With just over 90% of the Spanish population over 12 years of age vaccinated with the complete COVID-19 vaccine schedule, efforts are now focused on booster vaccines. For this reason, the biotechnological pharmaceutical company Hipra, which continues to develop its Spanish vaccine against the coronavirus, has just obtained authorization from the Spanish Agency for Medicines and Health Products (AEMPS) to start its phase III clinical trial.
With this new study, which will have the scientific and regulatory advice of the AEMPS, it is intended to know exactly the safety, efficacy and tolerability of this drug as a booster dose. To do this, the effects of this vaccine will be analyzed in some 3,000 volunteers over 16 years of age from 20 hospitals in Spain, Portugal and Italy.
All participants must have received one or two doses of Comirnaty (Pfizer-BioNtech), Spikevax (Moderna), Vaxzevria (AstraZeneca), Janssen (Johnson&Johnson), or combinations of these vaccines, at least three months ago. In addition, if the volunteer has had COVID-19 for a month or more and has not been admitted to a hospital, they can also choose to participate in the trial.
The step prior to requesting authorization from the EMA
This study is the first phase III trial of a vaccine developed in Spain. After the results obtained in the previous trials, which have shown that it is a safe drug with adequate efficacy in generating neutralizing antibodies against the virus, if it is shown in this work that it is effective as a booster dose, the next step would be to present an authorization request to the European Medicines Agency (EMA).
If this phase III clinical trial is successfully completed, the Spanish Hipra vaccine could request authorization from the European Medicines Agency (EMA)
Hipra’s COVID-19 vaccine is an adjuvanted recombinant protein-based vaccine containing the receptor-binding region of the alpha and beta variants of SARS-CoV-2. According to previous trials, this drug is capable of generating an immune response against different variants of the SARS-CoV-2 virus.
According to the AEMPS, “It is important to emphasize that, unlike other clinical trials in which there is the possibility of receiving a placebo, in this study all participants will receive an active vaccine.” The status and data of the phase II clinical trial, which the AEMPS approved on November 15, can be consulted in the Spanish Registry of Clinical Studies (REec).
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