CORBEVAX approved as India’s first heterologous COVID-19 booster shot for 18 years and above

• CORBEVAX® is expected to be available as a Booster dose on the CoWIN App in Public and Private Vaccination Centres from August 12, 2022
• Many countries have adopted the Heterologous Booster dose over the homologous booster dose to target better vaccination outcomes, particularly against emerging variants
• CORBEVAX® has demonstrated a significantly increased immune response to the Omicron strain

Hyderabad, August 11, 2022: Biological E. Limited (BE), a Hyderabad-based pharmaceutical and vaccines company, announced that its COVID-19 vaccine CORBEVAX® was approved by the Union Health Ministry as a heterologous COVID-19 booster dose under emergency use authorization for individuals aged 18 years and above after 6 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. Limited 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 7 crore doses have been administered and 2.9 crore children have completed the two-dose vaccination regimen.  Excellent safety profile of CORBEVAX® has been confirmed in one of the largest paediatric COVID19 vaccination campaign in the world.

CORBEVAX® has undergone comprehensive booster trials on Indian subjects and subsequently received approval from the Indian regulatory authority. BE's CORBEVAX® is the first Indian vaccine to be approved as a heterologous COVID-19 booster dose. 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 neutralization 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.
   
Ms. Mahima Datla, Managing Director, Biological E. Limited, 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. We are very pleased with this endorsement, which recognizes the safety and efficacy of our vaccine."
 
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.