Pfizer Quietly Drops Vaccine Application After Regulator Demands Safety Trial

Fact checked
Pfizer has dropped an application for emergency-use authorization of its Covid-19 vaccine in India after the regulator demanded local trials.

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.

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.

Latest Videos

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.

Baxter Dmitry

Baxter Dmitry

Baxter Dmitry is a writer at News Punch. He covers politics, business and entertainment. Speaking truth to power since he learned to talk, Baxter has travelled in over 80 countries and won arguments in every single one. Live without fear.
Email: baxter@newspunch.com
Baxter Dmitry

4 Comments

  1. Various doctors say families of loved ones hospitalized with covid19 are resorting to desperate measures when approved treatments(slow death protocols) have failed. When it’s not too late, some have seen tremendous success by sneaking Ivermectin medication prohibited by hospitals to patients. It is really sad situation what has our country become. You can get your ivm by visiting ivmcures/com (Looks like I can’t post links, replace / with .)

Leave a Reply

Your email address will not be published.




This site uses Akismet to reduce spam. Learn how your comment data is processed.