NEW DELHI (BERNAMA): U.S. pharmaceutical company Pfizer has withdrawn its application for Emergency Use Authorisation (EUA) of its COVID-19 vaccination in India, officials said Friday.
Pfizer has developed its COVID-19 vaccine with Germany’s BioNTech and was the first firm to seek an emergency use authorisation from drug regulator Drugs Controller General of India (DCGI), China’s Xinhua news agency reported.
In pursuance of the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3.
“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,” a company spokesman was quoted by local media as saying.
“Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future.
“Media reports said the nature of the information sought by the Subject Expert Committee was not known so far. However, the company said it remains committed to make its vaccine and keep it available for the use in India.Pfizer approached the DCGI for emergency authorisation in December.– BERNAMA