Hipra is going to expand the clinical trial of its Covid-19 vaccine with more volunteers who have previously received the two doses of the AstraZeneca version. The Catalan company extends this study at the request of the European Medicines Agency (EMA), which considers the proportion of participants vaccinated with the British laboratory’s product to be low.
The Madrid hospitals Gregorio Marañón, HM Sanchinarro and HM Puerta del Sur (Móstoles), in addition to HM Modelo (A Coruña) and HM Rosaleda (Santiago de Compostela), will participate in the extension of the trial, according to the HM Hospitales group.
Some 270 people over the age of 18 will participate, and they will be given the Hipra vaccine as a booster. The volunteers must have received the two doses of AstraZeneca and not have been infected with Covid-19.
Hipra is currently developing a phase III trial as a booster dose with its recombinant protein vaccine. It has recruited 3,000 volunteers in Spain, Italy and Portugal, from people who previously received the full guideline from Pfizer/BioNTech, Janssen, Moderna or AzstraZeneca. But the EMA has asked the Catalan company to extend the study, considering that the proportion of participants with AstraZeneca from the previous phase is insufficient. Most of the volunteers had received the punctures from Pfizer/BioNTech and Moderna.
The request from the EMA is not expected to delay the possible approval of the vaccine in Europe from the Girona pharmaceutical company, according to sources familiar with the clinical trial.
This expansion with volunteers who have received the AstraZeneca guideline may be relevant for an approval of the Hipra vaccine as a booster outside of Europe, since the British multinational’s alternative has been widely used in Asia and Latin America. The Hipra vaccine is stored at refrigerator temperature (between 2 and 8ºC), facilitating storage and distribution.
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