By Alexis Bandrich Vega, Cuban Ambassador to Iran

Soberana 01 has been called the phase I-II clinical trial that will validate the efficacy of the Cuban vaccine candidate against COVID-19, which began to be applied to a group of volunteers on August 24.

The works are developed by the Finlay Vaccine Institute, which has more than 30 years of experience in vaccine development and a long history of cooperation with the Pasteur Institute of Iran.

Initially, work began with 20 volunteers from two population groups, between 19 and 59 years old and another from 60 to 80, to whom different doses of the drug are applied. The research cycle includes 28 days during which four blood samples are taken from the patients.

Another 20 Cubans recently joined the Soberana 01 tests. They are between 60 and 80 years old.

Numerous steps, all exquisitely organized and planned, have been taken as part of a necessary study to which all Cubans direct their gazes and wish it success in order to subsequently immunize the entire population against this new coronavirus.

The clinical trial is a study, it is an investigation that is done in volunteers and that has, this time, two phases.

The two groups in turn are randomly divided into three subgroups for the different doses of the research product or for the control product, which is the VA-MENGOC-BC vaccine.

The purpose of this research is to determine if the vaccine is safe so that it can be spread to a larger group of volunteer participants and then to the population.

It is a preventive vaccine, it is a single protocol that has this first phase where the safety of the product is measured.

By having Cuba platforms developed for other epidemics, specifically for meningitis in the 1980s, it has allowed it to obtain these relevant results.

In Cuba, the industrial strategy has been developed that allows the millions of doses necessary to protect the entire Cuban population once the investigations have been satisfactorily concluded, which is scheduled to be in February 2021.

The achievement of this vaccine is the result of the integrated work between the Finlay Vaccine Institute, the Molecular Immunology Center and the Chemical and Biomolecular Synthesis Laboratory of the University of Havana. It is the result of the heroic struggle of a people of women and men of science, as conceived by Commander in Chief Fidel Castro who, even under conditions of the longest and most unjust economic, commercial and financial blockade in the history of humanity, has managed to stand firm and unyielding, and ensure the health of all its citizens and that of millions of people in the world.

More than half a dozen drugmakers around the world are conducting advanced clinical trials, each with tens of thousands of participants, and several expect to know if their COVID-19 vaccines work and are safe by the end of this year.

Klaus Cichutek, head of the Paul Ehrlich Institut, told the Funke group of newspapers that data from Phase I and Phase II trials showed some vaccines triggered an immune response against the coronavirus.

“If data from Phase III trials shows the vaccines are effective and safe, the first vaccines could be approved at the beginning of the year, possibly with conditions attached,” he said, Reuters reported.

“Based on assurances from manufacturers, the first doses for people in Germany will be available at that time, in accordance with the priorities set by the Standing Committee on Vaccination,” Cichutek said, referring to the group that makes recommendations for the use of licensed vaccines in Germany.

Infections in Germany have risen in recent weeks and data from the Robert Koch Institute (RKI) for infectious diseases on Wednesday showed the number of confirmed coronavirus cases climbing by 1,510 to 226,914.

The RKI said 39% of cases were probably imported, with Kosovo, Turkey and Croatia most often reported as the likely source of infection in recent weeks.

Several companies, including Moderna, AstraZeneca, and Pfizer Inc, say they each expect to make more than 1 billion doses of a vaccine next year.

German biotechnology firm CureVac has not ruled out a speedy approval process for its prospective vaccine and expects to have it on the market by mid-2021.

Russia has said its vaccine will be rolled out by the end of this month.