FDA Claims It Needs 55 Years Before Revealing Data on Approval of Pfizer Vaccine

Doctor giving vaccination to patient

On Monday, the Food and Drug Administration (FDA) requested that the courts allow the agency to wait until the year 2076 to release all of the relevant documents regarding the approval of the vaccine developed by Pfizer and BioNTech, as reported by the Daily Caller.

The FDA made its request after a lawsuit was filed against the agency by the group Public Health Medical Professionals for Transparency (PHMPT). The PHMPT had previously made a Freedom of Information Act (FOIA) request on September 9th asking for the release of the vaccine approval documents; after the FDA denied the request, the group filed its lawsuit on September 16th.

The FDA concluded that there were roughly 329,000 pages in total that would qualify under this FOIA request. In its appeal to the courts, the agency said that, at most, employees would be able to “process and produce the non-exempt portions of responsive records at a rate of 500 pages per month.” Under this process, the FDA said that it would hand over prioritized documents to the plaintiff, and release non-exempt documents on a “rolling basis.”

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FDA Approves Moderna and Pfizer Boosters for Adults

The Food and Drug Administration (FDA) approved Moderna and Pfizer’s COVID-19 vaccines for booster shot use for adults in the U.S., the agency announced Friday,

The announcement was made just two months after the FDA first rejected the White House’s plan to administer booster shots to all adults the week of Sept. 20. FDA Acting Commissioner Janet Woodcock approved the booster without holding the usual public meeting to review the data, and the Centers for Disease Control and Prevention (CDC) will meet Friday afternoon to discuss the authorization, according to the FDA press release.

“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19,” Woodcock said in the press release.

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Mom to Sue After Son Vaccinated at School Without Consent

A Louisiana mother is threatening to sue, claiming that her 16-year-old son was vaccinated for COVID-19 while at his Jefferson Parish high school without her consent.

Jennifer Ravain alleged that during a visit by an Oschner Health System mobile vaccination clinic to East Jefferson High School, her son was allowed to sign a consent form and receive a COVID-19 vaccination despite the Louisiana Department of Health requirement of a parent’s signature for persons under 18 being vaccinated, WWL-TV reported.

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Commentary: Tennessee Legislature Must Pass Big COVID Test in ‘Special Session’

The red state/blue state dichotomy is not simple.

Nowhere is that more apparent than Tennessee where—despite having one of the most conservative electorates in the country—the leadership has been passive at best in responding to the wishes of their supporters during these days of great crisis.

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Commentary: Defense Department Pulls a Bait and Switch on Vaccines

On August 24, Secretary of Defense Lloyd Austin issued a memo to senior Pentagon leadership announcing that he was implementing a mandatory COVID-19 vaccination policy for all military service members. The day before, the FDA had issued full authorization to Pfizer for their Comirnaty COVID-19 vaccine product (the nomenclature of which is meant to be a mashup of the words “COVID”, “mRNA”, and “community”) . At first glance it would seem that the mandatory vaccination policy, while scientifically unsound and strategically foolish, was at least a policy being implemented according to both the letter of the directive and in accordance with the law. But a further examination of the facts and the manner in which this order is being implemented makes clear that the military’s implementation of this order is illegal and highly unethical.

In the memo, Secretary Austin issued a directive and a promise, that “Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance.” The problem with this is that the Comirnaty vaccine product that was approved by the FDA is not available anywhere in the Military Health System. It is not even in production, according to the military’s TRICARE healthcare providers. If a soldier goes to a military hospital or a private provider to receive an approved Pfizer COVID vaccine, he will be administered the unapproved Pfizer-BioNTech vaccine which is a vaccine that is not approved but has been administered under an Emergency Use Authorization (EUA). We are told that this is but a brand name difference, that the formulation is the same, and they can be used interchangeably. But as the FDA was approving the Comirnaty product, they were renewing the authorization for the Pfizer-BioNTech product. If it’s just a matter of brand name, why issue an approval for one brand name and an EUA renewal for the other? This is because they are not actually the same. 

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Commentary: Vaccination Rates Not Linked to Lower COVID Rates, Epidemiology Paper Finds

On Friday, the San Francisco Chronicle published an article noting that California has some of the lowest COVID-19 case rates in the US, even though the Golden State’s vaccination rate lags many states that are currently struggling with the delta variant.

“One clear example is the New England states of Vermont and Maine,” the Chronicle reported. “Relatively shielded from the worst of the nation’s previous surges, they have struggled against the delta variant, which has sent their case rates soaring.”

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Analysis: COVID-19 Is Not a ‘Pandemic of the Unvaccinated’

On Friday, September 17, the CDC published a study that refutes the common claim that COVID-19 is a “pandemic of the unvaccinated.” Coauthored by more than 50 MD’s and Ph.D.’s, the study contains data on the vaccine status of adults hospitalized with COVID-19 (C-19) at 21 U.S. hospitals across 18 states during March to August of 2021.

Contrary to assertions from the Associated Press and Anthony Fauci that fully vaccinated people comprise only 1% of those being hospitalized or killed by C-19, the study found that 13% of patients hospitalized with C-19 had been fully vaccinated. Moreover, that 13% figure is just the tip of the iceberg because the authors excluded from their study a large group of hospitalized C-19 patients, the bulk of whom were likely vaccinated.

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Feds: Vaccinated Americans Will Need Booster Shots

The Biden administration announced Wednesday that federal health experts now recommend vaccinated Americans receive a COVID booster shot.

The boosters will be widely distributed to the public after research indicated that the vaccine’s effectiveness declines over time.

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Commentary: Government’s Failed COVID Messaging Is to Blame for Vaccine Hesitancy

It was always going to be Herculean to inoculate, with an untried vaccine, a multi-ethnic nation of 330 million, across a vast continent—in an era when the media routinely warps the daily news.

Some minorities understandably harbored distrust of prior government vaccination programs.

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Biden Administration Allegedly Planning to Distribute Johnson and Johnson Vaccine to Illegal Aliens

Joe Biden is planning an effort to distribute doses of the Johnson & Johnson vaccine to illegal aliens pouring into the United States across the southern border, as reported by Breitbart.

The report first came from the Washington Post, after several officials with the Department of Homeland Security (DHS) spoke under condition of anonymity. According to the officials, federal authorities will soon begin administering the single-shot vaccine to illegals currently held in U.S. custody along the southern border with Mexico. DHS plans to get illegals vaccinated as soon as possible upon their entry into the country, to be done even before they are fully processed.

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Not One State Reported a Sizable Increase in Coronavirus Cases Last Week

Sick person talking to CDC employee

For the first time in months, not one state reported a dramatic weekly increase in coronavirus cases.

While average daily cases fell by less than 10% in 11 states, 37 states saw cases fall by over 10% and just two states had cases marginally increase, according to data from Johns Hopkins University. The United States also averaged fewer than 40,000 daily cases last week, a 21% drop from the week prior and the lowest total since September.

Death and hospitalization rates have also plummeted nationwide. The U.S. has averaged 600 deaths per day, the lowest point in approximately 10 months. If the number continues to fall the nation could soon hit its lowest point of the entire pandemic, according to the Associated Press.

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