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The Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, has authorized the clinical trial of the PHH-1V vaccine against Covid-19, from the Hipra company.

This is the first human trial of a vaccine developed in Spain.

It is a phase I / IIa trial of dose escalation, randomized, controlled and masked (the Hipra vaccine or an authorized vaccine is administered masked, so as to prevent its identification by both the patient and the research team), which will

study primarily the safety and tolerability of this vaccine

, as well as its immunogenicity and efficacy as secondary targets.

For this, several dozen volunteers will be recruited from hospital centers who will begin, as soon as possible, the process to select volunteers who meet the inclusion criteria specified in their protocol.

This vaccine is based on two structurally similar recombinant proteins, one corresponding to the alpha variant and the other corresponding to the beta variant, which come together to form a unique structure called a dimer, and which are accompanied by an adjuvant that increases the immune response. This combination is

capable of generating an immune response against one of the proteins of the

SARS-CoV-2

virus

, known as protein S (from spike, also called spike protein in Spanish).

This platform is the same that has been used for the Novavax and Sanofi / GSK vaccines, which are already in the process of being evaluated for potential authorization by the European Medicines Agency (EMA). But unlike them, this 'Spanish' vaccine expresses proteins from two different variants.

In the study, the volunteers will be divided into groups (cohorts) and the lowest dose will begin to be administered to the first cohort. After evaluation by an independent surveillance committee of the safety data of these participants, they will be escalated to the next doses if no safety problems have been detected. Health explains that this practice, "common in this type of trial", is

aimed at evaluating the optimal dose of vaccine

. Each participant will receive 2 immunizations 21 days apart.

Throughout the trial, close monitoring of all volunteers and identification of all cases of adverse events and SARS-CoV-2 infection that occur will be carried out.

This will allow carrying out preliminary analyzes with intermediate data that allow to continue advancing in the investigation.

However, the Ministry of Health points out that "it will be necessary to wait until the clinical trial has finished to be able to analyze all the data and draw final conclusions."

Quality, safety and efficacy

"These clinical trials are part of the requirements that all investigational vaccines must carry out to demonstrate their quality, safety and efficacy. Only after they have been evaluated and if they comply with regulatory standards will they be authorized for marketing", they add in this regard. .

The President of the Government, Pedro Sánchez, and the Minister of Health, Carolina Darias, visited the Hipra plant in April to follow first-hand the advances in vaccine research.

The company expects the clinical trials to be completed successfully

to start production in October of this year

, with the aim of launching its commercialization by the end of 2021, subject to obtaining the appropriate authorizations.

According to current HIPRA projections, 400 million doses are expected to be produced in 2022. By 2023, 1,200 million doses could be reached.

It will be kept between 2 and 8ºC, which will facilitate its logistics and distribution.

Hipra is also carrying out a line of research in collaboration with the Hospital Clínic de Barcelona for the development of a vaccine against Covid-19 based on the mRNA of the virus.

According to the criteria of The Trust Project

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