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Bharat Biotech’s Covaxin allowed to vaccinate children above age 12 during clinical trial stage

All the patients administered Covaxin will be tracked and monitored as if they are participating in a trial.

SNS | New Delhi |

Bharat Biotech’s Covaxin, which has received emergency approval for its Covid-19 vaccine in its ‘clinical trial mode’ on Sunday, has been allowed to conduct trials on children above the age of 12. The Hyderabad based firm is conducting phase 3 trials.

The government, so far has said that the vaccination drive is intended for adults but this trails provides hope that if there is sufficient data then it can be extended to children in future.

Union Health Minister Dr Harsh Vardhan on Sunday clarified that the approval given to Covaxin id different from the one given to Pune-based Serum Institute’s Covishield as Covaxin’s use will be in clinical trial mode. All the patients administered Covaxin will be tracked and monitored as if they are participating in a trial.

Bharat Biptech’s Covaxin which received the nod from the government, is yet to complete clinical trials and submit data on efficacy. This turned into a political controversy as Congress demanded that the use of Covaxin be avoided till its clinical trials are over. Union health minister Harsh Vardhan said that Congress was politicising a ‘critical issue’ and ‘science-backed protocols’ were followed to give approval. He further added that Covaxin is more likely to work against the mutant strain of Covid-19 virus like the one emerged in United Kingdom.

Drug Controller General of India (DCGI) VG Somani said, “We’ll never approve anything if there is slightest of safety concern. The vaccines are 100 per cent safe,” adding that Oxford vaccine Covishield was found to be 70.42 per cent effective and Bharat Biotech’s Covaxin was found to be ‘safe and provides a robust immune response.’

He further said that 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.’

Bharat Biotech’s Covaxin which conducting trails with Indian Council of Medical Research (ICMR) and Phase 1 and 2 trials were conducted in around 800 people. The Phase 3 trial in on and 22,500 of 25,800 participants have been vaccinated.

The expert committee set up by the government reviewed Bharat Biotech’s data on ‘safety and immunogenicity’ and permitted it for ‘restricted use in emergency situation in public interest.’

India recorded 16,504 Covid-19 cases in the last 24 hours taking the country case tally to 1,03,40,369.