Have Clinical Trials Concluded? How Safe Is the Vaccine?

No, phase III trials for Covaxin that began in November are still ongoing across 22 sites in India. After reports that clinical trial sites were struggling with recruitment, Bharat Biotech issued a statement saying they’ve recruited 23,000 volunteers of the 26,000 required to carry on the trials.

The vaccine was evaluated in 1,000 subjects in Phase I and Phase II clinical trials.

We don’t exactly know. The company has submitted multiple data to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). They’ve been asked to keep the SEC updated with all new information as it emerges. An efficacy of a vaccine can only be determined after it has gone through large scale phase III trials, which are still ongoing.

Covaxin has released phase 1 data which showed success in inducing an immune response and no serious adverse events in any of their 375 volunteers.

The interim findings of the phase 1 trial data were published in Medrexiv, and revealed…

Exit mobile version