24-Hour Crisis Hotline: (877)SAFEGBC or (877)723-3422 Mental Health & Substance Abuse Issues

6502 Nursery Drive, Suite 100
Victoria, TX 77904
(361)575-0611
Fax: (361)578-5500
Regular Hours: M-Fri 8am - 5pm
Every 3rd Thurs of the Month - Extended Hours Until 7 pm

Child & Adolescent Development: Overview
Resources
Basic InformationMore InformationLatest News
Many Marijuana Vendors Aim Advertising at Kids: StudyHeart Function Rebounds for Kids With COVID-Linked MIS-CWhich Kids Are Most Vulnerable to Severe COVID-19?At-Home COVID Tests Accurate for Ki​ds: StudyCDC Study Shows Power of Flu Vaccine for KidsCOVID Hospitalizations Rising in Kids Too Young for VaccineNearly 600,000 U.S. Kids Had COVID Last WeekWhite House to Give Schools 10 Million Free COVID Tests Every MonthKids' Behavior Worsened With Remote Learning: StudyLater School Start Times Boost Parents' Health, TooUrban Air Pollution Drives Millions of Cases of Asthma in KidsCDC Backs Boosters for High-Risk Kids Aged 5-11, Shorter Time Between ShotsA Better Way to Correct Severe Scoliosis in Kids?Getting Your Child Their Vaccine?  Some Tips on Easing Needle FearsU.S. Hospitals Seeing Record Numbers of Young COVID PatientsSevere Illness in Children Brings Hardship for FamiliesReal-World Data Confirms Pfizer Vaccine Safe for Kids Ages 5-11Family Factors Affect Child's Odds for Cleft PalateAs Omicron Spreads, Child Hospitalizations Climb 30% in Past WeekNew Clues to Sudden Unexplained Deaths in Young KidsSevere Illness in a Child Takes Big Toll on Parents, Siblings: StudyProgram Aims to Get Lifesaving Drugs to Kids With Cancer in Poorer CountriesSchool COVID Outbreaks Drop When Adults Wear Masks, Study FindsMany Overweight Kids Already Have Hardened Arteries, DiabetesCDC Supports 'Test-to-Stay' Strategy for SchoolsJunk Food Ads Reaching Kids Through Livestream Gaming PlatformsWhat Does 'Long COVID' Look Like in Kids?New Drug a Good Treatment Option for Severe Asthma in KidsFebrile Seizures: How to Protect Your ChildNew Treatment Greatly Boosts Survival for Kids With a Rare, Aggressive CancerRisk of Vision Trouble Rises in Children With Type 2 DiabetesMore Time Outdoors May Lower Risk of MS in YouthNew Asthma Drug Helps Kids, But Price Tag Is HighUS Surgeon General Report Warns of Mental Health Crisis Hitting YouthAnother Benefit to Asthma Control for Kids: Less Bullying1 in 3 U.S. Children Lack Adequate Health InsuranceWhat's Behind Unexplained Epilepsy in Kids? A Gene Test May TellIs the Mumps Vaccine Becoming Less Effective?Autism Now Diagnosed in 1 in Every 44 Children, CDC SaysKids With Uncontrolled Asthma at Higher Odds for Severe COVID-19Nearly 7% of U.S. Kids Have Had a Head Injury or ConcussionAre Your Holiday Gifts on the 'Noisy Toy List'?Many Kids, Teens Think Girls Don't Care About Computer ScienceMost Parents Say Their Kids Aren't Thankful Enough: PollPandemic Curbed Kids' Efforts to Lose Excess WeightClimate Change May Not Increase Allergies in Kids With Asthma: StudyNearly 10% of Younger Kids Have Gotten First COVID Vaccine DoseAHA News: Family-Based Programs Targeting Childhood Obesity Can Be Good for Parents, TooCases of Children's Severe COVID-Linked Illness Were Worse in Second WaveFace Masks Don't Hide Emotions From Kids: Study
Questions and AnswersLinks
Related Topics

ADHD: Attention Deficit Hyperactivity Disorder
Childhood Mental Disorders and Illnesses
Child Development & Parenting: Infants (0-2)
Child Development & Parenting: Early (3-7)

FDA Approves Pfizer COVID Vaccine for Kids 5-11

HealthDay News
by By Dennis Thompson and Robin Foster HealthDay Reporters
Updated: Oct 29th 2021

new article illustration

FRIDAY, Oct. 29, 2021 (HealthDay News) -- The U.S. Food and Drug Administration on Friday approved the emergency use of a smaller dose of Pfizer's coronavirus vaccine for children ages 5 to 11, paving the way for 28 million kids across the country to get their shots.

These youngest Americans can now receive one-third of the adult dose, with two injections given three weeks apart. If the U.S. Centers for Disease Control and Prevention signs off on the approval after its advisory panel meets Tuesday, young children could start getting shots as early as Wednesday.

"As a mother and a physician, I know that parents, caregivers, school staff and children have been waiting for today's authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy," Acting FDA Commissioner Dr. Janet Woodcock said in an agency statement announcing the approval. "Our comprehensive and rigorous evaluation of the data pertaining to the vaccine's safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards."

