The trial will enrol 28,500 adult participants in 25 sites across 10 states in India. Credit: fernando zhiminaicela from Pixabay.

Indian firm Bharat Biotech has initiated the Phase III human clinical trial of the anti-Covid-19 vaccine candidate, Covaxin, at the AIIMS.

The company is developing Covaxin in partnership with the Indian Council of Medical Research (ICMR).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Bharat Biotech received approval to conduct the clinical trials of Covaxin from the Drugs Controller General of India (DCGI).

The randomised, double-blind, placebo-controlled, multi-centre trial will enrol around 28,500 adult participants in 25 sites across ten states in the country, PTI reported.

The trial participants will receive a 0.5ml intramuscular injection of the vaccine candidate on day 0 and day 28.

Initially, AIIMS Neurosciences Centre chief Dr M V Padma Srivastava, as well as three other volunteers received the first dose of Covaxin.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

They were observed for two hours and will be followed up for the next few days.

In the coming few days, approximately 15,000 volunteers at the AIIMS will receive the vaccine.

Srivastava told the news agency: “Covaxin is the first indigenously-developed anti-coronavirus vaccine and on top of that, my institute is participating in the trial.

“I am honoured to be the first volunteer to receive the shot. I am happy to be a part of such a great cause. I am perfectly fine and I’m working.”

The latest development is backed by the safety and immunogenicity data from Phase I and II trials submitted to the central drug regulator.

While seeking approval for the Phase III trial, Bharat Biotech said that the vaccine was well-tolerated in all dose groups and no serious adverse events were observed in the previous trials.

Apart from Covaxin, four other vaccines are being trialled in India.

In August, Bharat Biotech reported that Covaxin demonstrated an encouraging safety profile in a Phase I trial.