Serum Institute seeks permit to conduct bridging trial of Novavax COVID vaccine in India

After the roll-out of Covishield, the Serum Institute of India (SII) has now sought the Drug Controller's permission to conduct the bridging study for the Novavax COVID-19 vaccine candidate in India. The pharmaceutical firm has applied for the permission of the Novavax vaccine candidate, just a day after the American firm released data of its UK trial, revealing that the vaccine had an efficacy of 89%. Bridging trial is a supplementary trial conducted before proceeding to the clinical stage to gather additional data on efficacy, safety and dose regimen. 

Mass production by April

The Novavax COVID vaccine candidate, named - NVX-CoV2373 - is a protein-based vaccine, which is now being examined by the Drug Controller General of India (DCGI) for its bridging trial. The Serum Institute, which is already mass-producing Covishield - developed by Oxford-AstraZeneca - in India, plans to begin bulk production of the Novavax vaccine from April. The Indian pharmaceutical firm has also received funding from GAVI - The Vaccine Alliance - for pre-producing and stockpiling the vaccine candidate at risk, similar to the way it did with the Oxford-AstraZeneca vaccine in India. 

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Nearly 60 million doses of the Novavax COVID vaccine have been already procured by the UK government as the country's medicine regulators assess the vaccine data. The doses are expected to be delivered by the second half of this year, as per reports in UK media. The Novavax vaccine candidate is also said to be effective against the new Coronavirus variant found in the UK after completion of the Phase 3 trials which enrolled more than 15,000 people aged between 18-84. 

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COVID immunization drive in India 

The Union Health Ministry on Thursday revealed that under India's mammoth nationwide vaccination drive, 25 lakh vaccine doses had been administered so far to the healthcare and frontline warriors in the country. The Health Ministry also informed that India was showing a constant declining trend of new cases of Coronavirus in the country, with the nation now battling only 1.75 lakh active cases. Individuals are being administered with Covishield and Bharat Biotech's Covaxin. 

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Health Secretary Rajesh Bhushan also revealed that India was the fastest country in the world to achieve 1 million vaccinations, reaching the target in only 6 days. As compared to India, the US, Spain, and the UK achieved the target in 10, 12, and 18 days respectively. India has also begun delivering shipments of vaccines to neighbouring countries under the 'Vaccine Maitri' programme. 

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