India says Pfizer Covid vaccine not recommended for emergency use ’at this stage’
- India's drug regulator committee on Pfizer Covid-19 vaccine says it noted side effects reported abroad and causality of events are being investigated
- The committee also says Pfizer did not propose any plan to generate safety and immunogenicity data in Indian population
India's Central Drugs Standard Control Organization (CDSCO)'s expert committee on Friday said that it does not recommend granting permission for emergency use authorization of Pfizer's Covid-19 vaccine in the country "at this stage."
The CDSCO's Subject Expert Committee (SEC) noted that "incidents of palsy, anaphylaxis and other SAE’s have been reported during post-marketing and the causality of the events with the vaccine is being investigated."
The committee also stated that the firm "has not proposed any plan to generate safety and immunogenicity data in Indian population."
"After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage," SEC further stated in its document.
Earlier today, the US-based pharma company, which was the first drugmaker to seek emergency approval in India for its vaccine developed with Germany's BioNTech, made the withdrawal decision after a meeting with CDSCO.
"Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time," Pfizer said in a statement.
"Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future," the company added.
Pfizer's Covid-19 vaccine needs to be stored in an extremely low temperature of minus 70 degrees Celsius since the vaccine uses synthetic messenger RNA (mRNA) to prompt an immune response against the virus.
Moreover, Pfizer on Tuesday said it expects to generate $15 billion, or about a quarter of its total revenue this year, from sales of its Covid-19 vaccine co-developed with German partner BioNTech SE.
Sales from the vaccine - on track to be the drugmaker's top product this year - could top $15 billion if the company signs more supply contracts, it said.
Pfizer aims to make two billion doses of the Covid-19 vaccine in 2021.
Meanwhile, India started its mass vaccination against the virus from 16 January after approving two Covid-19 vaccines from emergency use in the country – Serum Institute of India's locally produced Oxford Covid-19 vaccine Covishield and Bharat Biotech's indigenously manufactured Covaxin.
Moreover, local company Dr Reddy's Laboratories Ltd is running trials for Russia's Sputnik V vaccine, which is expected to be approved this month or next.
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Business NewsNewsIndiaIndia says Pfizer Covid vaccine not recommended for emergency use ’at this stage’
First Published:5 Feb 2021, 03:17 PM IST
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