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Serum Institute seeks approval from DCGI for clinical trials of the Covid-19 Covavax vaccine | India News

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Serum Institute seeks approval from DCGI for clinical trials of the Covid-19 Covavax vaccine |  India News

(Reuters)

NEW DELHI: Pharmaceutical giant Serum Institute of India (SII), whose Covishield vaccine has already received emergency restricted-use approval from the Controller General of Medicines of India (DCGI), has now applied for permission to start clinical trials of ‘ Covavax ‘, a Covid-19 vaccine developed by Novavax.
In a tweet Saturday, Adar Poonawalla, Executive Director of SII, said: “Our partnership for a Covid-19 vaccine with Novavax has also published excellent efficacy results. We have also requested to begin trials in India. We expect to launch Covavax in June 2021. ”
According to a government official, “The Serum Institute has applied to DCGI for its Novavax vaccine. The Subject Matter Expert Committee (SEC) has reviewed their application and asked them to submit the revised protocol.
“The application will be thoroughly evaluated by the panel of experts when the company presents the review.”
It should be noted that IBS is already manufacturing millions of doses of the Covishield vaccine in technical collaboration with the University of Oxford and AstraZeneca.
In the latest press release, Novavax announced that NVX-CoV2373, its protein-based Covid-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its phase clinical trial. three conducted in the United Kingdom (United Kingdom). The study evaluated efficacy during a period of high transmission and with a new variant strain of the virus in the UK emerging and circulating widely. It was carried out in partnership with the UK Government Vaccine Task Force.
The study, which has enrolled 15,000 people aged 18 to 84, is expected to be used to apply for use in Britain, the European Union and other countries.
NVX-CoV2373 contains a full-length prefusion peak protein made using Novavax’s recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 peak (S) protein and is produced in insect cells. It cannot cause Covid-19 or replicate, is stable between 2 degrees Celsius and 8 degrees Celsius (refrigerated), and is shipped in a ready-to-use liquid formulation that allows distribution using existing vaccine supply chain channels.

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