Healthcare e-Compendium
A joint initiative of DPSRU & DRSC
Healthcare e-Compendium
A joint initiative of DPSRU & DRSC
Author: Medical Team (Alniche Life Sciences)
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The Drug Controller General of India (DCGI) has approved Biological E. Limited's (BE) COVID-19 vaccine Corbevax as a heterologous COVID-19 booster dose for individuals aged 18 and up after 6 months of primary vaccination (two doses) with Covaxin or Covishield vaccines for restricted use in emergency situations. A heterologous booster is the third dosage of the vaccine which differs from the previous two dose.
Earlier in April this year DCGI granted Emergency Use Authorisation (EUA) to the same vaccine for the age group of 5 to 12 years along with the Bharat Biotech's Covaxin for children in the age group of 6 to 12 years.
Corbevax is a recombinant protein sub-unit vaccine against COVID-19 developed and manufactured completely by Biological E. Limited in collaboration with Texas Children's Hospital and Baylor College of Medicine. The main component of the vaccine is derived from the spike protein, which aids the body's immune response against the virus. The Receptor Binding Domain Protein is the core antigen of the vaccine, having Aluminium Hydroxide and CpG 1018 as adjuvants formulated in Tris buffer. It can be administered as an intramuscular injection, preferably to the deltoid muscles
Biological E. Limited performed a multi-centre phase III placebo-controlled heterologous booster clinical study in 416 patients ranging in age from 18 to 80 years old who had received two doses of either Covishield or Covaxin at least six months prior to receiving Corbevax as a booster dose. When compared to placebo, the booster dose of Corbevax significantly boosted neutralising antibody titers in the Covishield or Covaxin groups. As per Biological E, the booster vaccination was safe and well tolerated and no severe or adverse effects were observed for the three months following the booster dose.
B.E has also provided the Indian government with 100 million doses of Corbevax for the smooth vaccination program. The current booster shot recommendations in India call for a nine-month interval between the second and third jab. If Corbevax is presented as a treatment option, this may need to be changed. With the frequent mutations in the virus such type of advancements become necessary to combat the situations. Hence, DCGI’S approval is a way forward.
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