Covaxin Phase 3 data in: Efficacy 77.8% against symptomatic Covid

[bhaigan]

Bharat Biotech’s Covaxin vaccine has shown the ability to bring down symptomatic Covid-19 cases by 77.80 per cent, according to data from its much awaited phase 3 trials.

The results of the phase 3 trials come a day before the Hyderabad company’s scheduled meeting with the World Health Organization (WHO), where it is expected to submit its proposal for an Emergency Use Listing of the vaccine.

The EUL would make it easier for Covaxin — developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) — to receive recognition in other countries where it has not received regulatory approvals.

On Tuesday, a Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO), the country’s apex drug regulatory body, reviewed and accepted data from late-stage clinical trials of Covaxin, said sources.

The data, collected from 25,800 participants, also included information related to the vaccine’s efficacy “for all forms of the disease”. This translates to the vaccine’s ability to reduce symptomatic Covid-19 cases compared with those who have not been vaccinated. “Everything was looked at — the efficacy, safety, lot-to-lot comparisons, etc,” said one of the sources on condition of anonymity.

SEC’s review and acceptance of this data is expected to offer more credence to Covaxin’s efficacy, which had become the subject matter of controversy starting with when it was granted restricted-use permission without this information in January.