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The drugmakers had received DCGI nod to conduct phase I and II trials simultaneously. (Reuters)
The drugmakers had received DCGI nod to conduct phase I and II trials simultaneously. (Reuters)

Zydus Cadila, Bharat Biotech covid vaccine trials move to phase II

With enrolment of contenders starting in July, the completion of trials in such a short time is unprecedented

NEW DELHI : Bharat Biotech International Ltd and Zydus Cadila Ltd have completed phase I of clinical trials for their respective vaccine candidates against covid-19, just three weeks after the two companies started human dosing of the immunization shots against the fatal respiratory disease, Indian Council of Medical Research (ICMR) director-general Balram Bhargava said.

“At present, we have three vaccines in different levels of clinical testing. The first one is the inactivated virus vaccine, which is the Bharat Biotech vaccine, which has completed its phase I study in 11 sites and has started its phase II study. Similarly, for the DNA vaccine of Zydus Cadila, India has completed the phase I study and has embarked on phase II studies," Bhargava said at a press conference on Tuesday.

Bharat Biotech refused to comment on Bhargava’s statement. Calls and messages sent to Zydus Cadila’s spokesperson remained unanswered at the time of publishing.

The two drugmakers had received approval from drug controller general of India (DCGI) V.G. Somani for conducting simultaneous phase I and II trials, which studies the vaccine’s safety and immunogenicity, which is the ability to provoke an immune response in the body. The nod allowed the firms to start the second phase without complete analysis of data of the first phase.

Enrolment and human dosing of the vaccine candidates began only in mid-July and the completion of trials in such a short time is likely to be unprecedented. The phase I trial is faster than the candidate developed by the University of Oxford, deemed a frontrunner among covid-19 vaccines.

The trial protocol for Bharat Biotech’s candidate showed that phase I studies were to be conducted through administration of vaccine two weeks apart, with monitoring of adverse events happening after two hours of the first dose and then seven days. Later, monitoring would happen at regular intervals throughout the study duration.

Zydus Cadila’s trial protocol indicated that the first phase would last for 84 days, or 12 weeks, with three doses being administered 28 days apart and monitoring at regular intervals, while the second phase will be conducted in parallel till the 224th day.

“These are pandemic times, and I know, everyone is compressing (trial) timelines. Some are wrapping up a phase, analyzing data, and then moving to the next phase. Others conducting a parallel phase I and II and they are overlapping with each other… They have to make sure they also monitor the safety in phase II and phase III," public health and bioethics researcher Anant Bhan said.

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