Corbevax as Booster Dose

In News: Indian drug regulator Drug Controller General of India (DCGI) has given green signal Corbevax as a booster dose for all adults above 18 years who have received two doses of either Covishield or Covaxin as part of primary vaccination

• With the approval of Corbevax as a booster dose, India will have a heterologous shot
• India has been using the same vaccine for both primary vaccination and booster (homologous boosting).
• In clinical trials, a booster dose using a vaccine that is different from the one used for primary vaccination — technically called heterologous boosting — produced higher immune responses when compared with a same vaccine for primary and booster vaccination.
• Bio E’s phase-3 heterologous booster vaccine trial using Corbevax in people who have received two doses of either Covaxin or Covishield did produce significantly higher immune responses.
• But with the control group not receiving a homologous booster shot but only a placebo, the trial failed to bring out the enhanced immune responses by using Corbevax as a heterologous boost
• Any vaccine administered as a booster — immaterial of being homologous or heterologous — months after primary vaccination will, by default, increase the immune responses.
• The trial has thus only shown that Corbevax as a heterologous booster increases the immune responses but failed to show that heterologous boosting with this vaccine produces superior immune responses than homologous boosting with Covishield or Covaxin.

Drug Controller General of India (DCGI)

• Drugs Controller General of India is the head of department of the Central Drugs Standard Control Organization of the Government of India.
• Responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India
• DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
• Comes under the Ministry of Health & Family Welfare
• DCGI lays down the standard and quality of manufacturing, selling, import and distribution of drugs in India.
• Acting as appellate authority in case of any dispute regarding the quality of drugs
• Preparation and maintenance of national reference standard
• To bring about the uniformity in the enforcement of the Drugs and Cosmetics Act
• Analysis of Cosmetics received as survey samples from CDSCO (central drug standard control organization)
• DCGI will also act as Central Licensing Authority (CLA) for the medical devices which fall under the purview of Medical Device Rules 2017