Cuba on Monday began a new phase of clinical trials for Soberana 02, the most advanced of the four candidates for a vaccine against covid-19, which is being developed in cooperation with Iran by the island’s Finlay Vaccine Institute (IFV).
In the “Phase II b” study, which will be used to assess the immune response, safety and “reactogenicity” of the medicine, the doses will be applied to about 900 volunteers aged 19 to 80 years for three weeks in two centers. medical in Havana. reported health authorities in the Caribbean.
The inoculations, which consist of two doses, will be performed randomly and blindly, comparing the results of the vaccine candidate with those of placebo, explained epidemiologist María Eugenia Toledo, from the Pedro Kourí State Institute, on the official Cubadebate website.
This stage will be followed by Phase III, which, according to the epidemiologist, “will reach a larger population, approximately 150,000 people, in places and in very high risk groups to benefit and evaluate the clinical efficacy of this candidate. ”.
Cuba signed an agreement with the Pasteur Institute of Iran on the 9th to work together in the clinical trials of “Soberana 02”. If Phase II is successfully completed, Phase III of the study will take place in that country, where the prevalence of the virus is three times higher than in Cuba.
To date, the first preclinical and clinical phases of this formula have been successfully completed, with a total of 140 Cubans without side effects.
“Sovereign 02”, a conjugate vaccine that combines virus antigen and tetanus toxoid, has been tested since October 19.
Along with this project, the Caribbean country has three other candidates in the previous research phases: “Soberana 01”, also responsible for IFV, “Abdala” (intramuscular) and “Mambisa” (intranasal), the last two from Centro de Ingineria genetics and biotechnology (CIGB) in the Caribbean.
Cuba, which has accumulated 18,443 positives since the beginning of the coronavirus epidemic and 173 deaths, has a recognized biotechnology and pharmaceutical industry that currently produces eight vaccines against diseases such as meningitis, lung cancer (therapeutic) and solid tumors, among others. .
Authorities have said they hope to vaccinate a “significant part” of the Cuban population against covid-19 before the end of the first half of 2021.
The country is going through the worst wave of infections so far and so far has shown no signs of importing any of the vaccines already approved and used in other countries, including those in the laboratories of Pfizer, Moderna, Sinovac, AstraZeneca. or Russian “Sputnik V”.