SII partner Novavax's Covid-19 shot 90% effective

Washington : US-based biotechnology company Novavax's protein-based vaccine has shown overall 90 per cent efficacy against Covid-19, results of Phase-3 trials have shown.

The vaccine NVX-CoV2373 is already being locally manufactured by the company's India partner Pune-based Serum Institute of India (SII) under the brand name Covovax.

In the US-based Phase-3 trials, NVX-CoV2373 also demonstrated 100 per cent protection against moderate and severe 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, in a statement.

"Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines," Erck added.

In August 2020, Novavax and SII announced an agreement under which the US biotechnology company had given SII the licence to manufacture and supply the vaccine in low- and middle-income countries.

In March 2021, CEO Adar Poonawalla said Covovax will be launched by September this year.

"Covovax trials finally begin in India; the vaccine is made through a partnership with Novavax and Serum Institute of India," said Adar Poonawalla.

"Hope to launch by September 2021!" the CEO of the world's biggest Covid-19 vaccine maker said.

The US-based Phase-3 trials began in December 2020 and 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.

The study "confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile", said Gregory M Glenn, MD, President of Research and Development, Novavax.

The company will file for regulatory authorisations in the third quarter. After receiving the approvals, Novavax will reach a 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 statement said.

NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralising antibodies. It contains purified protein antigen and can neither replicate, nor can it cause Covid-19.

The vaccine can be stored at 2 to 8 degrees Celsius, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

The two-shot vaccine is also being evaluated in Phase 3 trials in the UK that demonstrated efficacy of 96.4 per cent against the original virus strain, 86.3 per cent against the B117 (Alpha) variant and 89.7 per cent overall.

It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 55 per cent efficacy overall in HIV-negative participants and 48.6 per cent efficacy against the B1351 (Beta) variant, and a Phase 1/2 study in the US and Australia.

The company is also conducting trials in adolescents between ages 12 and 18.