- CoronaVac has been found safe for use in children and teenagers.
- This is the first vaccine to test immunology in children as young as three years old.
- The most reported side effect was injection-site pain.
A new study has found that two doses of the CoronaVac vaccine were safe and well-tolerated in children and adolescents aged three to 17 years old.
The research published in The Lancet is the first to report on the immunogenicity and safety of a Covid-19 candidate vaccine in children as young as three years.
CoronaVac was on Saturday approved for use in South Africa - with conditions - by the South African Health Products Regulatory (Sahpra).
The regulator, however, only approved the vaccine for adults aged between 18 and 59. The authorisation was based on the safety, quality and efficacy data submitted by Curanto Pharma to Sahpra between 22 March and 22 June, according to a News24 report.
The approval of the Chinese Sinovac vaccine was made with conditions, such as the periodic submission of data by the manufacturer.
The researchers performed two-phase clinical trials of CoronaVac on participants aged 18–59 years, and 60 years and older.
The first phase of the trial has 72 participants aged three to 17 years old. They were first given a low dose of the vaccine and then a high dose after a seven day safety interval to ensure they were fit to receive the second jab.
In phase two of the trial, a total of 480 participants were recruited with 120 aged three to five, 180 aged six to 11, and 180 aged 12 to 17 years. The phase two trial was only initiated after all participants in phase one had finished and completed the observation period after their first dose.
Safe vaccine for children
The study’s findings show that two doses of the CoronaVac were safe and general good reactions in children and teenagers aged 3–17 years old. More than 96% of children and adolescents who received two doses of the vaccine developed antibodies against SARS-CoV-2, which causes Covid-19.
The number of adverse were low and mild in the participants. The most reported side effect was injection-site pain.
The researchers state that age plays an important role in antibody response to vaccines. They observed a decreasing response to vaccination with increasing age, which has been seen in other vaccines, such as hepatitis B vaccine, seasonal influenza, pneumococcal disease, tetanus, pertussis, and diphtheria.
However, one of the study authors, Prof Bin Cao, says that it is vital to determining vaccines' safety in younger age groups.
“While vaccinating children is essential to reach herd immunity and limit the severity of Covid-19, safety should be the paramount factor to be considered before Covid-19 vaccines can be rolled out in younger children,” he says in a press statement.