The SEC committee noted that incidents of Palsy, anaphylaxis and other SAEs have been reported during the post marketing and the causality of the events with the vaccines is being investigated. Further Pfizer has not proposed any plan to generate safety and Immunogenicity data in Indian Population.
After the CDSCO decision, Pfizer Inc has withdrawn an application for emergency-use authorization of its COVID-19 vaccine in India that it has developed with Germany’s BioNTech, the company told Reuters on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.
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.
