The use of covacin has recently been approved for vaccination of children aged 15-18 years. Now Bharat Biotech, the company that manufactures covacin, has released the results of clinical trials of covacin (BBV152) phase 2 and phase 3 on children aged 2-18 years. With the release of data from covacin phase-2, 3 trials, children up to 2 years of age are also expected to start coronary vaccination.
Let us know what is the result of the clinical trial of Phase 2/3 on children of 2-18 years of Covexin? How safe is the vaccine experiment for children and what are its side effects?
What is the corona vaccine trial of 2-18 year old children?
Bharat Biotech on Thursday released Phase-2 and Phase-3 data of clinical trials of Covacin (BBV152) on children aged 2-18 years.
The company said in a statement that its vaccine (Covexin) had been found to be “safe, tolerable and immunogenic for children aged 2-18 years in a Phase 2/3 clinical trial.”
Are there any serious side effects in the vaccine trial of children?
Bharat Biotech says it conducted clinical trials of the covacin on children aged 2-18 between June and September 2021, which found the vaccine to be “extremely safe” for children.
In this trial 374 children showed very mild or less severe symptoms, of which 78.6 percent recovered within a single day. Pain instead of injection was one of the most common side effects.
The study found that no serious side effects were observed in children using covexin.
The data was handed over to the Central Drugs Standards Control Organization (CDSCO) under the Ministry of Health in October 2021. Recently, Bharat Biotech’s Covacin was approved by the Drug Controller General of India (DGCI) for emergency use for children aged 12-18.
How safe is covexin in trials for children?
The India Biotech Company said that the results of the trial of children aged 2-18 years showed that Covexin is completely safe for use on young children.
In a statement issued by Bharat Biotech, Krishma Ella, Chairman and Managing Director of the company, said: The safety of the vaccine is important to children and we are pleased to announce that Covexin has now demonstrated data on the safety and immunogenicity of children. “
“We have now achieved our goal of developing a safe and effective Covid-19 vaccine for adults and children,” he said.
How clinical trials of covacin were performed on children
Bharat Biotech said that clinical trials of covacin were performed on 525 children aged 2-18 years.
The children involved in the trial were divided into three groups: Group 1 12-18 years (175 children), Group-2 6-12 years (175 children), and Group-3 2-6 years (175 children).
In the trial, children in the respective age group were vaccinated with two doses of 0.5 mL of covacin, the same dose as in adults.
More antibodies made in children in vaccine trials
A special thing was found in the trials of Covexin in children that it produced more antibodies in children than in adults.
Clinical trials of covexin in children aged 2-18 years produced an average of 1.7 times more antibodies in children than in adults. At the same time, the incidence of antibodies in children during trials of covacin was 95-98%.
This means that the vaccine in children may be able to provide more protection against the corona virus than in adults.
Cove vaccine will be given to children aged 15-18 years in the country.
From January 3, 2022, children will be vaccinated against corona for the first time. Children aged 15-18 will be vaccinated first. Covexin from Bharat Biotech Company has been approved for children of this age group.
Prime Minister Narendra Modi announced on December 25 to start corona vaccination for 15-18 year old children and also to give precision dose to health workers, frontline workers and people with 60+ comorbidities from January 10, 2022.
India is also preparing to
introduce biotech nasal vaccine (BBV154) in 2022. The nasal vaccine is being developed by India Biotech and the Washington University School of Medicine (WUSM). India Biotech aims to produce 100 million doses of nasal vaccine by 2022.
The nasal vaccine will be a single dose, which will be given by nose instead of an injection, hence it is also called intranasal vaccine.