Hipra begins to test its vaccine against covid in people

The clinical trial to evaluate the validity of Hipra's COVID vaccine continues to advance. The Catalan pharmaceutical company, located in Amer (Girona), has become the first in all of Spain to test its solution against the coronavirus in humans, a key step for its future commercialization. It does so after having obtained the green light from the Spanish Agency of Medicines and Medical Devices (AEMPS) at the beginning of August.

Half a thousand people have come forward to participate in the trial of the first Spanish vaccine, an exceptional response, according to the study's principal investigator and specialist in the Infectious Diseases Service of Hospital Clínic, Lorna Leal. The medical teams have selected a total of 30 volunteers for this first phase of the study. To participate, they had to meet requirements such as being healthy and not having been previously infected with SARS-CoV-2 or having received any other COVID vaccine. During this week, the first six volunteers have already received the first dose at Hospital Clínic de Barcelona and Josep Trueta de Girona. The rest will receive it in the coming days.

This phase of the study aims to determine the safety of Hipra's vaccine, PHH-1V, and its efficacy against the coronavirus. It also needs to determine its optimal dose, which will be the one that generates the most immunity. To do this, the trial participants have been randomly divided into three groups. The first receives the lowest dose, which is scaled up in the second and third. Within a period of 21 days, all volunteers will receive the second dose. As the control vaccine for the study, Pfizer's has been chosen, which is also administered 21 days later. Neither the volunteers nor the doctors know which one has been administered in each case.

The clinical teams will monitor adverse reactions and infections that participants may have at all times. All of them have been recommended to avoid risky situations to prevent contagion during the process. The trial will last one year, a period during which volunteers will be monitored, with post-vaccination and follow-up visits. When the trial ends, all the information obtained will be analyzed and final conclusions will be drawn, but in the next three months, the first data on the vaccine's validity will begin to be available.

Hipra's vaccine is based on two recombinant proteins from the alpha (British) and beta (South African) variants. For Leal, this mechanism offers advantages over other already commercialized vaccines, thanks to its greater adaptation to future variants. In fact, this system is similar to the one used for Novavax and Sanofi/GSK vaccines, but, unlike Hipra's, they are based on the original variant (the Chinese one). Another of its virtues is that it can be stored between 2 and 8 degrees, a temperature that facilitates logistics compared to current options.

If all necessary procedures for its validation are overcome, the Catalan pharmaceutical company, historically specialized in animal health, plans to produce between 600 and 900 million doses in 2022. Manufacturing would begin this October and, once European approval is obtained, it would be commercialized during the first half of next year.