Emergency Approval For Bharat Biotech's Covaxin Pending For Kids: 10 Things to Know

Covaxin Approved For Kids:  Dr Bharati Pravin Pawar of Ministry Of Health And Family Welfare said in a statement that approval to Covaxin for 2-18 years age group hasn't been given yet. She said that the evaluation is still going on." There is some confusion & the talks are underway with the experts' committee. Till now Drugs Controller General of India (DCGI) hasn't approved it", she said.

The evaluation is still going on. There is some confusion & the talks are underway with the experts' committee. Till now Drugs Controller General of India (DCGI) hasn't approved it: MoS Health, Dr Bharati Pravin Pawar on approval to Covaxin for 2-18 years age group pic.twitter.com/OKb3AJDaOQ

— ANI (@ANI) October 12, 2021

It was earlier reported that Bharat Biotech's Covaxin had been granted emergency use approval for children in the 2-18 years age group. The step was taken by the Subject Expert Committee on Covid-19.

1. In September, Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age.
2. After this,  it submitted the trial data to the Drugs and Comptroller General of India (DCGI) at the start of October.
3. This indigenous vaccine on approval, which was used only on adult population so far, will be administered in two doses. There will be a gap of 20 days between the first and the second dose, as per a report.
4. The firm has also been asked to submit safety data including the data on AEFI and AESI.
5. This will be done after they carry out an analysis every 15 days for the first two months and monthly thereafter and also as per requirement of New Drugs & Clinical Trials Rules, 2019, it said.
6. The World Health Organisation hasn't granted emergency use authorisation to Covaxin.
7. All the documents by Bharat Biotech had been submitted for the listing to World Health Organisation by July 9.
8. The review process by World Health Organisation takes around six weeks started in July end.
9. Covaxin has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
10. Serum Institute’s Novavax is a third vaccine potential for children in India. In fact, it has been given the go-ahead for trials by Drugs and Comptroller General of India.