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PM Modi to meet vaccine makers; J&J seeks permission for Phase 3 trial in India

The total number of COVID-19 cases is rising at a record pace in India

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With the government opening the COVID-19 vaccination drive to everyone above 18 years of age, Prime Minister Narendra Modi has called a meeting with vaccine manufacturers on Tuesday. During the meeting, scheduled to be held through video conference at 6pm on Tuesday, the Department of Biotechnology (DBT) will make a presentation and also coordinate with all the participants.

Those expected to be present include representatives of top drugmakers from India and abroad, including the companies whose vaccines have already been approved by the Government of India. So far, two vaccines, Oxford/Astrazeneca vaccine COVISHIELD manufactured by Serum Institute in India and indigenously developed COVAXIN by Bharat Biotech, are being administered in India, while a third vaccine Sputnik V (developed in Russia and to be imported and sold in India by Dr Reddy's Laboratories) has also been approved by the Indian drug regulator.

Other vaccines available globally and expected soon in India include those made by Pfizer, Moderna and Johnson & Johnson. While the total number of COVID-19 cases is rising at a record pace in India with the total caseload crossing 1.5 crore, the government has allowed everyone above the age of 18 years to be eligible to get vaccinated from May 1.

The Serum Institute of India (SII) CEO Adar Poonawalla had earlier noted that the company was facing a shortfall of Rs 3,000 crore to ramp up vaccine production capacities. "We need roughly Rs 3,000 crores which is not a small figure considering we have already spent thousands of crores. We have to find other innovative ways to build our capacity so we can support our nation in light of COVID surge," Poonawalla said. He said the existing production capacity was "very stressed", reported NDTV

The company hopes to increase its capacity of Covishield to 110 million doses per month from June onwards, he added. The company is producing 2 million doses per day, Poonawalla said. "We have delivered over 100 million doses to India alone and exported around 60 million doses to other countries," he added. Serum Institute, along with other vaccine producers, have agreed with the government to sacrifice profits. There is no vaccine industry on the planet that has agreed to provide vaccines at such a subsidised price, he added.

J&J seeks permission for Phase 3 trials

Multinational pharma giant Johnson & Johnson has applied to India's drug regulator seeking permission to conduct Phase 3 clinical trial of its single-dose COVID-19 vaccine in India as well as import licence. They said the company has sought an early meeting of the subject expert committee on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) to take a decision on its application.

The J&J vaccine can be stored for up to three months in a temperature between 2 and 8 degrees Celsius. Johnson & Johnson's vaccine is a single-dose jab, whereas the three vaccines cleared by India so far are of doubles doses.

This comes close to the heels of the central government last week deciding to fast-track emergency approvals for all foreign produced coronavirus jabs that have been given a similar nod by the World Health Organisation or regulators in the United States, Europe, Britain or Japan. Such vaccines will be given emergency use approval mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial under the provisions of the New Drugs and Clinical Trials Rules 2019, the health ministry had said.

-Inputs from agencies

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