Biological E announced that its COVID-19 vaccine CORBEVAX was approved by the Union Health Ministry as a heterologous COVID-19 booster dose under emergency use authorisation for individuals aged 18 years and above after six months of administration of primary vaccination (two doses) of COVAXIN or COVISHIELD vaccine.
The Union Health Ministry’s approval is based on the recommendations made recently by the COVID-19 Working Group of the National Technical Advisory Group on Immunisation (NTAGI). 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 individuals aged 18 years on June 4, 2022.
CORBEVAX had received emergency use authorization as primary two-dose vaccination regimen in Adults, Adolescents and Children 5 years and above, in a series of approvals from December’21 to April’22.
Biological E. has delivered 10 crore doses of CORBEVAX to the Government of India till now. Pan-India roll-out of CORBEVAX in children 12-14 years of age was initiated on March 16, 2022 and till now almost crore doses have been administered and 2.9 crore children have completed the two-dose vaccination regimen.
CORBEVAX uses a traditional recombinant protein-based technology, which is also used for vaccines such as Hepatitis B. The CORBEVAX heterologous booster-dose clinical trials demonstrated significant boosting of humoral immune response measured in terms of neutralisation antibody titres against the ancestral as well as the omicron strain, binding antibody titres as well as cellular immune response along with minimal adverse events that were mild in 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 combating the pandemic.”
The price of CORBEVAX for private COVID-19 vaccination centres is Rs. 250, inclusive of GST. For the end-user, the price is Rs 400, including taxes and administrative charges. CORBEVAX is expected to be available as a booster dose on the CoWIN App in public and private vaccination centres from August 12, 2022.