The EMA evaluates the Spanish Hipra vaccine as a booster against COVID

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The European Medicines Agency (EMA) announces that it has begun the evaluation of the Spanish HIPRA vaccine against COVID-19 for its approval, which if approved, could be included in the group of booster vaccines.

The Spanish vaccine against COVID-19 HIPRA, also known as PHH-1V, developed by the Girona Hipra laboratory, is one step closer to being approved to be used as a booster dose against the disease, and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced that the continuous review of this drug has begun.

This represents a decisive step for the Hipra vaccine, which has been carried out after the good results obtained in the preliminary studies in laboratories and in clinical studies in adults, they explain in a statement from the EMA, which also suggest that this The vaccine could be effective against the omicron variant, which is the predominant one today.

Clinical investigations have compared the immune response to the vaccine, reflected in the level of antibodies generated against SARS-CoV-2, with that produced when the Pfizer-BioNTech mRNA-type vaccine is injected. Preliminary results, according to the EMA, suggest that the vaccine could be effective against COVID-19 and against worrying variants such as omicron.

Assess whether the benefits outweigh the risks

Carrying out these evaluations is necessary to be able to decide if the benefits of this vaccine outweigh the risks, and if so, it would receive the green light to authorize its marketing, after it is approved by the European Commission. Although they do not speak of deadlines, from the European regulatory body they clarify that “it should take less than normal to evaluate any eventual request due to the work carried out during the continuous review”.

The Hipra vaccine would be used as a reinforcement of the vaccination schedule and has the advantage that it can be adapted to possible new variants of the virus

The Hipra vaccine is made up of two versions of part of the spike protein that has been produced in the laboratory, one of which belongs to part of the spike protein of the alpha variant and the other to beta. These proteins are on the surface of the SARS-CoV-2 virus and it is what it uses to colonize cells and infect. Therefore, if these proteins are received in the vaccine, the immune system will already be prepared to react in the event of a future infection.

Another of the great advantages of this vaccine is that it can be easily stored in a conventional refrigerator, since it needs between 2ºC and 8ºC. This makes their storage and distribution more accessible and the possibility of distributing them all over the world more easily. This vaccine would be intended to be the booster dose for adults who have already received their full immunization schedule.

Finally, the technology used by this Spanish vaccine allows it to be adapted to possible new variants of the virus, if needed in the future, since in the results obtained so far it seems that this drug is capable of generating neutralizing antibodies against the variants current and a significant efficacy in the prevention of the disease.

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