The Drugs Controller General of India (DCGI) has accorded permission to conduct the Phase II-III clinical trial of Covaxin (Covid vaccine) in the age group of 2 to 18-years-old to its manufacturer Bharat Biotech Ltd, Union Health Ministry said on Thursday.
"The trial will be conducted in 525 healthy volunteers," said the Ministry.
In the trial, the Ministry said, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
After careful examination, the DCGI accepted the recommendation of Subject Expert Committee (SEC). The national drug regulator of the country on Wednesday gave the approval to conduct the clinical trial in the age group of youngest age group till now paving way for them to be saved from the deadly pandemic outbreak.
Hyderabad-based Bharat Biotech International Ltd (BBIL) had proposed to carry out a Phase II-III clinical trial of Covaxin in the age group of two to 18 years. As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (Covid-19) on May 11 this year.
The committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II-III clinical trial to certain conditions.
Covaxin shortage
Once the trial is over, it may take some weeks for the company to apply for Emergency approval and soon ship Covaxin to distribution centres. However, the Covaxin vials are far below the supply demanded by states, including Telangana and Karnataka where the company is ramping up efforts to increase its production of the vaccine.
Bharat Biotech has announced last month to enhance its capacity to produce about 700 million doses of Covaxin annually, which falls far below the demand for the vaccine in Covid-battered country that is struggling to fight the disease.
Manufacturing scale up has been planned "mainly due to the availability of new specially designed BSL- 3 facilities, first of its kind for manufacturing in India that have been repurposed and preexisting expertise and know-how to manufacture, test and release highly purified inactivated viral vaccines," said the company in its statement recently.
Bharat Biotech has also partnered with Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin and the technology transfer process is well underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines at commercial scale and under biosafety containment, said the statement.
