India Blocks Rollout of Experimental Pfizer Vaccine, Demanding Clinical Trial

ER Editor: Thanks to Principia Scientifica International (PSI), a site we highly recommend, for running these two stories a few days ago.

India is requiring Pfizer to run a clinical trial of its experimental vaccine before general, ’emergency’ rollout can take place, whereas Pfizer was expecting a waiver of this (second story below). In response, America’s Frontline Doctors are throwing it back to Biden’s team to justify why it’s permitting the vaccine to be given in view of the clinically appropriate response of Indian health officials (first story).


Doctors Call On US To Address India’s Pfizer COVID Vaccine Block

America’s Frontline Doctors (AFLDS) today (ER: Feb 6) released the following statement urging the Biden administration to immediately respond to the decision by Indian health officials to deny authorization for Pfizer’s COVID-19 vaccine based on a lack of safety and efficacy evidence, according to a Reuters report:
“President Biden and his COVID-19 task force need to immediately and clearly explain to the American people why the Pfizer-BioNTech experimental vaccine is safe for Americans despite Indian drug regulators denying its emergency use based on concerns about potential side effects, immunogenicity, and other data. The burden of proof should fall on the Biden White House to provide Americans with greater transparency and information so that they can make informed decisions about their own healthcare. Science should guide this administration’s COVID response plan not public relations, polls, and politics.”



Pfizer In COVID Vaccine Retreat After India Demands More Data

Pfizer says it has withdrawn a request to have its Covid-19 vaccine authorized for use in India. The company has promised to resubmit the application once it gathers more data.

The US-based drug-maker said that the decision was taken after a meeting with an expert panel from India’s state regulator on Wednesday (ER: Feb 3).

“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’s spokesperson said in a statement.

The company added that it will “resubmit its approval request with additional information as it becomes available in the near future.”

The Economic Times newspaper cited a government source saying that Pfizer wanted a clinical trial waiver for its vaccine, developed jointly with the German firm BioNTech, but the regulator has insisted on a bridging study in India. The experts wanted to see how the vaccine would work among the Indian population before it could be cleared for general use in the country, the source explained.

Vinod K. Paul, the head of a government panel on vaccine strategy, told Reuters earlier this month a bridging trial in India is a “precondition” for any vaccine to be allowed in the country.

India launched a nationwide immunization campaign on January 16, using a locally manufactured version of the AstraZeneca-Oxford vaccine and a vaccine called Covaxin, made by an Indian pharmaceutical company, Bharat Biotech.




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