WorldPhase-3 studies on Turkey's CoronaVac vaccine published in The Lancet

Phase-3 studies on Turkey’s CoronaVac vaccine published in The Lancet

ChinaThe new type of coronavirus (Covid-19) by the pharmaceutical company Sinovac inCovid-19) “CoronaVac” vaccine developed against Phase-3 The results of their studies were published in the medical journal “The Lancet”.

According to the statement made by the press office of “The Lancet”, the interim data obtained from the Phase-3 study conducted in Turkey of the Covid-19 vaccine CoronaVac developed in China showed that two doses of the vaccine provided 83.5% protection against Covid-19 infection. .

In preliminary findings, it was reported that CoronaVac induced a “strong antibody response”.

It was also noted that no serious side effects or deaths were reported among more than 10 thousand participants included in the study in Turkey, most of the side effects were mild and occurred within 7 days after infection.

The article noted that the long-term efficacy of the vaccine against emerging worrisome variants should be tested in a more diverse group of participants.

CoronaVac vaccine

CoronaVac uses inactivated virus. When a person is vaccinated, their immune system attacks the harmless form of the virus and produces antibodies to fight the virus. This leads to immunity.

The vaccine, developed by Sinovac Life Sciences, can be stored and transported at 2-8 degrees and approved for emergency use in 22 countries, has been tested in Phase 3 studies since mid-2020 in Brazil, Indonesia, Chile and Turkey. In the study included in the article, two doses of CoronaVac were administered to the participants, 14 days apart.

Hacettepe University Faculty of Medicine Prof. Dr. Murat Akova, in a statement to The Lancet, said, “We need each dose of safe and effective vaccines to control Covid-19. The results we have obtained are also important evidence of the safety and effectiveness of inactivated virus vaccines. One of the advantages of CoronaVac “It doesn’t need to be frozen. This makes it easy to transport and distribute. This could be particularly important for the worldwide distribution of the vaccine. Because in some countries it can be difficult to store large volumes of vaccine at very low temperatures.” used his statements.

The study was carried out in 24 centers in Turkey.

The journal included the following information about the results of the study:

“Between September 14, 2020 and January 5, 2021, 10,218 adults aged 18 to 59 were randomly assigned to receive two doses of vaccine (6,650) or placebo (3,568). The study was conducted in 24 centers in Turkey. Age Males comprised 5,907, or 58 percent of the participants, with an average of 45. After administration of the first dose, 87 participants in the vaccine group and 98 participants in the placebo group were excluded from the study. All 4 participants in the vaccine group were excluded after the second dose because they were over the age of 59. A total of 10 thousand 29 participants were included in the activity analysis and 10 thousand 214 participants were included in the security analysis.

After an average of 43 days of follow-up, a total of 150 Covid-19 cases were confirmed by PCR. 14 days after the second dose, 9 cases of symptomatic Covid-19 were reported in the vaccine group and 32 cases in the placebo group. As a result of the analysis, it is estimated that this corresponds to an efficiency of 83.5 percent.

A total of 1413 participants were included in the analysis of the vaccine-induced immune response, 981 from the vaccine group and 432 from the placebo group. CoronaVac induced an antibody response in 880 people, corresponding to 90 percent of those vaccinated.

According to the findings in the article, which states that the antibody response decreases with age in both men and women, data from 10,214 participants on side effects were used.

The incidence of side effects was recorded as 19 percent in people who were vaccinated.

A total of 3,845 adverse events were reported in 1862 participants. 90 percent of the reported side effects were mild, including “fatigue, injection site pain, and muscle pain.” While no serious adverse events or deaths were recorded during the study period, 6 participants in the vaccine group and 1 participant in the placebo group withdrew from the study due to adverse effects. Only one adverse event (allergic reaction) required hospitalization.

. (HAS) . ..


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