Bharat Biotech, which received emergency approval for its Covid-19 vaccine only in “clinical trial mode”, is allowed to conduct its trials on children who are above the age of 12 years. The vaccine has already been used for children above 12 in the last round and has been found safe. The Hyderabad-based firm is conducting Phase 3 trials.
So far, the government has said the vaccination drive is intended only for adults but this provides hope that if there is sufficient data, then it can be extended fully to children in the future.
Union Health Minister Dr Harsh Vardhan had clarified yesterday that emergency approval for Covaxin is different from the one given for Serum Institute’s Covishield because Covaxin’s use will be in clinical trial mode. All its recipients will be tracked and monitored as if they are participating in a trial.
The government’s green signal for Covaxin, which is yet to complete clinical trials and submit data on efficacy, had turned into a political controversy which stretched late into the evening.
Drugs Controller General of India (DCGI) gives licensing permission to Bharat Biotech to manufacture COVAXIN.
Bharat Biotech asked to submit updated safety, efficacy & immunogenicity data from the ongoing Phase I, II & Ill clinical trials till the completion of trials. pic.twitter.com/dsFSJPoIyb
— ANI (@ANI) January 3, 2021
To Congress’s demand that its use be avoided till the clinical trials are over, Union health minister Dr Harsh Vardhan had said the party was politicizing a “critical issue” and “science-backed protocols” were followed to give approval. Covaxin, he said, is more likely to work against the mutant strains on the virus, like the one that emerged in the UK.
In his announcement yesterday, Drugs Controller General VG Somani said Covaxin has been granted permission “for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.”
Dr Harsh Vardhan said it means that all Covaxin recipients will be tracked and monitored as if they are in trial.