ICMR, doctors at odds on vaccine
The head of India’s apex health research agency said on Tuesday that both indigenous vaccine candidates against the coronavirus disease had completed phase 1 safety studies and were undergoing phase 2 efficacy studies, but doctors conducting the trials contradicted the claim.
The director-general of the Indian Council of Medical Research (ICMR), Balram Bhargava, said the inactivated virus-based candidate developed by the Hyderabad-based Bharat Biotech and the DNA-based candidate developed by the Ahmedabad-based Zydus Cadila had “completed phase 1” studies.
Phase 1 safety studies examine whether a vaccine candidate has any adverse side-effects on the volunteers who receive it. Successful completion would be an early yet significant milestone followed by phase 2 efficacy studies that examine whether the candidate can generate an immune response.
“The inactivated virus vaccine… has completed phase 1 study in 11 sites and started its phase 2 study,” Bhargava said at a briefing called by the Union health ministry. “Similarly, for the DNA vaccine… India has completed phase 1 and has embarked on phase 2 studies at 11 sites. That is also progressing well.”
But three senior doctors who are principal investigators in the clinical trials — one in Bharat’s trials, two in Zydus’ trials — said phase 2 studies had not started yet. The doctors said data analysis for safety assessment was underway and volunteers had not received any dose under phase 2.