By Krishna N. Das
NEW DELHI (Reuters) – Pfizer Inc said Friday it had withdrawn an application for an emergency use permit of its COVID-19 vaccine in India after failing to meet the drug regulator’s demand for a local safety and immunogenicity study.
The decision means the vaccine will not be on sale in the world’s two most populous countries, India and China, for the foreseeable future. Both countries are conducting their immunization campaigns with other products.
Unlike other companies that conducted small studies in India for vaccines developed abroad, Pfizer had sought an exception by citing approvals it had obtained elsewhere based on studies conducted in countries such as the United States and Germany.
Indian health officials say they generally ask for so-called bridging tests to determine if a vaccine is safe and generates an immune response in citizens. However, there are provisions in Indian rules to waive such processes under certain conditions.
The US company, which was the first drug manufacturer to seek emergency authorization in India for its vaccine developed with Germany’s BioNTech, made the decision to withdraw on Wednesday after a meeting with India’s Central Drugs Standard Control Organization (CDSCO).
The drug regulator said on its website that its experts do not recommend the vaccine because side effects reported abroad are still being investigated. It also said Pfizer had not proposed a plan to generate safety and immunogenicity data in India.
“Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided at this time to withdraw its application,” Pfizer said in a statement.
“Pfizer will continue to liaise with the authority and resubmit its approval request with additional information as it becomes available in the near future.”
Reuters was the first to make the news.
Pfizer had requested approval for its vaccine in India late last year, but the government approved two much cheaper injections in January – one from Oxford University / AstraZeneca and another developed in India by Bharat Biotech with the Indian Council of Medical Research.
Both companies had applied for approval for their vaccines after Pfizer and their trials are underway in India. The local company Dr. Reddy’s Laboratories Ltd is conducting trials for the Russian Sputnik V vaccine, which is expected to be approved this month or next.
(Reporting by Krishna N. Das; additional reporting by Anuron Kumar Mitra; edited by Raju Gopalakrishnan and Jason Neely)