Covaxin has already been used in children older than 12 years in the last round.
New Delhi:
Bharat Biotech, which received emergency approval for its Covid-19 vaccine only in “clinical trial mode,” can conduct its trials in children older than 12 years. The vaccine has already been used in children older than 12 years in the last round and has been found to be safe. The Hyderabad-based company is conducting phase 3 trials.
So far, the government has said that the vaccination campaign is intended for adults only, but this provides hope that if there is enough data, it can be fully extended to children in the future.
Union Health Minister Dr. Harsh Vardhan clarified yesterday that the emergency approval for Covaxin is different from that granted for Covishield from the Serum Institute because the use of Covaxin will be in clinical trial mode. All your recipients will be tracked and monitored as if they were participating in a test.
The government’s green signal for Covaxin, which has yet to complete clinical trials and present data on efficacy, had become a political controversy that dragged on late into the night.
The Comptroller General of Drugs of India (DCGI) grants license to Bharat Biotech to manufacture COVAXIN.
Bharat Biotech requested to submit updated safety, efficacy, and immunogenicity data from ongoing phase I, II, and III clinical trials pending completion of the trials. pic.twitter.com/dsFSJPoIyb
– ANI (@ANI) January 3, 2021
Faced with a congressional demand that its use be avoided until clinical trials are over, the Union’s health minister, Dr. Harsh Vardhan, said the party was politicizing a “critical issue” and that “endorsed protocols were followed. by science “to pass it. Covaxin, he said, is more likely to work against mutant strains of the virus, like the one that emerged in the UK.
In his announcement yesterday, Comptroller General of Drugs VG Somani said that Covaxin has been granted permission “for restricted use in an emergency public interest situation as an abundant precaution, in clinical trial mode, to have more options for vaccination, 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 were on trial.
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