FDA authorizes Pfizer vaccine for 12-15-year-olds

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(NEW YORK) — The Pfizer vaccine has been authorized for children ages 12 and up, widening the U.S. population that will be protected against the virus and bolstering chances for a safe return to full-time school in the fall, the Food and Drug Administration announced Monday.

“We know this is a big step for our country. Vaccinating a younger population brings us closer to returning to a sense of normalcy and to ending the pandemic,” acting FDA Commissioner Janet Woodcock said at a press briefing on Monday night.

Woodcock said parents and guardians can “rest assured that in making our decision, the agency undertook a rigorous and thorough review of all available scientific data, as we have with all the COVID-19 vaccine authorizations.”

Pfizer vaccines for kids age 12-15 could be administered as soon as Thursday, Woodcock said, so long as all goes well at Wednesday’s Advisory Committee on Immunization Practices (ACIP) meeting, which is the next step in the vaccine rollout.

Pfizer announced in late March that its clinical trials showed the vaccine was safe and 100% effective in children ages 12-15, similar to the 95% efficacy among adult clinical trial participants.

It was the first vaccine to show data in children as young as 12, a promising first step toward vaccinating younger Americans. The vaccine was the only option for 16- and 17-year-olds in the U.S., with Moderna and Johnson & Johnson authorized for those 18 and older. Now, the FDA authorization means kids throughout middle and high schools will have the opportunity to be vaccinated before the fall, alleviating many of the hurdles schools face in stopping transmission.

Currently, about 115 million Americans are fully immunized — about 35% of the population.

After a trial with over 2,000 children, Pfizer found no cases of infection among the children who had been given the vaccine and 16 cases of infection among the children who received a placebo, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at the press briefing.

No cases of COVID occurred in the 1,005 adolescents that received the vaccine, while there were 16 cases of COVID among the 978 kids who received the placebo, “thus indicating the vaccine was 100% effective in preventing COVID-19 In this trial,” said Marks.

Adolescents experienced a similar range of side effects as seen in older teens and young adults — generally seen as cold-like symptoms in the two to three days after the second dose — and had an “excellent safety profile,” Marks said.

“Based on all this available information, the FDA determined the Pfizer-BioNTech vaccine has met all of the criteria required to amend the EUA, which concluded that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the vaccine’s known and potential risks,” Marks said.

Marks encouraged parents who were hesitant to vaccinate their children to speak with their pediatricians, urging confidence in the trial and data.

“The vaccine had an excellent profile in children, and though one can say that often children don’t get terribly sick from COVID-19, there are kids who do get very sick from it and in addition, they can bring it asymptomatically around to their grandparents and others,” Marks said. “So this is part of the totality of getting our country protected against COVID-19, which is just waiting around the corner to come have another wave if we don’t get to a sufficient degree of vaccination.”

In an interview with ABC News ahead of the authorization, Pfizer CEO Albert Bourla said getting children the vaccine would be “great news,” not only for the kids, “but also for the parent, grandfathers and therefore the American society in general.”

Bourla acknowledged that some parents might be nervous to vaccinate their young kids, but said Pfizer has been “extremely careful with children” and waited to begin studying the vaccine with anyone 15 or younger until hundreds of millions of doses were studied in adults.

According to recent polling from the Kaiser Family Foundation, just 29% of parents of children under 18 said they’ll get them vaccinated as soon as it’s available for their age group. A third said they’re inclined to wait and see and the rest remained more hesitant.

“What we can promise to our parents is that we have done very thorough examination, more thorough than in any other vaccine, exactly because of the visibility that this vaccination is having,” Bourla told ABC News.

Moderna, the second mRNA vaccine approved for use in the U.S., said it is still studying the results among children ages 12 and up.

Dr. Ashish Jha, dean of the Brown University School of Public Health, said on ABC’s Good Morning America recently that getting vaccines to kids “will make an enormous difference for infection numbers in the community and schools for fall as well.”

While children are not considered at high risk of severe illness from the coronavirus, they represent about a quarter of the U.S. population and vaccinating them is critical to stopping the spread of the virus.

Bourla also noted that kids can still spread the virus.

“When the kids are vulnerable, they are also contributing to the pool where the virus can replicate and, of course also, they are contributing to the chain of reinfections to other group ages,” he said.

“In addition to protecting the kids, as I said, the most important thing is that you can contribute to herd immunity in the country,” he added.

Experts predict the U.S. needs anywhere between 70% to 85% of the U.S. population to be vaccinated before it can reach herd immunity, when there is enough of a defense against the virus that it will no longer be able to spread. Specialists said the higher number of people with immunity the more difficult it is for the virus to spread, so every vaccinated person reduces the risk for those around them from getting COVID too.

