FDA Grants Emergency Authorization of Pfizer’s Bivalent COVID-19 Booster in Children Under 5 Years Who Completed Three Monovalent Shots
On Tuesday, the Food and Drug Administration (FDA) announced that it granted an emergency use authorization for Pfizer’s bivalent COVID-19 booster in children under 5 years who had previously received three monovalent shots, despite concerns from well-respected doctors about the dangers of the COVID-shots.
“Pfizer Inc. and BioNTech SE announced today that the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to provide a single booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 4 years of age (also referred to as under 5 years of age) at least 2 months after completion of primary vaccination with three doses of the Pfizer-BioNTech COVID-19 Original Vaccine,” according to the company’s release.
“Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner,” the company said.
Under the expanded EUA, the bivalent booster dose may be given to children at least 2 months after they received a third dose of Pfizer’s monovalent vaccine. The FDA said children who have not yet completed their primary series should complete it with a dose of bivalent vaccine and are not eligible for a bivalent booster.
“[This] authorization provides parents and caregivers of children aged 6 months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 bivalent vaccine,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.
In the release, the FDA said immune response data from a study of 60 children aged 6 months to 4 years showed that participants had an immune response to both strains 1 months after receiving the bivalent shot.
It also detailed findings from a clinical study that included 24 participants aged 6 months through 23 months and 36 participants aged 2 years through 4 years of age. Common side effects in the former group included irritability, drowsiness, injection site redness, pain and swelling, decreased appetite, fatigue and fever; and the most common side effects in the latter group included fatigue, injection site pain, redness and swelling, diarrhea, vomiting, headache, joint pain and chills.
Recall, the reformulated bivalent COVID boosters were not tested on humans – only mice.
So the bivalent boosters tested in these human studies were not exactly the same as the bivalent ones being administered now in clinics, pharmacies, and other vaccination sites throughout the country. No, if you want human clinical trial data specifically on the bivalent BA.4/5 booster, you’re gonna have to wait a little while. According to a company announcement on August 31, the human clinical trial for the Moderna bivalent BA.4/5 booster is “fully enrolled and currently underway.” That same day, Gretchen Vogel reported for Science that the clinical trial for the Pfizer-BioNTech bivalent BA.4/5 booster will commence in September this month.
So what data specific to the BA.4/BA.5 boosters, did the FDA use to expand the EUAs to include the BA.4/BA.5 boosters? Well, the answer is at least in part very “mice.” Apparently, both Moderna and Pfizer-BioNTech have provided non-human animal data on the BA.4/BA.5 boosters to the FDA to state their case for the EUA. But they haven’t yet shown this data to the rest of the scientific community or the public.
BIDEN ECONOMY: Federal Government Spending UP 40% Since 2019 as Inflation Soars and Recession Looms
The Biden economy is destroying America and our way of life as we know it. The main element behind the 40-year high inflation, the rising interest rates and the banking segment collapse is Biden’s spending. It’s almost uncontrollable.
Steve Bannon laid it out nicely. Biden’s spending is leading to inflation, rising interest rates and the banking segment collapse.
DEVELOPING: Moody’s Cuts Outlook For Entire US Banking Sector, Puts Six Banks on ‘Downgrade’ Watch
The CATO Institute laid out the massive spending in a recent report.
Federal spending jumped from $4.45 trillion in 2019 to $6.21 trillion in 2023, according to the Congressional Budget Office. That is a 40 percent increase in four years. The pandemic supercharged the federal budget, and spending and deficits are expected to continue rising unless policymakers pursue major reforms.
What is all the new spending since 2019? The answer is surprising, as shown in the two tables below. The main drivers of the recent increases have not been the largest three programs—Social Security, Medicare, and defense—but rather rapid growth in numerous other programs.
CATO shows the amount of spending by category:
Below is the increase in spending by Department. Food stamps are the big driver under the Department of Agriculture.
Hidden in these numbers are the costs for the millions of illegal aliens who have been allowed to enter this country and the costs of paying people to stay home.
This mess is a nightmare and will only accelerate as the Biden regime works daily to take down America.
