While most of the world's COVID vaccine development efforts have been focused on adults, Bharat Biotech has said that it can ready a children's vaccine in 3-4 months for kids between 2 to 12 years of age. While current vaccines can only be administered to adults 16 years of age or above, the Hyderabad-based company's indigenously developed vaccine, Covaxin, is the only jab approved for children 12 years or above under emergency use authorisation.
Talking to BusinessToday.In, Dr. Krishna Ella, Chairman and MD, Bharat Biotech, said the trial would take "around four months and if the regulator gives quick permission, we might start with the clinical trial."
He stated that the company is preparing to conduct a clinical trial on children between two to 12 years of age and will soon submit a proposal regarding the same to the SEC (Subject Expert Committee).
"We have completed our phase-3 efficacy trials and will soon present a protocol to the regulators for children between two to 12 years of age for permission to conduct a clinical trial," Dr. Ella added.
He further noted that since vaccines based on mRNA and chimpanzee adenovirus vector platforms "cannot be given to children under the age of 16 years" only inactivated vaccines can be administered to them.
"The inactivated vaccine is a wonderful platform for children, but other platforms may not fit in," Dr. Ella said.
He said the company's indigenously developed coronavirus vaccine will be tested on toddlers as young as two years, adding that Covaxin is an inactivated virus vaccine based on a tested Vero cell platform that has been used for numerous jabs.
The vaccine, which is being developed by Bharat Biotech in collaboration with ICMR (Indian Council of Medical Research) and NIV (National Institute of Virology), was the first vaccine to be tested on children in September last year.
Covaxin's phase-2 clinical trial was conducted on 380 study participants comprising volunteers in the 12 to 65 years of age bracket.
Bharat Biotech, which was granted emergency use approval for its COVID-19 vaccine by DCGI only in "clinical trial mode", was on January 4, allowed to carry out trials on children above the age of 12 years.
The company has completed its phase-1 and phase-2 human trials, wherein its coronavirus vaccine, which was already tested on children above the age of 12 years, was found to be safe.
Covaxin was "safe and provides a robust immune response," said DCGI's VG Somani recently.
The Hyderabad-based company is presently conducting phase-3 clinical trials with 26,000 volunteers. Thus far, the government has said that the coronavirus vaccination drive is intended only for adults, but this approval gives hope that it can be extended entirely to children in the future if there is sufficient and satisfactory data available.