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Biological E has announced that its COVID-19 vaccine CORBEVAX has been approved by the Union Department of Health as a heterologous COVID-19 booster dose under emergency use authorization for persons aged 18 years and over after six months of administration of the primary vaccination course (two doses) of COVAXIN or COVISHIELD vaccine.

The Union Department of Health endorsement is based on recommendations made recently by the National Technical Advisory Group on Immunization (NTAGI) COVID-19 Task Force. This approval came after the Drug Controller General of India (DCGI) approved the vaccine for emergency use as a heterologous COVID-19 booster dose for people aged 18 on June 4, 2022.

CORBEVAX received emergency use authorization as a two-dose primary vaccination schedule for adults, adolescents and children 5 years of age and older, in a round of approvals from December 21 through April 22.

So far, Biological E. has delivered 10 million doses of CORBEVAX to the Indian government. Pan-India roll-out of CORBEVAX in children aged 12-14 was launched on 16th March 2022 and so far almost crore doses have been administered and 2.9 crore children have completed the vaccination regimen at two doses.

CORBEVAX uses traditional recombinant protein technology, which is also used for vaccines such as hepatitis B. Clinical trials of heterologous CORBEVAX booster doses have demonstrated significant stimulation of the humoral immune response measured in terms of titers of neutralizing antibody against progenitor as well as omicron, binding antibody titers as well as cellular immune response as well as minimal adverse events of a mild nature.

Mahima Datla, MD, Biological E, said, “CORBEVAX has become the first vaccine in India to be approved as a heterologous COVID-19 booster. The approval by the Ministry of Health today is another important step in the fight against the pandemic.

The price of CORBEVAX for private COVID-19 vaccination centers is Rs. 250 including GST. For the end user, the price is Rs 400, including taxes and administrative costs. CORBEVAX should be available as a booster dose on the CoWIN app in public and private vaccination centers from August 12, 2022.