SII aims to launch Covovax by September as US eases supplies

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

The Pune-based vaccine maker has received the first lot of supplies of key raw materials for Covovax production, company insiders told ET.

“Now that we have started receiving raw material, we hope things will pick up pace,” one of them said.


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 US curbs had resulted in disruptions in supplies of key inputs needed for Novavax vaccines to Serum Institute. These raw materials included nano filters, plastic bags to store materials at specific temperatures, vials and stoppers.

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. SII is conducting a phase 2/3 observer-blinded, randomised, active controlled study of Covovax with 1,600 adult participants to “evaluate the safety of its vaccine Covovax in comparison with Novavax-SARS-CoV-2 rS (with Matrix-M1™ Adjuvant) and placebo”.

The trials across 15 centres in the country started in May.

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.

Serum Institute is also planning to start clinical trials of Covovax for children in July.

Novavax had on Monday said its Covid-19 vaccine candidate has demonstrated 93% efficacy against predominantly circulating variants of concern and variants of interest. The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, immunogenicity and safety of the vaccine.

VK Paul, Niti Aayog member, had said on Tuesday that the efficacy data of Novavax vaccine candidate is promising and encouraging. In May, the government officials had said India will see a major vaccine ramp up starting August, projecting over 200 crore doses between August to December.

The supply projection has estimated Novavax supplies of around 20 crore doses from August-December, but by the current estimates this is likely to reach the market only towards the fag end of the year.