The Spanish vaccine against Covid is effective against subvariants BA.4 and BA.5 according to Hipra

The latest analyzes of the Covid-19 vaccine developed by Hipra show protection against subvariants of omicron, BA.2 and BA.4/BA.5causing the latest wave of infections of coronaviruses registered in the population.

In addition, it has been observed that, after 14 days from the administration of the vaccine as a booster dose in participants previously vaccinated with two doses of the Pfizer/BioNTech mRNA vaccinehay an increase in neutralizing antibodies against subvariants BA.2 and BA.4/BA.5 of omicron

Similarly, it has been found a increased neutralizing antibodies against BA.4/BA.5 14 days after receiving the Hipra vaccine booster in a subgroup of participants previously vaccinated with Moderna’s mRNA vaccine.

[España dobla la curva de la séptima ola Covid y aguarda a un nuevo pico de fallecidos]

In addition, in the results obtained in the recently published phase IIb trial, the Hipra vaccine, as a heterologous booster dose, elicits a strong neutralizing antibody response (more than 10-fold) against all the variants studied (Wuhan, Beta, Delta and Omicron (BA.1) at 14 and 98 days, these increases being statistically higher than those obtained with the booster dose with the Pfizer-BioNTech vaccine at 98 days against the beta, delta and omicron variants (BA.1), and at 14 days versus the beta and omicron variants (BA.1)).

These results indicate that the Hipra vaccine generates a more sustained neutralizing antibody response over time than the Pfizer-BioNTech mRNA vaccine, suggesting a “more durable and effective” protection against the new circulating variants.

Regarding the safety of the vaccine, during clinical trials the vaccine has been shown to have a “good safety and tolerability profile“since no “relevant” adverse effects have been detected in the study participants. Specifically, the most common adverse effects have been pain in the inoculation area, headache or fatigue that has not prevented them from developing their normal life and that have disappeared in the following days.

With the aim of expanding the data collected in clinical trials and, parallel to the process of continuous review (or ‘rolling review’) of the European Medicines Agency (EMA, for its acronym in English), the company plans to start an extension of the phase IIb study (‘HIPRA-HH-2’). The objective is to evaluate the safety and immunological response of a fourth booster dose with the Hipra vaccine.

A total of 200 volunteers from 10 hospitals in Spain. Of these participants, half will have previously received two doses of the Pfizer-BioNTech vaccine + one dose of the Hipra vaccine, and the other half will have received three doses of the Pfizer-BioNTech vaccine.

The study, scheduled for start in late summerwill begin once authorization is received from the Ethics Committee of the Hospital Clínic de Barcelona and the Spanish Agency for Medicines and Health Products (AEMPS).

“The Hipra vaccine fits with the current needs in Europe. With a percentage of the population close to 50 percent that has not yet received the booster dose, and thinking about the autumn vaccination campaigns, it is positive that the European population have vaccines from other alternative technologies to those of mRNA. The broad spectrum of protection against the variants that have appeared and its good safety profile make the Hipra vaccine an interesting solution for people who must be vaccinated in accordance with the recommendations of the health authorities,” the company has settled.

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