None of the volunteers participating in the phase III clinical trials with the Cuban COVID-19 vaccine candidates has presented serious adverse effects, said the vice president of the Cuban Biotechnology and Pharmaceutical Industries Conglomerate (BioCubaFarma), Eulogio Pimentel this Thursday.
After the start of the second stage of the process this Monday, more than 1,200 subjects in Havana received the second dose of Soberana 02, while another 4,000 were injected with Abdala in the provinces of Santiago de Cuba, Granma and Guantánamo, the executive explained in an appearance on Cuban television.
⚫️🇨🇺|| El vicepresidente de @BioCubaFarma, Eulogio Pimentel, afirmó que los ensayos clínicos fase III con los candidatos vacunales💉 antiCovid-19 de #Cuba, ‘Soberana 02’ y ‘Abdala’, marchan bien y sin eventos adversos graves. Ver más👉https://t.co/D6lgkKfZDJ#CubaPorLaVida pic.twitter.com/ntxACIh6uL
— Radio Habana Cuba (@RadioHabanaCuba) April 8, 2021
Pimentel said the clinical trials “are going well,” and affirmed that the drugs against the coronavirus produced on the island have demonstrated safety.
Likewise, the deputy head of BioCubaFarma, quoted by Cubadebate, clarified that “the first injection with any vaccine candidate does not generate the necessary protection against COVID-19,” which is why he asked to continue applying personal protection measures against contagions. He stressed that to prove that someone is fully immunized and does not transmit the virus, it is necessary to wait until the entire vaccination scheme is completed.
Regarding the design of the trial using the double-blind method with placebo, he stated that, once the study is finished, the codes of the volunteers are opened and it is verified if the highest percentage of those who became ill or transitioned to serious forms of the disease are those vaccinated or placebos.
“It is possible to indicate the efficacy of a vaccine if the highest number of infected coincides with those who received the placebo,” said Pimentel.
Designed by the state-run Finlay Vaccine Institute, Soberana 02 is going through the third phase of clinical trials in Havana with a sample of 44,010 people.
For its part, Abdala, from the Center for Genetic Engineering and Biotechnology (CIGB), is being administered to 48,000 volunteers from the eastern provinces of Santiago de Cuba, Granma and Guantánamo during this stage of the study. At the same time, controlled interventions are being carried out with both drugs in vulnerable populations, which include volunteers from the health sector.
In addition, the deputy director general of health in Havana, Dr. Nilda Roca, announced this week that at the end of April another intervention study will begin with Soberana 02 and Abdala, in which 1.6 million volunteers from the Cuban capital will participate.
The study will include the seven Havana municipalities not included in the phase III clinical trial, where 812,600 volunteers, over 18 years of age, must be recruited to receive the necessary doses of one of these two drugs developed on the island against the coronavirus.
Another 842,300 volunteers will be vaccinated in the eight municipalities of the capital where the study with Soberana 02 is currently being carried out, and the goal is to administer the drug to an average of 100 people every day per doctor’s office.