Pfizer vaccine authorized for kids ages 12 to 15: What parents should know

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(NEW YORK) — COVID-19 vaccine eligibility has now been widened for children ages 12 and up.

The U.S. Food and Drug Administration (FDA) on Monday authorized the Pfizer vaccine for children ages 12 to 15, bolstering chances for a safe return to full-time school in the fall. Vaccinations for 12-15-year-olds may start later this week after the director of the U.S. Centers for Disease Control and Prevention (CDC) endorses recommendations on distribution plans.

All people in America 16 years and older are already eligible to receive the Pfizer vaccine, and anyone 18 years and older is eligible for Moderna or Johnson & Johnson.

Pfizer, which is currently conducting clinical trials with children as young as 6 months old, has said it will likely seek an emergency use authorization for its vaccine for children ages 2 to 11 in September.

Moderna — which, like Pfizer, received emergency use authorization for its COVID-19 vaccine from the FDA in December — and Johnson & Johnson — which received emergency use authorization from the FDA for its vaccine in February — are also both currently conducting clinical trials with children.

The rapid pace of progress has left parents searching for answers as quickly as the science develops.

Here is what parents may want to know about the COVID-19 vaccines and kids to help them make decisions.

1. What is the science behind the COVID-19 vaccine?

Both the Pfizer and Moderna vaccines use mRNA technology, which does not enter the nucleus of the cells and doesn’t alter human DNA. Instead, it sends a genetic “instruction manual” that prompts cells to create proteins that look like the virus — a way for the body to learn and develop defenses against future infection.

The Johnson & Johnson vaccine uses an inactivated adenovirus vector, Ad26, that cannot replicate. The Ad26 vector carries a piece of DNA with instructions to make the SARS-CoV-2 spike protein that triggers an immune response.

This same type of vaccine has been authorized for Ebola, and has been studied extensively for other illnesses — and for how it affects women who are pregnant or breastfeeding.

Neither of these vaccine platforms can cause COVID-19.

2. Why do kids need to be vaccinated against COVID-19?

While have not been as many deaths from COVID-19 among children as adults, particularly adults in high-risk categories, kids can still get the virus and just as importantly, they can transmit the virus to adults.

The American Academy of Pediatrics reported this week that children now make up 22.4% of all new weekly cases, and over 3.7 million children have been diagnosed during the pandemic.

“There are really two big reasons why kids need to get the vaccine,” explained Dr. Jennifer Ashton, ABC News chief medical correspondent.

“One of them is that it is possible that they could be infected and then unknowingly pass COVID-19 to someone with a serious or underlying, pre-existing medical condition,” she said. “And also, though it’s very uncommon and unlikely, it is still possible that children infected with COVID-19 could become seriously ill or worse. We have seen that.”

“It’s important to think in ripple effects, outside the box,” Ashton added. “It’s not just your home environment that you need to worry about.”

3. Will kids experience the same vaccine side effects as adults?

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,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said at a press briefing announcing Pfizer’s authorization.

“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 vaccines 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.

Moderna has said that an initial analysis of its COVID-19 study with teens ages 12 to 17 found the majority of side effects were mild or moderate in severity, and said no serious safety concerns had been identified. The FDA will scrutinize Moderna’s clinical data before authorizing the use in anyone under 18.

4. How effective is the Pfizer vaccine in children?

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.

Marks confirmed on May 10 that 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.

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.

5. Will kids get the same dose of the vaccines as adults?

The FDA has authorized the same dosing for 12- to 15-year-olds as adults with the Pfizer two-dose vaccine.

6. What will fully vaccinated kids be able to do?

Children who are fully vaccinated will be able to follow the updated guidance for vaccinated people from the CDC.

That means not wearing a mask while outdoors, except in crowds, and not having to quarantine after known or suspected exposure to COVID-19, according to the CDC.

Kids who are fully vaccinated may also attend small outdoor gatherings with fully vaccinated family, friends, or those who are unvaccinated, and dine at outdoor restaurants with friends from multiple households, according to the CDC.

