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The first clinical trial of a Spanish vaccine against covid-19 has been approved

This article was published on
August 16, 2021

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The Spanish Agency of Medicines and Medical Devices has approved the first clinical trial in humans of a Spanish vaccine against covid-19; this is PHH-1V, manufactured by Hipra Laboratories.

The Spanish Agency of Medicines and Medical Devices has approved the first clinical trial in humans of a Spanish vaccine against covid-19; this is PHH-1V, manufactured by Hipra Laboratories.

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Information and context on vaccines. Article written by the science journalists of the SINC agency with the analysis and review of expert sources.

A Spanish vaccine developed by Hipra Laboratories and called PHH-1V will be the first vaccine against SARS-CoV-2 developed entirely in Spain to be tested in humans, as announced recently.

The first clinical trial (Phase I) will be conducted at the Hospital Clínic in Barcelona and the Hospital Josep Trueta in Girona and will include 30 participants, aged between 18 and 39. The volunteers will receive two doses of the vaccine, separated by a period of 21 days.

It is a recombinant protein vaccine (like the Novavax and Sanofi vaccines) that has been designed to offer protection against different variants of SARS-CoV-2, and induce a potent immune response with virus-neutralising capacity. The vaccine is expected to be stored at 2-8°C, i.e. it does not require freezing, which should facilitate logistics and distribution on a global scale.

The Spanish Medicines and Health Products Agency (AEMPS) will initiate, as soon as possible, the screening process to find candidates that meet the inclusion criteria specified in the protocol.

Clinical trials in humans are essential to guarantee the quality, safety and efficacy of vaccines and involve close monitoring of volunteers and an identification of all cases of adverse events and covid-19 infection as they occur.

The Spanish government, through the Ministry of Science and Innovation and the Ministry ofHealth, has followed the development of this vaccine from its earliest stages and has supported the company in different areas.

On 16 April 2021, the Prime Minister himself, Pedro Sánchez, who has expressed his satisfaction with the approval of this first clinical trial in humans, and the heads of the Ministries of Science and Innovation and Health, visited Hipra's headquarters to gain first-hand knowledge of the progress of the research done.

This article is also available in Spanish.

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