Tag: Pfizer-BioNTech

Just the News Sues Biden Administration to Force Disclosure of COVID-19 Vaccine Safety Data

Just the News
COVID Vaccines

Just the News on Thursday sued the Biden administration in federal court seeking to force the disclosure of COVID-19 safety data that is being kept outside the government’s normal adverse events reporting system

In the lawsuit filed in partnership with the America First Legal public interest law firm, Just the News asked the U.S. District Court in Washington, D.C., to order the Department of Health and Human Services to comply with two Freedom of Information Act requests to the Food and Drug Administration and the Centers for Disease Control and Prevention seeking COVID-19 reactions data kept in a back-end, nonpublic system to the nation’s Vaccine Adverse Event Reporting System (VAERS).

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FDA Quickly Authorizes COVID Shots for Infants and Young Children

Susan Berry, PhD

The Food and Drug Administration (FDA) quickly authorized the Moderna and Pfizer-BioNTech COVID vaccine shots for infants and young children Friday, paving the way for the Centers for Disease Control and Prevention (CDC) advisory committee to vote on authorization over the weekend to allow the youngest children to get the shots as early as next week.

Per the press announcement by the FDA, the Emergency Use Authorization (EUA) for the Moderna COVID vaccine for older children and adults has been “amended” to “include use of the vaccine in individuals 6 months through 17 years of age,” while the EUA for the Pfizer COVID shot will now include use of the vaccine for babies as young as “6 months through 4 years of age.”

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FDA Announces Postponement of Approval of COVID Vaccine for Babies and Young Children

Susan Berry, PhD
Young girl with a blue shirt on getting a vaccine

Pfizer and the Food and Drug Administration (FDA) said Friday they are delaying their plan for Pfizer’s Emergency Use Authorization (EUA) for its coronavirus vaccine for children under five years old due to insufficient data on the efficacy of a third dose.

Pfizer announced February 1 FDA had asked the drug company, and its partner BioNTech, to submit data on a COVID vaccine series for babies as young as six months old and young children up until age five.

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Pfizer Plan for COVID Vaccine Series for Babies of 6 Months Draws Fierce Controversy

Susan Berry, PhD
closeup of a baby

Pfizer announced last week the Food and Drug Administration (FDA) had asked the drug company, and its partner BioNTech, to submit data on a COVID vaccine series for babies as young as 6 months old.

Albert Bourla, chairman and CEO of Pfizer, said in the statement:

As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus. Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.

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6th Circuit Ruling Restoring Employer Vaccine Mandate Falsely Claims ‘Options Available to Combat COVID-19 Changed Significantly’ When ‘FDA Granted Approval to One Vaccine on August 23, 2021’

Peter D'Abrosca

The majority opinion released on Friday by the 6th Circuit Court of Appeals, which restored the Biden administration’s Occupational Safety and Health Administration (OSHA) Emergency Temporary Standard (ETS) requiring employers with more than 100 employees to mandate that all employees take a COVID-19 vaccinefalsely asserts that Pfizer’s Food and Drug Administration (FDA) fully approved vaccine is currently available and in use among the general public.”

“At the same time, the options available to combat COVID-19 changed significantly: the FDA granted approval to one vaccine on August 23, 2021, and testing became more readily available,” the majority opinion asserts on page 24 of the ruling.

The majority opinion was written by Obama-appointed Judge Jane Branstretter Stranch of the United States Court of Appeals for the Sixth Circuit.

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FDA Approves Moderna and Pfizer Boosters for Adults

Minnesota Sun Staff

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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Commentary: Defense Department Pulls a Bait and Switch on Vaccines

Minnesota Sun Staff

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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Pfizer-BioNTech to Seek Approval to Vaccinate 5-Year-Olds

Minnesota Sun Staff

BioNTech, the vaccine maker collaborating with Pfizer, is set to seek worldwide approval for its COVID-19 vaccine for children between the ages of 5 and 11 within the coming weeks, according to company executives.

“Already over the next few weeks, we will file the results of our trial in five to 11-year olds with regulators across the world and will request approval of the vaccine in this age group, also here in Europe,” Chief Medical Officer Oezlem Tuereci told Der Spiegel, according to Reuters.

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