On A Fast Track: Covaxin COVID-19 Vaccine Phase 2 Trials Halved

By
OB Bureau

Hyderabad: Bharat Biotech’s COVID-19 vaccine is being fast-tracked by reducing the size of Phase 2 trials by half.

Developed in collaboration with Indian Council of Medical Research (ICMR), Covaxin will now be tested on 380 healthy volunteers in Phase 2, instead of 750 as decided earlier, according to a report in Moneycontrol.

Safety and immunogenicity (vaccine’s ability to induce immune response) data will be submitted to the Drug Controller General of India (DCGI) in the next few weeks to seek approval for starting Phase 3 trials. The subject expert committee (SEC) of the central government had also asked for the same and in a meeting on October 5, had found Covaxin’s design of Phase 3 study “in principle satisfactory”, and suggested to conduct large trials.

The Phase 3 trial will be carried out on about 28,500 volunteers aged 18 years and above from 19 cities including Delhi, Mumbai, Patna and Lucknow.

In Phase 3 clinical trial, a dose of 0.5 ml each will be given on day 0 and 28.

Currently, the Phase 2 trial is going on and the second dose is yet to be given to volunteers at some sites.

Apart from Bharat Biotech, a vaccine by Zydus Cadila Ltd is also in Phase 2 trials. Serum Institute of India is also conducting Phase 2 and Phase 3 trials of the Oxford-AstraZeneca vaccine.

Also Read: COVID-19 Antibodies Last For 5-7 Months, Provide Enduring Immunity: Study

OB Bureau

Recent Posts

Berhampur Cops In Odisha To Wear Body Cameras After Alleged Assault Case

Berhampur: After Bhubaneswar Commissionerate Police, Berhampur police have introduced body cameras for its personnel to…

November 5, 2024

States Can’t Take Over All Private Properties For Common Good, Rules SC

New Delhi: The Supreme Court on Tuesday held that states are not empowered by the…

November 5, 2024

Centre Sends Notice To Wikipedia Over ‘Bias & Inaccurate Information’

New Delhi: The central government has sent a notice to Wikipedia—which endorses itself as a…

November 5, 2024

4 Journalists From Odisha Injured In Road Accident In Tamil Nadu

Bhubaneswar: Four journalists from Odisha sustained critical injuries when as the SUV carrying them rammed…

November 5, 2024

‘Untimely’ Rath Yatra In Huston: Puri Gajapati Asks ISKCON Not To Test Patience Of Lord Jagannath Devotees In Odisha

Puri: Gajapati Maharaja Dibyasingha Deb on Tuesday said legal action would be initiated against International…

November 5, 2024

Madrasas Can Now Function In UP, SC Upholds Constitutional Validity Of 2004 Act

New Delhi: In a big relief to about 16,000-odd madrasas in Uttar Pradesh, the Supreme…

November 5, 2024

Social Worker Critical In Sword Attack By Bike-Borne Miscreants In Odisha Capital

Bhubaneswar: A young man, stated to be a social worker, was critically injured after being…

November 5, 2024

Cricket, Queen Of Hearts, Social Media & The Big Rohit-Virat Question

Off with his head', orders the Queen of Hearts and off goes a head. The…

November 5, 2024