Pfizer has dropped an application for emergency-use authorization of its Covid-19 vaccine in India, after refusing to cooperate with the regulator’s demands for local safety trials.
The decision by Pfizer means their vaccine will not be available for sale in the world’s two most populous countries, India and China, in the near future.
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Unlike other companies conducting studies in India for foreign-developed vaccines, Pfizer had sought an exemption citing approvals it had received elsewhere including the United States. When the regulator insisted on a local safety trial, Pfizer pulled the pin.
The news days after Moderna’s CEO was caught dumping hundreds of millions of dollars of Moderna stock and deleting his Twitter account. Another senior Moderna executive also dumped a huge amount of stock in the Big Pharma Company.
Pfizer also admitted last week that a safety audit could wipe billions off their stock market valuation.
Reuters report: The U.S. company, which was the first drugmaker to seek emergency approval in India for its vaccine developed with Germany’s BioNTech, made the withdrawal decision after a meeting with India’s Central Drugs Standard Control Organisation (CDSCO) on Wednesday.
The drug regulator said on its website its experts did not recommend the vaccine because of side effects reported abroad were still being investigated. It also said Pfizer had not proposed any 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 to withdraw its application at this time,” Pfizer said in a statement.
“Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.