CAJICA, Colombia – The Russian vaccine candidate Sputnik V, developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology to prevent the SARS-CoV-2 virus that causes COVID-19, is undergoing phase III trials in Venezuela under complete secrecy. Little is known about the way the vaccine it is being tested or about any preliminary results.

"The Russian Federation has a universe of more than 40,000 people in the world in which it is applying this phase III, and Venezuela was chosen for the application of 2,000 people, who will be included in this trial in Venezuela that we will begin in the next days," said Carlos Alvarado, Venezuela’s minister of health, after a shipment of the vaccine arrived in the capital of Caracas on Oct. 2 aboard a Russian Air Force jet.

“For the first time in history, Venezuela is participating in phase III testing of a vaccine that will save humanity from the pandemic. Once all the stages have been completed, it will be applied in phases, from the most vulnerable to the entire population. It is historic!” tweeted President Nicolas Maduro. About 50 countries do not recognize Maduro as the legitimate president but Russia is not among them.

“Venezuela is the first country in Latin America to take part in foreign clinical trials of the Sputnik V vaccine,” said Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF). “Trials are already ongoing in Belarus with more of them planned in a number of other countries, including Brazil, India and the United Arab Emirates.”

The trials being done in Venezuela are double-blind, randomized and placebo-controlled, according to RDIF, with about 2,000 people taking part. But these trials are shrouded in secrecy and official registries of clinical trials do not show any information related to the Sputnik V vaccine.

“The information still does not appear on the page of the Ministry [of Health] or on the pages of the regulatory authority, which is the one that normally authorizes clinical research protocols; there is no information on how the vaccination program will be,” Ariadne Dhersy, a regulatory affairs professional with years of clinical trials experience in the country, told BioWorld. “The truth is that we don't know where they are carrying out the medical protocols. I don't think there are any.”

Dhersy´s concern is shared by many in the life sciences sector. A group of exiled Venezuelan physicians called Physicians United for Venezuela issued warnings about the trials as soon as the vaccine arrived in the country.

“We alert the population about the introduction of a batch of vaccines of Russian origin to prevent COVID-19 for which the protocol for its application is unknown,” the group said in its Twitter account. “The use of the vaccine has not been communicated to scientific societies nor have their opinions been solicited. Any protocol must have the informed consent of those selected explaining benefits and risks for health.”

The government made some official announcements suggesting school teachers that volunteer could be among the first to receive the vaccine as part of an effort to help classes restart as soon as possible, but there are multiple indications that the doses are ending up elsewhere.

“My son, Nicolás Ernesto Maduro Guerra, announced to me his decision to be vaccinated with the Russian vaccine, to join the test, the third and last of the Sputnik V clinical trials,” Maduro said on national television. “My older sister, María Teresa Maduro, an anesthesiologist, scientist and researcher, has also announced that she is joining and is going to get the Russian vaccine.”

And Maduro’s family takes part in the trials – or at least appear ready to participate – political allies from the region, such as former Honduras president Manuel Zelaya, are also flying to Caracas to get their shots.

“I volunteer to test the Russian vaccine,” said Zelaya, before traveling to Venezuela.

There don’t appear to be any clear guidelines about who will have access to Sputnik V at this point. Organizations like the National Center of Bioethic (CENABI) have also warned about irregularities surrounding the trials.

“These requirements, which are not being met, are based on respect for human dignity, the fundamental principles of bioethics (autonomy, beneficence, non-maleficence and justice) and the universal declaration of human rights…,” CENABI said in a press release on Oct. 15. “We urge the population to demand respect for their rights expressed herein, and we raise the complaint of this irregular situation to the national and international organizations that defend human rights.”

Chinese vaccines

Sputnik V is also about to enter phase III trials in Brazil, where 10 states are moving almost independently and in a different direction than the one taken at the federal level by President Jair Bolsonaro, who has chosen to partner with the University of Oxford.

And as the debate heats up in Venezuela around the lack of information of the Sputnik V clinical trials, Maduro already announced that more vaccines are set to arrive shortly to expand the trial, including one vaccine from China.

“In the next few days, the Chinese vaccine will arrive in Venezuela as part of its experimental trials,” he said, without disclosing which vaccine he was talking about. There are three different Chinese vaccines against SARS-CoV-2 in phase III trials.

“We do not know what will happen with the Russian vaccine, obviously with the Chinese vaccine either. They are not going through the official channels openly, as it was done in the past. There is no information available,” said Dhersy.

Maduro´s regime is subject to several international sanctions, including from the European Union and the U.S. Department of the Treasury. Maduro himself is wanted by U.S. authorities, which offered a reward in March of up to $15 million for information that could lead to his detention on drug trafficking charges.