Vaccine was declared word of 2021, but before certifying them, these products go through clinical trials which set the pace of research and are processes that celebrate their World Day today.

The arrival of the Covid-19 pandemic in 2020 put a pause on many events, but it streamlined and resized the times of these studies that, as the director of the Finlay Institute of Vaccines of Cuba, Vicente Vérez, would say in an interview with Prensa Latina, they had to be done in “mouse times”.

It was this disease that pushed research at record speeds and drug trials to treat it and vaccines, in order to prevent it or prevent patients from reaching serious and critical stages, experienced unprecedented changes in history.

In Cuba alone, with respect to Covid-19, from March 2020 to April 20, 2021, the country’s highest health directorate approved 28 clinical trials to prevent and treat this disease, four of which ended in 2020.

In exclusive statements to Prensa Latina, directors of the National Coordinating Center for Clinical Trials (Cencec) indicated that until the end of 2021 the entity had participated in 130 clinical trials in the country, in any of its stages.

Of that figure, 43 were intended for cancer treatment and 42 related to Covid-19, from vaccines to innovative drugs such as Nimotizumab, Jusvinza, Biomodulin T and Hyperimmune Gamma.

When speaking with the deputy director of Clinical Trials at Cencec, the Master of Science Mayté Amoroto said that this entity plans to carry out another 62 national and international clinical trials by 2022.

Cuba achieved three of its own vaccines approved for use in emergencies against Covid-19 (Soberana 02, Soberana Plus and Abdala) and two candidates in development (Soberana 02 and Mambisa), the last one is among the 11 in the world designed with forms of nasal application.

In fact, Abdala became the first in Latin America to obtain this approval.

Although more than 89 percent of all Cubans already have a complete immunization schedule and some seven million also have the anti-Covid-19 booster, the Caribbean nation does not stop trials in this branch. Scientists dedicated to activities to combat the pandemic recently presented the design of new clinical trials and other actions that are being evaluated today as part of the vaccination strategy.

It is a study called Pequeñuelo, planned to be phase I/II, whose promoter is the Center for Genetic Engineering and Biotechnology (CIGB) with the Abdala vaccine, and will be carried out in Havana in infants from 6 to 11 months of age, in order to assess the safety and immunogenicity of that vaccine.

The other test proposed to the Center for the State Control of Medicines, Equipment and Medical Devices (Cecmed), the regulatory authority of the Caribbean nation, is Sovereign Chiquitines in charge of the Finlay Institute of Vaccines and will take place in the Cuban capital and in the city of Cienfuegos.

The head of the Provincial Vaccination Program of the central province of Cienfuegos, pointed out that everything has been organized and the vaccines are in each of the polyclinics and 114,434 children under two years of age will be the subjects of these trials.

A clinical trial is a research methodology that is carried out with the participation of human beings as volunteers, to evaluate the effect of an intervention of drugs, equipment or medical devices on a specific health problem.

This is reached once the preclinical studies (pharmacology and toxicology) in cells and then in laboratory animals, those of formulation and stability of the pharmaceutical product, have been completed, based on the established regulations.

Every May 20, since 2005, scientists around the world celebrate International Clinical Trial Day, with the aim of making the public aware of what the scientific work behind a vaccine or drug for a specific disease consists of.

The date commemorates the first clinical trial in history, carried out by the Scottish doctor James Lind in 1747, who laid the foundations for clinical research by trying to identify the absence of vitamin C as a cause of scurvy that affected sailors of the British Army.