PM Narendra Modi reviewed the development of COVID-19 vaccine candidate ZyCOV-D in Ahmedabad.
The analysis of the additional data and information submitted by Serum Institute of India (SII) and Bharat Biotech is still being conducted by regulator Central Drug Standard Control Organisation s (CDSCO) Subject Expert Committee and their next meeting will be held on January 1.
The Subject Expert Committee met on Wednesday to consider the Emergency Use Authorisation (EUA) request of Pfizer, SII and Bharat Biotech Private Ltd.
Further time was requested on behalf of Pfizer, while the additional data and information presented by the SII and Bharat Biotech was perused and analysed by the SEC.
In the Phase 1 study, which is being jointed conducted by the ICMR, the researchers have said the reactogenicity “was absent in the majority of participants, with mild events”. And on immune response, the researchers concluded that both “robust humoral and cell-mediated responses were observed”.
“…this study has several strengths. To ensure generalizability, this study was conducted with participants from diverse geographic locations and socioeconomic conditions, enrolling 375 participants across 11 hospitals. Despite the fact that enrollment occurred during a national lockdown, which led to several operational challenges, the overall participant retention rate was 97%. The sample size was intentionally large to enable the inference of meaningful conclusions regarding immunogenicity and safety,” the researchers concluded.
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Global Ventilator Market to Reach $3,110 Million by the End of 2020 Due to COVID-19 Pandemic
The global ventilator market is witnessing an exponential rise in the size of the market due to the ongoing COVID-19 pandemic. The overall market was estimated to be $1,072 million in FY 2018, and it was expected to grow at a CAGR of 7.1% in the pre-COVID scenario.
However, the COVID-19 pandemic has resulted in an extensive rise in the ventilator demand and has increased the growth rate by up to 172% in 2020. Presently, more than 45 companies are operating in this market, including already exiting healthcare companies and emerging non-healthcare companies.
Covid vaccine emergency use approval: What are the rules in India? Why are 3 vaccines facing hurdle financialexpress.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from financialexpress.com Daily Mail and Mail on Sunday newspapers.