1st July 2022

Did Recent Court Rulings Force the FDA to Delay Approving Pfizer’s COVID Shots for Infants?

Pfizer-Infant-vaccination

 
Health Impact News, February 12, 2022, Print This Post Print This Post

 

by Brian Shilhavy
Editor, Health Impact News

Operation Warp Speed has hit its first bump in the road.

The U.S. Food and Drug Administration (FDA) announced yesterday that it was delaying approval of Pfizer’s COVID-19 vaccines for young children between the ages of 6 months and 4 years old.

Since up until this point the FDA has illegally approved all other Pfizer COVID-19 “vaccines” by simply rubber-stamping Pfizer’s own data which is hidden from the public, the question that begs to be answered is, why?

Pfizer has worked hard to hide the clinical data from their trials from the public, but recent court rulings have not exactly gone their way. The FDA had originally asked the court to delay releasing their clinical data for 75 years, but then agreed to provide 500 pages per month.

In late January, Attorney Aaron Siri reported that a federal judge shot down the FDA’s requested rate of 500 pages per month and instead ordered the FDA to produce at the rate of 55,000 pages per month starting on March 1. Siri also reported that Pfizer was joining the FDA in the case. And why not, since the FDA basically works for Pfizer?

As explained in prior posts, in a lawsuit seeking all of the documents the FDA relied upon to license Pfizer’s COVID-19 vaccine, a federal judge shot down the FDA’s requested rate of 500 pages per month and instead ordered the FDA to produce at the rate of 55,000 pages per month starting on March 1.

Since the government has trillions of dollars of our money, it is putting it to good use by fighting to assure that the public has the least amount of transparency possible.  To that end, it has now asked the Court to make the public wait until May for it to start producing 55,000 pages per month and, even then, claims it may not be able to meet this rate.

The FDA’s excuse?  As explained in the brief opposing the FDA’s request, the FDA’s defense effectively amounts to claiming that the 11 document reviewers it has already assigned and the 17 additional reviewers being onboarded are only capable of reading at the speed of preschoolers.

Meanwhile…

As the FDA tries to obtain months of delay, guess who just showed upon in the lawsuit?  Yep, Pfizer.  And it is represented by a global chair and team from a law firm with thousands of lawyers.  Pfizer’s legal bill will likely be multiple times what it would cost the FDA to simply hire a private document review company to review, redact, and produce the documents at issue.  Within weeks, if not days.

Pfizer is coming in as a third party.  But Pfizer assures the Court it is here to help expedite production of the documents.  Sure it is!  Where was Pfizer before the Court ordered the 55,000 pages per month?  Right, doing what it normally does: letting the government work on its behalf – like the way the government mandates, promotes, and defends Pfizer’s product. (Full article.)

Last week, the judge in this case, U.S. District Judge Mark Pittman, denied Pfizer’s request (for now) to join the case. (Source.)

The next day, Pfizer redlined changes in their 4th quarter earnings release from 2021. ZeroHedge News reported:

Two weeks ago, the FDA begged a Texas judge to delay production on the first monthly batch of 55,000 pages of Covid-19 vaccine data submitted to the agency by Pfizer. Originally, the agency was set to produce just 500 pages-per-month.

Now, Pfizer – which just forecast $54 billion in Covid-related sales in 2022, appears to be anticipating some bad newsas evidenced by several redline changes in their Q4 earnings releases.

As Rubicon Capital’s Kelly Brown notes on Twitter, the changes center around disclosures of unfavorable safety data.

For example, in Q4 they added: “or further information regarding the quality of pre-clinical, clinical or safety data, including by audit or inspection.”

More from Brown, who notes that Pfizer is now highlighting “concerns about clinical data integrity…”

The company also notes that Covid-19 may “diminish in severity or prevalence, or disappear entirely.”

What’s behind the curtain, Pfizer? (Full article.)

Here’s the spin on the FDA decision that was released to the media, as reported by Courthouse News Service (via AP):

WASHINGTON (AP) — Covid-19 vaccinations for children under 5 hit another monthslong delay Friday as U.S. regulators abruptly put the brakes on their efforts to speed review of the shots that Pfizer is testing for youngsters.

The Food and Drug Administration, worried about the omicron variant’s toll on kids, had taken the extraordinary step of urging Pfizer to apply for OK of the extra-low dose vaccine before it’s clear if tots will need two shots or three. The agency’s plan could have allowed vaccinations to begin within weeks.

But Friday, the FDA reversed course and said it had become clear the agency needed to wait for data on how well a third shot works for the youngest age group. Pfizer said in a statement that it expected the data by early April.

FDA’s vaccine chief Dr. Peter Marks said he hoped parents would understand that the agency’s decision was part of its careful scientific review of the evidence Pfizer has submitted so far.

That information “made us realize that we needed to see data from a third dose from the ongoing trial in order to make a determination,” Marks told reporters. “We take our responsibility for reviewing these vaccines very seriously because we’re parents as well.”

The nation’s 18 million children under 5 make up the only age group not yet eligible for vaccination. (Full article.)

It’s too bad for Pfizer that Donald Trump is no longer president, because he could have intervened to help Pfizer get their shots out to those 18 million children by strong-arming the FDA, like he originally did back in December 2020 when he threatened the FDA head, Dr. Stephen Hahn, to approve the COVID-19 shots or be fired.

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