Serum Institute India (SII) CEO Adar Poonawalla (File image: Twitter/@adarpoonawalla)
The clinical trials of the COVID-19 vaccine ‘Covovax’ are in an advanced stage of completion in India, and the Serum Institute of India (SII) hopes to launch it by September, said its CEO Adar Poonawalla.
In September 2020, Novavax announced a manufacturing agreement with SII for its COVID-19 vaccine candidate NVX-CoV2373.
The trial of Novavax’s coronavirus vaccine in India is likely to conclude by November, said Poonawalla in talks with CNBC-TV18.
The pharmaceutical giant can apply for licensure of the vaccine even before its trial in the country concludes on the basis of the global data of trial, he told the news channel.
The vaccine candidate ‘NVX-CoV2373’ demonstrated 100 percent protection against moderate and severe disease, 90.4 percent efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial, Novavax said in a statement on June 14. The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity of the vaccine, it added.
The Phase 3 trial data of the vaccine candidate from Novavax looks very promising, he said.
Also read | Explained: What Novavax data means to India, approval timelines, volumes and price
The CEO of SII, which is currently producing Oxford-AstraZeneca’s COVID-19 vaccine Covishield, also said that the company will launch Covovax by September if it receives the required regulatory nod.
The pharma company is also planning to start clinical trials of Covovax for children in July. It will soon apply to the drug regulator to approve the vaccine’s trial on children, Poonawalla added.
Novavax’s coronavirus vaccine has demonstrated 93 percent efficacy against predominantly circulating variants of concern and variants of interest, Novavax said in the statement.
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“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,” Novavax President and Chief Executive Officer Stanley C Erck said.
As per reports, the Novavax vaccine can be stored in standard refrigerators, making it easier to distribute. The vaccine was effective against several variants, including the one first detected in the UK that’s dominant in the US, and in high-risk populations including the elderly and people with other health problems.
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