PremiumBharat Biotech’s covid-19 vaccine Covaxin has received approval for emergency use in Children 12 - 18 years of age, the company said on Saturday.
Hyderabad-based pharmaceutical company said that Covaxin is formulated uniquely such that the same dosage can be administered to adults and children.
“Covaxin has established a proven record for safety and efficacy in adults for the original variant and subsequent variants," Bharat Biotech said in a statement.
“We have documented excellent safety and immunogenicity data readouts in Children. We look forward for covaxin to provide similar levels of protection for adults and children alike," it said.
Bharat Biotech thanking Prime Minister Narendra Modi said that it is also thankful to the Ministry of Health and Family welfare, Drugs Controller General of India (DCGI) and National Technical Advisory Group on Immunisation in India (NTAGI) for their diligent review of all data and for their fastidious approval process.
In October, Subject Experts Committee (SEC) of country’s apex drug regulatory organisation Central Drugs Standard Control Organisation (CDSCO) had recommended granting emergency use authorisation (EUA) to Bharat Biotech’s Covaxin for the age group 2-18 years.
The company had presented its proposal for grant of market authorisation of its Whole Virion, Inactivated coronavirus Vaccine candidate (BBV152) in the 2 to 18 years age group for restricted use in emergency situation along with the interim safety and immunogenicity data of phase 2/3 clinical trial conducted. The trials showed that the safety and immunogenicity of covaxin are almost the same in children, as adults above 18-years of age.
In India there has been debate over an anticipated third wave of coronavirus infections that may impact children as this is the only population left unvaccinated and hence is vulnerable. Government’s estimates state that India has more than 50% of its population below the age of 25 and the 0–14 year age group only constitute 28.6% of the total population. Experts recommend scaling up efforts to get vaccines for children against covid-19 also from 2-years onwards. Indian DCGA has already given EUA to world's first DNA vaccine by Zydus cadila which will also be used to vaccinate adolescents from 12- 18 year age group. The vaccine is yet to be rolled out.
Covaxin is already approved in adults and in clinical trials it demonstrated 77.8% efficacy against symptomatic Covid-19 disease and 93.4% against severe symptomatic Covid-19.
