US Younger kids could be getting a Covid-19 vaccine within weeks
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Some 28 million children ages 5 to 11 in the United States may soon be eligible for the Covid-19 vaccine, and plans are alreadyto help them get it.
The US Food and Drug Administration'swill meet Tuesday to discuss whether Pfizer and BioNTech's Covid-19 vaccine should be authorized for younger kids. If authorized, it would become the first vaccine available for younger children. Pfizer's vaccine is already authorized for children 12 to 15 and is people age 16 and older.
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If the FDA committee votes in its favor, the FDA will then make the final decision about whether to authorize it.
Then, the US Centers for Disease Control and Preventionmeets November 2 and 3, and will vote on whether to recommend it. Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or modify the committee's recommendation.
Once Walensky signs off, younger children could start getting Covid-19 shots immediately.
How well does the vaccine work and is it safe?
Since children are not small adults, as many pediatricians like to say, the FDA needs to examine data from trials done specifically with children.
Children's bodies are still developing and react differently to a vaccine than an adult would, so as with any vaccine for kids, scientist tested different doses to determine what a child's body can tolerate and what dose level would be protective. For younger children, Pfizer requested authorization for a 10-microgram dose; the doses used in people 12 years and older is 30 micrograms. The vaccine still requires two doses given three weeks apart.
FDA says Pfizer vaccine appears to work in young kids; study shows lower mortality rates for vaccinated people: Live COVID updates
Pfizer’s COVID vaccine appears highly effective at preventing symptomatic infections in young kids and caused no unexpected safety issues, feds say.The Food and Drug Administration posted its analysis of Pfizer’s data ahead of a public meeting next week to debate whether the shots are ready for the nation’s roughly 28 million children ages 5 to 11. The agency will ask a panel of outside vaccine experts to vote on that question and is expected to authorize the vaccine for young children as early as next week.
Data Pfizerfrom a Phase 2/3 trial showed its Covid-19 vaccines generated in children ages 5 to 11. In a posted ahead of the FDA meeting, Pfizer said its vaccine is safe and 90.7% effective against symptomatic Covid-19 in children ages 5 to 11.
Inwhich involved around 2,000 children, there were three cases of Covid-19 among the group that got the vaccine and 16 in the placebo group. In the trial, twice as many kids got the vaccine as the placebo.
Pfizer reported that there were no serious side effects like pericarditis, inflammation of the lining around the heart, or myocarditits, inflammation of the heart muscle, while participants were being monitored in the three months after the shots. These rare side effects have shown up in some adults and older teens who got the vaccine. The study size was small enough that scientists say it is unlikely the problem would show among the volunteers.
Overnight Health Care — Presented by Altria — FDA advisers endorse Pfizer vaccine for kids
Welcome to Tuesday's Overnight Health Care, where we're following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup.Lemurs at the Indianapolis Zoo celebrated National Pumpkin Day by exploring and eating a jack-o'-lantern in this adorable video. Younger children are one step closer to being able to get vaccinated against COVID-19 after an FDA advisory panel endorsed the safety and effectiveness of Pfizer-BioNTech's shot.For The Hill, we're Peter Sullivan (firstname.lastname@example.org), Nathaniel Weixel (email@example.com) and Justine Coleman (firstname.lastname@example.org).
In an assessment posted late Friday night, the FDA said the benefits of Pfizer/BioNTech's Covid-19 vaccine outweigh the risks to children ages 5 to 11 under current pandemic conditions. The FDA said the vaccine carries a theoretical risk of myocarditis or pericarditis that could require treatment and even hospitalization. But the risk of Covid-19 is higher if enough virus is circulating.
"It's a really high level of efficacy," said Dr. Ashish Jha, the dean of the Brown University School of Public Health. "This is the kind of stuff we saw early days of Pfizer, before the Delta variant and other variants of concern came into effect, so I thought that was pretty compelling."
Why a kids vaccine is needed.
Nearly 6.2 million children have tested positive for Covid-19 since the start of the pandemic. While cases have been trending downward recently, this past week alone about 131,000 more children were diagnosed with Covid-19, according to the
Severe illness is rare among children -- they make up less than 5% of hospitalizations and less than 0.025% of deaths -- but there have been 637 children who have died from Covid-19,. Covid-19 was among the causes of death for children 5 to 14 years of age in the first half of this year.
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"Covid has not been benign among children even though they do better than older adults, we've had hundreds of children who have lost their lives, thousands who have been hospitalized and whose lives have been disrupted because of Covid-19," said US. "We want to protect our kids. We want them to get their lives back."
