Biological E's COVID-19 vaccine Corbevax has been cleared for booster dose for those 18 and above. It can be administered to people six months after they have taken the primary two doses of either Covaxin or Covishield for restricted use in emergency situation, the company said in a statement today. This makes Corbevax India's first heterologous Covid booster.
"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.
The booster dose of Corbevax increased the neutralizing antibody titers - or a measurement of the amount or concentration of a substance in a solution - in the Covishield and Covaxin groups significantly when compared to placebo, the company said.
India's drugs regulator DCGI had given emergency use authorisation (EUA) to Corbevax for children between 5 and 12 years in late April. Until then, the vaccine was administered to those in the 12-14 age group.
Biological E also reduced the price of Corbevax to Rs 250 from Rs 840 a dose, inclusive of goods and services tax, for private vaccination centres in May.
In March when the inoculation of children in the age group of 12 to 14 years started in India, Corbevax vaccine was used and its price was fixed at Rs 145 for the government's vaccination programme.
BE had collaborated with Texas Children's Hospital and Baylor College of Medicine in the development of Corbevax. Prior to receiving EUA for vaccination, the company said it conducted phase II and III multi-centre clinical trials in 624 children aged 5-12 and 12-18.
When Corbevax was launched in March for 12-14 years group, Ms Datla had indicated that the affordability of her vaccine was one of the key goals they worked for.
Calling it the "most affordable" vaccine, Ms Datla had told NDTV that the firm "needed to keep affordability at the centre of this".