INDIA. Mumbai: The Drugs Controller General of India (DCGI) has accorded permission to conduct the Phase II-III clinical trial of Covaxin, an indigenous COVID-19 vaccine,in the age group of two to 18-years-old to the Hyderabad based manufacturer Bharat Biotech International Ltd(BBIL).
DCGI, the national regulator, after careful examination, has accepted the recommendation of the Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin in the age group 2 to 18 years, to BBIL on May 12, 2021, the Union Health Ministry said in a statement on Thursday.
The trial will be conducted on 525 healthy volunteers and in the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. The DCGI granted its approval to conduct the clinical trial in the youngest age group, paving way for them to be saved from the deadly pandemic outbreak, the ministry added.
The BBIL had proposed to carry out a Phase II-III clinical trial of Covaxin in the age group of two to 18 years. As a rapid regulatory response, the proposal was deliberated in SEC on May 11, 2021, Tuesday. The committee after detailed deliberation recommended for grant of permission to conduct the Phase II-III clinical trials on certain conditions.
Once the trial is over, it may take some weeks for the company to apply for emergency approval and ship Covaxin to distribution centres. As of now 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 had last month announced 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 pre-existing expertise and know-how to manufacture, test and release highly purified inactivated viral vaccines,” said the company in its recent statement.
Bharat Biotech has also partnered with “Indian Immunologicals” (IIL) to manufacture the drug substance for Covaxin and the technology transfer process is underway. The IIL has the capabilities and expertise to manufacture inactivated viral vaccines at a commercial scale and under biosafety containment, said the statement.
Covaxin production in UP
In another development, the central government approved the proposal of Bharat Biotech to set up a new plant of Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL) in Uttar Pradesh’s Bulandshahr, on Wednesday. BIBCOL will manufacture two crore doses of Covaxin every month and the central government will provide Rs 30 crore to BIBCOL for this project.
In yet another development, Mumbai-based state-owned Haffkine Bio-Pharmaceutical Corporation Limited will be producing Covaxin, developed by Bharat Biotech on a technology transfer basis. It will take at least a year for setting up the project since Haffkine is required to develop a BSL-3 laboratory, at its premises at Parel in South Central Mumbai. The proposal was approved by the department of biotechnology of the Union ministry of science and technology on April 15.
Haffkine will be producing (228 million ( 22.8 crore) doses of the Covaxin vaccine in a year.
The Maharashtra government has decided to fund a Rs 154 crore project by granting Rs.94 crore, while the Central government has approved Rs.65 crore for the project under “Covid Suraksha Yojana”.
