Scientists and researchers from the Center for Genetic Engineering and Biotechnology (CIGB) expanded the information on the efficacy data of the Abdala vaccine, in its phase III clinical trial, of which it was already known that it showed a 92.28 % efficacy against symptomatic disease.
At the meeting it was announced that Abdala – an immunogen that recently obtained its authorization for emergency use by the Cuban regulatory authority – in its phase III trial showed 100% efficacy in preventing systemic disease severe and 100 % for the prevention of death in the vaccinated group.
“The clinical efficacy data from the phase III trial of Abdala are already available with excellent results, and at this moment it is being scaled to an effectiveness study with more than 300,000 people; But complying with the indicated sanitary measures is still vital. Vaccines need us”, she pointed out to Cubadebate Dr. Marta Ayala Ávila, director of CIGB.
Dr. Francisco Hernández, main monitor of Abdala’s phase one I / II and III clinical studies, pointed out that the phase III trial followed a randomized, double-blind, placebo-controlled design, and in which more than 48 participated 000 volunteers, from 18 clinical sites in Santiago de Cuba, Guantánamo and Bayamo.
This trial showed that the Abdala vaccine, in its three-dose schedule, is 92.28 % effective in preventing symptomatic disease caused by SARS-CoV-2.
For this efficacy study, he said, 153 patients debuted, of them 142 placebos and 11 who received the vaccine, and in all cases were SARS-CoV-2 PCR-positive patients, in which there was no previous exposure to viral infection, which was corroborated by determining total antibodies to SARS-CoV-2 at the beginning of the investigation.
He added that they were subjects who developed symptoms and signs of the disease from 14 days after inoculation of the third dose of the research product, which could be the vaccine or could be placebo.
“At this time, and as part of other efficacy analyzes, we can report that the Abdala vaccine shows 100% efficacy in preventing severe systemic disease. It should be understood that these types of patients present a torpid evolution of the disease, that they develop complications, generally require invasive mechanical ventilation and, unfortunately, in some of them there is a fatal outcome. In the efficacy study carried out no patient vaccinated with Abdala evolved into this severe systemic disease”, he said.
Likewise, in the patients vaccinated with Abdala within the trial, a 100% efficacy in the prevention of death was evidenced, he pointed out.
Vaccines need us
Ayala Ávila insisted that in the vaccination process, in the case of Abdala specifically with a scheme of three doses spaced 14 days apart, it is vital to adhere to the vaccination protocol, that is, to receive all three vaccine dose.
On the other hand, he said, knowing that not only completing this scheme is an essential requirement for, in case we are SARS-CoV-2 positive, not to go to severe stages of the disease.
He reiterated that efficacy has been evaluated 14 days or more, after the last dose of the vaccine was administered. “After receiving this last dose, your immune system expresses itself , according to the analyzes carried out, 14 days or later, so you have to be vaccinated and after this time we will have the antibodies so in the event that we face the virus, we are in better conditions not to get sick and not go to stages severe or critical of the disease, “explained the scientist.
“We have not said at any time that vaccination prevents contagion, we have said that if you are vaccinated and are infected, you will have the disease of a slight way. But the responsibility to prevent each one individually the possibility of contagion is the best vaccine, because this way we are taking care of ourselves and we are taking care of our relatives, friends, and we expose less those vulnerable to suffering from the disease “, commented Ayala Ávila.
She insisted that the vaccine is part of a set of measures that from the individual, family, work and country, we have to bear in mind, such as distancing, the use of means of protection, hygiene. “Given this epidemic peak, we are vaccinating in different territories of the country. Already in Havana, the vaccination process has been completed in a group of municipalities and work is under way in another three. By the end of July, the entire capital should have received its three doses”, she said.
In this sense, the expert added that a study to measure the effectiveness of the vaccine is already planned. She explained that although efficacy is measured in clinical study settings with ideal research conditions, effectiveness refers to evaluation in real life, that is, how the vaccine behaves after a large number of individuals are immunized. where there are no control groups but refers to those not vaccinated for certain reasons.
“We insist that the good results that we are sharing with all Cubans are also part of the results that Cubans themselves can obtain, with discipline, individual responsibility. We have already demonstrated that our vaccines are effective, let us also demonstrate that they are effective ”, she pointed out.