American company Pfizer Inc has withdrawn its application for emergency-use authorisation in India for the covid 19 vaccine. The development came, reportedly after a meeting with India’s drug regulator Drugs Standard Control Organisation (CDSCO).
Reuters said in a report that Pfizer failed to meet the drug regulator’s demand for a local safety and immunogenicity study. “Unlike other companies conducting small studies in India for foreign-developed vaccines, Pfizer had sought an exception citing approvals it had received elsewhere based on trials done in countries such as the United States and Germany,” the news agency said in its report published this week.
The New York-based company said in a statement, “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.”