Russia approves second vaccine against Covid-19 after preliminary tests | Vaccine

The vaccine was developed by the Vector Institute in Siberia, which completed the initial human testing stage in September. The Phase I study injected immunization to five volunteers, with the possibility of expanding the trials to 100 volunteers between the ages of 18 and 60.

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“We need to increase the production of the first and second vaccines,” Putin said in comments broadcast on state television.

The immunization developed by the institute is made from a technology initially created for Ebola. It is made up of protein fragments (peptides) from the virus that can stimulate the immune system to induce a protective response.

Russia registered its first vaccine candidate in August, developed by the Gamaleya Institute in Moscow. The advanced stage tests of this candidate with at least 40 thousand people are on the way.

The vaccine, named “Sputnik V” in honor of the world’s first satellite, launched by the Soviet Union, is not yet in general circulation.

Steps to produce a vaccine

It takes time to produce a vaccine. The fastest developed so far was the mumps vaccine, which needed about four years before obtaining the license and its distribution to the population.

Before starting volunteer testing, immunization goes through several phases of preclinical experimentation (in the laboratory and with guinea pigs). Only after its safety and efficacy have been evaluated, human testing, the so-called clinical phase – which are three:

• Phase 1: is a preliminary assessment of immunizer safety, is done with a small number of healthy adult volunteers who are closely monitored. It is at this moment that it is understood what the type of response produced by the immunizer in the body. It is applied to dozens of participants in the experiment.
• Phase 2: in the second phase the clinical study is expanded and has hundreds of volunteers. The vaccine is given to people with characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In this phase it is vaccine safety evaluated, immunogenicity (or protection capacity), a dose and how it should be administered.
• Phase 3: large-scale trial (with thousands of people) that must provide a definitive evaluation of its effectiveness and safety in larger populations. Furthermore, designed to predict adverse events and ensure protection durability. Only after this phase can a medical history be taken.

According to the National Health Surveillance Agency (Anvisa), to carry out a clinical trial in Brazil, the approval of the National Research Ethics Commission (Conep) is required, a body linked to the Ministry of Health. Volunteers are recruited by research centers.

* With information from Reuters agency

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