Third (and last) phase of Hipra's vaccine trial authorised
Spanish Medicines Agency greenlights testing of Catalan serum as booster dose on 3,000 volunteers
GironaThe Girona-based pharmaceutical company Hipra can now start the third phase trials of its vaccine against covid-19. After reviewing the results of Phase 2b, the Spanish Agency for Medicines and Health Products (AEMPS) has approved a step forward in its research. In this third stage, the new serum will be tested on 3,000 volunteers over 16 years of age, with the collaboration of some twenty hospitals in Spain, Portugal and Italy. The aim is to test whether the new drug is safe and effective as a booster dose in people who have received other vaccines, and they will be followed up medically for 52 weeks. Once it is finished, and if it receives the endorsement of the health authorities, the company will be able to market it.
Hipra's solution 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. Compared to other vaccines already on the market, Hipra's vaccine has two main advantages: it can be kept at a temperature of between two and eight degrees Celsius – i.e. in a normal refrigerator – and it does not require any preparation before administration, which would make logistics and transport much easier.
The pharmaceutical company, based in Amer (La Selva), has so far manufactured two million doses of the new drug. Its forecast is to produce 600 million more by 2022, which could be doubled (1,200) by 2023.
Two phases completed
The clinical trials of the new solution began in early August 2020 with phase 1. Thirty volunteers were chosen – half of whom received the new vaccine and the other half one of the currently available on the market – and underwent medical follow-up with the collaboration of the Josep Trueta Hospital in Girona and the Clínic Hospital in Barcelona. 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 in Spain, four of which are Catalan (Josep Trueta, Clínic, Vall d'Hebron and Germans Trias i Pujol).
In preclinical trials, the vaccine showed an "effective immune response" and "no adverse effects," the company said in November. To analyse this, they administered Hipra's solution to humanised mice (i.e., genetically modified to reproduce the disease as humans do) and, after infecting them with covid, found that it had "100% efficacy in preventing mortality." Moreover, 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.
During a visit in early January, the Spanish Minister of Science and Innovation, Diana Morant, also assured that the new serum showed "good results and resistance" to the Omicron variant.