NEW DELHI/MUMBAI: The Indian drug regulator’s subject expert committee has denied emergency use authorisation to Pfizer’s Covid-19 vaccine on the ground that causality of its reported adverse events was being probed and the company had not presented any plan to generate safety and immunogenicity data.
The decision came even as US-based Pfizer on Friday said it was withdrawing its application for emergency use approval. The panel also held absence of data from local clinical trials as a reason for not proceeding with its application. It observed that serious adverse events, including palsy and anaphylaxis, were reported during post-marketing of vaccine globally.
The regulator maintained that any foreign firm with a vaccine candidate developed outside India would have to conduct at least bridging studies in India to ensure immunogenicity. It is understood that Pfizer had sought the nod to import vaccine, besides a waiver of clinical trials on Indian population.
A Pfizer spokesperson said, “Based on the deliberations and our understanding of information that the regulator may need, the firm has decided to withdraw its application at this time. Pfizer will continue to engage with the authority and resubmit its request with additional information as it becomes available. It remains committed to making its vaccine available for use by Indian government and to pursuing the requisite pathway for emergency use authorisation.”
Over 4,000 adverse events were reported after people got Pfizer-BioNTech Covid-19 vaccine in US, a report by Centers for Disease Control and Prevention said in January.