India's Homegrown Vaccines Advance to Phase II Clinical Trials Amid Surging COVID-19 Cases

Amid India's growing COVID-19 caseload, with over 1.91 million cases recorded, the country has accelerated its vaccine development efforts. Two homegrown vaccines, Covaxin and ZyCoV-D, have been granted permission to start phase II of their experimental vaccine trials. This development comes just three weeks after these vaccines were granted licensing to start phase I clinical trials in July. The announcement was made by ICMR head Balram Bhargava, stating that the vaccines are now undergoing studies for phase II.

Key Takeaways:

  • India has granted permission for two homegrown vaccines, Covaxin and ZyCoV-D, to start phase II of their experimental vaccine trials.
  • These vaccines were granted licensing to start phase I clinical trials in July and have now completed phase I testing.
  • Phase II testing of a vaccine involves mid-scale testing, involving a larger pool of candidates, usually several hundred, who are then split into focus groups.
  • This phase is critical as makers study the actual safety and other protocols pertaining to vaccine delivery.
  • Oxford University has also started simultaneous phase II/III testing in centres across India, in partnership with Pune-based Serum Institute of India (SII).
  • Authorities had earlier stipulated August 15 as an ambitious launch date for Covaxin, but the launch date has not been confirmed yet.
  • Testing conducted at a medical centre in Rohtak showed a good immune response from volunteers who were administered with doses of COVAXIN.

Statistics:

  • 1.91 million COVID-19 cases recorded in India.
  • 52,000 new infections detected on August 4.
  • 110+ vaccine candidates are in phase II testing.
  • Phase I testing of Covaxin and ZyCoV-D was completed in several centres across the country.
  • 66% of vaccine groups have completed phase I testing according to ICMR head Balram Bhargava.

Sources:

  • "India’s two homegrown vaccines advance to phase II clinical trials amid surging COVID-19 cases" - The Times of India
  • ICMR head Balram Bhargava quotes - The Times of India
  • Covaxin and ZyCoV-D vaccine information - The Times of India