, has developed a vaccines which offers "good results and resistance" against the Omicron variant –the dominant variant in Catalonia– according to the Spanish Minister of Science and Innovation, Diana Morant, during a visit to the company in Amer (Selva). The company has been working for months on a new vaccine and expects to start its third phase of clinical trials midway through this month, if it receives the endorsement of the Spanish Agency for Medicines and Health Products (AEMPS). At this stage it would be tested on 3,000 volunteers, with the collaboration of 15 hospitals in Spain and "other countries," according to Morant.
Hipra's vaccine is based on two recombinant proteins, one from the alpha variant and the other from the beta variant, which are joined together in a single structure that generates an immune response against covid's Spike protein. The minister recalled that the company has the capacity to adapt it to other variants that may arise. "In the future, they could combine an Omicron protein with one from another variant," she said.
If it proves to be effective and safe – and receives permission from the health authorities – the new vaccine will be available on the market in the second quarter of this year. Hipra's vaccine has two main advantages over vaccines which have already been approved: it can be kept at a temperature of between two and eight degrees – that is, in a normal refrigerator – and it does not need any kind of preparation before administering it, which would make logistics and transport much easier.
Hipra has so far manufactured two million doses of the new vaccine. Its forecast is to produce 600 million more by 2022, which could be doubled by 2023.
Two phases completed
In the preclinical trials carried out so far, the vaccine has shown an "effective immune response" and "no adverse effects", the company said in November. To analyse it, they administered the Hipra solution to humanised mice and, after infecting them with covid-19, they found that it was "100% effective in preventing mortality". In addition, they did not detect the presence of the virus in either the lungs or the brain, which are two of the organs most susceptible to infection.
In the clinical trials of the new vaccine, 15 volunteers received the new vaccine and another 15 one of the vaccines on the market. They then underwent medical follow-up with the collaboration of the Josep Trueta Hospital in Girona and Barcelona's Hospital Clínic. Once all the controls and analyses had been passed, in November the company received authorisation to start phase 2b with the participation of 1,075 people and the collaboration of 10 hospitals across Spain, four of them in Catalonia (Josep Trueta, Clínic, Vall d'Hebron and Germans Trias i Pujol).
With these studies, Hipra wants to check whether its vaccine provides immunity against covid and also wants to analyse whether it could be used as a third dose or booster dose in people who have received other vaccines