Serum seeks regulatory nod for second Covid-19 vaccine

By: |
January 30, 2021 2:15 AM

Adar Poonawalla, CEO of SII, has committed to start manufacturing and stockpiling the Novavax vaccine from April 2021. SII will be making around 50 million doses a month of this vaccine.

Novavax on Friday announced that their Covid-19 vaccine had demonstrated 89.3% efficacy in UK Phase III trial.Novavax on Friday announced that their Covid-19 vaccine had demonstrated 89.3% efficacy in UK Phase III trial.

Vaccine maker Serum Institute of India (SII) has sought regulatory approval for carrying out trials in India for its second Covid-19 vaccine Novavax. SII has a tie-up with US-based biotech company Novavax to manufacture one billion doses of the vaccine in 2021. Novavax on Friday announced that their Covid-19 vaccine had demonstrated 89.3% efficacy in UK Phase III trial. Novavax said this was the first vaccine to demonstrate clinical efficacy against both the UK and South African variants of the Covid-19 strain.

SII had tied up with Novavax in September 2020 for manufacturing the NVX-CoV2373 protein-based vaccine. The supply and license agreement with Novavax is to manufacture and commercialise Novavax’s vaccine. Serum has got exclusive rights for the vaccine in India and non-exclusive rights during the pandemic period in all countries excluding upper-middle/high-income countries. Both partners will be having a revenue sharing arrangement.

Adar Poonawalla, CEO of SII, has committed to start manufacturing and stockpiling the Novavax vaccine from April 2021. SII will be making around 50 million doses a month of this vaccine. With the SII agreement, Novavax will have a global production capacity of two billion doses annually.

The Coalition for Epidemic Preparedness Innovations (CEPI) has provided $385 million for development of the NVX-CoV2373 Novavax vaccine. The vaccine also received $15-million grant from the Bill & Melinda Gates Foundation. The Gates Foundation has also provided $150 million to SII for manufacturing both the Oxford-AstraZeneca and Novavax vaccine in India. Novavax’s candidate, if successful, is to be made available to all 92 countries. CEPI is an public, private, philanthropic and civil society partnership for developing vaccines to stop future epidemics.

Stanley C Erck, president and CEO of Novavax, said the NVX-CoV2373 had potential to play an important role in solving this global public health crisis and they would work with regulators around the world to make the vaccine available as quickly as possible. The vaccine can be stored between 2°-8°C and can be distributed using existing supply chains.

The UK Phase III results covered 15,000 participants between 18 and 84 years and had an efficacy of 89.3%. The efficacy of the vaccine against the Covid-19 virus variant in South African was lower and it was around only around 60% effective. For those suffering from HIV, the efficacy in South Africa was around 49.4%.

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