Spain’s Hipra coronavirus vaccine enters the last phase of clinical trials

The Spanish Agency for Medicines and Health Products (Aemps) has authorised Spain’s Hipra vaccine against Covid-19 go ahead to the third and final stage of testing. If it passes this stage of the trials, it will be approved for marketing.

During this last phase, the "the safety and efficacy aspects of the drug are robustly verified," Aemps said in a statement on 1 February.

The trial will be carried out in 17 hospitals and will involve 3,000 volunteers over the age of 16 who must have received one or two doses of one of another authorised vaccines such as Pfizer, Moderna, AstraZeneca or Janssen, in the past three months. People who tested positive for Covid more than one month ago can also participate in the study. All volunteers, including those who took part in previous trails will be followed up on 12 months later.

According to the Minister of Science, Diana Morant, the vaccine produced “very satisfactory results” during earlier phases of the trial. “The results have been very good, it gives a great immunity response against Covid-19 and even presents good results against Omicron,” she said on 1 February.

Hipra's formula uses two recombinant proteins of a similar structure, one from the Alpha variant and the other from the Beta variant, which together form a single structure that bolsters the immune response,

Trials of Hipra began on 27 August 2021. According to the first set of results, the vaccine generates an immune response against one of the proteins of the SARS-CoV-2 virus. If and when it is approved by the European Medicines Agency (EMA), there are plans to produce up to 600 million vaccine doses during 2022 and up to 1.2 billion in 2023.