Serum India, Bharat Biotech to test intranasal COVID-19 vaccines post regulatory nod: Dr Harsh Vardhan
He clarified that Phase III clinical trial is generally with thousands of participants, sometimes even close to 30,000 to 40,000 participants
Dr Harsh Vardhan, Union Minister of Health and Family Welfare, GoI, said that although there are no intranasal COVID-19 vaccines under trial in India at the moment, Serum India and Bharat Biotech are expected to pursue clinical trials of such vaccines in India in the coming months on receipt of regulatory approval. He clarified that the Phase III clinical trial is generally with thousands of participants, sometimes even close to 30,000 to 40,000 participants. It is possible that from a specific city or hospital, couple of hundred participants are selected at a given time, but in general, the overall Phase III participant pool is much larger.
Sharing details on the Special Drive for Adverse Drug Reaction (ADR) reporting and monitoring of drugs used in COVID-19, Dr Vardhan said that the initiative is not because of an adverse reaction reported with an existing drug, but is part of a proactive COVID-19 preparedness programme.
Dr Vardhan was speaking to social media interactors on the sixth episode of Sunday Samvaad.