(NEW YORK) — An independent panel of advisers to the Centers for Disease Control and Prevention voted Wednesday to recommend the Pfizer vaccine for use in children ages 12 to 15.
It marks a crucial milestone in the nation's push to tamp down COVID-19, with more shots in more Americans' arms helping pave the gradual path towards recovery and a return to normalcy. The Food and Drug Administration authorized the Pfizer vaccine for this age group Monday.
President Joe Biden hailed the decision in remarks on vaccinations Tuesday afternoon.
"My hope is that the parents will take advantage of the vaccine, and get their kids vaccinated," Biden said. "Let's remember that millions of 16- and 17-year-olds have been safely vaccinated and as more and more Americans are vaccinated, COVID-19 hospitalizations and death rates continue to fall."
Getting adolescents vaccinated was part of the plan he laid out last week with a goal of getting 70% of Americans vaccinated by July 4.
Biden touted the safety of the vaccines and also the increasing convenience of access to doses for those who want them.
"This new population is going to find the vaccine rollout fast and efficient," Biden said Tuesday. "As of tomorrow, more than 15,000 pharmacies across this country will be ready to vaccinate this age group."
CVS and Walgreens announced they would begin offering vaccinations for 12- to 15-year olds on Thursday.
Parental or legal guardian consent is required to receive the vaccine and children must be accompanied by an adult. Both companies encouraged people to make appointments.
CDC Director Rochelle Walensky signed off on the recommendation later Wednesday, meaning that vaccinating children as young as 12 is now the official recommendation by the nation's top public health experts.
While health experts said it's rare for children to get very sick with COVID-19, there is still a risk. Also, officials hope adolescent vaccinations will help lower the risk of transmission, as classrooms and summer camps both look towards reopening.
It comes as children now make up 22% of recent COVID-19 cases in the nation, according to the American Academy of Pediatrics and the Children's Hospital Association report.
Pfizer's clinical trials have shown their vaccine safe and 100% effective in children ages 12-15, aligning with the 95% efficacy among adult clinical trial participants. Among the more than 1,000 adolescents who received the vaccine, there were no cases of COVID-19 recorded; there were 16 cases among the 978 participants who got the placebo.
On safety, clinical evidence showed no current safety concerns for these children receiving this two-dose vaccine, with side effects similar to those observed in adults -- like a sore arm at the injection site, fatigue and headache, which should stop within a few days of getting the shot.
Children who are fully vaccinated would be able to follow the updated guidance for vaccinated people from the CDC. That includes not having to wear masks outdoors unless in a crowded venue and not having to quarantine if there is a known exposure.
(NEW YORK) -- Starting this week, fully vaccinated Hawaii residents can skip COVID-19 testing and quarantine requirements when flying between the islands.
According to the new rules, which Gov. David Ige announced last month, Hawaii residents who were vaccinated in the state are exempt from testing and quarantine on the 15th day after their final vaccine shot.
To participate in the inter-county travel program, island residents will need to provide their Centers for Disease Control and Prevention vaccination record card, as well as register with Hawaii's "Safe Travels" program and affirm they are fully vaccinated, to get a digital record card.
Travelers under the age of 5 can bypass the requirements, as long as they are on the same travel itinerary as a fully vaccinated parent or guardian.
The new rules went into effect Monday.
For now, only state residents are eligible for the program, and visitors will still have to either test negative for COVID-19 before flying or quarantine for 10 days when traveling between islands. Ige said the state is hoping to troubleshoot the process before rolling it out to out-of-state Americans as early as this summer and international visitors later this year.
"It will allow us to validate the screening process necessary, and I think most importantly, learn about what kinds of bottlenecks and delays it may inject into our screening process for inter-island travel," Ige told reporters last month.
As of Tuesday, 41% of the population in Hawaii was fully vaccinated and 59% had received at least one dose of the vaccine, according to the Centers for Disease Control and Prevention.
Hawaii is the second state after New York to issue a vaccination verification certification for state residents.
(NEW YORK) -- With over a third of the United States population now fully vaccinated against COVID-19, scientists hope to preserve this newly acquired immunity as the pandemic continues. Now, researchers are exploring whether we might all need booster shots in the coming months and years in order to maintain immunity or to protect against newly emerging variants.
