By Krishna N. Das
NEW DELHI (Reuters) – Pfizer Inc. said on Friday it withdrew an application for an emergency use authorization for 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 that the vaccine will not be available for sale in the two most populous countries in the world, India and China, in the near future. Both countries are running their immunization campaigns using other products.
Unlike other companies conducting small studies in India for vaccines developed abroad, Pfizer sought an exception by citing approvals it had received elsewhere based on tests done in countries like the United States and Germany.
Indian health officials say they often ask for so-called transition tests to determine whether a vaccine is safe and generates an immune response in its citizens. There are, however, provisions in India’s rules for waiving such judgments under certain conditions.
The American company, which was the first pharmaceutical company to seek emergency approval in India for its vaccine developed with the German BioNTech, made the withdrawal decision after a meeting with the Central Drugs Standard Control Organization (CDSCO) in India on Wednesday .
The drug regulator said on its website that its experts did not recommend the vaccine because the side effects reported abroad were still being investigated. He also said that Pfizer has not proposed any plans to generate safety and immunogenicity data in India.
“Based on the deliberations of the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its order at this point,” Pfizer said in a statement.
“Pfizer will continue to engage with the authority and resubmit your approval request with additional information as it becomes available in the near future.”
Reuters was the first to break the news.
Pfizer had sought authorization for its vaccine in India at the end of last year, but in January the government approved two much cheaper vaccines – one from the University of Oxford / AstraZeneca and the other developed in India by Bharat Biotech with the Indian Medical Research Council. .
Both companies applied for approval of their vaccines after Pfizer, and their trials are underway in India. Local company Dr. Reddy’s Laboratories Ltd is running tests for the Russian Sputnik V vaccine, which is expected to pass this month or next.
(Reporting by Krishna N. Das; additional reporting by Anuron Kumar Mitra; editing by Raju Gopalakrishnan and Jason Neely)