- Pfizer retracts application for emergency use of its COVID-19 vaccine in India
- Pfizer and Drugs Controller General of India had a meeting on Wednesday following which the decision was taken
- DCGI asked for additional information from Pfizer
On Friday, talking to the international news agency Reuters, Pfizer said that it has retracted an application for emergency use authorisation of its COVID-19 vaccine in India which the pharma firm developed with BioNTech, a company based out of Germany.
Pfizer, which is a US based Pharmaceutical firm, was the first drugmaker in India to apply for emergency use authorisation of its Coronavirus vaccine and had a meeting with the Drug Controller General of India (DCGI) on Wednesday following which the firm made its decision, Pfizer said.
In a statement to Reuters, the firm 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”.
Pfizer added, that in the future it might resubmit its application with the additional information sought by the Indian regulator.
Having said that, Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available soon, the statement said.
The company’s spokesperson 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”.
In India, Pfizer was the first pharma company to have sought the emergency use clearance for its COVID-19 vaccine from the Drugs Controller General of India (DCGI)
Meanwhile, India started its mass vaccination run to combat the virus from the 16th January after approving two COVID-19 vaccines for emergency use in the country – Serum Institute of India’s locally produced Oxford COVID-19 vaccine Covishield as well as Bharat Biotech’s indigenously manufactured Covaxin.
The United Kingdom was the first country in the world to approve Pfizer and BioNTech coronavirus candidate on 2nd December after the Medicines and Healthcare Products Regulatory Agency (MHRA) found it safe.
The country has already ordered 40 million (4 crore) doses of the Pfizer vaccine to vaccinate its 20 million (2 crore) population.
After the UK, Bahrain also approved the vaccine for “emergency use”. Bahrain’s drug regulatory body said that the approval was granted after a thorough analysis and review of all available data.
The COVID-19 vaccine from Pfizer has to be stored in an extremely low temperature of minus seventy degree Celsius (-70 °C) as the vaccine uses synthetic messenger RNA (mRNA) to prompt an immune response against the virus.
Additionally, on Tuesday, the US based Pharmaceutical firm Pfizer said it is expecting to generate a revenue of $ 15 billion (around ₹ 1.1 lakh crore) or about a quarter of its total revenue this year, from sales of its COVID-19 vaccine which was 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