Pfizer withdraws plea on emergency use of vaccine

New Delhi, February 5

Pfizer today withdrew its application seeking grant of “emergency use authorization” for its Covid-19 vaccine in India after subject experts at the national regulatory body sought additional data denying immediate approval for the grant of licence.

The subject expert committee of the Central Drug Standards Control Organisation met on February 3 to review the application by Pfizer, which has not presented any bridging data on its vaccine from India.

The experts took note of the serious adverse events during post-market authorisation of the vaccine such as anaphylaxis and Bell’s palsy.

Pfizer said, “We will continue to engage with the authorities and resubmit our approval request with additional information, as it becomes available in near future.” — TNS

7 more vaccines in line

Health Minister Harsh Vardhan has said two Covid vaccines are already in use, while work is on on seven others, three of them in the third phase of trials.