Being fully vaccinated — a milestone achieved two weeks after a person’s final vaccine shot — will also make it easier for children to travel internationally and gain entry into concerts or sporting events.

7. Could COVID-19 vaccines impact puberty, menstruation?

There is currently no clinical evidence to suggest the vaccines can have long-term effects on puberty or fertility, according to Ashton, a practicing, board-certified OBGYN.

Ashton noted that while there has been anecdotal discussion of the emotional event of finally receiving the vaccine temporarily impacting menstruation for adult women, the idea of the cause being from the vaccine itself “defies science and biology.”

It is really important to understand basic biology here,” Ashton said. “Women can have changes in their menstrual cycle and also have gotten the vaccine, that does not mean that one caused the other.”

“Right now there is no puberty concern. There is no fertility concern,” she added.

8. Will the Johnson & Johnson COVID-19 vaccine be available for kids?

Johnson & Johnson announced in April that it had begun vaccinating a “small number of adolescents aged 16-17 years” in a Phase 2a clinical trial.

As of April, the trial was enrolling participants only in Spain and the United Kingdom, with plans to expand enrollment to the U.S., the Netherlands and Canada, followed by Brazil and Argentina.

9. Where will children access COVID-19 vaccines?

As with the distribution of vaccines to adults, the process of distributing COVID-19 vaccines to children will differ by state.

The vaccines will likely be available to kids through a combination of pharmacies, pediatricians, medical centers and larger vaccine events.

Pfizer has announced they are going to ship their vaccine in smaller shipments of 450 doses per box instead of over 1000 doses, which means it can be kept in places like pediatricians’ offices.

10. What are health groups saying about COVID-19 vaccines and kids?

The American Academy of Pediatrics (AAP) has called on all adults and teens who are eligible to receive a COVID-19 vaccine to do so, while also pushing for clinical trials for younger teens and children.

“Research has shown the new vaccines to be remarkably effective,” AAP President Dr. Lee Savio Beers said in a statement. “The vaccine is a powerful tool that — in conjunction with other safety measures like face masks, good hygiene and physical distancing — can help us end the suffering and death caused by COVID-19. Pediatricians can play a key role in making that happen.”

The AAP also cheered the FDA’s decision to authorize the Pfizer vaccine for children ages 12 and up, calling it a “critically important step.”

“Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development,” Savio Beers said in a statement, in part. “We look forward to the discussion by the Advisory Committee on Immunization Practices of the CDC, which will make recommendations about the use of this vaccine in adolescents. Meanwhile, pediatricians stand ready to assist in efforts to administer this and other COVID-19 vaccines.”

11. Are other countries giving COVID-19 vaccines to children?

Yes. Canada’s health department authorized the use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age on May 5.

12. Will COVID-19 vaccines be required by schools?

It will be up to each state’s government to decide whether a COVID-19 vaccine is required for school entry. Many colleges and universities in the U.S. have announced they will require students to be vaccinated from COVID-19.

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In NYC, vaccinations are coming to a subway station near you

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(NEW YORK) — In an effort to meet New Yorkers where they are, the state is offering pop-up COVID-19 vaccination sites at some subway and commuter stations this week, Gov. Andrew Cuomo announced Monday.

The eight sites include Penn Station, Grand Central, Coney Island, Myrtle-Wyckoff in Brooklyn, E.180 St. in the Bronx, 179 St. in Queens, LIRR Hempstead and MetroNorth Ossining. They will be open from May 12 to May 16.

“We’ve made huge progress vaccinating New Yorkers across the state, but vaccination rates are slowing and we have to redouble our efforts,” Cuomo said. “New Yorkers may struggle to take time out of their schedules to get the vaccine, so we’re bringing it directly to them at these new sites in MTA stations.”

The sites will operate on a first-come, first-served, walk-in basis, with each location offering up to 300 single-shot Johnson & Johnson vaccines per day. As an additional incentive, vaccine recipients will earn a free seven-day MetroCard or a free roundtrip ticket for the Long Island Rail Road or Metro-North, the city’s commuter rails.

