Venezuela will begin to apply Cuban vaccine Abdala, without customary trials or regulatory approval

RIO DE JANEIRO, BRAZIL – Venezuelan president Nicolás Maduro said this Thursday that his regime intends to be able to start in July the immunization of the Venezuelan population with doses of Abdala, the Cuban vaccine against Covid-19 that has not been evaluated or authorized by international regulators and is still in the trial phase.

“We are working with the Chinese vaccine, with the Russian vaccine and we are starting now in April the experiments in Venezuela with the two Cuban vaccines, Soberana 2 and Abdala, with the idea that in July we will be massively vaccinating with Abdala”, said the Chavista leader.

“And we are looking for other interesting, safe, proven and scientifically approved vaccines by the Venezuelan health authorities as it should be,” he added.

Last Sunday, Maduro announced that Venezuela will receive the first week of April 60,000 doses of the Cuban vaccine projects Soberana 02 and Abdala, which the country will use to participate in the final phase of clinical trials of the potential inoculants.

In another televised speech, he informed that 30,000 units of each of these vaccines will arrive in the country to be applied in the third and final phase of trials, as occurred with the Russian Sputnik V, which chose Venezuela as the first country in America for its studies.

The decision has been widely criticized by Venezuelan health organizations. On Thursday, the Venezuelan National Center for Bioethics (CENABI) warned about the “great risks” faced by those who participate in the tests of the Cuban vaccines against the coronavirus.

Through a communiqué, it indicated that it supports the pronouncement of the National Academy of Medicine – issued on March 22nd – in which it questioned “the experimental application to our population, of the two ‘vaccine candidates’.

“The technological infrastructure of that country is currently obsolete and there is no reliable information on the results of test phases 1 and 2, which demonstrate the immunogenic capacity of the product. Phase 3, to which it is intended to involve our country, seeks to evaluate the efficacy and safety of the product and involves the administration of placebo (an inert substitute of the ‘vaccine candidate’) in about half of the people included in the study”, states CENABI.

The entity also affirmed that “the upturn that the Covid-19 disease is experiencing in a population in a complex humanitarian emergency does not allow for the testing of products that do not have a solid scientific basis, as is the case with these ‘vaccine candidates’, carvativir, chlorine dioxide and other products imposed by government authorities.”

The Academy of Medicine, meanwhile, indicated that “what little is known” comes from the Cuban regime itself and that the methodology used is “old” and “has not been tested in the case of COVID-19″.

Sovereign 02 and Abdala, said Maduro, are the vaccines of ALBA, a “bolivarian” trade group of countries created by the late Venezuelan President Hugo Chávez and which has as members Venezuela, Cuba, Nicaragua, Bolivia and several Caribbean countries.

“Abdala”, in charge of the state-owned Center for Genetic Engineering and Biotechnology (CIGB), received the approval of the Center for the State Control of Medicines, Equipment and Medical Devices of Cuba (CECMED) to start phase 3 tests, which will be carried out in the capitals of three eastern provinces of the island: Santiago, Guantánamo and Granma.

Cuba already has another potential vaccine in this final phase, “Soberana 02”, which earlier this month began to be administered in Havana to 44,010 volunteers from 19 to 80 years old and which will also be tested in Iran, where 100,000 doses of the formula have been sent.

In contrast, the regime reiterated on Wednesday that it will not allow the entry into the country of AstraZeneca’s vaccines – which have been approved by multiple regulatory agencies globally and are already being administered in numerous countries – whose arrival was arranged by opposition leader Juan Guaidó via the COVAX mechanism of the World Health Organization (WHO).

Delcy Rodríguez, Maduro’s vice president, insisted during a conference from the Miraflores Palace that “on March 15th we met with representatives of the Pan American Health Organization (PAHO) where we advised that Venezuela did not approve the use of the AstraZeneca vaccine.” “We do not need handouts,” he expressed.

Source: Infobae