Both Pfizer and Moderna are continuing to study the vaccines in trials of children ages 6 months to 11 years old. Bourla, the CEO of Pfizer, confirmed that the company is expecting to have data on vaccines for elementary school students by the end of the year.

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Moms search for lifesaving bone marrow donors for daughters with rare diseases

DKMS

(NEW YORK) — A group of moms from across the country celebrated Mother’s Day this year with one wish — to find the bone marrow donors who will save their daughters’ lives.

“If she gets the bone marrow transplant, she’ll be a normal baby,” Anessa Haden said of her 8-month-old daughter, True, who has been told by doctors she likely won’t live past the age of 3 without a matching donor. “A bone marrow transplant is literally her hope to a long life.”

True was diagnosed three months ago with congenital amegakaryocytic thrombocytopenia (CAMT), a rare disease in which bone marrow no longer produces platelets, which are critical to blood clotting and preventing bleeding, according to the National Institutes of Health (NIH).

Haden, of Huntsville, Alabama, said True, her first child, was quickly categorized as an “emergency transplant” case because she needs a bone marrow transplant to survive.

The past three months of Haden’s life have, as a result, been a dizzying mix of hospital stays and doctors’ appointments for True, while Haden does everything she can to find a bone marrow match for her daughter.

Making the task more difficult is True’s interracial background — a mix of African American, Indian, Puerto Rican and Caucasian — which makes it harder to find a match because these ethnicity groups are underrepresented in the global donor pool, according to DKMS, an international nonprofit organization that works to find bone marrow matches.

“It’s definitely an isolating experience,” said Haden. “A lot of people hear bone marrow transplant and they don’t really get to see the life and face of a kid who needs a bone marrow transplant.”

After finding each other through both DKMS and social media, Haden has formed a lifelong bond with three other mothers from across the country who are also searching for matching blood marrow donors who could save their daughters’ lives.

Destiny Van Sciver, of California, is looking for a matching donor for her two daughters, Kylie, 9, and Kimora, 13, both of whom were diagnosed with sickle cell disease at 6 weeks old.

Doctors have told Van Sciver that one matching donor could help both of her daughters but they have yet to find that donor. Like True, the girls’ race, Black, has made it harder to find a donor because people of color are underrepresented on the bone marrow registry.

People of color account for 7% of all registrants on the registry, according to DKMS.

“We always fantasize about a day where we won’t have to do all these things,” said Van Sciver, whose oldest daughter, Kimora, recently had to undergo a hip transplant. “It’s so frustrating seeing my daughter trying to learn how to walk every day, knowing that there’s a cure out there that can save her.”

In Louisiana, Jaimie Havard is looking for a bone marrow match for her 16-year-old daughter, Courtlynn, who was diagnosed with aplastic anemia and paroxysmal nocturnal hemoglobinuria in October. The high school sophomore went from playing baseball and softball to undergoing weekly blood and platelet transfusions to stay alive, according to Havard.

“Her life is totally different now,” said Havard. “A [bone marrow] transplant is the cure. It’s truly a difference between life and death for these children.”

Just before Mother’s Day, the three moms and one more, Tara Forrest, of Boston, whose 14-year-old daughter Ali Pantoja is battling acute myeloid leukemia, met on Zoom for the first time after spending weeks connecting by phone, texts and social media.

“You instantly have a connection with them because you feel the pain and desperation,” said Havard. “It’s just amazing to be able to talk to somebody who actually knows what you’re feeling on the inside.”

“Other people can be sympathetic but they can’t be empathetic because they’re not quite walking in my shoes,” said Haden. “To have other moms or dads who understand, it’s definitely vital. It means the world to us to be able to connect.”

All four moms are working with DKMS to recruit bone marrow donors for their daughters.

“It truly is all consuming,” Havad said of the search for a donor. “The focus is on your child and their future. Knowing that their future lies in a stranger’s hand, your mindset then goes to what can I do to get this story out, to get people to swab their cheek and get on the donor list to save a life?”

Only around 30% of patients are able to find a compatible bone marrow donor in their family, according to DKMS co-founder and chairwoman Katharina Harf, whose family started the nonprofit when Harf’s mother died of leukemia after not being able to find a bone marrow donor match.

Each year in the United States, around 18,000 people are diagnosed with life-threatening illnesses where a bone marrow transplant or umbilical cord blood transplant is their best treatment option, according to the U.S. Health Resources and Service Administration (HRSA).

All it takes to join the bone marrow registry is to request a swab kit, which DKMS offers online, and to swab the inside of your cheeks.

If a person is found to be a match, in most cases, the process of donating their bone marrow or stem cell is an outpatient procedure and one that does not require surgery, according to Harf.

