FDA places millions at risk by restricting access to vaccines

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Just imagine if you got your local plumber to do a heart valve replacement..

Vaccines eliminated the scourge of smallpox - the biggest killer in history

"...In a significant shift in COVID-19 vaccination policy, the Food and Drug Administration (FDA) announced plans this week to limit access to future vaccine doses in the United States. Under the new regulatory framework, outlined by FDA officials Drs. Vinay Prasad and Martin A. Makary in the New England Journal of Medicine, annual COVID-19 booster shots will primarily be available to older adults—typically those over 65—and to individuals aged 6 months and older with underlying medical conditions that put them at high risk for severe COVID-19 outcomes.

This policy marks a major departure from previous policy. It is being promoted as a way to further normalize the ongoing COVID-19 pandemic and treat SARS-CoV-2 as just another respiratory virus among the many that sicken the population each year.

The Centers for Disease Control and Prevention (CDC) defines eligible high-risk conditions broadly, including obesity, mental health conditions like depression, asthma, cancer, heart disease and diabetes. FDA officials estimate that, under the new strategy, between 100 million and 200 million Americans—roughly 30 to 60 percent of the US population—will remain eligible for vaccines. However, this framework would leave many healthy Americans, including younger adults and children, potentially ineligible for routine vaccination, despite the risks posed by Long COVID, which affects 4-10 percent of the US population. Roughly 1 in 10 adults who have had COVID-19 develop this debilitating condition.

For healthy individuals between 6 months and 64 years old without risk factors, the FDA now requires randomized, controlled trial data evaluating clinical outcomes before granting Biologics License Applications for vaccines in this group. This demand for more robust evidence exceeds previous authorization processes for updated boosters, which often relied on immunogenicity data.

In their NEJM article, Prasad and Makary cynically argue that these policy changes aim to prevent further declines in immunization rates caused by eroding public trust in vaccination. They reference declining MMR vaccination rates for measles, correctly noting that these vaccines are safe and protective. However, they do not acknowledge that mistrust in vaccines has been fueled by the very individuals and institutions now shaping public health policy, who have promoted conspiracies and alternative treatments instead of sound scientific advice.

Prasad and Makary themselves have a well-documented history of undermining public health measures and promoting pseudoscientific positions. Both have been outspoken critics of previous FDA policies, with Prasad labeling the agency a “failure” and calling annual COVID-19 boosters “a public health disaster the likes of which we’ve never seen before.” Makary, meanwhile, has repeatedly minimized the dangers of COVID-19, falsely predicting the pandemic would be “mostly gone” by April 2021, and has lent credibility to the Wuhan Lab Lie conspiracy theory, despite a lack of supporting evidence.

Their rhetoric mirrors that of the anti-vaccine movement, recycling arguments long used by opponents of science-based medicine. During the pandemic, Prasad in particular became a prominent critic of mask mandates, lockdowns and efforts to speed the deployment of vaccines, aligning himself with reactionary figures and platforms that have consistently opposed effective public health interventions.


plus

This is an extensive three-part interview with Dr. Daszak, which was conducted on May 4, 2025, with the World Socialist Web Site as part of the Global Workers’ Inquest into the COVID-19 Pandemic, which was initiated to “break through the cover-up, falsification and misinformation that have been deployed to justify policies responsible for the avoidable deaths of millions since the initial detection of SARS-CoV-2.” We urge our readers to share this interview as widely as possible.




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Just imagine if you got your local plumber to do a heart valve replacement..

Vaccines eliminated the scourge of smallpox - the biggest killer in history

"...In a significant shift in COVID-19 vaccination policy, the Food and Drug Administration (FDA) announced plans this week to limit access to future vaccine doses in the United States. Under the new regulatory framework, outlined by FDA officials Drs. Vinay Prasad and Martin A. Makary in the New England Journal of Medicine, annual COVID-19 booster shots will primarily be available to older adults—typically those over 65—and to individuals aged 6 months and older with underlying medical conditions that put them at high risk for severe COVID-19 outcomes.

This policy marks a major departure from previous policy. It is being promoted as a way to further normalize the ongoing COVID-19 pandemic and treat SARS-CoV-2 as just another respiratory virus among the many that sicken the population each year.