"The goal is to prevent future outbreaks -- not react to them," said Dr. Thaddeus Stappenbeck, chair of the department of inflammation & immunity at Cleveland Clinic.
The Biden administration said during a Senate hearing Tuesday that the government has enough funding to buy booster shots if needed.
"There could be two reasons why booster shots may be needed," said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center. The first is the "natural waning" of vaccine immunity, and the second is that new variants could emerge that might not be fully covered by the current vaccines, he said.
Some experts predict vaccine immunity will last roughly a year and that COVID-19 vaccines might one day be folded into annual flu shots. Meanwhile, with new mutations of COVID-19 emerging worldwide, scientists and vaccine manufacturers are thinking one step ahead by testing booster shots specifically designed to enhance protection against these new variants.
“If we start to see breakthrough infections of clinical significance, then booster doses would likely be recommended. It may be that boosters are recommended for travel to countries where significant transmission continues -- we just don’t know,” said Dr. Anna Durbin, professor of international health and infectious diseases at Johns Hopkins University.
Last week, Moderna announced positive preliminary results showing a third booster shot could both preserve immunity and add protection against two variants -- one that was first identified in South Africa and another first identified in Brazil.
“It's a very good piece of news,” Dr. Stephen Hoge, president of Moderna, told ABC News. “It suggests not only can we boost people's immunity back up and keep it high during the pandemic but also that we can specifically boost it up against some of the new variants of concern.”
Hoge acknowledged that recently vaccinated Americans may be frustrated that additional shots could be needed in the future.
“Well, I’m sympathetic to the disappointment,” Hoge said. “Our current expectation is that we're going to need a booster probably annually for the near term, and then maybe in the future we'll be able to do it much less frequently.”
Pfizer is also testing booster vaccinations and monitoring the need to develop a specific booster shot against a newly emerged variant first identified in India.
“We want to make sure to have a vaccine available before the variant will raise levels of infections that are dangerous for the society,” Dr. Albert Bourla, chairman and CEO of Pfizer, said.
Booster shots being studied by manufacturers include existing vaccine formulations, new strain-matched compounds or a combination of both. Multivalent vaccines contain multiple strain-matched compounds and could potentially expand protection against several new variants with a single booster shot.
Scientists say the mRNA technology behind the Pfizer-BioNTech and Moderna vaccines lends itself to rapid modifications of the vaccine. The vaccine developed by Johnson & Johnson could also be updated quickly.
“We should be able to produce it in less than 100 days," Bourla told ABC News. "And this is our goal right now, so that we can always stay ahead of the [virus].”
With a major portion of the country and world still unvaccinated, some specialists caution that the most effective approach to ending the pandemic may not necessarily be through booster shots. The World Health Organization says existing vaccines remain effective at preventing severe illness and death even for newer variants.
And recent data has shown that the more people are vaccinated with existing vaccines, the sooner the pandemic will end.
“We have a global need for vaccine doses now, and the best way to reduce transmission and reduce the number of variants is to vaccinate as many people as possible,” Durbin said.
(NEW YORK) -- A growing consensus among public health experts that the U.S. could soon safely end mask mandates has put pressure on the Centers for Disease Control and Prevention to update its guidance in the weeks ahead or risk losing credibility with the public.
All adult Americans who want to get a vaccine will have had the chance to do so in the next two months, the thinking goes, and they should then be able to make their own risk assessment based on the strong efficacy of the vaccines, which experts believe largely protects fully vaccinated Americans from getting severely ill with the virus and from transmitting it.
"What's happening in the past week or so is that we're seeing the effect of the vaccine winning this race against the variants, winning the race against the virus, and that's freeing us up -- and forcing us, rightly so -- to reevaluate our control strategies that are in place," said Joe Allen, a professor at the Harvard T.H. Chan School of Public Health.
The CDC has begun to loosen its recommendations for fully vaccinated people, defined as someone who has received the full regimen of the vaccine and waited two weeks for full immunity to kick in, but it hasn't gone so far as to say people can ditch their masks indoors if they're vaccinated.
Experts believe that is the logical next step.
