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OCT. 13, 2020

Government meets with Sinovac for first COVID-19 vaccine clinical trial in Chile

The Science and Health ministers announced that doses for the phase III trial led by Universidad Católica will arrive next week. The effort involves three thousand volunteers. They also stated that the clauses included in the negotiations with the biopharmaceutical company allow for the preferential purchase of 20 million doses if it is successful.

As part of the government strategy for obtaining potential vaccines against Coronavirus, Science Minister Andrés Couve, Health Minister Enrique París and Undersecretary of International Economic Relations Rodrigo Yañez met this morning with high-level representatives of the laboratory Sinovac, which will soon begin clinical trials for its vaccine project “Coronavac” in Chile.

The meeting was attended by the Vice President of the company, Dr. Weining Meng; International Regulatory Affairs Director Li Teng; the Vice President for Research at Pontificia Universidad Católica, Pedro Bouchon; and doctors Alexis Kalergis and Pablo González of the Millennium Institute on Immunology and Immunotherapy (MIII), who are leading the trial in Chile.

During this meeting, we learned about the progress that is being made in the phase III trials of this vaccine, which already has over 10,000 volunteers recruited from around the world and is making progress towards securing certifications from international agencies for final approval in Indonesia, China and Brazil. We will be able to start this clinical trial in Chile over the next few weeks,” Minister Andrés Couve remarked. He noted that “the first doses for this trial will arrive next week.”

Meanwhile, Minister Enrique París said, “We have established a vaccine agreement with Sinovac to provide us with 20 million doses of vaccines. The use of a vaccine requires approval from a qualified agency, such as the Public Health Institute of Chile or ANVISA (the National Health Surveillance Agency) in Brazil. We hope that ANVISA will approve the vaccine soon so that we can also do so and begin to use it in Chile.” 

After the meeting, Dr. Alexis Kalergis said that “Universidad Católica will partner with China, Brazil and other countries and will work with eight or nine centers within Chile, in Santiago and other regions of the country. The international scientific community -which includes Chile- is working towards a vaccine, and the efforts that are being made to reach trade agreements as well as scientific collaboration agreements are fundamental.”

The Sinovac trial in Chile

This phase III study is being developed in the context of a partnership between UC and Sinovac thanks to the experience of Chile’s scientific community and the support of State capacities and public sector funding, as well as contributions from the Confederation of Production and Commerce (CPC) and the university.

The “Coronavac” vaccine is currently being tested in Brazil, Indonesia and Turkey, countries that have a high level of circulation of the virus. The formula is called a first-generation vaccine because the technology is based on a classic methodology that consists of using an inactivated virus. 

The execution of this trial in Chile, which has been approved by the ISP, will follow a protocol that involves testing and working with over 3,000 volunteers between the ages of 18 and 60. They will initially be recruited from health care teams through a process that will last several months and includes two doses and immunological response measurements. 

Clinical trial safety

When asked about the safety of clinical trials and the possibility of adverse effects in volunteers, Minister Couve said, “These tests are developed with the highest standards, and we are monitoring the possibility of adverse effects.  This is a concern among the population and it is important to note that to date this vaccine (Coronavac) has only been found to have moderate adverse effects that are characteristic of these phase III trials, such as minor temporary temperature variations, which is good news regarding the progress that the trials are making.”

In regard to the announcement made by multinational corporation Johnson & Johnson regarding its decision to stop its COVID-19 vaccine trials due to an “unexplained illness” in one participant, Minister Couve stated, “It is normal for phase III clinical trials to be put on hold when the type of problems that Janssen announced today are reported. An independent research commission evaluates the reasons for the adverse effects found and then the decision is made to continue or not. Today Janssen is on hold and the trials that will be conducted in Chile are as well. This shows that these clinical trials are necessary for proving the safety of the vaccine at all times, which is a guarantee that we must make to the population.”