2 min read.Updated: 05 Feb 2021, 10:59 AM IST Written By Staff Writer( with inputs from Reuters )
Pfizer has taken the decision after understanding what additional information the regulator requires, says company's spokeswoman
New Delhi: Pfizer Inc has withdrawn an application for emergency-use authorization of its COVID-19 vaccine in India that it has developed with Germany's BioNTech, the company told Reuters on Friday.
The US-based pharma company, which was the first drugmaker to apply for emergency use authorization of its COVID-19 vaccine in the country, had a meeting with India's drugs regulator on Wednesday and the decision was made after that, the company said.
"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," it said in a statement to Reuters, adding it will in the future look to resubmit its application with the additional information that the regulator requires.
Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future, the statement said.
"Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment," the spokesperson said.
In response, the Indian drug regulator committee said not recommended granting permission for emergency use for Pfizer's Covid-19 vaccine .
In a statement, the CDSCO's expert committee said, "Pfizer did not propose any plan to generate safety and immunogenicity data in Indian population."
The committee also said that it noted side effects reported abroad, causality of events being investigated.
Pfizer was the first pharmaceutical firm to seek from the Drugs Controller General of India (DCGI) for the emergency use authorisation for its Covid-19 vaccine in the country. Meanwhile, India started its mass vaccination against the virus from 16 January after approving two Covid-19 vaccines from emergency use in the countyr – Serum Institute of India's locally produced Oxfoed Covid-19 vaccine Covishield and Bharat Biotech's indegenously manufactured Covaxin.
The UK became the first country in the world to approve Pfizer and BioNTech coronavirus candidate on December 2 after the Medicines and Healthcare Products Regulatory Agency (MHRA) found the jab safe.
The country has already ordered 40 million doses of the Pfizer vaccine to vaccinate its 20 million population. After the UK, Bahrain has also approved the vaccine for 'emergency use'. Bahrain's drug regulatory body said the approval was granted after a thorough analysis and review of all available data.
Pfizer's Covid-19 vaccine need 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.