By Krishna N. Das
NEW DELHI (Reuters) – Pfizer Inc. on Friday said it had withdrawn an application for emergency permits for its COVID-19 vaccine in India after failing to comply with the drug regulator’s requirement for a local safety and immunogenicity study.
The decision means that the vaccine will not soon be on sale in the two most populous countries in the world, India and China. Both countries run their vaccination campaigns using other products.
Unlike other companies that did small studies in India for vaccines developed abroad, Pfizer sought an exception stating approvals it received elsewhere based on trials conducted in countries such as the United States and Germany. is.
Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and elicits an immune response in the citizens. However, there are provisions under India’s rules to waive certain hearings in certain circumstances.
The US company, which was the first drug manufacturer to seek emergency approval in India for its vaccine developed with German BioNTech, made the withdrawal decision after a meeting with the Indian Central Drug Standards Organization (CDSCO) on Wednesday.
The drug regulator said on its website that its experts do not recommend the vaccine because there are still side effects reported abroad being investigated. It is also said that Pfizer has not proposed any plan to generate safety and immunogenicity data in India.
“Based on the deliberations during the meeting and our understanding of additional information that the regulator may require, the company has decided to withdraw its application at this time,” Pfizer said in a statement.
“Pfizer will continue to contact the authorities and resubmit its request for approval with additional information as it will be available in the near future.”
Reuters was the first to announce the news.
Pfizer requested permission for the vaccine in India late last year, but the government approved two much cheaper shots in January – one from Oxford / AstraZeneca University and another developed by Bharat Biotech in India with the Indian Council for Medical Research.
Both companies have applied for approval of their vaccines after Pfizer and their trials continue in India. The local business Dr. Reddy’s Laboratories Ltd is holding trials for the Russian Sputnik V vaccine, which is expected to be approved this month or next year.
(Reporting by Krishna N. Das; Additional Reporting by Anuron Kumar Mitra; Editing by Raju Gopalakrishnan and Jason Neely)