"We should not undersell the vaccines. They offer excellent protection," said Linsey Marr, an expert in virus transmission at Virginia Tech. "I think we can really start thinking about ending mask mandates once everyone who wants to be vaccinated has had a chance to be fully vaccinated. And that should be in another month or two."
And President Joe Biden said as much on Tuesday, telling governors that there could be guidance on indoor mask mandates "at some point soon."
"We've gone a little slower to make sure we're exactly right in terms of the percent of the population that has been vaccinated," Biden said, but added that the White House would be "moving on that in the next little bit."
Beginning last month, the CDC released guidance that fully vaccinated people can gather in small groups without masks indoors and do the same with unvaccinated friends and family so long as they're low risk. Then, two weeks ago, the CDC said that fully vaccinated Americans could safely ditch their masks in spacious outdoor settings.
But this week, the CDC has come under increasing pressure from lawmakers to offer more incentives for Americans to get vaccinated, demonstrating through national guidelines that getting a vaccine is the path back to normalcy.
CDC Director Rochelle Walensky, testifying before Congress on Tuesday, defended the CDC's conservative decision-making so far. The CDC has to consider every situation before it can issue guidance, she said.
"I think it's important to realize that we, at CDC, are responsible for putting out guidance for individuals as well as for populations, for public health. We are responsible for putting out guidance for counties that have less than five cases per 100,000 and for counties that have greater than 100 cases per 100,000, as well as for counties that have less than 10% of people vaccinated and counties that have more than 50% of people vaccinated. Our guidance has to be science-based for all of these situations," Walensky said.
The timeline on just how soon the CDC could loosen guidelines is unclear, since experts say masks indoors should stick around until every adult who wants the vaccine has had a chance to reach full vaccination. At the same time, over 116 million Americans have already hit that mark.
Allen, the professor at the Harvard T.H. Chan School of Public Health, thinks "top-down" mask mandates can be walked back around July 4, a symbolic date of independence and freedom, but also when he estimated there will have been enough time to guarantee Americans have fairly and adequately had access to the vaccine.
"Once everyone has had the chance to get it, then we start to move into this personal risk decision making," Allen said. "And my feeling is that it's reasonable by July 4 or so that we'll be in a place to pull back on some of these mandates, assuming cases keep dropping as we expect them to."
At the same time, risks for fully vaccinated Americans are already very different.
Marr, who is fully vaccinated, said she'd now be comfortable indoor dining, going to a grocery store without a mask on, or attending an outdoor barbeque mask-less, with people who are both vaccinated and unvaccinated -- though she would follow the rules in her community. She said she would be comfortable with her children, who aren't vaccinated, doing the same because she's generally been more concerned about them spreading it to someone who's vulnerable to COVID than she is about their risks of severe illness.
The place she would still consider wearing a mask, Marr said, would be in a really crowded indoor environment, like a standing-room only indoor concert or a packed worship service with lots of singing. Marr would also consider if case numbers are high or vaccination rates are low, which would increase the risk of exposure.
Allen said he looks forward to traveling with his family this summer, mostly without masks. Like Marr, he said he would pay attention to how much virus is circulating in the community, as well as the social norms of the area he's in.
"It's going to vary based on what part of the country you're in and it's going to vary based on your own risk tolerance," he said.
William Schaffner, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, said vaccinated people should feel confident indoors even in congregate settings, so long as they're not immunocompromised, and be comfortable ditching their masks around children.
"Vaccinated people don't have to wear masks indoors. Period. Except if you're immunocompromised. Whereas unvaccinated people, they still need to be cautious for their own good, and for the good of others," he said.
It's difficult to enforce masks for unvaccinated people while no longer requiring them for fully vaccinated people, largely because it's awkward to single people out. But, Shaffner said, an important part of ushering in the "new normal" is to "formally, in recommendations, permit the vaccinated people to behave much more as they did pre-COVID, because we have so much confidence in the vaccines."
"The CDC has been hearing from many people, informally, that it's time to allow a little more risk out there. If we're going to get more people vaccinated, you have to reward them," Schaffner said.
And if the CDC doesn't act soon to acknowledge those new freedoms, it could erode people's confidence in the recommendations.
"I'm worried that if we don't relax restrictions, then people say, 'What's the point of getting the vaccine?'" said Allen.
