There is opinion in this article.
As reported earlier, Doctor Robert Malone informed on his substack this morning that the FDA has gone rogue. They are now developing their own EUAs – Emergency Use Authorizations. We now find that the FDA self-approved vaccines for children.
No sooner did we write about that when along comes another notice from the FDA via attorney Aaron Siri.
Mr. Siri wrote on X, “Today, FDA approved (12+ year olds) & authorized (6 months to 11 year olds) new monovalent C-19 vaccine based on “manufacturing data” and no clinical trial. Your taxpayer dollars at work.”
The FDA standard is now “the totality of the evidence.” It strikes some as a low bar. This is not the standard we are used to from the FDA, particularly for our children.
Also, based on the standard, Mr. Siri notes that you cannot give informed consent. You are basing everything on faith. The FDA believes they have enough evidence and data from past tests. Some will be okay with this.
THE FDA NOTICE
“Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.,” the FDA writes.
Data Supporting the Updated mRNA COVID-19 Vaccines (2023-2024 Formula) via FDA
The mRNA COVID-19 vaccines approved and authorized today are supported by the FDA’s evaluation of manufacturing data to support the change to the 2023-2024 formula and non-clinical immune response data on the updated formulations, including the XBB.1.5 component.
- The updated mRNA vaccines are manufactured using a similar process as previous formulations. In studies that have been recently conducted, the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5 and BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with prior versions of the vaccines against corresponding prior variants against which they had been developed to provide protection. This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants.
- The benefit-risk profile of previously authorized and approved mRNA COVID-19 vaccines is well understood as these vaccines have been administered to hundreds of millions of people in the United States.
Based on an evaluation of the totality of the evidence, the benefit-risk profile is favorable for individuals 6 months of age and older to receive an updated COVID-19 mRNA vaccine. Although serious outcomes from COVID-19 are less common in younger individuals, they do occur, and it has been demonstrated that recently receiving a COVID-19 vaccine reduces the risk of such serious outcomes.
THE CONCERNS
The booster is mismatched, says Dr. Malone. In other words, it’s for Omicron, which is almost extinct.
As you know, Pfizer won’t release the trial data for 75 years. There is no need to wait 75 years in this case because there is none, as Mr. Siri states.
Good news is that we don’t need to wait 75 years to get the clinical trial data for this vaccine. Because there is none! https://t.co/dATPggBDc7
— Aaron Siri (@AaronSiriSG) September 12, 2023