"We are confident in the safety, effectiveness and manufacturing data behind this authorization. As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon. We hope this information helps build [the] confidence of parents who are deciding whether to have their children vaccinated," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in the same statement.

Infectious disease experts welcomed the approval.

"It's an incredibly important tool in the return to normalcy," Dr. Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center in Seattle and a leader of the COVID-19 Prevention Network, told the New York Times. "To be able to know that your child is protected and not going to get severely ill by going to school is an incredible psychological relief."

Earlier in the week, the FDA's vaccine advisory panel voted to recommend the approval. The vote was nearly unanimous at 17-0, with one abstention.

Despite the vote count, some panel members noted at the time that they struggled with the decision.

"This is a much tougher one, I think, than we had expected coming into it," panel member Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, said during the meeting, NBC News reported. "The data show that the vaccine works and it's pretty safe ... [yet] we're worried about a side effect that we can't measure yet," he said, referring to a heart condition called myocarditis that has cropped up in rare cases in some younger recipients of COVID vaccines.

Another panel member questioned whether the vaccinations were needed at all for these youngest Americans.

"It just seems to me that in some ways, we're vaccinating children to protect the adults, and it should be the other way around," committee member Dr. James Hildreth, president and CEO of Meharry Medical College in Tennessee, told NBC. "I do believe that children at highest risk do need to be vaccinated. But vaccinating all of the children ... that seems a bit ... much for me."

Panel member Dr. Paul Offit, a vaccine researcher at Children's Hospital of Philadelphia, said, "It's always nerve-racking, I think, when you're asked to make a decision for millions of children based on studies of only a few thousand children."

But he stressed that the potential threat from a pediatric infection with COVID-19 is real.

"The question is, when do you know enough?" Offit added. "And I think we certainly know that there are many children between 5 and 11 years of age who are susceptible to this disease who could very well be sick and are hospitalized or die from it."

Panel member Dr. Amanda Cohn, chief medical officer at the U.S. Centers for Disease Control and Prevention, saw the decision similarly.

"When I look at this question, it is pretty clear to me that the benefits do outweigh the risk, when I hear about children who are being put in the ICU, who are having long-term outcomes after their COVID, and children are dying," Cohn said. "We vaccinate routinely against a couple of vaccine-preventable diseases for which far fewer deaths and hospitalizations and ICU admissions occur."

In fact, more than 1.9 million children aged 5 to 11 have tested positive for the coronavirus over the course of the pandemic, and more than 8,400 have been hospitalized, said Dr. Fiona Havers, a medical officer with the CDC, NBC News reported. And when hospitalized with COVID-19, children are more likely to be admitted to the intensive care and more likely to need a ventilator than children hospitalized with the flu are, she added.

Children who contract COVID-19 are also at risk for a rare inflammatory condition called multisystem inflammatory syndrome (MIS-C). As of Oct. 4, more than 5,200 children of all ages have developed MIS-C, and 46 have died, Havers said, adding that the condition was most common in younger children.

Two doses of the Pfizer vaccine is nearly 91% effective in preventing symptomatic illness in young children and brings no unexpected safety issues, according to a study posted last Friday by the FDA.

"Overall, it is very promising news that the FDA has decided to approve the vaccine, allowing parents to collectively breathe a sigh of relief. The bottom line is that they can now extend this much needed protection to their children and families as a whole," said Dr. Robert Glatter, an emergency medicine physician with Lenox Hill Hospital in New York City.

Now, the Biden administration's plans to roll out the vaccine through pediatricians' offices, community clinics and pharmacies will begin, as U.S. health officials hope to reassure hesitant parents that the jab will protect their kids from COVID-19.

The White House has decided that pediatric COVID-19 shots will be delivered in settings that parents know and trust, rather than mass vaccination sites.

More than 25,000 pediatric and family doctor clinics will provide vaccinations to children, along with tens of thousands of pharmacies, children's hospitals and community health centers, according to the White House plan.

"Our planning efforts mean that we will be ready to begin getting shots in arms in the days following a final CDC recommendation," a White House statement on the plan said.

The federal government has already bought enough vaccine to fully cover all 28 million American kids aged 5 to 11, and it will be distributed in smaller packages of about 100 doses each, to make things more manageable for doctors' offices and community health centers, the White House added.

And there will be takers for the pediatric version of the vaccine: Two-thirds of U.S. parents of kids aged 5 to 11 plan to get their children vaccinated once the shots are approved, according to a recent poll by the COVID-19 Vaccine Education and Equity Project.

More information

The U.S. Centers for Disease Control and Prevention has more about COVID vaccination for children ages 5 to 11.


SOURCES: U.S. Food and Drug Administration, news release, Oct. 29, 2021; Robert Glatter, MD, emergency medicine physician, Lenox Hill Hospital, New York City; White House, statement, Oct. 20, 2021; COVID-19 Vaccine Education and Equity Project, news release, Oct. 14, 2021; New York Times; NBC News