The stage is set for phase II clinical trials of Bharat Biotech's coronavirus vaccine from Monday.
The Hyderabad-based vaccine maker received the approval from Central Drugs Standard Control Organisation under the Directorate General of Health Services to conduct the phase II trials of indigenous vaccine candidate Covaxin.
Joint Drugs Controller Dr S. Eswara Reddy wrote a letter to Bharat Biotech International, conveying the organisation's nod for conducting the phase II trials.
These trials of the BBV152 coronavirus vaccine or Covaxin will be conducted on 380 participants, who will have to be screened for four days after they receive the vaccine shots.
Through the letter, which IANS has seen, the Joint Drugs Controller said that the directorate had no objection to conducting the trial titled 'An adaptive, seamless Phase I, followed by Phase II randomized, double-blind, multicentre study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy volunteers'.
The letter mentions that Bharat Biotech's request for approval to initiate phase II clinical trials was examined in consultation with Subject Expert Committee (COVID-19) experts held through virtual meeting on September 3.
"This is to inform you that the subject proposal was examined in consultation with SEC (COVID-19) experts held through virtual meeting on 03-09-2020, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised to 4 days," reads the letter dated September 3.
Phase I clinical trials of the vaccine began on July 15 at 12 centres across the country where healthy volunteers were administered two doses of vaccination shots with a gap of 14 days. These trials on 375 volunteers are still continuing.
The subjects were monitored at the respective centres for two days after they were administered the vaccine shots. In the phase II clinical trials, this period has been revised to four days.
Bharat Biotech had announced on June 29 that it had successfully developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The 'indigenous, inactivated vaccine candidate' has been developed and manufactured in Bharat Biotech's high containment facility located in Genome Valley, Hyderabad.
Last month, SEC also approved Bharat Biotech's proposal to conduct trials using the intradermal (ID) vaccine delivery route.
Under this route, the vaccine shot is given in the dermis, one of the layers of the skin. Experts say the shot is less invasive, requires lesser dosage and sometimes, helps the vaccine show better immune response.
At the SEC meeting held on August 13, Bharat Biotech presented its proposal for the conduct of Phase I and II clinical trials of Covaxin by ID route.
The SEC, while recommending approval, laid down the conditions that the trial sites should be different from the sites where the present clinical trials are going on for the vaccine through the intramuscular route and that the subject should be followed up for six months for clinical and antibody assessments.