"I also think public health will have a credibility problem. When we urge people to put in controls, people put in controls, largely. If we then don't pull back controls when it's time to pull back, we lose credibility," he said.
(NEW YORK) -- A new sunscreen contouring "hack" gaining popularity on TikTok has experts warning users to be very cautious about skin damage.
TikTok user Eli Withrow shared a technique that she's convinced gives your face a chiseled, radiant boost.
She advised that if you use a base sunscreen of SPF 30 and an SPF 90 in all the spots where you would use highlighter (the highest planes of your face), you will be left with a contoured look following sun exposure.
"You'll be naturally snatched all summer," said Withrow.
Withrow's sunscreen contouring hack video has since received more than 12 million views and left many people with questions on how, or if, it works. Others wondered whether it was safe to be doing at all.
NYC-based dermatologist Dr. Michelle Henry told "GMA" it's "absolutely unsafe."
"Any excess sun exposure can increase the risk for skin cancer. UV is a known carcinogen and not a natural source of contouring the skin," she said.
It can possibly lead to skin cancer in the future, burns and accelerated aging from exposed areas, according to Henry.
While these potential skin dangers could be an unwanted result, TikTokers have continued to try out the "hack."
"It's definitely not something any dermatologist can recommend," NYC-based dermatologist Dr. Dhaval Bhanusali told "GMA."
He continued, "In reality, any kind of tan is usually the result of damage to your skin from UV radiation and, long term, will not only increase your chances of skin cancer, but it will also increase sun damage, including collagen breakdown, pigment issues and increased vascularity."
Experts recommend that it's better to use a tinted sunscreen or contouring with regular makeup.
How should you be using sunscreen?
"I love using an elegant lightweight sunscreen over the entire face to both protect the skin and hydrate it," said Henry. "Olay Regenerist Whip SPF 25 is lightweight, powerfully hydrating thanks to vitamin B3, and has SPF 25 -- it's a must-try."
She recommends applying sunscreen to your full face -- about a nickel-sized amount of product to ensure adequate coverage. Also, be sure to remember your ears and under your chin, and reapply every two hours.
In addition to using a daily SPF, Bhanusali also recommends wearing adequate sun protection such as hats or staying in the shade when possible. He likes sunscreens that absorb easily, such as offerings from EltaMD, Supergoop and Neutrogena.
Bhanusali also advised, "Consistency is key and it's worth experimenting with a few brands to find the ones that fit your skin best."
(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.
(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."
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:
7. Isabella 8. Mia
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:
(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.
(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."
(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.
(NEW YORK) -- More than half of U.S. adults have now received at least one COVID-19 vaccine, but children remain unimmunized and unprotected from potential infection.
The American Academy of Pediatrics is now reporting that in some states, up to 18% of all COVID-19 cases occurred in children during the month of April. In Michigan, where COVID-19 cases have surged in recent weeks, there has been a 237% increase in admissions to pediatric hospitals from mid-February to mid-April.
While children overall tend to only have mild symptoms with SARS-COV-2 infection, as a higher percent of children contract the virus, some will likely experience severe respiratory disease.
It is also more likely that some will experience a rare consequence of infection with the virus, multi-system inflammatory syndrome, or MIS-C.
What is MIS-C?
Last year, a small but increasing number of children were admitted to hospitals with MIS-C, which was first identified back in April 2020.
The main features of this mysterious illness are persistent fevers and impaired functioning of many vital organs, including a serious heart condition known as cardiogenic shock.
The U.S. Centers for Disease Control and Prevention has recorded over 3,185 official cases of MIS-C in the U.S. since May 2020. Of those, 36 cases resulted in the death of a child.
Last year, in the early days of the pandemic, pediatric doctors in London set out to discover what sufferers of this disorder had in common.
None of the children's parents had been aware of any recent illnesses. Yet, each child's blood work was positive for high antibody levels against SARS-COV-2, proving recent infection with the virus. Like most young people, these children had all experienced a symptom-free infection.
What was going on?
It seems that for a very small number of children, after SARS-COV-2 infection, the immune system gets triggered inappropriately into producing massive amounts of unnecessary inflammation within the body.
This inflammation is what had caused the high fevers and dysfunction of the heart and other organ systems.
