By Shalini Bhardwaj
New Delhi [India], August 9 (ANI): The Union government is considering giving its final approval to the Corbevax heterologous COVID-19 booster for 'Restricted Use in Emergency Situation' soon, sources said.
In the month of July, the National Technical Advisory Group on Immunisation (NTAGI) recommended Biological E's Corbevax as a heterologous booster for adults.
Earlier, on June 4, 2022, Biological E's Corbevax received DCGI approval for a heterologous COVID-19 booster shot for Restricted Use in Emergency Situation. It is the first vaccine in India to get DCGI approval for a heterologous COVID-19 booster shot.
Biological E Limited (BE), a Hyderabad-based pharmaceutical and vaccine company, announced that its Corbevax COVID-19 vaccine has been approved by the Drug Controller General of India (DCGI) as a heterologous COVID-19 booster dose for individuals aged 18 years and above after 6 months of administration of primary vaccination (two doses) of Covaxin or Covishield vaccines for restricted use in emergency situation.
"BE's Corbevax is the first such vaccine in India to be approved as a heterologous COVID-19 booster. Recently, BE has furnished its clinical trials data and submitted it to the DCGI, which after a detailed evaluation and deliberations with Subject Experts Committee (SEC), granted their approval for administering Corbevax vaccine as a heterologous booster dose to people who have already taken two doses of either Covishield or Covaxin," read the statement of Biological E.
"BE's clinical trial data showed that Corbevax booster dose provided a significant enhancement in immune response and excellent safety profile required for an effective booster," it said.
Mahima Datla, Managing Director, Biological E Limited, said, "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."
"BE has conducted a multicentre Phase III placebo-controlled heterologous booster clinical trial in 416 subjects from 18 to 80 years of age who were previously vaccinated with two doses of either Covishield or Covaxin at least 6 months prior to the administration of Corbevax as a booster dose," stated Biological E in a statement.
"The booster dose of Corbevax increased the neutralizing antibody titers in the Covishield and Covaxin groups significantly when compared to placebo," it said.
Meanwhile, India recorded a total of 12,751 new COVID-19 cases in the last 24 hours, taking the total number of infections to 4,41,74,650, according to the Ministry of Health and Family Welfare.
With 42 new fatalities due to Covid, the death count has climbed to 5,26,772.
India's active caseload currently stands at 1,31,807 and accounts for 0.31 per cent of the total cases.
The recovery rate is currently at 98.50 per cent. As many as 16,412 recoveries from the infection were logged in the last 24 hours, thereby increasing the total recoveries to 4,35,16,071. (ANI)