Cuban Sovereign 02 vaccine ended phase 3 of e …

The Sovereign 02 coronavirus vaccine, one of those developed by Cuba, The last phase of clinical trials ended on Wednesday, at the end of the vaccination schedule in all volunteers who participated in the test. With the Abdala vaccine – which has already completed its phase 3 at the beginning of May – Sovereign 02 is one of the two most advanced formulas of the five that the island is developing against covid-19. If these studies show its effectiveness they would become the first vaccines developed in Latin America.

Confirmation of efficacy would also allow the island’s health authorities to obtain emergency use authorization or pharmacological registration, which they hope to achieve in June.

These authorizations would make it possible to start mass vaccination in the Caribbean country, which is going through the worst moment of the pandemic, with a third wave of infections which for weeks has not fallen below a thousand cases per day despite the restriction measures in force.

The Cuban government plans to have its entire population vaccinated before the end of the year.

Test phase

In this third stage of trials, carried out in Havana in double blind and with a placebo group, the experimental vaccine was administered to 44,010 volunteers aged 19 to 80 years with two vaccination schedules: one with two doses of Soberana 02 and another with two doses of Soberana 02 and a booster of Soberana Plus, another of the formulas under study.

Sovereign 02 is a subunit conjugate vaccine – traditionally very safe – which combines viral antigen and tetanus toxoid, and it also uses aluminum hydroxide to stimulate the immune system response. Its development has been entrusted to the National Institute of Vaccines Finlay (IFV).

The director of clinical research at IFV, Meiby Rodríguez, explained that once all the doses have been administered begins to monitor volunteers for possible infections “as part of the evaluation of the efficacy variable, essential for the registration of the vaccine”.

Comparing the number of infections that occur between those who received the vaccine candidate and those who received the placebo is the data that will reveal the percentage of effectiveness of the formula.

Preliminary data

Rodríguez said they were already able to verify that those who received a placebo in the first two phases of clinical trials “were twice as likely to get sick than those who were vaccinated,” the agency reported. Cuban press.

According to preliminary data from these steps, 76% of volunteers increased the concentration of specific antibodies against the SARS-CoV-2 virus after receiving two doses of Soberana 02, a percentage that climbs to “around 90 percent” in the case of those who received the extra dose of Soberana Plus, the scientist said.

Cuba too sent 100,000 doses of this vaccine to Iran for a phase 3 study there, the results of which have not yet been published.

The other more advanced formula, called Abdala and developed by the Center for Genetic Engineering and Biotechnology (CIGB), ended phase 3 of clinical trials on May 1 with the participation of 48,000 volunteers from the capitals of the eastern provinces of Santiago. of Cuba, Guantanamo. and Granma.

Own vaccines

In parallel with traditional clinical trials, the health authorities have launched in Havana and in the eastern part of the island, the areas with the highest contagion rate, a massive health intervention study with Soberana 02 and Abdala.

The formulas They have already been inoculated to health workers and at risk, and it is planned to administer them to 1.7 of the 2.2 million inhabitants of the capital.

Cuban scientific institutions, which have long experience and proven results in the biotechnology sector, are also working on two other formulas: Soberana 01 (intramuscular) and Mambisa (intranasal), which are in the previous stages of evaluation.

Cuba does not integrate the Covax mechanism created by the World Health Organization for low- and middle-income countries to access vaccines, nor has it purchased vaccines on the international market.

Since the start of the pandemic and to date, the island has accumulated 136,628 positives for the coronavirus and 912 deaths.