The pediatric doctors in London reported their findings on the first eight patients in April 2020. Children's hospitals worldwide started recognizing and reporting cases shortly afterward.
What can be done to protect children?
Though at first a medical mystery, one year later, doctors have now learned more about MIS-C, and how to treat it.
Researchers are actively investigating why the immune system is triggered so inappropriately after SARS-COV-2 infection in some children but not in others.
But for now, doctors have discovered the most effective way to treat MIS-C is to dampen down the over-exaggerated inflammation response in the body before permanent damage occurs.
Steroid therapy and intravenous immunoglobulin (a blood product made up of antibodies) reduce inflammation in the body. They are now proven to be successful first-line therapies for most children suffering from MIS-C. Some children will require admission to a pediatric intensive care unit for advanced medical support.
If a child does not respond to these first-line treatments, more targeted biological therapies to reduce inflammation are also available.
Experts say that MIS-C can be serious, even deadly, but that is extremely rare. Most children with MIS-C will have a complete recovery with appropriate medical care.
The symptoms of MIS-C can be highly variable. Some common symptoms include persistent fevers, abdominal pain, vomiting, diarrhea, neck pain, bloodshot eyes and fatigue.
Signs that a child should be seen immediately by a medical provider include the following; trouble breathing, persistent chest pain, difficulty staying awake, or pale blue-colored skin, lips, or nail beds, along with any other concerning signs.
Any parent concerned their child has MIS-C should contact their doctor immediately. Over the past year, doctors have learned how best to treat children with MIS-C, dramatically improving their chance of recovery.
A recent ABC News/Washington Post poll found that still nearly 1 in 4 Americans are disinclined to get vaccinated.
Those ages 18 to 29 are the highest among the "wait and see" crowd, according to the latest Kaiser Family Foundation vaccine monitor report. An Axios-Harris Poll released earlier this month also found that Generation Z (those younger than 25) are more likely to say "they will get the vaccine whenever they get to it.”
Banks now wishes he got the vaccine when he had the chance. On April 30, he told the station he had a slight headache that progressively got worse. He was bedridden for four days, he said, before he tested positive for COVID-19.
"Me believing that being young and strong and in great shape that ... it wouldn't affect me this way, it's not true," Banks told KGTV. "I do regret not getting the vaccine earlier because I would not want to go through what I'm going through right now."
With vaccination numbers dropping from an average of over 3 million daily doses administered a month ago to now under 2 million, according to Centers for Disease Control and Prevention data, public health officials are trying to reach those Americans who have yet to get inoculated, especially young adults. As of May 8, 10.8% of 18- to 29-year-olds in the U.S. are fully vaccinated and 0.8% of those between 16 and 18 are, per the CDC.
"There's been a lot of people talking about, well, we've gotten the easy 40%," Dr. Aaron Tande, an infectious disease specialist with the Mayo Clinic in Rochester, Minnesota, told ABC News. "Now it's going to be the more difficult."
Vaccination barriers -- and possible solutions
Experts say one of the greatest challenges with the vaccine rollout is access. Since demand has dropped, the focus needs to turn to making the vaccine as easy as possible to get in order to reach more hesitant populations, Brian Castrucci, an epidemiologist and president and CEO of the de Beaumont Foundation, which advocates for public health, told ABC News.
"Wouldn't it be nice if a vaccine was as easy and accessible to get as a Quarter Pounder with Cheese?" Castrucci said. "If you're gonna take it, it's gonna be right there. We need to work much harder to get these vaccines available in the offices of primary care providers."
To reach neighborhoods hard-hit by the pandemic, Chicago's Rush University Medical Center set up a vaccine clinic in a gym and deployed "SWAT-like teams" to nursing homes, halfway houses, the homebound and the homeless, chief nursing officer Angelique Richard told ABC News.
"If we're not thoughtful about getting the vaccine into those communities and helping them, they'll be even more devastated," she said.
Incentives -- like free beer, baseball tickets and even college scholarships -- have also been dangled to entice apprehensive people to get the shot. They can be part of what needs to be a multifaceted vaccination approach, Richard said.
These incentives could be the "carrot" people need, Dr. Gabor Kelen, head of the emergency medicine department and a COVID-19 response leader at Johns Hopkins Medicine, told ABC News.
