It was on March 15, four days after the change of command, that a large group of representatives from the Chinese laboratory Sinovac arrived at the offices of the Institute of Public Health, at 3:00 p.m., to meet with Paola Medelhead of the ISP Establishment Authorization Section; Patricia Carmonahead of the Subdepartment of Registration and Authorizations in the Department of the National Medicines Agency; Juan Roldanhead of the department of the National Medicines Agency, and Barbara Orellanainspector of the Inspections subdepartment.
Among the professionals who attended the appointment on behalf of the laboratory were Weining Meng, vice president of the laboratory; Guang Yang, Investor Relations Officer, and Victoria Barraza, Regulatory Affairs Supervisor. In addition, at the meeting Sinovac introduced his general manager, Deyu Jiang.
The agenda had several topics. The first of these was the new vaccine developed by Sinovac against the three variants of concern to the World Health Organization -ómicron, delta and Wuhan-in what was the first rapprochement between both parties by this formula that is under study.
Since December 2019, in the Chinese city of Wuhan, a patient was hospitalized with symptoms that did not match any known disease -the Covid-19, a virus that plunged the whole world into a pandemic- 509,820,028 people have been infected globally and 6,219,848 have died from the virus, according to data from John Hopkins University.
Precisely because of its contagious capacity, the virus has had several mutations, that is, changes in their genetic information, which generated variants with new characteristics, behaviors and scopes.
In that context, the Sinovac laboratory is working in China on a trivalent vaccine that includes the omicrom, delta and Wuhan (the original lineage) variants. Initially, the vaccine was manufactured with the original variant, so its formula does not consider new strains, which have spread rapidly. In fact, during November, delta was the variant with the highest circulation in Chile, the same thing that is happening now with ómicron, Well, since February it appears in 100% of Covid-19 samples processed by the ISP.
Experts have described this last variant as the most transmissible. After its appearance, cases in Chile increased explosively, surpassing peaks of the previous waves. The curve continued to rise until February 11, when the Ministry of Health reported 38,446 infections, what remains to this day as the record for daily transmissions.
At the meeting organized through the Lobby Law on March 15, the pharmaceutical –that produces the most widely used vaccine in Chile, with 25,971,217 doses administered– told the ISP of this process. In addition, they commented that so far the vaccine has been shown to be significantly more effective than the others.
Vice President of Corporate Affairs Sinovac Biotech Chile, Virginia Garretón, who was at the meeting, maintains that the project is well advanced, but there are still important stages to be met.
“The process is well advanced, we have it on a GMP scale, that is, in good manufacturing practices, which is a product quality that allows practices to be carried out on human beings.. After passing the development stage, it goes to a stage where a product is produced under safe conditions to carry out tests, in order to know if it is a safe and effective vaccine, ”he says.
At the same time, Garretón adds that “We are making the records to be able to carry out clinical trialsit is likely that they will not be made in Chile, it is not yet decided, but we already know that the vaccine is more effective in animals, and the protection lasts longer than the vaccine against a single variant”.
In that instance, the ISP director, Heriberto Garciatold them that it was important to advance in the registration of the Coronavac vaccine and if modifications arise, these can be included over time.
Another point they addressed is the construction of the Chinese pharmaceutical company’s plant, for which it signed an agreement in 2021and that will allow to finish producing vaccines against coronavirus, hepatitis and influenza, and later add for chickenpox and polio.
The laboratory authorities consulted if it is possible that the plant has the authorization to fill different vaccines. The ISP responded that they should submit as much background as possible on how they do this work at their China plant for background checks.
According to Garreton, the construction of the property in Quilicura has already begun, and it is most likely that everything will be ready at the beginning of next year.
For the experts, the mutations of the virus, that is, changes in their genetic information, which generates strains with new behaviors, can affect how well vaccines work and even the protection they provide.
Carlos Pérez, dean of the Faculty of Medicine and Science at the Universidad San Sebastián and infectologist at the Universidad de Los Andes Clinic, explains that “the variants may have the particularity that they are not recognized by the antibodies generated by the vaccines, so the immunized people are less protected against these variants, and that has already happened, with omicron for example”.
Erna Cona, infectologist at the Indisa Clinic, points out that “the appearance of new lineages affects. To the extent that the variants become more differentiated from the original strain, that is where the vaccine will not be effective. As long as there are few mutations, there will be no problems with effectiveness.”
However, the doctor adds that so far the vaccines have worked well: “For the latest variants that have arrived in the country, such as omicron, the vaccine has worked well. Immunization does not prevent infections so much, but rather works fundamentally to protect from the most serious clinical conditions.
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