Covid vaccine developed in Spain set to get EMA green light for distribution

The European Medicines Agency (EMA) has started the evaluation of the commerical authorisation of Hipra's Spanish Covid-19 vaccine, which is to be sold under the name Bimervax.

Delays have hampered the roll-out, which had been expected last year, after the EMA asked Hipra for additional data on the quality of the manufacturing process.

Spain's Minister of Science and Innovation, Diana Morant, said last January: "The truth is that the EMA is being very demanding. But the times are the times set by the EMA and we can only respect them".

Both Hipra and the Spanish government have defended the usefulness of the vaccine. The minister said that what they are doing is working with the pharmaceutical company, whose vaccine "is very good" and is showing "very good results" and all the clinical trials "are going well".

At the end of 2022, the process of the continuing review of the vaccine began, a step prior to authorising its commercialisation. In this phase of clinical trials – in which the Regional Hospital of Malaga participated – the immunogenicity and safety of this prophylaxis was evaluated as a fourth dose against Covid-19 in people previously vaccinated with three doses of the Comirnaty vaccine (Pfizer) or with two doses of the Comirnaty vaccine plus a booster of the Hipra vaccine, which was administered in a previous clinical trial phase.

All that remains now is for the EMA's Committee for Medicinal Products for Human Use to recommend approval of the vaccine at its monthly meeting next week. Within hours or days, the European Commission could ratify it and give the green light for the distribution of Hipra's injectable Bimervax.

Unlike Pfizer and Moderna's messenger RNA vaccines, Bimervax is based on two recombinant proteins capable of generating a response against one of the SARS-CoV-2 virus spike proteins. This type of recombinant protein vaccine – widely used to inoculate against influenza and hepatitis A – allows "small changes to be made quickly" so that it can adapt quickly to possible new strains of Covid-19.

Another advantage of the Hipra vaccine is that it does not require sub-zero temperatures: doses can be kept at between 2C and 8C, which facilitates storage and distribution.