The Curious Case Of FDA’s Approval Of Comirnaty

The FDA has long been criticized for its “revolving door” with Big Pharma where top executives move back and forth in top positions.


The case of FDA approval of BioNTech’s Comirnaty gene therapy injection abandoned all traditional precedents in pushing it through: incomplete data and trials, insufficient control group and no review board - Patrick Wood, Technocracy News


STORY AT-A-GLANCE


  • August 23, 2021, the U.S. Food and Drug Administration granted full approval to the COVID-19 mRNA injection developed by Pfizer/BioNTech, sold under the brand name Comirnaty, for use in people aged 16 and older

  • Normally, the FDA will hold a formal hearing and allow for public and expert input before a drug is moved from emergency use authorization to full approval but, in this instance, no such hearing was held

  • The notion that a “vaccine” that has killed more people in nine months than all other vaccines combined in three decades is considered safe stretches beyond the bounds of credulity and further undermines public trust in the FDA

  • The approval is based on six months’ worth of data from 44,047 people aged 16 and older. Half of them got the shots and half initially received a placebo. However, in early December 2020, Pfizer unblinded the control group and 93% of controls opted to get the real injection. This means we’ve had no control group since December 2020 and have nothing to compare the treatment group against

  • The FDA’s prescribing information for Comirnaty includes the risk of myocarditis and pericarditis, two types of heart inflammation that typically develop within seven days after the second injection


August 23, 2021, the U.S. Food and Drug Administration granted full approval1 to the COVID-19 mRNA injection developed by Pfizer/BioNTech, sold under the brand name Comirnaty, for use in people aged 16 and older.

It’s the fastest approval in history, granted less than four months after Pfizer filed for licensing May 7, 2021. It’s also based on just six months’ worth of data from 44,047 people aged 16 and older. Half of them got the shots and half initially received a placebo.

However, in the second week of December 2020, Pfizer unblinded the control group and 93% of controls opted to get the real injection rather than remain in the control group for the remainder of the trial, which is slated to continue for another two years.

Pfizer CEO Albert Bourla commented on the FDA’s approval, saying it “affirms the efficacy and safety profile of our vaccine,” and that he’s “hopeful this approval will help increase confidence in our vaccine …”


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