FDA Authorized Second Booster for Americans 50+ Without Consulting With Its Vax Panel
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On Tuesday, the FDA authorized Americans who are 50 years of age and older to receive a second booster of the Covid shot from either Pfizer-BioNTech or Moderna. The move comes after the Biden administration, disregarding the most basic “scientific” decorum and procedures, was reported to offer older Americans a fourth dose of the Covid vaccine. By fall, younger Americans will likely be able to get their second booster, too.

The news of the administration’s planning to make yet another dose available to the public was first reported by The New York Times over the weekend.

The article reads,

“Federal health officials have hotly debated the way forward, with some strongly in favor of a second booster now and others skeptical. But they have apparently coalesced around a plan to give everyone aged 50 and up the option of an additional shot in case infections surge again before the fall.”

Would the fourth dose taken by older Americans in the spring be their last? Not at all! According to the report, “In the fall, officials say, Americans of all ages, including anyone who gets a booster this spring, should get another shot.”

There’s a troubling caveat in that decision: it seems to have been made by the administration without discussion with the U.S. Food and Drug Administration’s (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) “independent” panels. Meaning, the Biden administration is releasing the fourth vaccine booster without any public deliberation on the matter.

Typically, the official evaluation of vaccines’ safety, efficacy, and appropriate use starts with the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewing and evaluating the data presented by the vaccine’s manufacturer.

The committee typically consists of a core of 15 voting members, including the chair. Members and the Chair are supposed to provide their knowledge and expertise in fields ranging from immunology, molecular biology, rDNA, virology, and vaccine safety science to allergy, microbiology, and biochemistry to ensure the product in question meets all standards.

After a public discussion, the committee may or may not authorize the use of the product.

If it does, then the CDC’s Advisory Committee on Immunization Practices (ACIP) would issue recommendations regarding the product’s use. That recommendation serves as public health guidance.

It has become common knowledge that the federal public health agencies have been operating under regulatory capture, as was depicted, among others, by Robert F. Kennedy Jr.’s book, Real Anthony Fauci: Big Farma, Bill Gates, and the War on Public Health. Still, the Biden administration practically put aside its “follow the science” mantra and is now aggressively charging ahead with what it claims would benefit Americans.

Notably, since there is no “science” behind such a move, the administration plans to merely “make available” the fourth dose without officially “recommending” it. In other words, if someone decides that he or she is at “higher risk” for severe disease, hospitalization, and death from Covid, and if it has been at least four months since the third dose, then this person could get a fourth shot.

It is not just older Americans who can take it. The FDA said in its Tuesday announcement that those older than 12 who have certain immunological issues may take their fourth dose as well. The move seems counterproductive, since the vaccines could potentially damage an immune system (see here, here, and here).

Vinay Prasad of the Brownstown Institute argues that the advisory committees’ meetings are skipped “because they [the Biden administration and the committees] know many smart people will disagree with them, and consider their plan reckless, and lacking data. These people will give great quotes.” Indeed, the non-establishment scientists can take part in discussions and ask questions or make statements that the committee members could be unprepared for (here’s an example).

While saying that “skipping the ad-com is not what we do in a democratic, free, and transparent society,” Prasad added, “There is no one left to resign at FDA.”

Remarkably, back in August 2021, two senior FDA regulators resigned from their positions over disagreement with the White House’s pressure to move forward with COVID booster shots without FDA approval, as well as with the CDC’s involvement in the approval process.

One month later, the VRBPAC decided that it was too early to throw its support behind a blanket authorization for booster doses of Pfizer’s COVID shot for people 16 and older and voted against recommending it to the general public. The panel, however, said the at-risk groups, as well as people older than 65 may benefit from the third dose.

 The decision was an utter disappointment to President Biden, who announced in late August that Americans would be offered booster shots five months after their initial inoculation, starting September 20.

Now, in an election year, Biden would likely strive to “keep Covid numbers low,” argues Prasad, reaffirming the assumption that the federal agencies responsible for the public health act as political organizations.

As for the vaccines’ efficacy, the situation seems quite dire.

For reference, the third dose of the Covid shots got the OK from the government on December, 9, 2021, when the FDA amended  the emergency use authorization (EUA) for the Pfizer shot, authorizing the use of a booster dose for people 16 and 17 years of age.

One month later, the agency shortened the recommended interval between the initial inoculation and booster shot from six to five months and recommended immunocompromised Americans get a fourth dose of the shot. The agency also expanded the booster eligibility to include adolescents aged 12 to 17.

In February, the CDC once again updated its guidance for immunocompromised Americans, shortening the interval between the third and fourth doses from five to three months.

The great number of breakthrough Covid infections even among the triple-vaccinated has prompted the Pfizer CEO to announce that the immune protection offered by the third dose “is not very good against infections” and “doesn’t last very long.” Therefore, he expressed his belief that it would be “necessary” for all Americans to take another dose to “really” go back to the “way we used to live.”