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Willing to invite other companies to scale up Covaxin production: Govt

DCGI approves Phase 2, 3 clinical trials of Covaxin on children aged 2 to 18 years.

Amid Covid-19 vaccine shortage being reported from several states, top government advisor and NITI Aayog member Dr V.K. Paul said on Thursday that the Central government and Bharat Biotech—which manufactures Covid-19 vaccine Covaxin—are willing to invite other companies which want to produce it. He, however, also stressed that Covaxin can only be produced in the Biosafety level 3 (BSL3) labs.

“People say that Covaxin should be given to other companies for manufacturing. I am happy to say that Covaxin manufacturing company (Bharat Biotech) has welcomed this when we discussed it with them. Under this vaccine, a live virus is inactivated and this is done only in BSL3 labs. Not every company has this. We give an open invitation to companies who want to do this. Companies that want to manufacture Covaxin should do it together. The Centre will assist so that capacity is increased,” Dr Paul said.

The Centre’s decision to invite other players to produce Covaxin comes at a time when several states in the country have said that there is a shortage of Covid-19 vaccine which has caused them to stop ongoing inoculation drive. Worst-affected Maharashtra and Delhi are among these states. BJP-ruled Karnataka too announced on Thursday that it has stopped the vaccination drive.

Talking about the vaccination coverage in his presentation, Dr Paul emphasised that one-third of the population aged 45 years and above are now covered. “We are happy to report that one-third of 45 and above are protected. The age group of 45 and above contribute to 88 per cent of deaths. So you can imagine, how many dents it would have made to reduce the risk of death of this population,” he added.

Highlighting the latest feat achieved by the country, Dr Paul disclosed that nearly 18 crore doses of Covid-19 vaccine have been administered in India, whereas, in the US, the number stands around 26 crores which state that India stands in the third position in the overall vaccination tally in the world.

Meanwhile, the Drugs Controller General of India (DCGI) on Thursday approved Phase 2 and 3 clinical trial of Bharat Biotech’s Covaxin vaccine in the age group of 2 to 18 years, informed the Ministry of Health and Family Welfare.

“The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (Covid vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on May 12, 2021,” the ministry said.

Bharat Biotech will conduct trials in 525 healthy volunteers.

“In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28,” it said.

As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (Covid-19) on 11 May 2021. The Committee after detailed deliberation recommended for grant of permission to conduct the proposed Phase 2 and 3 clinical trials to certain conditions.

Covaxin is one of the two vaccines being manufactured in India at present and has been developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology. The firm on Tuesday informed that it has been supplying its Covid-19 vaccine directly to 18 states since 1 May.

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