EMA starts review of Catalan vaccine against covid
Studies presented by Girona-based pharmaceutical company Hipra indicate it is effective against the virus, including the omicron variant
BrusselsThe European Medicines Agency (EMA) has announced this Tuesday that it has begun to study the pharmaceutical company Hipra's vaccine against the coronavirus. According to the EMA statement, the clinical studies submitted by the pharmaceutical company so far suggest that the drug may be effective against coronavirus and also against the omicron variant
The EMA review does not have a deadline, but it will evaluate the data as it becomes available to decide whether the benefits outweigh the risks. The review will continue until sufficient evidence is available to apply for a formal authorisation to market the vaccine.
Hipra's vaccine works differently from Pfizer's or Moderna's drugs, the most widely administered so far in Europe. In this case, the drug contains two proteins found on the surface of the SARS-CoV-2 virus (which causes covid) and which are precisely the proteins that the virus uses to enter the body's cells. When a person receives the Hipra vaccine, their immune system would have to identify the two proteins as alien elements and produce natural defenses (antibodies and T-cells against them). This would help prepare the bodies defences if it came into contact with SARS-CoV-2 at a later stage.
According to the EMA statement, this drug is intended to be used as a booster vaccine in people who have already received the full schedule with the vaccines which were already authorised (Pfizer, Moderna, AstraZeneca or Janssen).
Hipra, a company specialising in veterinary vaccination, started clinical trials with its drug in the summer of 2020, reached the second phase in 2021 and the final phase started in February this year. The vaccine has been tested on more than 3,000 people over 16 years of age, with the collaboration of up to seven Catalan hospitals. According to the pharmaceutical company, the Catalan vaccine provides "more antibodies than the Pfizer vaccine" and works also against the Omicron variant. When the third phase of the clinical trials began, the company expected to present data to the EMA in May, but in the end, by the end of March the European authority had already began the accelerated review that will allow it to be sold throughout the European Union.