FDA is (again) corrupt to its core — bivalent BA4-BA5 COVID vaccines

© 2022 Peter Free

 

12 September 2022

 

 

US public health has abandoned a legitimate definition of 'vaccine' . . .

 

. . . as well as all the rules underlying science-based vaccine approval.

 

 

From the FDA . . .

 

. . . comes the following bit of unalloyed corruption:

 

 

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.

 

The bivalent vaccines, which we will also refer to as “updated boosters,” contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.

 

The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older.

 

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.

 

The monovalent COVID-19 vaccines that are authorized or approved by the FDA and have been administered to millions of people in the United States since December 2020 contain a component from the original strain of SARS-CoV-2.

 

© 2022 US Food and Drug Administration, Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose, fda.gov (31 August 2022)

 

 

Think about this . . .

 

. . . particularly if you are not a gullible fool and do have a sound background in medically related matters.

 

First, the original monovalent mRNA COVID vaccines did not (and do not) perform the way previously accepted effective vaccines do.

 

 

They do not reduce infection transmission.

 

Nor do they perform preventatively well across even a few months time.

 

Worse, worrisome evidence keeps rolling in, that these mRNA vaccines do some well-populated demographic groups more harm than good. For example, potentially — here.

 

 

Second, the bivalent BA4 and BA5 versions of these have never been safety and efficacy tested on humans.

 

 

Of this latter point . . .

 

. . .The Financial Times made the obvious point — here quoted by The Daily Sceptic:

 

 

[S]everal health experts note that the boosters have yielded only limited data from a small number of tests on mice.

 

They say there is no evidence that they provide better protection against infection or severe disease than existing jabs.

 

“Without the data and getting a human response in at least a limited number of people you just set it up for the anti-vaxxers, anti-science [people],” said Eric Topol, founder and director of the Scripps Research Translational Institute.

 

“There are already groups calling it the mouse vaccine… We already have a trust problem in this country and we don’t need to make it worse,” he said.

 

The U.S. approach diverges with that of the EU, where regulators have said they want clinical data before authorising the latest generation of bivalent boosters.

 

© 2022 Toby Young, Biden Administration Criticised for Buying 171 Million New Covid Boosters for $5 Billion and Rolling Them Out Without Human Trials, Daily Sceptic (quoting the Financial Times)

 

 

For those of us who recognize the value of old-fashioned, patient-centered medical ethics . . .

 

. . . meaning that we have not sold our souls to Big Pharma and Big Government — physician-professor Vinay Prasad absolutely destroys the FDA's bullshit-based manipulation of the American public.

 

See:

 

 

Vinay Prasad, FDA Authorizes Pfizer & Moderna Bivalent Booster, What does it mean? — A doctor explains, YouTube (31 August 2022)

 

Vinay Prasad, CDC recommends the booster WIDELY after ACIP meeting — A Professor Reflects on this action, YouTube (02 September 2022)

 

 

The moral? — Randomized controlled clinical trials remain absolutely necessary . . .

 

. . . to support any medical measures of this gravity. Especially so, when being applied indiscriminately across such widely different demographic and vulnerability groups.

 

Therefore, I agree with Prasad's assessment that the FDA's one-size-fits-all approach is "reckless and dangerous".

 

He considers the FDA — "delinquent".

 

I agree. On precisely the same systemic and ethical grounds that he presents.