MADRID – The first human clinical trials of a Spanish corona vaccine have now been approved by the Agency of Medicine and Medical Products (AEMPS). The vaccine has been developed by Hipra, a Spanish pharmaceutical company.
The initial phase will be aimed at testing safety, tolerance, immune response, and effectiveness. Initially, 30 people will be chosen between the ages of 18-30. Some of the trial candidates will have the new vaccine, while others will have a previously approved vaccine. All volunteers will not have been infected by the virus previously, nor will they have received any other approved vaccination.
Each person will be vaccinated and then given a second dose following a three-week gap. The volunteers will be monitored by an independent committee to check for any side effects or infections.
AEMPS anticipates this initial trial will take months to complete. Following this, a second trial involving a larger group of volunteers will begin.
Prime Minister Pedro Sanchez said in a tweet, “We take a big step in the fight against the pandemic. The AEMPS has authorised the first clinical trial in humans of a Spanish vaccine against COVID19. It is about the HIPRA vaccine, which has also had the collaboration of the Government to advance the project.”
Hoy damos un gran paso en la lucha contra la pandemia. La @AEMPSGOB ha autorizado el primer ensayo clínico en humanos de una vacuna española contra el #COVID19. Se trata de la vacuna de HIPRA, que ha contado también con la colaboración del Gobierno para avanzar en el proyecto. pic.twitter.com/UFBb1FErFj
— Pedro Sánchez (@sanchezcastejon) August 11, 2021
Based in Girona, Hipra, said it could produce up to 400 million doses of the vaccine in 2022. And 1.2 billion in 2023 if the trials are successful.
Effective against new mutations
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. Together they form a unique structure called a dimer. And that is accompanied by a component that increases the immune response.” This combination can 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. Currently, this is being reviewed by the European Medicines Agency (EMA) for possible authorisation. 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.
Second Spanish corona vaccine candidate
The decision to authorise 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 authorisation. 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.