Home / News / India /  Novavax vaccine efficacy data promising, clinical trials in India in advanced stage: Govt

The Centre on Tuesday said that recently declared Novavax Covid vaccine efficacy data in a large trial are promising and that clinical trials are being conducted and are in an advanced stage of completion in India.

"What we're learning from data available in the public domain that this vaccine is very safe and highly effective. It'll be produced in India," said Dr VK Paul, Member-Health, Niti Aayog said in a routine briefing by the Union Health Ministry on Covid-19 situation in India.

He also added that there will be some gap in production (of Novavax vaccine) for a while. "I am also hoping they (US company Novavax) would also start trials on children too," Paul said.

To be sure, Novavax's vaccine candidate has partnered with Pune-based vaccine manufacturer Serum Institute of India to produce 1.1 billion doses in India.

On Monday, Novavax its COVID-19 shot was highly effective against the disease and also protected against variants in a large study in the U.S. and Mexico, potentially offering the world yet another weapon against the virus at a time when developing countries are desperate for doses.

The two-shot vaccine was about 90% effective overall, and preliminary data showed it was safe, the American company said. That would put the vaccine about on par with Pfizer's and Moderna's.

Its Covid-19 vaccine provides 100 per cent protection against moderate and severe symptoms of the disease and 90.4 per cent efficacy overall in phase 3 trials.

The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.

"Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection," said Stanley C Erck, President and Chief Executive Officer, Novavax.

According to the company's statement, it intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements.

Upon regulatory approvals, Novavax remains on track to reach the manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.

The company said it was "stored and stable at 2-8 degrees Celsius, allowing the use of existing vaccine supply chain channels for its distribution".

Last year, Novavax, announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX-CoV2373, Novavax's COVID-19 vaccine candidate.

Novavax vaccine NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19.

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