New Delhi: India’s drug regulatory authority has withheld approval of Pfizer’s Covid vaccine after the Subject Expert Committee (SEC) said that it does not recommend granting permission for its emergency use authorisation (EUA) in the country “at this stage”.
The Central Drugs Standard Control Organisation’s (CDSCO) expert committee has noted number of serious adverse events (SAE) observed post-marketing of the Pfizer vaccine in other countries as a prime reason behind its non-recommendation for EUA here, minutes of the meeting accessed by IANS said.
“The committee noted that incidents of palsy, anaphylaxis and other SAEs have been reported during post-marketing and the causality of the events with the vaccine is being investigated,” the committee observed, as per the document.
Besides, the SEC noted that the firm has not proposed any plan to generate safety and immunogenicity data “in Indian population”.
“After detailed deliberation, the committee has not recommended grant of permission for emergency use in the country at this stage,” the directions from experts’ committee in the document said.
The US-based pharmaceutical giant was the first drugmaker to apply for the EUA of its Covid vaccine in the country on December 5. The Pune-based Serum Institute of India followed it on December 6 for EUA of Covishield while Bharat Biotech sought EUA for Covaxin on December 7.
Both Covishield and Covaxin were permitted for EUA on January 3 by the Drug Controller General of India. Their administration is underway in the country’s Covid immunisation programme.
Meanwhile, Pfizer has issued a statement, saying that it has withdrawn its application for now and would re-apply with the additional data in hand sought by the SEC.
“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,” it said in the statement.
“Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future,” the company added.