Bharat Biotech's Covaxin For Children To Get Approval For Emergency Use; Two Other Vaccines Are On The Pipeline

The central drug regulator’s expert panel, Subject Expert Committee (SEC) on 12 October has recommended that Bharat Biotech's Covid-19 vaccine, Covaxin, be given an emergency use authorization (EUA) for children aged 2 to 18.

The SEC has made this recommendation to the Drugs Controller General of India (DCGI), who will approve the EUA, after which the vaccine can be rolled out for children.

This is the second vaccine for children that has been approved. Zydus-Cadila had previously got EUA for giving their ZyCov-D Covid-19 vaccination to children aged 12 to 18. Covaxin is the country's first vaccine for children under the age of 12.

However, according to the Times of India, top government sources stated: “The SEC has only partly recommended EUA for Covaxin. The recommendations are given along with many conditions. The application is still under evaluation and will take a few more days before we arrive at a final conclusion.”

As reported, the National Technical Advisory Group on Immunisation (NTAGI) for Covid-19 will assess the data after the DCGI gives final regulatory approval for Covaxin for restricted emergency use in the 2 to 18 age group.

Bharat Biotech said that it had submitted data from Covaxin Phase 2/3 clinical trials in the 2 to 18-year-old age group to the Central Drugs Standard Control Organisation (CDSCO), and the data had been thoroughly reviewed by the CDSCO and SEC.

After SEC’s recommendation, the Hyderabad-based company said: “This represents one of the first approval worldwide for Covid-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thanks the DCGI, SEC and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children."

Bharat Biotech would continue the research, present a risk management strategy and give data with analysis every 15 days.

This is a two-dose vaccine with a 28-day interval between doses. The trials involved almost 1,000 children from all over the country. Officials from the Ministry of Health have previously stated that adults would continue to be given priority for the national Covid-19 immunisation programme, and when it is approved for children, those with comorbidities will be given first priority.

During an interview, Dr Randeep Guleria, Director of the AIIMS in Delhi, said that there is sufficient evidence to demonstrate that Covaxin is effective. He also believes that children with comorbidities should be given priority for immunisation and that long-term data on vaccines for children is essential.

Covid-19 Vaccines for Children

Apart from Bharat Biotech’s Covaxin and Zydus Cadila’s ZvCoV-D, there are two more vaccines on the horizon for children—Corbevax by Biological E and Covovax by Serum Institute of India (SII).

ZvCoV-D was the first Covid-19 vaccine for children that received approval from regulators in India after the trials showed positive results. It has not, however, been included in the immunisation campaign as the government is working on the trainers and its logistic issues since it does not require the use of a traditional syringe or needle, said the Union Health Ministry.

The drug regulator has granted EUA to the indigenously developed and needle-free ZyCoV-D vaccine, making it the first vaccination in the country to be administered to children aged 12 to 18.

In the case of Corbevax, trials in children aged 5 to 18 have been approved. The vaccine was developed with the help of the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC).

Covovax has been cleared for trials in children aged 2 to 18. It is the Indian version of the Novovax vaccine, which was brought to the country by the SII. Adar Poonawalla, the SII's CEO, said last month that he expects Covovax to be approved for people under the age of 18 in January or February of 2022.