"We're still, on some days, upwards to 1,000 deaths and 40, 50,000 new infections, that's devastating. And so I think it's appropriate to really encourage rapidly getting to herd immunity," Kelen said. "If we have to give people a few candies along the way, then that's what we're gonna do.”
In some cases, it works.
In Benicia, California, 17-year-old Harjot Saini decided to get the vaccine after the city offered young people free pizza for getting inoculated.
For young people in particular, who don't have any underlying health concerns, there's also a "messaging challenge" in helping them understand why they need to get vaccinated, Castrucci said.
"It's really the same reason you wear a seatbelt," he said. "You don't wear a seatbelt because you know you're going to get into an accident. You wear a seatbelt to mitigate the damage should you get into an accident. And there are plenty of young folks, healthy folks who have died from COVID or had their quality of life irreparably changed because of COVID."
Public health officials should be focusing less on the goal of herd immunity, and instead tying vaccination to things people want to do, such as gathering safely with friends and family or being able to do certain activities without needing a COVID-19 test, experts said.
"Herd immunity, the societal good, is very important, but it may not be the primary motivating factor," Tande said.
'The four Ps'
Celebrities, athletes and even former President Barack Obama have endorsed the vaccine on social media to encourage their admirers to follow suit. Former President Donald Trump also used encouraged the public to take the vaccine before his exit from office.
Leaning on trusted messengers will be key to reaching the vaccine-hesitant, experts said.
From focus groups with vaccine skeptics, Castrucci has found that the most trusted messengers are what he calls the four Ps: physicians, pastors, parents and peers.
Rush University Medical Center invited 120 faith leaders from across the Chicago's pandemic-stricken neighborhoods to the hospital for the shot to encourage congregants to follow suit.
"We first started with people who are trusted, leaders within their community, and we charged them with going back to their communities to tell their story, because we knew that their congregations trusted them," Richard said. "That was really, very effective.”
Peer networks may be particularly effective in vaccinating young adults, according to the Kaiser Family Foundation. In its April vaccine monitor report, it found that "those who say at least half of their close friends are vaccinated are much more enthusiastic about getting vaccinated themselves compared to those who say just a few or none of their friends have gotten a shot."
"We all have people that we trust their opinion of. So if somebody hasn't felt comfortable getting a vaccine based on guidance from Dr. [Anthony] Fauci and the CDC and their local public health authorities, more of the same may not change their minds," Tande said. "But that same message with accurate information from their local pastor or peer group may do the trick."
He pointed to recent comments from the Biden administration about identifying trusted, influential messengers as being a good strategy.
Opening a shame-free dialogue
Experts stress that the best way to reach the vaccine-hesitant -- whether it's healthy young adults who aren't in a rush to get the shot, people on the fence or those mistrustful of the science -- is to "meet them where they are."
Kelen said the worst thing you can do is shame someone.
"Something that we're not very good at when encountering people with sort of a more political/philosophical hesitancy or resistance is trying to empathize with where they're coming from, and truly listening to them, [so] that you feel that you can establish a relationship and a dialogue," he said.
One of the common concerns Tande hears from his patients about the COVID-19 vaccine is over safety, from immediate to long-term side effects. He said he's been able to have effective conversations when patients feel comfortable asking questions in the first place.
"I think the things that are probably going to be helpful for people are to be listened to and have their questions validated and addressed," he said. "There's nothing worse for people than feeling belittled for their concerns."
(MIAMI) — Variant COVID-19 infections skyrocketed following spring break in Florida and there have been more than 10,000 variant cases reported throughout the state, the South Florida Sun Sentinel reported based on data from the Florida Department of Health.
A total of 753 variant cases from three strains -- the B.1.1.7, the P.1, and the B. 220.127.116.11. -- were reported on March 14, according to variant infection data shared with ABC News. The Florida Department of Health does not disclose variant cases on its public dashboard.
That number swelled to 5,177 cases from five types of variants on April 15. Just two weeks later, the number of variant infections exploded to 9,248 on April 27, according to local ABC affiliate , WFTV.
The surge falls in line with mid-March into April spring break celebrations, when college students and vacationers flock to the sunshine state.
