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EMA agency starts review of Spain’s Hipra Covid-19 vaccine

EMA’s human medicines committee (CHMP) has started a rolling review of the vaccine against Covid-19 of the biotechnological pharmaceutical company HIPRA.

The HIPRA’s Covid-19 bivalent vaccine is based on an adjuvant recombinant protein and it has been developed as a booster dose for fully vaccinated adults.

The HIPRA COVID-19 VACCINE is a heterologous recombinant protein vaccine, a technology widely used in biotechnology and for which there is widespread experience in vaccines extensively used in the population (flu, hepatitis A, papilloma, among others). The recombinant vaccine consists of synthetic (artificial) fragments of the virus causing the disease, the spike or S protein in the case of the SARS-CoV-2 virus causing COVID-19.

The CHMP’s decision to start the rolling review is based on preclinical development and preliminary results obtained in the clinical studies. The clinical studies compared the immune response generated by the vaccine (measured by the level of neutralizing antibodies against SARS-CoV-2) with that seen with an mRNA vaccine (Comirnaty). The preliminary results suggest that the immune response is effective against SARS-CoV-2, including variants of concern such as Omicron.

EMA, through the rolling review, will evaluate exiting data of the HIPRA’s vaccine and those generated up to the marketing authorisation, following the usual EU standards for effectiveness, safety and quality. HIPRA estimates that the conditional marketing authorization can be received between the end of May and the beginning of June. The company is already prepared at the production level to have the vaccine available in a few days.


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