Corbevax, a Covid-19 vaccine developed by Hyderabad-based Biological E, has received emergency use authorization for children between 12 and 18 years of age from India’s drugs regulator, the company announced on Monday.
The approval was based on interim results of the ongoing phase II and III clinical trials. The Drugs Controller General of India has already approved the use of Corbevax among adults on December 28 last year.
“We are pleased with this significant development, which helps extend the reach of our vaccine to the age group of 12 to 18 years in our country,” Mahima Datla, managing director of Biological E, said after the approval.
Earlier this month, the central government placed an order for 50 million doses of Corbevax at the cost of ₹145 per dose before taxes. Quality checks are complete, and supplies are likely to start soon, the company said.
{{/usCountry}}Earlier this month, the central government placed an order for 50 million doses of Corbevax at the cost of ₹145 per dose before taxes. Quality checks are complete, and supplies are likely to start soon, the company said.
{{/usCountry}}Biological E in September 2021 received approval to conduct phase II and III clinical trials in children and adolescents aged 5 to 18 years.
India has now approved eight vaccines against covid, of which three vaccines-- Covaxin, zyCoV-D and Corbevax-- have been approved for use in children. Of these, Covishield by Serum Institute of India and Covaxin by Bharat Biotech are being used in the national immunisation programme.
The country has fully vaccinated 777,155,672people and 184,420,944have received at least one dose of a vaccine as on Monday.
Corbevax is administered through an intramuscular jab. It requires two doses spaced 28 days apart.
Corbevax is manufactured by Biological E after a no-strings-attached tech transfer from its developers, Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine.
The vaccine is a an RBD protein sub-unit dose, made using a platform that is used for many commonly used inoculations, including those given to children after birth.
Clinical trials of the Corbevax vaccine among adults have been completed, according to the company. It has also conducted a phase III active comparison clinical trial to evaluate its superiority over the Covishield vaccine.
Corbevax’s developers have said the vaccine has shown similar efficacy levels as other approved Covid-19 doses using a method of assessment known as correlate of protection. The company, however, is yet to disclose clinical trial data.