The Spanish Agency of Medicine and Health Products (AEMPS) authorized on Wednesday 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 (the ability to provoke an immune response) 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.
From 400 million to 1.2 billion doses
The Spanish company Hipra, which is based in Amer in Girona province, reported that it would be able to produce 400 million doses of the PHH-1V vaccine throughout 2022. The vaccine does not need to be stored at ultra-cold temperatures, and can be kept at temperatures of between 2ºC and 8ºC, which makes storage and distribution easier.
If the results of the human trial are positive, the company forecasts that it will be able to begin production in October and deliver the first shipment of 75 million doses by the end of this year. If all goes to plan, Hipra expects that it will be able to deliver 400 million doses in 2022 and scale up to 1.2 billion in 2023.
Hipra specializes in animal immunology and has more than half a century of experience. But as the company explains on their website: “Viruses that affect animals and humans have great biological similarities, so our know-how and experience in epidemiology provide high added value.”
Hipra has more than 2,000 employees working across the world and 39 operating and distribution subsidiaries. The company also has two production plants, in Spain and Brazil, three Research and Development centers in these two countries as well as the United States and 11 diagnostic centers globally.
Other vaccine candidates from Spain
The decision to authorize the PHH-1V vaccine for human clinical trials comes two weeks after another vaccine candidate, developed by Spain’s research agency CSIC, was denied the same authorization. This team, led by virologist Mariano Esteban, had requested permission to begin a Phase 1 trial from the AEMPS, but the agency said it needed to see more data before it could give the green light. The team is now working to provide this information.
The Spanish Health Ministry and Science Ministry are also supporting a vaccine candidate, developed by researchers Luis Enjuanes and Isabel Sola. This candidate features a prototype of an RNA messenger and is currently being trialed on animals.
English version by Melissa Kitson.