• Health The 'failure' of childhood vaccination against Covid-19
  • Covid-19 The European Medicines Agency begins the evaluation of the Spanish Hipra vaccine

The European Medicines Agency (EMA) has announced the marketing approval of Bimervax, the anti-covid vaccine from the Spanish company Hipra, whose evaluation began last week. The recommendation is as a booster dose starting at age 16 in people who have previously had an mRNA-based vaccine.

On August 2, the European Commission announced the signing of a contract for the acquisition in autumn of 250 million doses of the COVID-19 vaccine developed by Hipra. Also by autumn, former minister Carolina Darias hoped to have this vaccine, as announced in July during a visit to the Marqués de Valdecilla University Hospital in Santander.

In August 2022, ten Spanish hospitals participated in a clinical trial to study their vaccine against covid-19 as a fourth dose.

At the end of March 2022, the EMA announced that it was starting the evaluation of the vaccine. According to the European body, the decision to start the evaluation is due to the preliminary data obtained in the clinical and laboratory studies. The company had then begun phase III of the investigation.

Bimervax is a recombinant protein vaccine, a technology used in biomedicine and of which there is a lot of experience in vaccines widely used in the population (influenza, hepatitis A or papilloma, among others). According to company sources, the vaccine is ready for administration and does not need to be recomposed. It also highlights its versatility, since its technological platform has a high capacity to adapt to future variants, and can be kept between 2 and 8 ºC, which facilitates its logistics and distribution.

Production of the antigen it uses started in January 2022 in order to have the necessary doses available as soon as marketing is authorised. Already in October 2021, Elia Torroella, pharmacist and director of R+D and Records of the company, explained to this newspaper – shortly after Pedro Sánchez's visit to his headquarters facilities in Amer (Girona) – that "a frozen vaccine has more handicaps than one that is kept in a refrigerator".

Given the perspectives that were created from the Executive of Pedro Sánchez, the vaccine will not be used for primary vaccination, that is, doses in previously unvaccinated people. José Gómez Rial, immunologist at the University Clinical Hospital of Santiago, in statements to SMC, points out that "I am sorry to cool down a little the expectations that have been created with Hipra and the statements of the minister in this regard. First, it has yet to prove that it is a better vaccine than existing ones; there is not enough evidence to say so. Second, Hipra employs a technology (recombinant protein) that does not allow rapid adaptation to changes in the virus. In this sense, mRNA technology is always more flexible and faster, and it is precisely one of the advantages of mRNA technology with respect to those existing until now."

"I am convinced that very good results will be obtained with it. This vaccine, which uses a different platform, should especially be indicated for those people who have not responded efficiently to the initial regimen with an mRNA vaccine and, therefore, take advantage of a heterologous combination, which has shown such good results so far, "concludes Gómez Rial.

According to The Trust Project criteria

Learn more

  • Covid 19
  • Vaccines