Union Health Secretary Rajesh Bhushan on Wednesday said that the Centre has approved Biological E's Corbevax as a precaution dose after completion of six months from the date of administration of the second dose of either Covaxin or Covishield vaccines for the population above 18 years.
The provision for the administration of heterologous precaution dose using Corbevax to those who are eligible and due for precaution dose has been made on the Cowin portal. This provision would be live from August 12, 2022, added Bhushan.
Union Health Secretary Rajesh Bhushan has written a letter to the additional chief Secretary, Principal Secretary and Secretary of state and UTs regarding Biological E's Corbevax as an option of precaution dose for heterologous groups above the age of 18.
"All necessary changes in regard to the administration of heterologous precaution dose using Corbevax to those who are eligible and due for precaution dose have been made on the Cowin portal. This provision would be live from August 12, 2022," read the letter issued by the Union Health Secretary.
"Corbevax will be available as a precaution dose after completion of six months or 26 weeks from the date of administration of second dose either Covaxin or Covishield for population above 18 years. This enables the use of Corbevax as heterologous COVID19 vaccine for precaution dose administration in this age group." It said.
The letter has also mentioned that there will be no change in the existing guidelines.
"In the addition to the homologous precaution dose the option of a heterologous precaution dose with Corbevax would be available to all age groups above 18 years of age," stated the letter.
On Tuesday, ANI reported that the Corbevax booster for heterologous first has been approved by the Centre.
Last month the National Technical Advisory Group on Immunisation (NTAGI) recommended Biological E's CORBEVAX as a heterologous booster for adults above 18 yrs old.
On June 4, this year Biological E. Limited (BE), a Hyderabad-based pharmaceutical and vaccines company announced that its CORBEVAX COVID-19 vaccine has been approved by the Drug Controller General of India (DCGI) as a heterologous booster dose after 6 months of administration of primary jabs of Covaxin or Covishield vaccines for restricted use in the emergency situation for the individuals aged 18 years and above.
"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 to the DCGI who after a detailed evaluation and deliberations with the Subject Experts Committee, granted their approval for administering the Corbevax vaccine as a heterologous booster dose to people who have already taken two doses of either Covishield or Covaxin," an official statement from BE read.
"BE's clinical trial data showed that Corbevax booster dose provided significant enhancement in immune response and excellent safety profile required for an effective booster," it added.
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 that once again 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," the statement read further.
"The booster dose of Corbevax increased the neutralizing antibody titers in the Covishield and Covaxin groups significantly when compared to the placebo," it added.
So far, India's cumulative COVID-19 vaccination coverage has exceeded 207.03 crore (2,07,03,71,204) till 7 am today. (ANI)