Pfizer has decided to withdraw its application for regulatory approval of its Covid-19 vaccine under emergency circumstances in India, nearly two months after approaching authorities here for this permission.
The US-based pharma company, which was the first drugmaker to apply for emergency use authorisation of its 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, adding it will in the future look to resubmit its application with the additional information that the regulator requires.
Pfizer says it will “continue to engage” with the authority and resubmit its approval request with additional information “as it becomes available in the near future.”
At this stage, it is unclear what additional information has been sought from the firm, which developed its mRNA Covid-19 vaccine in collaboration with German biotech firm BioNTech.
“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.
Pfizer was the first firm to approach the Central Drugs Standard Control Organisation (CDSCO) for an EUA in early December after it had received such an approval in the United Kingdom. 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.
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.
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.
