First human trial of a Spanish vaccine against Covid-19 authorised

Latest: Coronavirus in Spain figures (20 Aug)

The Spanish Agency for Medicines and Health Products (AEMPS) this week authorised the first human clinical trial of a Spanish vaccine against Covid-19. It has been developed by the Spanish pharmaceutical company, HIPRA, based in Amer, near Girona (Catalonia).

The Phase I trial will be a ‘randomised, controlled and blinded trial’ – meaning that it will be administered to hospital volunteeers in a way that prevents its identification by both the patient and the research team.

Several dozen volunteers aged between 18-39 will be recruited from hospitals as soon as possible, and two doses of the vaccine will be injected 21 days apart in order to first analyse the safety and tolerability of the vaccine as well as its effectiveness.

The vaccine is based on two structurally similar ‘recombinant proteins’, one corresponding to the alpha variant and the other corresponding to the beta variant, which are joined together to form a unique structure called a ‘dimer’, and which are accompanied by an ‘adjuvant that enhances the immune response’. This combination is able to generate an immune response against ‘one of the SARS-CoV-2 virus proteins, known as the S (spike) protein’.

This platform is the same as that used for the Novavax and Sanofi/GSK vaccines, which are already under evaluation for potential licensing by the European Medicines Agency (EMA), but unlike them, it expresses proteins from two different variants.

The Phase I trial will divide the volunteers into groups and will increase the dose that each group will receive depending on the response it generates in the first dose.

HIPRA believes the clinical study will begin during August at the Hospital Clínic in Barcelona and the Trueta Hospital in Girona.

Prime Minister Pedro Sánchez and Health Minister Carolina Darias on a visit to HIPRA in Amer (Girona) in April. (Pool Moncloa / HIPRA)

Close monitoring of all volunteers and identification of all cases of adverse effects and Covid infection as they occur will be carried out throughout the trial. This will allow preliminary analyses to be carried out with intermediate data that will allow further research to be performed. However, it will be necessary to wait until the clinical trial is completed before all the data can be analysed and final conclusions drawn.

These clinical trials are part of the requirements for all vaccines to demonstrate their quality, safety and efficacy. Only after they have been evaluated and meet regulatory standards will they be authorised for use.

HIPRA has said it would be able to produce 400 million doses of its 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, making storage and distribution easier.

If the results of the human trial are positive, HIPRA hopes to start production in October and deliver the first shipment of 75 million doses by the end of this year. After delivering 400 million doses in 2022, it hopes to increase to 1.2 billion in 2023.

‘Unsurprisingly, Spain has invested more than 13 million euros in transfers and almost 6 million euros in credits to collaborate with science in developing new vaccines in Spain,’ said Prime Minister Pedro Sánchez, welcoming the news of the authorisation for human trials. Sánchez visited the pharmaceutical company’s facilities in April this year.

Latest figures (up to 13 Aug) show that Spain has administered 60,919,867 jabs of Covid-19 vaccines. 34,455,543 people have now received at least one jab, representing 72.6% of the total population. 29,526,380 people have now been fully vaccinated, which is 62.2% of the total population. In a separate report, we publish the amount of vaccines administered for each region and its population in Spain, as well as the overall percentage of citizens vaccinated per age group: Covid-19 Vaccinations in Spain