The hipra labs expect to market next June the first spanish vaccine against him covid once they complete the last phase of the study, which began on February 1.
The director of the company’s Human Health division, Carles Fabregahas advanced to EFE that the forecast is to send all the information on the first Spanish vaccine to the European Medicines Agency in April, to receive a response in May or at the beginning of June, so the marketing deadline for the second quarter given in January by the Minister of Science, Diana Morant.
Two weeks to manufacture the vaccine
Once the green light from Europe arrives, Hipra will enter the industrial manufacturing phase of the vaccine, which would last just over two weeks, after months of preparing the antigen.
The investigation is currently in phase III, the last one before presenting the documentation, which evaluates “safety and tolerability”, according to Carles Fàbrega.
In the laboratories of Hipra work some 3,000 volunteers and the work carried out in different hospitals in Spain with some 2,500 has already been completed. On the other hand, in Portugal and Italy, where they are also collaborating with the investigation, they have not yet finished supplying their doses.
Carles Fàbrega has underlined that the results for the moment are going “well” and that the summary of the data that is being obtained is “very positive”.
Stronger dose than Pfizer’s
So much so that, in clinical phase IIb, the booster dose of Hipra generates a most powerful response against variants that mRNA vaccineas is the case of Pfizer.
The data leaves the Spanish experts “calm” “in terms of safety and efficacy”, with numbers that demonstrate the superiority of their vaccine.
Thus, among people who received Pfizer as a booster, the amount of neutralizing antibodies against covid multiplied by 67 fourteen days after their injection, while it did so by 147 in the case of the Hipra dose.
In this line, Fábrega has highlighted the “versatility and broad spectrum of protection” of the vaccine, with an evident superiority in previous studies when compared to Pfizer against variants beta and omicron.
This is the Hipra vaccine
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The Spanish Hipra vaccine is based on two proteins structurally similar recombinants, one corresponding to the alpha variant and the other to the beta variant, which come together to form a single structure called dimer and that it is accompanied by an adjuvant that increases the immune response.
This combination is capable of generating a response against one of the proteins of the SARS-CoV-2 virus, known as protein S (‘s’ for spike, called spike protein in Spanish).