SII begins phase 2/3 trials for Covovax, supply likely by Sept
In August 2020, US-based vaccine maker Novavax, Inc announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in low and middle-income countries and India.
The Serum Institute of India (SII) on Saturday began the phase 2 and phase 3 bridging trials for the Covid-19 vaccine, Covovax.
The company, which is already supplying the Covishield vaccine, hopes to launch the Covovax vaccine by September this year.
“Covovax trials finally begin in India; the vaccine is made through a partnership with @Novavax and @SerumInstIndia. It has been tested against African and UK variants of #COVID19 and has an overall efficacy of 89%. Hope to launch by September 2021!” said SII CEO Adar Poonawalla in a tweet.
In August 2020, US-based vaccine maker Novavax, Inc announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in low and middle-income countries and India.
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The trial in India was initiated weeks after the country’s apex drug regulator, Central Drugs Standard Control Organisation, gave its approval to SII. “After detailed deliberation, the committee recommended for the conduct of the clinical trial with observer blind design,” the minutes of the meeting of the subject expert committee under the CDSCO held on March 15 said.
The phase II/ III study will establish that the Indian version of the vaccine produces the same immune response as the Novavax vaccine. The trial will be conducted on 1,600 people across 19 sites in India, including the All India Institute of Medical Sciences (AIIMS) in Delhi.
Of the 1,600 trial participants, 460 will be in the immunogenicity group who will be given either Covovax or the vaccine by Novavax in a 3:1 ratio and the others will be in the safety cohort who will be either given Covovax or a placebo in 3:1 ratio.
Bridging studies to establish immunogenicity have been conducted for all Covid-19 vaccines developed outside India. A separate efficacy trial was not conducted in India.
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The development and commercialisation pact between Novavax and SII excludes major upper-middle and high-income countries, for which Novavax continues to retain rights.
Novavax said its two-shot vaccine has shown a 96% efficacy against the dominant global variant, and an 86% efficacy against the UK variant. The vaccine also showed an efficacy of 60% against the South African variant. The overall efficacy of the vaccine was 89%.
The Novavax vaccine is a protein subunit vaccine, where a lab-made version of the spike protein of Sars-CoV-2 is given to people to illicit an immune response.
