Pfizer will re-submit its application with additional information on the vaccine required by the Drugs Controller General of India (DCGI).
As per SEC- who advises the regulator- Pfizer had "not proposed any plan to generate safety and immunogenicity data in the Indian population."
Prizer requested a waiver on clinical trials citing the data submitted by them from the trials conducted in the UK, U.S., and other countries that showed the vaccine's safety and efficacy, The Print reported. The SEC declined to accept the approval request without a small local trial on the vaccine's safety in the Indian population.
The SEC also noted that "incidents of palsy, anaphylaxis, and other SAE's have been reported during post marketing," and the cause of these events is being investigated.
In a statement to Reuters, Pfizer 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 said it would continue to engage with the authority and resubmit its application with additional information on the vaccine required by the DCGI.
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