[News] The vaccines being tested by Chile: The schedule of the three trials that are underway

[S e u o n g]

President Piñera announced on Wednesday that he hopes to begin the inoculation plan during the first months of 2021. Meanwhile, Janssen, Sinovac and Oxford are analyzing their formulas in Chilean volunteers.

 

The data, seven months after the hit of the toughest pandemic in modern society in memory, seem encouraging. In Chile and the rest of the world, expectations are swirling around the possibility that, sooner rather than later, the use of a vaccine that can stop the spread of the virus will be approved. The data, in fact, seem so encouraging that the authorities have clarified that it is not necessary to trust. "We are not going to lower our guard, nor our arms, nor are we going to fall into any reckless sense of false confidence," President Sebastián Piñera himself said this Wednesday. And the fact is that the plan that he unveiled is, indeed, promising: he hopes to start vaccinating 5 million people at risk from the first months of 2021. Then, he plans to "reach 14 million people" during the first semester of next year.

 

For that, explained the Minister of Science, Andrés Couve, the Government works in two parallel tracks: the clinical trials that have already begun in the national territory and the commercial agreements so that, when the vaccines are approved by regulatory bodies, "Chile has the option of being able to acquire them and supply them to the national po[CENSORED]tion ". "We must not forget what the President said," emphasized Health Minister Enrique Paris. "We are not claiming victory, as some have said, quite the contrary: we are calling for us to continue with our arms up," he said. The minister also thanked the public, private and academic ecosystem that carries out clinical trials, a gear that tests the formulas developed abroad, in which their own creators place high expectations. On Wednesday, the chief investigator of the Oxford vaccine trial, Andrew Pollard, told British lawmakers that he is "optimistic" and thinks they could get approval for his product "before the end of this year." In the meantime, some Chileans are already beginning to circulate through the national territory with the doses in the body or with the corresponding placebo. The schedule of each current or authorized test in the country, its dimensions, associated centers and expectations, below.

 

The first vaccinated by Janssen

On October 31 The University of Chile obtained the registration and authorization to begin the trial of the vaccine from Janssen, a Johnson & Johnson pharmacist, in Chilean volunteers. "We have already started the enrollment," explained one of the main researchers of the project, Dr. Miguel O'Ryan, academic at the Institute of Biomedical Sciences of the School of Medicine of the campus.

 

So far, ten volunteers have been inoculated. "We are, at the moment, working. While I am here, there are three teams of researchers in each of the sites, with more than ten people among doctors, vaccinators, nurses, who are recruiting volunteers. We hope to meet the goal.The trial was carried out in three hospitals in the Metropolitan Region: the Family Health Centers (Cesfam) of Colina and San Bernardo, and at the Exequiel González Cortés Hospital. The prototype will also be applied at the Center for Clinical Studies and Medical Research (Cecim), at a center in Temuco, another in Viña del Mar and at the Center for Integral Medicine and Clinical Research in Talca. The vaccination will be extended in a period of between 45 and 60 days, where health personnel and also the community in general of people over 18 years of age will be immunized. For this, the project continues to recruit volunteers. Once vaccinated, the participants will be monitored for 25 months, with controls every four months.

 

Sinovac landing
Along with Janssen's vaccine, the one developed by Sinovac Biotech was cleared for Phase 3 trials in late September. This Wednesday, 6,000 doses landed in Chile, which will be tested thanks to an agreement with the Catholic University, after the Public Health Institute (ISP) approves the "use and destination" protocol to begin the trials. "The vaccines arrived today and fortunately we were informed that they arrived safely," said Alexis Kalergis, director of the Millennium Institute of Immunology and Immunotherapy and principal investigator of the project. The study, he estimates, will include between 2,500 and 3,000 participants, initially the po[CENSORED]tion at risk and health personnel, but they seek to "expand the study to the general po[CENSORED]tion." "For that we have managed to get a sufficient number of doses to carry out the studies," he said.

 

It is an associative work that includes more universities, centers and public hospitals in regions, such as the Gustavo Fricke Hospital in Viña del Mar and the Carlos van Buren in Valparaíso. Antofagasta could also join. The volunteers will be monitored for a year to evaluate the appearance of possible adverse effects or diseases, but in addition, a subgroup of volunteers will undergo an immunological study to understand the "mechanism of action" of the vaccine. "It seeks to understand whether the vaccine generates antibodies, whether it generates T cells, and most importantly, how long they last," Kalergis explained. The particularity of this trial is that UC made an agreement with Sinovac to secure about 20 million doses once the vaccine is registered. "Through an agreement with the Minsal, the UC has transferred those rights to the Government. There is the option. Without a doubt, the final decision is made by the Minsal through the National Immunization Program and with the support of the Cavei," he said. In addition to the agreement with Sinovac, the Government joined the WHO initiative, Covax, to accelerate equitable access to vaccines worldwide.