Amid criticism, Bharat Biotech's Covaxin allowed for trial on children below age 12

Amid the criticism of the Drug Controller General of India (DCGI) for granting approval for emergency use of Covid-19 vaccine Covaxin, Hyderabad-based firm, Bharat Biotech is allowed to conduct its trials on children who are above the age of 12 years,reports NDTV. The vaccine has already been used for children above 12 in the last round and has been found safe.

The Hyderabad-based firm which received emergency approval for its Covid-19 vaccine only in "clinical trial mode" 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.

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."

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.

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.

Comments Dr Harsh Vardhan said it means that all Covaxin recipients will be tracked and monitored as if they are in trial.

Meanwhile, Covaxin's manufacturer Bharat Biotech claimed on Sunday that its vaccine generated excellent safety data with robust immune responses to multiple viral proteins that persist.

In a statement the company said that Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine which is manufactured in a Vero cell, a manufacturing platform with an excellent safety track record of more than 300 million doses/

Earlier, DCGI has come under flak from various quarters for approving Covaxin even before the completion of Phase 3 trials. Critics wondered how the regulator could approve the vaccine in the absence of the data from Phase 3.

The DCGI's approval to Covaxin came a day after the Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) made the recommendation.

Bharat Biotech said it submitted all the data to the DCGI and CDSCO as per the regulatory guidelines.

India's indigenous Covid vaccine by Bharat Biotech has been developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

The Phase 3 human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers across India. This is India's first and only Phase 3 efficacy study for a Covid-19 vaccine, and the largest Phase 3 efficacy trial ever conducted for any vaccine in India.

This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility, one of its kind in the world, said Bharat Biotech Chairman and Managing Director Dr Krishna Ella.

It was in June that Bharat Biotech had announced that it successfully developed Covaxin in collaboration with the ICMR and the NIV.

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.

The Phase 1 trials began in July while Phase 2 trials started in September.

( with inputs from agencies)