Florida is home to the most variant COVID-19 cases in the country. State health officials reported more than 11,800 cases of COVID-19 variants on Wednesday, according to the Sun Sentinel.
In total, variants have led to the hospitalization of 243 residents and the death of 67 people in Florida, the Sun Sentinel reported.
Only 1% of all COVID-19 cases in Florida undergo testing to study their genetic coding, meaning the number of variant infections is likely much higher than reported.
The data regarding variants was first released Monday hours after Gov. Ron DeSantis announced the lift of all local COVID-19 restrictions.
The Florida Department of Health released the data as a part of a legal settlement with the Orlando Sentinel after the paper sued in March to obtain a county breakdown of variant cases. A judge ended up agreeing with the paper’s claim that the data was vital “to understand how the virus continues to spread and affect Floridians.”
As vaccinations across the country slow, there are concerns over the threat of highly transmissible variants. In Florida, the B.1.1.7. variant, which first emerged in the United Kingdom in December, makes up the highest number of variant cases. There are also several reports of the South African and Brazilian variants.
As of May 1, Miami-Dade County led the state with 2,279 variant cases, followed by Broward County with 1,950 variant cases, the Sun Sentinel reported.
While variants seem to be gaining traction, overall COVID-19 cases in the Sunshine State are slowing. Health officials reported a 4.67% COVID-19 positivity rate on Friday -- the second day in a row that it has dipped below 5%, per state data.
Now doctors are warning the public to stay vigilant and get vaccinated to prevent cases from going back up.
Dr. Bernard Ashby, a Miami-based cardiologist who has worked in the front lines of the pandemic, is warning of the dangers of the variants, especially in populous areas.
"If you look at the county breakdown, Miami-Dade leads the state in the variants followed by Broward County. And we've led in infections rates in general," Ashby told ABC News. "What's interesting is the degree to much the counties dominated ... [those counties] essentially account for almost 40% of the variants in the state that's out there."
"It's hard to ignore that we are essentially open for business," he said noting DeSantis' lift of COVID-19 restrictions this week. "Now we're seeing this little explosion."
(NEW YORK) -- Pfizer and partner BioNtech announced they are starting the process to seek full Food and Drug Administration approval in the U.S. for their COVID-19 vaccine.
Since December, their vaccine has been distributed in the U.S. under an "emergency use authorization," which is a distinct regulatory status reserved for emergency situations, such as a pandemic.
Pfizer is the first COVID vaccine maker to request full approval in the U.S., and it will likely take several months for the FDA to review additional data and make an approval decision.
As Pfizer submits the required data for full Biologics License Application (BLA) approval, the FDA will take several months to review the full set of data before granting it.
This submission shows Pfizer believes it has enough effectiveness and safety data to meet the stringent Biologics License Application (BLA) requirements, which includes at least six months of safety data from a majority of the volunteers in a large, Phase 3 trial. The regulatory requirements for the current emergency authorization required only two months of safety data. Vaccine specialists say that any safety problems from a vaccine are likely to arise shortly after injection.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Albert Bourla, Pfizer chairman and CEO, said in a statement Friday. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
Pfizer said it has delivered more than 170 million doses in the U.S.
"... the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” Ugur Sahin, M.D., CEO and co-founder of BioNTech, said in a statement. “We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”
Along with Pfizer, Moderna and Johnson & Johnson's COVID-19 vaccines were previously given emergency use authorization.
Moderna announced Thursday that it plans to start the BLA process later in May.
Companies were always expected to formally submit for approval, rather than emergency authorization, once they hit the six-month safety requirement.
As more Americans get vaccinated and cases decline in the U.S., the Centers for Disease Control and Prevention has updated its guidelines for mask-wearing outdoors, small group gatherings and more. Many states and cities have also quickly reversed strict lockdown policies. In New York, Gov. Andrew Cuomo announced the easement of most restrictions, while New York City Mayor Bill de Blasio said he expects the city to be fully open by July 1.
"After a long and incredibly difficult fight, New York state is winning the war against COVID-19, and that means it's time to loosen some restrictions put in place to protect the public health and help our local businesses," Cuomo said last week.
Since the pandemic began, more than 32 million Americans have been diagnosed with COVID-19, according to a count kept by Johns Hopkins University. Of those, at least 580,061 deaths have been reported.