09/18/2021 2:27 PM
Clarín.com
Society
Updated 09/18/2021 2:27 PM
According to the results of the phase 1 and 2 trials of its development, the Sinopharm coronavirus vaccine was shown to be safe and to have generated a “
strong immune response
after two doses”
in children between the ages of three and 17 years
.
This was published by the prestigious scientific journal
The Lancet Infectious Diseases
.
Its efficacy will only be evaluated in phase 3. However, Chinese scientists reported that the formula, formally called BBIBP-CorV
“is safe and well tolerated”
, and that “elicits strong humoral responses [generation of antibodies] against infection by SARS-CoV-2 after two doses ”.
In the
randomized, double-blind and controlled
phase 1 and 2 trial, reported in the scientific journal
The Lancet Infectious Diseases,
healthy volunteers were stratified by age.
The researchers divided into three groups, which were given different dosages of immunization:
From three to five years.
Six to 12.
From 13 to 17.
According to the researchers, the doses were administered
28 days apart
.
445 boys participated in phase 1, while 810 children were selected for phase 2.
When it comes to safety, the scientists said the
most common
adverse reaction
was
pain at the injection site
, followed by
fever
.
In most cases, the severity of these effects "was mild to moderate," and they were "transitory or resolved within a few days."
“The inactivated covid-19 BBIBP-CorV vaccine
is safe and well tolerated at all levels tested in participants aged three to 17 years,
” the scientists stated, adding: “Adverse reactions occurred predominantly after the first dose and showed a frequency similar to what was evidenced in participants aged 18 to 59 and in those aged 60 and over ”.
Meanwhile, when evaluating its immunogenicity, that is, the ability of serum to induce an immune response, they stated that it "elicited
strong humoral responses against
SARS-CoV-2
infection
after two doses."
They remarked that, although the efficacy of the vaccine is still unknown, the immune response induced by the serum in children between the ages of three and 17
is similar to that expressed in adults
, since “a seroconversion of 100% was achieved in all participants for day 56 ″.
In relation to phase 3 of the study, the scientists anticipated that for this age group it will
be carried out in the United Arab Emirates
, where the vaccines will be administered "21 days apart to obtain additional safety, immunogenicity and efficacy data."
LGP
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