New Delhi: Biological E in a statement today said that Corbevax, their COVID-19 vaccine has been given clearance as a booster shot for those 18 and above, making Corbevax India's first heterologous Covid booster. This dose can be given to those who have taken the primary two doses of either Covaxin or Covishield, and can be administered as a restricted use in an emergency six months after the primary doses.
"We are very happy with this approval, which will address the need for COVID-19 booster doses in India. We have crossed yet another milestone in our COVID-19 vaccination journey. This approval reflects once again the sustained world class safety standards and high immunogenicity of Corbevax," Biological E Managing Director Mahima Datla said in a statement today.
According to the company, the booster dose of Corbevax increases the amount or of neutralizing antibody titers - or a measurement of the amount or concentration of a substance in a solution - in the Covishield and Covaxin groups, compared with placebo.
In late April, DCGI, the Drugs Regulator of India, had issued the Emergency Use Authorization (EUA) to Corbevax for children between the ages of 5 and 12. Until then, only 12-14 year old were administered the vaccine.
In May, the cost of Corbevax was reduced for private vaccination centres by the company from Rs. 850 to Rs. 250 per dose, inclusive of goods and services tax.
In March, when the vaccination for children between the ages of 12 and 14 began in India, the Corbevax vaccine was used and the price was set at Rs. 145 for the government's vaccination program.
The development of the vaccination was done in collaboration with Texas Children's Hospital and Baylor College of Medicine. The company said that it had done phase II and III multi-centre clinical trials in 624 children aged 5-12 and 12-18 before EUA for vaccination was approved.
When Corbevax launched in March for the 12-14 year group, Ms Datla pointed out that one of the main goals they worked on was to make the vaccine affordable.
Referring to it as the "most affordable" vaccine, Ms Datla had told NDTV that the firm "needed to keep affordability at the centre of this".