The latest analyzes of the Covid-19 vaccine developed by Hipra show a protection against Ómicron, BA.2 and BA.4/BA.5 subvariantscausing the latest recorded coronavirus infections in the population.
Moreover, it was observed that after 14 days from the administration of the booster vaccine In participants previously vaccinated with two doses of the Pfizer/BioNTech mRNA vaccine, there is an increase in neutralizing antibodies against Omicron subvariants BA.2 and BA.4/BA.5.
Antibodies more powerful than the Pfizer vaccine
Likewise, it was found a increase in neutralizing antibodies against BA.4/BA.5 14 days later to receive the Hipra vaccine booster in a subset of participants previously vaccinated with Moderna’s messenger RNA vaccine.
Moreover, in the results obtained in the phase IIb trial recently published, the Hipra vaccine, in a heterologous booster dose, gives rise to a powerful neutralizing antibody response (multiplied by more than 10) against all the variants studied (Wuhan, Beta, Delta and Ómicron (BA.1) at 14 and 98 days, these increases being statistically greater than those obtained with the booster dose with the Pfizer-BioNTech vaccine at 98 days against the beta, delta and omicron (BA.1) variants, and at 14 days against 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 “longer and more effective” protection against new circulating variants.
Regarding the safety of the vaccine, in clinical trials the vaccine has been shown to have a “good safety and tolerability profile” since no “relevant” adverse effects were detected in study participants. Specifically, the most common side effects were pain in the inoculation area, headache or fatigue that did not prevent them from developing their normal life at all times and disappeared in the following days .
In an effort to expand the data collected in clinical trials and, alongside the rolling review process of the European Medicines Agency (EMA), the company plans to launch a extension of the phase IIb study (“HIPRA-HH-2”). The objective is to assess the safety and immunological response of a fourth booster dose with the Hipra vaccine.
This will be the trial with more than 200 volunteers in Spain
A total of 200 volunteers from 10 hospitals in Spain. Among 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, which is scheduled to start at the end of the summerwill begin once authorization has been received from the Ethics Committee of the Hospital Clínic de Barcelona and the Spanish Agency for Medicines and Health Products (AEMPS).
“The Hippra vaccine corresponds to current needs in Europe. With a percentage of the population close to 50% who have not yet received the booster dose, and thinking of the autumn vaccination campaigns, it is positive that the European population has vaccines with other alternative technologies to those of mRNA. The broad spectrum of protection against the variants that have emerged and its good safety profile make the Hipra vaccine an attractive solution for people who need to be vaccinated in accordance with the recommendations of health authorities,” the company said.