The EMA could authorize the Spanish Hipra vaccine against covid as a booster

The European Medicines Agency (EMA) began this Tuesday the real-time review of the safety, quality and efficacy data against COVID-19 of the Spanish PHH-1V vaccine, developed by Hipra laboratories as a booster dose for adults who have already received the primary schedule with a different vaccine.

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The Committee for Medicinal Products for Human Use (CHMP) today began this process of analyzing the data that are published in real time on this vaccine, a decision that is based on the preliminary results of laboratory studies and clinical studies in adult volunteers.

”Clinical studies compared the immune response to the vaccine with that seen with the Comirnaty (Pfizer) mRNA vaccine. Preliminary results suggest that the immune response with the Hipra vaccine may be effective against SARS-CoV-2 (the virus that causes COVID-19), ”, add the EMA.

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The review, which will assess whether the benefits of using this vaccine outweigh its risks, will continue until sufficient evidence is available to request a formal marketing authorization in the European Union (EU), similar to that of the other five licensed vaccines. European: Pfizer, Moderna, AstraZeneca, Janssen and Novavax.

on the use of this vaccine, but the aim of initiating the continuous review is precisely to shorten the time in which the application for a European license will be analyzed later on.

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In addition to the balance between benefit and risk, the EMA will have to assess whether this Hipra vaccine meets the usual EU standards for efficacy, safety and quality.

This preparation contains two versions of parts of the spike protein that have been produced in the laboratory: one version corresponds to the part of the spike protein of the alpha variant and another of beta.

The vaccine also contains an “adjuvant,” a substance that helps strengthen immune responses to the vaccine, so when a person receives a dose, their immune system identifies the two proteins in the vaccine as – antibodies and T-cells. , against them.

If a person vaccinated with PHH-1V subsequently comes into contact with SARS-CoV-2, their immune system will recognize the spike protein of the virus and be ready to attack it.

This vaccine is stored at refrigerator temperature (between 2 and 8 ºC), facilitating storage and distribution. However, the technology used allows great versatility to adapt it to new variants of the virus, if necessary in the future. The results obtained so far show that the vaccine produces neutralizing antibodies against the variants of current concern and is also effective in preventing the disease.

On March 11, the Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, authorized a second phase IIb clinical trial of this vaccine. The objective of this research is to determine and compare the changes in immunogenicity against the omicron variant in volunteers who have received two doses of the AstraZeneca vaccine and the HIPRA vaccine as a booster dose (PHH-1V is its technical name), versus to those who have received two doses of BioNTech/Pfizer as a booster.

Agencies