First-in-Human Trial – First Spanish Covid vaccine approved.

The candidate has been developed by Hipra, which says it will be able to produce 1.2 million doses by 2023.

The Spanish Agency of Medicine and Health Products (AEMPS) authorized the first human clinical trial of the PHH-1V vaccine against Covid-19, developed by the Spanish pharmaceutical company Hipra. This is the first time a Spanish Covid-19 vaccine has been approved for human trials.

The Phase 1 trial is aimed at testing safety, tolerance, immunogenicity and effectiveness. It will compare the PHH-1V vaccine candidate against other vaccines that have been authorized for use in humans. Thirty people between the ages of 18 and 30 are expected to be involved in this first phase. The vaccine will be tested on volunteers who have not had the coronavirus nor a single dose of a Covid-19 vaccine. Volunteers will also not know if they are receiving the PHH-1V vaccine or if they are in the control group, which will be given two doses of an authorized vaccine that uses RNA messenger technology, such as the Pfizer-BioNTech, at a three-week interval.

According to Hipra, the PHH-1V vaccine candidate is also effective against the more contagious delta coronavirus strain

An independent committee will monitor the volunteers for any possible adverse effects or cases of infections. The trial is expected to take months, but AEMPS has not outlined a specific timeframe. According to Hipra, it would be able to begin the manufacturing phase in just over 60 days, and expects to have authorization from the European Medicines Agency (EMA) by the first quarter of 2022.

According to AEMPS, the PHH-1V vaccine “is based on two recombinant proteins that are structurally similar, one corresponding to the alpha variant and the other to the beta variant, that together form a unique structure called a dimer, and that are accompanied by a component that increases the immune response.” This combination is able to provoke an immune response to one of the proteins of the SARS-CoV-2 virus, known as the spike-shaped S protein, which helps the virus enter human cells and destroy them.

This is the same method used by the Novavax and Sanofi/GSK vaccines, which are currently being reviewed by the European Medicines Agency (EMA) for possible authorization. Unlike these vaccines, however, Spain’s PHH-1V has proteins from two different variants, as it was modified to be more effective against new mutations of the coronavirus.

Ahead of the AEMPS’s green light, Toni Maneu, the head of Human Health at Hipra, said that the results of the pre-clinical trials (in laboratories and on animals) indicated that the PHH-1V vaccine was even effective against the more contagious delta strain, which is now dominant in Spain.


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