A volunteer receives a dose of the Hipra vaccine. / EFE

Spain’s Hipra coronavirus vaccine is one step away from obtaining authorisation for its marketing in the EU

The European Medicines Agency begins a new phase of evaluation based on preliminary results that show a better immune response of this injection compared to that of Pfizer

RAQUEL MERINO

The Spanish vaccine against Covid-19, developed by the pharmaceutical company Hipra, is one step away from obtaining authorisation for its release on the market if it passes the evaluation launched by the European Medicines Agency (EMA).

The EMA’s Committee for Medicinal Products for Human Use is going to study the vaccine as a booster dose for those people who have received the full schedule with a different vaccine. It will do so through a rapid process known as a 'rolling review', whereby data is evaluated as it is generated. According to the Spanish Agency for Medicines and Health Products (Aemps), this is the preliminary step for a medicine to obtain marketing authorisation in the European Union.

The evaluation will be carried out based on the preliminary results of the manufacturing data, preclinical experimentation and clinical trials in adults of the Hipra vaccine, which show an adequate safety profile and indicate a better immune response generated for this as a booster dose against the Beta and Omicron variants in comparison with the Comirnaty vaccine from Pfizer.

Although the European Medicines Agency hasn’t given a timescale, it has suggested that if Hipra submits an application for marketing authorisation for its vaccine, "the decision will take less time than normal due to the work carried out during the rolling review."

The vaccine developed by the Hipra laboratory received the approval of Spain’s Aemps for the phase III clinical trial on 1 February as a booster dose for people with the complete regimen with a different vaccine, after the results obtained in the previous trials demonstrated a good safety profile and adequate efficacy.

On 11 March, Aemps also authorised a second phase IIb clinical trial to observe how it acts against Omicron in volunteers who have received two doses of Vaxzevria (AstraZeneca) and a Hipra booster, compared to those who have been vaccinated with two dose of Vaxzevria and Comirnaty. In the previous phase IIb trial, authorised on 15 November, the study was carried out with volunteers who had been administered Comirnaty.

Characteristics of the Hipra vaccine

Unlike the messenger RNA vaccines from Pfizer and Moderna, Hipra is based on two recombinant proteins capable of generating a response against one of the proteins of the SARS-CoV-2 virus known as protein S (spike). This type of vaccine is designed to protect against new strains of the coronavirus by allowing “small changes quickly” to make adaptations in a short period time.

Another of Hipra's advantages is that it does not require subzero temperatures to be stored, and doses can be kept between 2 and 8C, which facilitates storage and distribution.

Pending its authorisation, once all phases of clinical trials are completed, the company has already announced that it has the capacity to manufacture between 600 and 900 million doses a year. The most optimistic forecasts suggest that it could be available by the second half of this year.