India holds COVID vaccine drills ahead of mass inoculation drive

India holds COVID vaccine drills ahead of mass inoculation drive”

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) is considering EUA requests from Serum Institute of India (SII) and Bharat Biotech's application for COVID-19 vaccines when it will reconvene on January 1, 2010, reported CNN-News18.

Friday's key meet comes a day after Drugs Controller General of India (DCGI) hinted that it might allow emergency use authorisation to SII in the country.

The Oxford-AstraZeneca vaccine, branded as Covishield, has been developed in collaboration with Pune based Serum Institute of India (SII), one of the world's largest vaccine manufacturers.

The massive exercise came a day after a government-appointed panel of experts held a meeting to review the applications of potential vaccine candidates, including front-runner Covishield, developed by Oxford University and United Kingdom -based drugmaker AstraZeneca.

While granting emergency use approval for the Oxford-AstraZeneca vaccine, Covishield, the panel imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of 4 to 6 weeks.

World Bank has approved $1 billion for India, allowing it to use these funds for any aspect of the vaccine programme.

A decision on Bharat Biotech's Covaxin was still awaited at the meeting which is still underway, the Health Ministry said. Earlier media reports had claimed that Covaxin of Bharat Biotech has also been approved by the committee, but no official statement has been made on it yet.

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It had also asked for details of the product that would be included in the package insert, as well as the specific conditions that the UK Medicines and Healthcare products Regulatory Agency (MHRA) had imposed on AstraZeneca while granting emergency authorisation for its candidate, known as AZD1222.

"Probably we will have a new year with something in hand", DCGI's Dr VG Somani said.

Indian Health Minister Harsh Vardhan reviewed the preparedness for the vaccination drive at a government hospital in New Delhi on Saturday and urged the public not to pay heed to anti-vaccine rumors.

SII CEO Adar Poonawalla had said at a virtual press conference on Monday that the firm expected the regulator's approval for Covishield to come "in a few days" - and that the vaccine should, therefore, be licensed in the country in January.

The government has planned to vaccinate 300 million people in the next six to eight months.

The federal government has signed a deal with AstraZeneca for almost 54 million doses of the vaccine in 2021, with 20 million to be produced in Australia by CSL.

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