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By Jenny Goldsberry
The U.S. became the first country to officially approve the Pfizer COVID-19 vaccine for everyone 16 years old and older Monday. It is currently the only vaccine fully licensed by the Food and Drug Administration.
According to a statement from the FDA, the vaccine received a new name and “will now be marketed as Comirnaty (koe-mir’-na-tee).”
“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” the statement read.
Then, Acting FDA Commissioner Janet Woodcock, M.D. lauded the announcement. “The approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Woodcock said in a statement. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
Next Pfizer CEO Albert Bourla made a statement to commemorate the approval. Bourla hopes this latest update “will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.”
You can follow Jenny Goldsberry on Twitter @jennyjournalism.
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Nebraska woman who detransitioned sues doctors who facilitated removal of ‘healthy breasts’ when she was a teen battling mental health
Nebraska woman Luka Hein is suing Nebraska Medicine, the Nebraska Medical Center, and University of Nebraska Medical Center (UNMC) Physicians who facilitated in her gender transition when she was a teenager; Hein has since detransitioned.
Hein, who is being represented by the Center for American Liberty, filed the suit last week, for removal of her healthy breasts when she was a depressed teenager who struggled with mental health.
“Proceeding straight to breast amputation in a depressed, anxiety-ridden, gender-confused adolescent, who was incapable of understanding the lasting consequences of her decision, constitutes negligence for which Defendants are jointly and severally liable,” the lawsuit states.
Fox News reports:
Throughout adolescence, Hein struggled with her mental health and traumatic experiences, including being allegedly groomed and threatened by an adult man. She had serious mental-health struggles at age 13. By 15 she was diagnosed with “gender identity disorder” and put on a fast track to have her breasts removed, according to the lawsuit.
The lawsuit claims that despite Hein’s history, doctors rushed her into gender transition without considering her psychological comorbidities. It says the defendants used deceptive euphemisms and unscientific terminology to sell gender-transition procedures to Hein.
For instance, their use of the phrase “masculinizing hormone therapy” was misleading as the process does not heal the patient but does “inflict harm that causes malfunctioning and malformation of the teenage body and brain,” according to the lawsuit. Testosterone injections, which Hein received as part of her attempted sex change, can cause many negative side effects including high blood pressure and permanent bodily changes such as the development of an Adam’s apple, deepening of the voice, abnormal hair growth, and male pattern balding of the scalp.
The lawsuit says defendants were also negligent in other ways, such as in their shifting from a standard medical diagnosis to the “affirming care” model, which embraces a person’s gender delusion as fact and discourages questioning.
Allegedly one doctor, Nahia J. Amoura, was prepared to go even further. “About a year after starting Luka on testosterone, Dr. Amoura recommended to Luka that she surgically remove her uterus in a partial hysterectomy as the next step in her ‘transition,’” the lawsuit states. The hysterectomy would have permanently sterilized Hein and created hormonal imbalances that would have required long-term medical follow-ups.
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