Oxford University's AstraZeneca Covid-19 Vaccine Clearance for Clinical Trials in India

Strategic Insights -

In a significant development towards combating the COVID-19 pandemic, the institutional ethics committees of the Bharati Hospital and Research Centre, KEM Hospital, and other hospitals in Pune have granted approval for the conduct of clinical trials of the Oxford University's AstraZeneca COVID-19 vaccine. The trials, which aim to study the safety and potency of the vaccine, are set to begin in the city soon. Principal investigators at the trial sites have expressed excitement and readiness to commence the recruitment of volunteers, with anticipation of around 200-250 participants at the KEM Hospital site and 300-350 volunteers at the Bharati Hospital.

Key Takeaways:

  • The institutional ethics committees of the Bharati Hospital and Research Centre, KEM Hospital, and other hospitals in Pune have granted approval for the clinical trials of the Oxford University's AstraZeneca COVID-19 vaccine.
  • The trials aim to study the safety and potency of the vaccine, with no fixed sample size but anticipation of around 200-250 participants at the KEM Hospital site and 300-350 volunteers at the Bharati Hospital.
  • The recruitment of volunteers at the KEM Hospital site is expected to begin in the last week of August, due to delays in the arrival of vaccine vials.
  • The principal investigators have expressed excitement and readiness to commence the trials, with a meeting of principal investigators from across the country scheduled to be held on Friday to discuss the study details.
  • The trials are expected to provide valuable insights into the efficacy and safety of the AstraZeneca COVID-19 vaccine.

Statistics:

  • 200-250 participants anticipated at the KEM Hospital site
  • 300-350 volunteers expected at the Bharati Hospital
  • Recruitment of volunteers at the KEM Hospital site expected to begin in the last week of August
  • No fixed sample size for the trials
  • Meeting of principal investigators scheduled to be held on Friday to discuss study details

Sources:

  • TOI (exact date not provided) - quote from Ashish Bawdekar, Principal Investigator at the KEM Hospital clinical trial site
  • TOI (exact date not provided) - quote from Sanjay Lalwani, Medical Director, Bharati Hospital