The Centers for Disease Control and Prevention (CDC) defines eligible high-risk conditions broadly, including obesity, mental health conditions like depression, asthma, cancer, heart disease and diabetes. FDA officials estimate that, under the new strategy, between 100 million and 200 million Americans—roughly 30 to 60 percent of the US population—will remain eligible for vaccines. However, this framework would leave many healthy Americans, including younger adults and children, potentially ineligible for routine vaccination, despite the risks posed by Long COVID, which affects 4-10 percent of the US population. Roughly 1 in 10 adults who have had COVID-19 develop this debilitating condition.

For healthy individuals between 6 months and 64 years old without risk factors, the FDA now requires randomized, controlled trial data evaluating clinical outcomes before granting Biologics License Applications for vaccines in this group. This demand for more robust evidence exceeds previous authorization processes for updated boosters, which often relied on immunogenicity data.

In their NEJM article, Prasad and Makary cynically argue that these policy changes aim to prevent further declines in immunization rates caused by eroding public trust in vaccination. They reference declining MMR vaccination rates for measles, correctly noting that these vaccines are safe and protective. However, they do not acknowledge that mistrust in vaccines has been fueled by the very individuals and institutions now shaping public health policy, who have promoted conspiracies and alternative treatments instead of sound scientific advice.

Prasad and Makary themselves have a well-documented history of undermining public health measures and promoting pseudoscientific positions. Both have been outspoken critics of previous FDA policies, with Prasad labeling the agency a “failure” and calling annual COVID-19 boosters “a public health disaster the likes of which we’ve never seen before.” Makary, meanwhile, has repeatedly minimized the dangers of COVID-19, falsely predicting the pandemic would be “mostly gone” by April 2021, and has lent credibility to the Wuhan Lab Lie conspiracy theory, despite a lack of supporting evidence.

Their rhetoric mirrors that of the anti-vaccine movement, recycling arguments long used by opponents of science-based medicine. During the pandemic, Prasad in particular became a prominent critic of mask mandates, lockdowns and efforts to speed the deployment of vaccines, aligning himself with reactionary figures and platforms that have consistently opposed effective public health interventions.


plus

This is an extensive three-part interview with Dr. Daszak, which was conducted on May 4, 2025, with the World Socialist Web Site as part of the Global Workers’ Inquest into the COVID-19 Pandemic, which was initiated to “break through the cover-up, falsification and misinformation that have been deployed to justify policies responsible for the avoidable deaths of millions since the initial detection of SARS-CoV-2.” We urge our readers to share this interview as widely as possible.




comrade stalin
The FDA placed millions of Americans at risk by releasing covid vaccines that were insufficiently tested and had track records of serious side effects.


tCheck.org® A Project of The Annenberg Public Policy Center

It’s Not News, Nor ‘Scandalous,’ That Pfizer Trial Didn’t Test Transmission​

By Catalina Jaramillo

Posted on October 18, 2022 | Clarification on October 19, 2022

SciCheck Digest​

The COVID-19 vaccine clinical trials were designed to study the vaccine’s safety and efficacy in preventing symptomatic disease, not transmission. But online publications now misleadingly present the fact that the Pfizer/BioNTech vaccine was not tested for transmission as a “shocking admission” and proof that the company and the government lied.


How were the COVID-19 vaccines tested?

Full Story​

More than 16 million Americans had contracted COVID-19 and more than 300,000 had died from the disease when the first COVID-19 vaccine, from Pfizer/BioNTech, was cleared for use.

The Food and Drug Administration authorized the use of the vaccine on Dec. 11, 2020, in what the agency called a “milestone” in the fight against the coronavirus, or SARS-CoV-2, and “a true testament to scientific innovation and public-private collaboration worldwide.”

The emergency use authorization followed a review of data from phase 3 clinical trials that showed the vaccine was safe and 95% effective in preventing symptomatic COVID-19 a week or more after the second dose (the figure fell to 91% in the updated analysis reviewed for full approval). The clinical trials did not assess if the vaccine could reduce transmission, and neither the companies nor the government ever claimed they did.

“At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person,” the FDA stated when it announced the emergency use authorization.

How can a person transmit covid to someone else if he has been immunized from covid by the vaccine?
 
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