Serum Institute plans to introduce 'Covavax' in India by September, to begin trials for children in July

With the US easing supplies of vaccine raw materials for its production, Serum Institute of India is wishing to introduce Covovax, its version of US firm Novavax’s Covid-19 vaccine candidate, in India by September this year, according to sources.

The US government had early this month lifted the Defense Production Act (DFA) ratings on Covid-19 vaccine makers, enabling exports of vaccines and inputs.

The company is yet to receive raw materials rom the US needed to produce the Novavax vaccine. The delay in receiving raw materials such as bioreactor bags and enzymes means that SII’s launch of the Novavax vaccine, branded as Covovax in India is delaying the manufacturing process even though the vaccine maker hopes to introduce the vaccine by September.

While the ongoing trial in India is likely to conclude by November, SII is likely to apply for licensure for Covovax in September on the back of global data, sources said.

According to a report by India Today, SII is expected to being clinical trials of the Novavax vaccine for children in July this year. This will be the fourth Covid-19 vaccine to go under clinical trial. Hyderabad based Bharat Biotech and Zydus Cadila have begun the trials for Covid-19 vaccine for children aged 12 to 18 years of age.

The company had in January said it hoped to launch the Novavax jab in June but delayed it possibly because of the raw material shortage.

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.

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Free Press Journal