Utah State Wide Receiver Josh Davis Suffers Sudden Cardiac Arrest During Practice
On Friday, Utah State revealed that football player Josh Davis suffered a “non-traumatic sudden cardiac arrest” on Thursday during practice.
Davis, a wide receiver for Utah State, had a medical emergency during practice at Maverik Stadium and was taken to Logan Regional Hospital.
He was initially reported to be in critical condition, but his condition was upgraded to fair the following morning, according to ESPN.
According to Utah State, Davis was “taken off life-sustaining medical devices and is breathing on his own.”
Read the statement below:
Josh Davis, a football player for Utah state, has been upgraded from critical to fair condition as of Friday morning, following a non-traumatic sudden cardiac arrest during Thursday’s spring practice on Merlin Olsen Field at Maverick stadium.
Davis, who is currently in the intensive care unit at McKay Dee Hospital in Ogden, has been taken off life-sustaining medical devices and is breathing on his own.
Davis, a redshirt freshman wide receiver from Carlsbad, California, collapsed during practice on Thursday and was immediately treated by USU’s athletic training staff, led by Mike Williams, associate athletics Director for sports medicine, followed by emergency medical personnel, who transported him to Logan regional hospital.
Davis received initial critical treatment and was stabilized at Logan regional hospital before being transported to McKay-Dee Hospital, where their critical care team continued treatment with therapeutic hypothermia to lower the body temperature to preserve his neurological function.
Davis’ parents, Matt and Chrissy, arrived in Utah Thursday evening, and were met at the hospital by Utah State team physician Dr. David G. Liddle, interim athletic director Jerry Bovee, head football coach Blake Anderson, and athletic trainer Kendra Gilmore.
Update on Josh Davis.
We ask that you continue to keep Josh and his family in your thoughts and prayers. pic.twitter.com/ASuhTLjVkC
— USU Football (@USUFootball) March 24, 2023
Davis is “awake, alert, and breathing on his own,” Anderson said, via Utah State football play-by-play radio voice Scott Garrard per Si.com.
He added, “The training staff absolutely saved his life. No hesitation at all. Miracle.”
Kentucky Gov. Andy Beshear Vetoes Bill to Ban Minors From Sex Change Surgeries and Hormones
Kentucky’s Democrat Governor Andy Beshear has vetoed a bill banning minors from receiving sex change surgeries and hormones.
Doctors who have already prescribed children puberty blockers or hormones will have to cease doing so or taper them off if stopping abruptly could harm them.
The legislation, SB 150, bans discussion of sexual orientation and gender identity in schools, requires students to use bathrooms intended for their biological sex, and dictates that educators must notify students’ parents when and if they receive any mental health services related to sexuality.
Fortunately, the bill had passed the state’s Republican-led House with a veto-proof majority, so the governor will likely be overridden next week.
“In Kentucky, the expanded version that reached Beshear’s desk was rushed through both legislative chambers in a matter of hours March 16 before lawmakers began an extended break. The fast-track work enabled lawmakers to retain their ability to override the governor’s veto. The action triggered outrage among opponents unable to stop the legislation,” CBS News reports.
In his statement about the veto, Beshear said that the legislation allows “too much government interference in personal healthcare issues and rips away the freedom of parents to make medical decisions for their children.”
The governor also claimed that not sterilizing or mutilating physically healthy minors could cause an uptick in suicide.
“My faith teaches me that all children are children of God and Senate Bill 150 will endanger the children of Kentucky,” Beshear said.
“Andy Beshear thinks it’s okay for children to have access to life-altering sex change surgery and drugs before they turn 18,” said Sean Southard, a spokesman for the Kentucky Republican Party, according to a report from ABC News. “Today, he revealed how radical he truly is.”
The American Civil Liberties Union of Kentucky has already threatened a lawsuit when the bill becomes law.
“Governor Beshear has demonstrated his commitments to protect Kentucky parents’ rights to raise their children as they see fit, and to keep medical decisions where they belong: between providers and patients,” wrote the ACLU Kentucky in a statement. “The adults in the General Assembly should focus on what students, teachers, and schools really need, rather than single out vulnerable children to score cheap political points. ”
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