Human trials of coronavirus vaccine candidate Covaxin begin at two more medical centres

The phase-1 clinical trials of Covaxin, India’s first indigenous vaccine candidate for Covid-19, have begun in two more designated trial sites of the country, on Monday.

Bharat Biotech International Limited has, in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, developed the vaccine.

12 medical institutes across the country including AIIMS New Delhi were designated as the clinical trial sites for the Phase-1 and 2 tests, to test the vaccine’s suitability for public health use.

AIIMS Patna and PGIMS Rohtak have started the trials on 15 and 17 July, respectively.

On Monday, these trials on humans also began at the SRM Medical College Hospital and Research Centre, Chennai and the Nizam's Institute of Medical Sciences, Hyderabad.

“The volunteers in the institute have been given the first dose of vaccine. They will be given the second dose of vaccine after an interval of 14 days,” SRM said in a statement.

At the NIMS, a government hospital, the first dose was administered on two volunteers.

“We are planning to give the dose to another 5-6 people on Tuesday,” NIMS director Dr K Manohar told DH. “Getting healthy volunteers suitable for the trials has become difficult. But we are looking at a sample size of at least 30 in Phase-1.”

Authorities at the King George Hospital in Visakhapatnam said they are awaiting the authorization letter from the Andhra Pradesh government. The letter would allow the ethics committee of the government general hospital to approve initiation of the vaccine trial process, Dr G Arjuna, KGH Superintendent told DH.

Phase-1 trials are a randomized, double-blind, placebo-controlled clinical trial on 375 volunteers across India.

Double blind denotes a trial process especially of a drug where the dose content (test vaccine or placebo) is unrevealed neither to the subject/volunteer nor the administrator.

750 volunteers would participate in the Phase-2 tests.

In an advisory to the trial site investigators on 2 July, ICMR director general Dr Balram Bhargava envisaged COVAXIN (BBV152 Covid Vaccine) for public health use launch by 15 August.

Following criticism from experts and opposition parties that the government was “rushing through an elaborate and time taking vaccine testing process,” the premier research body apparently eased on the Independence Day deadline.

The Drug Controller General of India had earlier permitted the two phased human clinical trials after Bharat Biotech submitted results from the preclinical studies, demonstrating safety and immune response, the Hyderabad based firm said.

(With inputs from ETB Sivapriyan in Chennai)