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The phase 1/2 clinical trial of a vaccine candidate product (CoronaVac) involved more than 700 healthy volunteers, ages 18 to 59, recruited from China between April 16 and May 5.
“The vaccine appeared to be safe and well tolerated at all doses tested. The most reported side effect was pain at the injection site, ”reads the information published by the Lancet.
14 days after the final dose, antibody “robust responses” were detected after two injections of the candidate vaccine, 14 days apart, even at the lowest dose tested.
The vaccine-induced antibody levels were lower than those seen in people infected and recovered from the covid-19 disease caused by the new coronavirus, but the researchers say they are still hoping that the vaccine can provide protection against the virus.
The main objective was to evaluate the immune response and the safety of the vaccine. The study was not designed to evaluate the effectiveness in preventing SARS-CoV-2 infection.
Results of the early phase clinical trial of the inactivated SARS-CoV-2 whole virus-based vaccine candidate (CoronaVac) were published in The Lancet Infectious Diseases, revealing that the formulation appears safe and induces an antibody response in healthy people. .
Antibody responses can be induced within 28 days after the first immunization by administering two doses of the candidate vaccine 14 days apart.
The study also made it possible to identify the ideal dose to generate the best antibody response, taking into account side effects and production capacity, which will be studied in more detail in other ongoing trials.
Scientists believe CoronaVac may provide sufficient protection against Covid-19, based on experience from other vaccines and data from preclinical studies in monkeys.
The study was not designed to evaluate effectiveness, and the results of the phase 3 studies will be crucial in determining whether the immune response generated by CoronaVac is sufficient to protect against SARS-CoV-2 infection.
“In addition, the persistence of the antibody response must be verified in future studies to determine the duration of any protection,” the paper said.
More studies will be needed to test the candidate vaccine in other age groups, as well as in people with pre-existing diseases.
“Our findings show that CoronaVac can induce a rapid antibody response within four weeks after immunization, by administering two doses of the vaccine within 14 days. We believe this makes the vaccine suitable for emergency use during immunization. pandemic. In the long term, when the risk of covid-19 is lower, our results suggest that giving two doses a month apart instead of two weeks may be more appropriate to induce stronger and potentially more immune responses. explained Fengcai Zhu, co-author of the study, from the Provincial Center for Disease Control and Prevention in Jiangsu, Nanjing, China, and argued the need for further studies.
CoronaVac is one of 48 candidate vaccines for COVID-19 currently in clinical trials. It is a chemically inactivated whole virus vaccine, based on a strain of SARS-CoV-2 that was originally isolated from a patient in China.
The covid-19 pandemic caused at least 1,328,048 deaths derived from more than 55 million cases of infection worldwide, according to a report prepared by the French agency AFP.
