Bharat Biotech to carry out Phase II/III clinical trial of covaxin in the age gr
Premium- The trial will be conducted in 525 healthy volunteers. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28
The Drugs Controller General of India (DCGI) on Thursday gave a green signal to Hyderabad based Bharat Biotech’s proposal to carry out a Phase- II/III clinical trial of covid-19 vaccine--Covaxin-- in the age group of 2 to 18 years.
The trial will be conducted in 525 healthy volunteers. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. “The National Regulator of the country, DCGI after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the trials," the union health ministry said in a statement.
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“As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (covid-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions," it said.
Earlier in April, in an early analysis of phase 3 clinical trials, Bharat Biotech’s Covaxin showed a 78% efficacy rate against the coronavirus. But more importantly, the covid-19 vaccine was found to be effective against some of the fast-spreading variants that are infecting millions of Indians. The effectiveness of the vaccine against severe covid disease was 100%, the Hyderabad-based company has claimed, suggesting that people receiving the vaccine will not develop severe symptoms or require hospitalization.
Covaxin showed 81% efficacy during a previous analysis of phase 3 trial data released in early March. The second interim analysis is based on results from 87 symptomatic cases of covid-19, the company had said in a statement.
Safety and efficacy results from the final analysis will be available in June, and the report will be submitted to a peer-reviewed publication. Based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of Covaxin.
Covaxin was developed with seed strains received from the National Institute of Virology (NIV), and the phase 3 clinical trial was co-funded by the Indian Council of Medical Research (ICMR).
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