“You’re giving a second chance at life to a person,” said Harf. “A lot of our patients really celebrate the day they receive the stem cells as a second birthday.”

Van Sciver said she and the moms she has met while searching for cures for their daughters may come from different backgrounds and have different stories but they are all just “moms asking for help.”

“I really hope that people hear this message and want to get out and make a difference,” she said. “One person would make a difference.”

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HHS to reverse Trump administration policy that restricted protections for gay and transgender patients

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(WASHINGTON) — The Biden Administration announced Monday it will move to protect gay and transgender people against sex discrimination in health care.

The Department of Health and Human Services said it will roll back a Trump administration policy that tried to narrow the legal protections against discrimination in health care by issuing rules defining sex as gender assigned at birth.

“Fear of discrimination can lead individuals to forgo care, which can have serious negative health consequences,” HHS Secretary Xavier Beccera said in a statement.

Beccera said this action today puts HHS in line with a 6-3 Supreme Court decision last year, which established that federal laws against sex discrimination on the job also protect gay and transgender people.

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Charlie Puth comes clean about his embarrassing YouTuber past

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Charlie Puth’s YouTuber past has come back to haunt him.

Much to his chagrin, TikTok has unearthed some of his old videos from before he was a signed artist. One includes him performing a song called “Sexy Shades,” about — you guessed it — his favorite pair of sunglasses.

“I’ve been waiting for this day to come. I lasted five years without anybody knowing this,” Charlie said in a TikTok video response. “Before I was a signed artist, I used to make YouTube comedy songs, and, bro, they’re so hard to watch.”

He added, “We tried so hard in the beginning when I first got signed to hide all of these videos, but, TikTok! So, if you want a good laugh, type in my name plus old videos and have fun.”

Some other gems include “The Pickle Song” and “Red Hyundai,” an ode to Charlie’s car.

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Cardi B joins YouTube’s billion views club with “Bodak Yellow”

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Cardi B‘s breakthrough debut single, “Bodak Yellow,” earned a major new accolade this week by being inducted into YouTube’s elusive one billion views club.

The song’s music video, which Cardi previously revealed was filmed on a tight $15,000 budget, crossed the billion-view threshold over the weekend after premiering a little over four years ago.

“Fifteen thousand dollars, A billion views later !!!!! Wow that’s crazy !,” Cardi shared Monday. “Super dope. Thank you all for all the support through out the years….. Back to the lab. Love & appreciate y’all .”

This isn’t the first time the Grammy winner made money moves past the one billion mark. Her previous collaborations with Maroon 5, as well as Bad Bunny and J Balvin, for “Girls Like You” and “I Like It,” respectively, also amassed over a billion views.  However, this is Cardi’s first solo effort to join the exclusive club.  It also officially makes Cardi the first female rapper to send multiple videos past the billion-views mark.

Also, according to Chart Data, “Bodak Yellow” obtained a billion views faster than any other song made by a female rap artist.

The song’s enjoyed an impressive run since being unleashed in 2017, when it became the first single by a female rapper to top the Billboard Hot 100 for three consecutive weeks.  The song’s success helped Cardi’s debut album, Invasion of Privacy, gain critical acclaim and chart on the Billboard 200 chart for three years.

Her follow-up album is rumored to drop later this year, but neither a name nor release date has yet been announced.

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Duran Duran turned down the chance to work with Michael Jackson in the ’80s

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In the ’80s, when Michael Jackson was the biggest star on the planet, any other star would’ve jumped at the chance to work with him, right? Well, not so much.

Appearing on Bravo’s Watch What Happens Live with Andy Cohen Monday night, Duran Duran was asked by Cohen if they were friendly with the King of Pop in the ’80s, when Thriller was all the range and they were topping the charts with “The Reflex.” 

Keyboardist Nick Rhodes revealed that around that time, he’d returned home from a tour and received a call from someone saying they were Michael Jackson.  He initially thought it was one of their crew members pranking him, but he finally realized that yes, it was THE Michael Jackson.

“He was keen to make a record, and I go the next day to everyone…’Hey, Michael Jackson called last night, do you fancy maybe doing a song with him or something?'” Nick recalled. “And they all went, ‘Nah!’

The band also insinuated that Princess Diana had a crush on bass player John Taylor, and said they wouldn’t mind making a biopic about themselves like Bohemian Rhapsody or Rocketman, with singer Simon LeBon adding, “Can we have a young Brad Pitt play me?”

Duran Duran, who are celebrating the 40th anniversary of their self-titled first album, will release their latest project, Future Past, on October 22.

