Bharat Biotech allowed COVAXIN trials on children aged 12+
Hyderabad-based pharmaceutical company Bharat Biotech has been allowed to conduct clinical trials for its COVID-19 vaccine on children above the age of 12. On Sunday, the firm's vaccine, called COVAXIN, had been granted emergency approval for use, albeit in "clinical trial mode" only. The vaccine has been undergoing Phase III trials and its efficacy is yet to be ascertained. Here are more details.
On Sunday, the government had approved two vaccines: COVAXIN and Covishield (developed by AstraZeneca and Oxford University, and manufactured by Pune-based Serum Institute of India). So far, the government has said the vaccination drive will only focus on adults. However, COVAXIN has been approved in "clinical trial mode," i.e., its recipients would be tracked and monitored as if they were in a clinical trial.
Notably, COVAXIN has already been given to children above the age of 12 in the last round of trials. It has been found "safe" so far. Phase I and II trials also showed that the vaccine had a "robust immune response."
The approval for restricted use for COVAXIN has invited controversy as the company is yet to complete clinical trials and submit data on efficacy. The Opposition has demanded that the vaccine's use should be avoided until the trials have concluded. Meanwhile, Health Minister Dr. Harsh Vardhan has said that the Opposition was politicizing a "critical issue," adding that "science-backed protocols" were followed for approval.
COVAXIN is an inactivated vaccine, i.e., it uses an inactivated or killed pathogen (SARS-CoV-2) to trigger an immune response. Indian Council of Medical Research (ICMR) Director-General Dr. Balram Bhargava told The Print that the vaccine is more likely to act against the new mutant strain of the coronavirus as it uses the whole virus. The ICMR has jointly developed COVAXIN with Bharat Biotech.
Dr. Bhargava said, "If there are say 1,000 points in a vaccine, of which two have mutated, this is still going to have 998 points to generate a response, unlike others such as mRNA vaccines, which...may not work as well when those areas mutate."
