Apex drugs body clears Covaxin phase-II & III trials for 2-18 age group
The Drugs Controller General of India (DCGI) on Thursday (May 13) cleared the indigenously produced Covaxin trials on children from two to 18 years. Covaxin maker Bharat Biotech said its phase 2 and 3 trials would be carried out on 525 healthy volunteers.
This is the first time in India that a Covid vaccine will be tested on children.
Covaxin, developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology, is pitched as the only made-in-India Covid shot. The second vaccine being used in India is the Oxford-AstraZeneca jab produced by the Serum Institute as Covishield.
In a government statement, the drug regulator accepted the recommendation of an expert committee on vaccines after careful thought. The trial involves two vaccine doses injected at day 0 and day 28.
The trials will take place at various places, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
On Tuesday (May 11), the Subject Expert Committee (SEC) on COVID took up Bharat Biotech’s application requesting permission to conduct phase two and three trials “to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years”.
The committee has put up a condition: that the firm should submit the interim safety data of phase 2 clinical trial before proceeding to phase III, according to an unnamed source quoted by Press Trust of India.
Covaxin ever since its launch has had to overcome various doubts and hesitancy among the recipients. A major boost to the vaccine’s acceptability came after Prime Minister Narendra Modi received the first dose of the vaccine in March, the publication of efficacy results gave the vaccine another shot in the arm.
In April, the government announced that three state-run vaccine makers will support Bharat Biotech International in scaling up the manufacturing capacity of Covaxin by at least 10-fold in about five months. To aid the scale-up, the government has provided ₹130 crore in aid to Bharat Biotech and one of the companies, Haffkine Biopharmaceuticals Corp. Ltd.
The financial aid will help double the Covaxin manufacturing capacity by June from 10 million a month now. The capacity will then go to around 60-70 million doses per month by August and then around 100 million by September.