Messages advertising the pop-up site locations and hours of operation will run on the MTA station, train and bus screens, and audio announcements will be played in more than 500 stations.

In New York City, 36% of the population is fully vaccinated and 46% have received at least one dose of the vaccine, according to the city’s Health Department.

“The vaccination rate has declined,” Cuomo said. “We have to get the numbers up.”

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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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Most popular baby names in US revealed as birth and fertility rates decline

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(WASHINGTON) — For the second year in a row, the top three baby names remain the same in America.

Girls’ names Olivia, Emma and Charlotte were repeated on the list published by the Social Security Administration (SSA), as were Liam, Noah and Oliver for boys.

The names were released Friday, two days after the Centers for Disease Control and Prevention announced U.S. birth and fertility rates have dropped to record lows in 2020.

The number of U.S. births in 2020 fell 4% from 2019, the lowest since 1979. The figure is double the average annual rate of decline of 2% since 2014 and marks the sixth consecutive year that the number of births have dropped, according to provisional data included in the new report.

Here are the top 10 boys and girls names for 2020:

Girl names:
1. Olivia
2. Emma
3. Ava
4. Charlotte
5. Sophia
6. Amelia
7. Isabella 8. Mia
9. Evelyn
10. Harper

Boy names:
1. Liam
2. Noah
3. Oliver
4. Elijah
5. William
6. James
7. Benjamin
8. Lucas
9. Henry
10. Alexander

Parents seemed to stick with the same names from 2019 for both girls and boys, the SSA reported. What’s more, only two names changed out of both top 10 lists with the names Henry and Alexander bumping Mason and Ethan from their spots.

The SSA said the name Henry was last seen in the top 10 over a century ago, in 1910.

The top five fastest rising names in 2020 were also revealed:

Girl names that are growing in popularity:
1. Avayah
2. Denisse
3. Jianna
4. Capri
5. Rosalia

Boy names:
1. Zyair
2. Jaxtyn
3. Jakobe
4. Kylo
5. Aziel

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

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(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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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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Three employees shot at Smile Direct Club in Nashville

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(NASHVILLE, Tenn.) — Three employees were shot and injured at a Smile Direct Club manufacturing facility in the Antioch neighborhood of Nashville, Tennessee, early Tuesday, officials said.

One employee was struck in the chest, one in the abdomen and one in the leg, Nashville police spokesman Don Aaron said at a news conference.
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One of the victims is in critical condition, he said.

The suspected gunman left the building as officers responded to the call, but officers spotted him at an intersection and demanded he drop the weapon, Aaron said. The suspect, armed with a semi-automatic pistol with an extended magazine, instead directed the gun toward officers, according to Aaron.

The suspect was shot by police and taken to a hospital where he was pronounced dead, police said.

Smile Direct Club said in a statement, “The safety of our team members is a top priority for our Company and we maintain strict security protocols and a no weapons policy at all of our facilities. We are working with the local police as they investigate this matter.”

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Employee allegedly shoots three co-workers at Smile Direct Club in Nashville

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(NASHVILLE, Tenn.) — An employee allegedly shot and injured three co-workers at a Smile Direct Club manufacturing facility in the Antioch neighborhood of Nashville, Tennessee, early Tuesday, officials said.

One worker was struck in the chest, one in the abdomen and one in the leg, Nashville police spokesman Don Aaron said at a news conference.

One of the victims is in critical condition, he said.

The suspected gunman, a 22-year-old employee, left the building as officers responded to the call, but officers spotted him at an intersection and demanded he drop the weapon, police said.

The suspect, armed with a semi-automatic pistol with an extended magazine, instead directed the gun toward officers, according to Aaron.

The suspect was shot by police and taken to a hospital where he was pronounced dead, police said.

It appears the gunman acted alone, police said. The suspect, who was not named, started working at Smile Direct Club in June, police said. He also worked there from late 2019 to early 2020.

Smile Direct Club said in a statement, “The safety of our team members is a top priority for our Company and we maintain strict security protocols and a no weapons policy at all of our facilities. We are working with the local police as they investigate this matter.”

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