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SEPT. 30, 2020

Public Health Institute authorizes two COVID-19 vaccine clinical trials in Chile

The effectiveness of the vaccines developed by Sinovac Biotech Co. Ltd. and Janssen Pharmaceutical Companies will be tested in Chile. The announcement was made by Health Minister Enrique Paris, along with the Director of the Chilean Public Health Institute, Heriberto García, and the rectors of the universities that will be overseeing the analyses, Ennio Vivaldi of Universidad de Chile and Ignacio Sánchez of Pontificia Universidad Católica, in addition to the specialists in charge of the studies, Miguel O’Ryan and Alexis Kalergis.

The Commission for Clinical Trials of the Chilean Public Health Institute (ISP) has authorized the launch of two phase III clinical trials to evaluate COVID-19 vaccines. The vaccines were developed by Sinovac Biotech Co., Ltd. and Janssen Pharmaceutical Companies.

This approval exemplifies the Chile’s capacity to develop innovation that benefits humankind, according to Health Minister Enrique Paris.

This is a major milestone because it shows that Chile can and must participate in these phase III clinical trials to approve, study and hopefully make headway in the development of these vaccines. Both Chile and the whole of humankind harbor the hope of obtaining a vaccine that creates antibodies and prevents the coronavirus from spreading,” said Minister Paris. 

The ISP Commission for Clinical Trials advises the technical agency’s director on evaluating different aspects to ensure there are sufficient guarantees that the trial has been adequately designed and complies with Good Clinical Practice and other international guidelines, as well as the quality of the vaccine under research.

Acting ISP Director Heriberto García explained the clinical trial process that is about to get underway in Chile.

This is important to the process of ensuring we get vaccines for Chile. For this reason we will begin with the clinical trials, after which the vaccines will be imported. The ISP will review the quality of the product and undertake the monitoring and active pharmacovigilance of our part of the study, so we can finally move forward with making the vaccine effective, in other words, making people immune to COVID-19,” he said. 

Clinical testing

Members of academia noted that this is a critical moment for defining the future development of biomedical innovation in Chile.

It’s essential we get a vaccine. Chile has relied on the quality of its researchers and universities and can proceed with confidence into this stage of generating vaccines. The different Chilean universities should also work together and we should have a vaccine center such as the ISP once was,” said the rector of Universidad de Chile, Ennio Vivaldi. 

Meanwhile, the rector of the Pontificia Universidad Católica, Ignacio Sánchez, highlighted the work undertaken by researchers in a consortium of universities that is behind these vaccines. “Hundreds of hours of hard work and dedication have been devoted by this consortium of universities. In the case of the Sinovac vaccine, there are eight centers, from Antofagasta to Valdivia, where researchers have given their all to reach this point,” said Sánchez.  

In practical terms, the Director of the Millennium Institute on Immunology and Immunotherapy, Alexis Kalergis, explained that as far as the Sinovac vaccine is concerned “with this approval we can begin to implement the process of enlisting the subjects, which will take a couple of weeks. The fundamental thing was to get this trial approved. It will be as territorial as possible,” said Kalergis.

Meanwhile, the professor and researcher at the Institute of Biomedical Sciences at the Universidad de Chile’s Faculty of Medicine, Miguel O’Ryan, stated that “this is not the importation of a ready-to-use vaccine. We need to see if these vaccines will be effective and safe.  I want to thank the hundreds of people who will take part to ensure that these clinical trials meet the required international standard,” said O’Ryan.

Anyone wishing to take part in the test must be an adult aged between 18 and 59 years old.  Pregnant women, people who have had COVID-19, confirmed with the latest PCR test, and immunocompromised people are exempted.

For the Sinovac vaccine, the trial will start with healthcare workers, after which it will open up to other subjects at high risk of contagion. For the Janssen vaccine, a subsequent stage includes adding subjects over 60 years of age.

Both studies will be able to include people with chronic medical conditions under proper treatment and not decompensated, such as diabetes, high blood pressure, asthma, as well as smoking and obesity. Three thousand participants are expected to enlist in each trial throughout the country.

Technical information on the vaccines

The vaccine developed by Janssen Pharmaceutical Companies is qualified as monovalent, which means that it protects against a single strain of a microorganism, in this case, the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2).  Furthermore, only one dose of the vaccine is required, after which it is followed up by a strict safety monitoring period.

This clinical study has been presented before 9 regulatory bodies: the United States, Brazil, Colombia, Mexico, Peru, the Philippines, South Africa, Ukraine and Chile.   The duration time of the immunization will be assessed along with the results of this clinical trial, with a two-year monitoring period.

The Sinovac SARS-CoV-2 vaccine is also monovalent but requires two doses on days 0 and 14. A thorough monitoring period of its safety is also enforced.

This vaccine is made from an inactivated virus, derived from the coronavirus (strain CZ02), cultivated in African green monkey kidney cells (Vero cells), then harvested, inactivated, concentrated, purified and absorbed with aluminum hydroxide.

The study will last for about one year after the first dose, and will be carried out in Brazil, Chile, Turkey, Indonesia and Bangladesh. The duration time of the immunization will be assessed along with the results of this clinical trial.

Monitoring

The ISP will be monitoring the proper implementation and carrying out of the clinical trials, overseeing the safety of the participants by notification of serious adverse events that occur during their development. In due course it will carry out one or more inspections of the protocol and Good Clinical Practice, once volunteers have enlisted.

Healthcare professionals that work at a healthcare center and are knowledgeable about the presentation of an Event Supposedly Attributable to Vaccination or Immunization (ESAVI) will directly notify the ISP National Pharmacovigilance Unit within the period of time established to that end.

At present, the Commission for Clinical Trials is evaluating a study of the AstraZeneca vaccine. Once the last interview stage with the laboratory and sponsor is completed, this would be the third phase III clinical trial of a vaccine for COVID-19 in Chile. This trial is for a different vaccine from the other two.