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NY AG probe finds Cuomo sexually harassed multiple woman

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(NEW YORK) — New York Gov. Andrew Cuomo was found to have sexually harassed multiple women, including current and former state employees, New York State Attorney General Letitia James announced Tuesday morning after a four-month probe into the allegations.

According to James, the probe found that Cuomo and his staff fostered a toxic work environment — though Cuomo has denied any wrongdoing and has sought in recent weeks to cast doubt on the integrity of the investigation.

Once considered a leading voice among national Democrats for his aggressive response to the coronavirus pandemic, Cuomo has suffered a meteoric fall from grace in recent months under a deluge of negative headlines.

When sexual harassment claims against Cuomo emerged in March, federal investigators were already reportedly probing his administration over concerns that it withheld damning data about nursing home deaths in New York. Cuomo has also faced scrutiny over reports that he prioritized testing for his family in the early days of the pandemic.

At least six women, including several who previously worked for the three-term governor, have accused Cuomo of inappropriate behavior and unwanted advances — claims that he has either dismissed as an exaggeration or outright denied.

“Wait for the facts,” Cuomo said in March. “An opinion without facts is irresponsible.”

Reports of the alleged misconduct prompted James to launch an independent investigation, tapping two seasoned investigators to lead the probe.

As part of the fallout from the sexual harassment claims, Cuomo faced calls from several high-profile Democrats — including Rep. Alexandria Ocasio Cortez, D-N.Y., and Senate Majority Leader Chuck Schumer, D-N.Y. — to resign. Cuomo has rebuffed those calls.

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Pentagon on lockdown due to police activity

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(WASHINGTON) — A Pentagon spokesperson said the building was put on lockdown Tuesday morning due to police activity outside.

Additional information was not immediately available.

This is a developing story. Please check back for updates.

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Carly Pearce’s new album, ‘Written in Stone,’ features collaborations with Patty Loveless, Ashley McBryde

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Carly Pearce‘s story of 29 continues with her upcoming album, Written in Stone. 

Carly is expanding upon the personal album she released in February, which processes her divorce from Michael Ray and the passing of her producer, busbee, with Written in Stone. It features eight new songs, alongside the original seven on 29. 

The project features collaborations with Patty Loveless on “Dear Miss Loretta” and Ashley McBryde on “Never Wanted to Be That Girl,” alongside other new tracks “Diamondback,” “What He Didn’t Do,” “Easy Going,” “Your Drinkin,’ My Problem,” “All the Whiskey in the World,” and “Mean It This Time.” 

Coinciding with the album news, the Kentucky native released “Dear Miss Loretta,” a country ode to Loretta Lynn with strong supporting vocals from Patty, in which Carly shares how she connects to the legend’s pain-soaked songs.  

“So much has happened to me in the last year. The more my life unraveled, the more the songs lifted me up,” Carly describes. “As the smoke cleared, and some unbelievable things started happening, I was writing even more truth and getting lifted up even higher — and I realized, as much as 29 captured a moment, I wasn’t done with the story.”

News of Written in Stone arrives on September 17, hours before the “I Hope You’re Happy Now” singer is to be inducted into the Grand Ole Opry.

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Tito Jackson explains the hold up on a hologram Michael Jackson for a Jackson 5 reunion tour

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Ahead of the release of his second blues-inspired solo album, Under Your SpellTito Jackson is setting the record straight about the status of The Jacksons. Contrary to the rumors, Tito says he and his brothers JackieJermaine and Marlon are still together and touring, but just not necessarily in the U.S.

“We have always been together and we work tremendously,” he tells ABC Audio. “I would say 90 percent of our work comes in other countries. So we’re always in Europe or Brazil or Asia or somewhere in Russia doing shows.”

In fact, Jackson says The Jackson 5, which included himself, Jermaine, Jackie, Marlon and Michael, would still be touring together today — if Michael was still alive.

“Sad thing for us all is that when Michael was going to do the O2 [arena shows], we had planned to do another tour of the complete members,” Jackson says. “And that never came to fruition… But, we will always sing together as long as we can, as long as the brothers are healthy enough to do so.”

While MJ’s planned 2009 concert residency at London’s O2 Arena, and a subsequent Jackson family tour never took place because of Michael’s untimely death, Tito says other options to reunite The Jackson 5 are being discussed.

Tito says the idea of incorporating an MJ hologram into a Jackson 5 reunion tour has “been discussed a few times, [but]…to have it done [takes] a tremendous knowledge, work in technology, what have you.”

Jackson adds, “And it’s not a cheap process. It’s getting cheaper and cheaper as time goes along. But to have a hologram Jacksons show live…would be the next thing.” 

Under Your Spell arrives this Friday, August 6, on the usual platforms.

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