DCGI gives nod for Intranasal Booster Dose Trials

DCGI gives nod for Intranasal Booster Dose Trials

Question: Recently which of the following vaccine manufacturer got the approval for conducting Phase-III clinical trials of an intranasal booster dose for those who have received both doses of Covaxin?
a) Bharat Biotech
b) Sun Pharma,
c) Reliance LifeSciences
d) Zydus Cadila
Answer: (a)
Related Facts:-

  • The Drugs Controller General of India (DCGI) has given vaccine manufacturer Bharat Biotech approval for its intranasal booster dose.
  • With this approval now the company can conduct Phase-III clinical trials of an intranasal booster dose for those who have received both doses of Covaxin.
  • Only the Central Drugs Laboratory (CDL), Kasauli, certified batches shall be used in the clinical trials.
  • These trials will be conducted at nine sites, including the All India Institute of Medical Sciences, New Delhi and Bihar.
  • The Chimpanzee Adenovirus Vectored COVID-19 Vaccine (BBV154) is to be administered through an intranasal route and each single dose is 0.5 ml.
  • The trials will evaluate BBV154 intranasal vaccine for both the 2-dose primary schedule and booster dose schedule.

By Rajesh Tripathi

Links:-
https://www.thehindu.com/news/national/dcgi-gives-nod-to-bharat-biotech-for-intranasal-booster-dose-trials/article38338977.ece