translated from Spanish: Head of Sinovac studies in the country after request for emergency use: “It will be data on how the vaccine works in people in Chile”

“We know that the disease that coronavirus causes is because the world’s population lacks immunity. Apparently this virus has the ability to evade, escape people’s immune defenses and that’s why it causes the severe disease we’ve seen this year and therefore it’s urgent to have safe and effective strategies to help people’s immune response, to respond effectively against an infection that, we know, has negative results. We know that the disease can be serious, deadly, that there can be aftermath. Therefore, the adequate, protective immune response could prevent the disease,” said Alexis Karlegis, an academic at the Catholic University, director of the Millennium Institute of Immunology and director of the Study of the Sinovac Vaccine in Chile who develops this study house.
“It is positive that science, at the international level and Chile connected to this process, has several vaccines that are in phase 3 clinical stages that, in addition to assessing safety, immune response, measure the effectiveness and fact that some vaccines have approval for emergency use such as Pfizer and others that could receive such approval , it is clearly a path that the world is following in order to control this pandemic,” he said in Radio Universe. It should be remembered that Cenabast reported yesterday that it applied to the PSI for emergency authorization for the Sinovac vaccine in our country, this, as the laboratory does not have representation in Chile. If approved, Coronovac – the name of the vaccine – would be the second to arrive in our country and join the immunization plan that today is developed only with Pfizer.
“Sinovac is a vaccine made from the inactivated virus, a strategy that has been occupied for several decades as with influenza, polio. It has a pattern, a history of mass use in humans with very good safety results. In terms of immunity, it is a vaccine that generates immunity, the virus is inactivated, cannot infect, but it does generate immune response,” explained Karlegis who coordinates studies from UC Medical School.
Karlegis clarified that “efficacy data are not available, they are under evaluation, this needs to be rigorously evaluated and the studies being done in other countries such as Brazil, Turkey, Indonesia, the idea is to aggregate the results to have a consolidated efficacy result. Brazil has already reported that the result is greater than 50%, which is in line with what WHO recommends, and the New York Times published that Turkey’s data would indicate a preliminary analysis of 90%, but that information will be formally delivered by Sinovac in the coming days, based on a consolidated analysis of all studies.”
On the reliability of this vaccine developed in China, the doctor noted that “quality science is the same in all countries beyond some perceptions or impressions that may exist. The work they have done in this particular laboratory was one of the first to be published in a high-impact review such as Science, an independent peer-reviewed scientific journal, then published the Phase 1 and Phase 2 studies in The Lancet, another of very high impact, so there is a solid scientific livelihood.”
“With regard to vaccine reliability, there has been quite a lot of discussion about vaccines that one might call innovative, which are newer, have less history of use, I am referring in particular to those designed on the basis of nucleic acids such as RNA, some based on the recombinant virus. I think it is important and understandable that citizens are concerned, they are new medicines, they are recent developments that, while they have been done with great strictness and very strong public scrutiny, never in the history of medicine has public opinion been so close to scientific development, but it is valid that there is such concern and it is very important that you give space to answer questions and contribute to deliver scientific information that underscores the quality of each technology” Said.
Asked about the fact that Sinovac will not go through the FDA, Karlegis stated that “this vaccine will most likely have approvals at several international agencies. Remember that each country has an agency and that agency does independent reviews to provide emergency use recommendations. In the case of the Sinovac vaccine it is highly unlikely to pass through the United States, probably in the United States (by) the political relations that exist between countries are not considered for use in that country, in that sense the FDA does not need to review it, but other agencies that have the same standard as the FDA as the agency in Brazil do.”
“In order for the clinical study to be done in Brazil, all the background was reviewed by Anvisa which is the regulatory agency in Brazil, so we already have a history of a large agency like Anvisa reviewed and approved the execution of the clinical study in Brazil and could approve, if the background warrants it, an approval for emergency use. The same could happen in Chile, but every review is independent and that should be the case, the discussions have been public, citizens can hear the review of the application and the points for and against,” he added.
“I do not know the stage of the (emergency) application in Brazil, I understand that this information is public. In the case of Brazil they are awaiting the final communication of effectiveness and I would expect it in our country to be equivalent. The background to emergency use approval includes efficacy value, but each regulatory agency is distinct and type 4 agencies such as Anvisa, ISP or FDA aim for a difficult and important task, which is to ensure citizens and the population’s access to medicines and vaccines, but also to ensure the safety and effectiveness of these drugs and vaccines” Held.
“Pfizer’s request was reviewed with a panel of experts unrelated to the study and that is a sign of rigorous evaluation. The PSI also sent a mission to China to fairly inspect manufacturing, production at Sinovac plants, and the report issued by the PSI commission was fairly favorable in terms of plant inspection. And it is an example that unlike others that approved emergency use, in this case the ISP has first source information, we from the university deliver all the information, but also in the case of Sinovac, the ISP made physical visit to review procedures, quality, etc. It’s important to note because a field inspection is different from reviewing only documentation,” he added.
During the interview he was asked how many doses will be needed and for what ages the Sinovac vaccine is recommended, against which he replied that “that will be known at the time when on the one hand the health authority, the Minsal, and the PSI, which is the regulatory agency, draw the conclusions. Those are decisions in which we as a university do not participate, we do clinical research of the vaccine (…). The important thing is that the study we are doing at UC, in addition to delivering immunity and efficacy results, was done in our population, will be first-come, first-source data on how the vaccine works in people in Chile, which has not happened with other vaccines.”
“One of the tasks is to look carefully at how the vaccine induces immunity to the elderly, it is one of the aspects that we are emphasizing, those (recommendations) will be made by the health authority with the PSI, these are decisions made by regulatory agencies and the health authority,” he concluded.

Original source in Spanish

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