To pediatricians and many anxious parents, the vaccines can't come soon enough.
"Here in Ohio, I think our pediatric Covid cases have finally plateaued a little bit, but our offices have been so overwhelmed with testing for Covid recently," said, director of Pediatric Infection Control with UH Rainbow Babies and Children's Hospital. "Hopefully that will quiet down just in time to start giving out the new shots ... because clearly we really need them."
Where could children get vaccinated?
Even before the official conversations at the FDA and CDC happen, thehas been working for months on vaccine logistics around children.
The Biden administration said it has contracted to get enough supply to vaccinate all 28 million children who will be eligible.
There will be fewer mass vaccination sites like the US used with adult vaccines. Pediatricians say long lines are not kid-friendly and crying can be contagious. So, the focus will be on places kids typically go for care and also where parents can ask questions of a trusted medical source.
FDA panel recommends Pfizer vaccine for kids 5-11; maker of COVAXIN looks to start US trials of vaccine: COVID-19 updates
Children are one step closer to being able to receive a COVID-19 vaccine. Ocugen plans to begin US trials of COVAXIN in US. Latest updates.The resounding support is a major step forward for making school-age children eligible for inoculation — likely by next week — but there are still three crucial hurdles to clear: The FDA will have to sign off, an independent CDC advisory panel will review the data, and then the CDC director would have to give her clearance.
"Kids have different needs than adults and our operational planning is geared to meet those specific needs, including by offering vaccinations in settings that parents and kids are familiar with and trust," White House Covid-19 response coordinator Jeff Zients told reporters Wednesday.
The Biden administration has been coordinating with more than 25,000 doctors' offices, community health centers, and rural health clinics, as well as thousands of pharmacies. The administration launched a partnership with theand is working with hundreds of school clinics.
The hope is to make it as easy as possible for kids to get these vaccines.
This version of the vaccine will also be packaged in smaller configurations that can be stored in the kind of refrigerator a doctor's office would have.
The kid-sized vials can also be stored for up to 10 weeks.
At the local level, doctors offices have been also been planning for months to vaccinate children.
In the UH Rainbow Babies and Children's Hospital system, Hoyen said they've been working hard to make sure all their pediatric practices get their licenses and the shipments they need. The health system has fliers printed and outreach efforts planned. They'll also have a few larger vaccination sites in case children don't have a regular pediatrician, or their doctor isn't set up to do the vaccines.
"For us it's going to be pretty routine and I think that's what the administration was hoping for," Hoyen said. "This will be up and running and when kids come in for their well child visit they can get their Covid shot too."
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Will parents get their kids vaccinated?
It's still not clear how many parents will take their kids to get vaccinated.
A recentsurvey in September found that about a third of parents with kids in this age range would want to wait and see before getting their child the Covid-19 vaccine. About a third said they would get their young children vaccinated right away.
If teen numbers are any indication, vaccinations for children could move slowly. Teens and preteens are the age groups that have been vaccinated the least among those already eligible.
While consideredin preventing hospitalization due to Covid-19 among children ages 12 to 18, currently only 46% of children age 12 to 15 and 54% of those age 16 to 17 are fully vaccinated, according to CDC data. Still, the Biden administration is optimistic.
"I hope that the vast majority of parents will realize the real benefit for the children to get vaccinated," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases told CNN's Chris Cuomo Wednesday.
Hoyen said she hopes parents understand that in addition to masks, a vaccine is one way to keep kids in school. It can also protect them for the future. Lately, she said, she's been treating a lot more kids with long Covid symptoms. Even kids who had mild cases to start with are dealing with symptoms months later.
"These vaccines are safe, they are effective," Hoyen said. "As we get into the holiday season and want to be together with friends and family, it would be a really nice holiday gift for all of us if everyone, including children were to get vaccinated once these vaccines become available."
Federal advisory committee, CDC director to decide on vaccines for kids ages 5-11: Live COVID-19 updates .
A federal advisory committee will meet Tuesday to decide whether to recommend coronavirus vaccines to children ages 5 to 11. More COVID updatesIf the Advisory Committee on Immunization Practices decides the benefits of vaccination outweigh risks in this age group, the director of the Centers for Disease Control and Prevention would weigh in. If Dr. Rochelle Walensky signs off, vaccines would become available as soon as Wednesday at pharmacies and pediatricians’ offices.