Health
When will it be approved, available?
Parents of younger children eagerly await recommendations from a Centers for Disease Control and Prevention advisory committee meeting Tuesday to review data from trials showing Pfizer-BioNTech’s COVID-19 vaccine is safe and effective for kids.
The vaccine is fully approved for people 16 and older, and it’s authorized for emergency use for children 12 to 15 years old.
On Friday, the Food and Drug Administration authorizedthe vaccine for kids ages 5 to 11. After Tuesday’s CDC committee meeting and the expected approval of the agency’s director, the vaccine is likely to be available to eligible children across the country as soon as Wednesday.
But a few hurdles remain, and many parents still have questions. Here’s everything health experts want parents to know about the vaccine.
Do kids need a COVID-19 vaccine? What does the American Academy of Pediatrics suggest?
The American Academy of Pediatrics says it won’t issue a formal recommendation on the vaccine for kids until after the CDC’s Advisory Committee on Immunization Practices completes its evaluation of the data.
But many health experts are going on the record recommending children ages 5 to 11 get the Pfizer-BioNTech vaccine as soon as it becomes available.
“As pediatricians, our sole purpose is to take care of children and protect them,” said Dr. Stan Spinner, vice president and chief medical officer at Texas Children’s Pediatrics and Texas Children’s Urgent Care. “We feel very comfortable (with this vaccine). If we didn’t, we wouldn’t be recommending it.”
More:Parents were confused about kids and COVID. The American Academy of Pediatrics stepped in.
Hundreds of children ages 5 to 11 have been hospitalized with COVID-19, and 94 have died this year, the FDA has reported. It was the eighth-leading cause of death in the age group over the past year, after accidents, cancer, malformations, murder, heart disease, chronic lower respiratory disease, and flu or pneumonia.
Children appear to be just as likely as adolescents and adults to catch COVID-19 and pass it on, health experts say. Though they seem to be less likely to become seriously ill, health experts urge parents not to take that chance.
“A third of our pediatric patients admitted to the hospital ended up in the ICU with COVID,” Spinner said. “So it’s not a benign disease for anybody. … Kids need the vaccine.”
Why should my kid get a COVID-19 vaccine?
Even with a mild infection, children are still at risk for developing a dangerous immune overreaction called multisystem inflammatory syndrome in children. COVID-19 has led to more than 5,000 cases of the condition; the average age is 9.
Children are less likely to have long-term symptoms of COVID-19 than adults, experts say, but they still can suffer from so-called long-haul COVID.
Recent data shows children are as likely to get infected by the delta coronavirus variant as adults, and about 50% of infections in children are asymptomatic, said Dr. Anthony Fauci, Biden’s chief medical adviser and the nation’s top infectious disease expert.
Fauci told reporters that vaccinating millions of children ages 5 to 11 will also stifle community transmission and nudge the country closer to herd immunity.
“If we can get the overwhelming majority of those 28 million children vaccinated, that would play a major role in diminishing the spread of infection in the community,” Fauci said.
If the pandemic is contained, health experts say, children will have more freedom to enjoy a sense of pre-pandemic normalcy, like going back to school with minimal restrictions and safely attending family events.
“The last point for why to vaccinate children now is to really allow kids the freedom to be kids,” said Dr. Emmanuel Walter Jr., professor of pediatrics at Duke University School of Medicine and chief medical officer of the Duke Human Institute.
More:Scientists examine the unique immune systems of kids as more get COVID-19
Has the FDA approved the COVID vaccine for children?
On Friday, the Food and Drug Administration authorized Pfizer-BioNTech’s vaccine for children 5 to 11.
However, this does not mean the vaccine is “approved” for kids.
Emergency use authorization allows Pfizer-BioNTech to provide safety and effectiveness data after tracking trial participants for an average of two months instead of the usual six months.
In the middle of a pandemic, it was more important to get vaccines to people faster, the FDA said, and vaccine side effects generally occur within the first four to six weeks after a shot.
The only age group that has official approval from the FDA is people 16 and older. Teenagers and children ages 12 to 15 have also been authorized to get the vaccine under emergency use.
An FDA official explains:Why don’t COVID-19 vaccines have full authorization?
Where do children’s vaccines from Moderna and Johnson & Johnson stand?
Moderna released its own study Monday finding that its COVID-19 vaccine at half the original adult dose is safe and effective in children 6 to 11. The company has not yet asked for authorization to provide its vaccine to this age group.
A Johnson & Johnson spokesperson told USA TODAY the company has started the first phase 3 study in adolescents ages 12 to 17 years and anticipates results for dose and regimen in the coming months.
When will kids be able to get the COVID-19 vaccine?
Two more steps remain before the vaccine will become available to children.
An independent panel of experts advising the CDC will review data on the safety and effectiveness. If the panel gives the vaccine its approval, CDC Director Rochelle Walensky will need to add her support before vaccines become available, which is likely as soon as Wednesday.
Presidential advisor Jeffrey Zients said Monday the Biden administration’s distribution program will be “running at full strength” to cover all 28 million American children in the age group the week of Nov. 8.
Where will my children be able to get a COVID-19 vaccine?
Pediatricians and primary care doctors, children’s hospitals, pharmacies and clinics at schools are among the places where kids can get the vaccine.
The Biden administration said it has purchased enough vaccine to cover the 28 million American children in the5 to 11 age group, and about 15 million doses will be available within the first week.
Those locations include more than 25,000 pediatricians’ offices and primary care sites, more than 100 children’s hospitals and health systems, tens of thousands of pharmacies, and hundreds of schools and community-based clinics. Administration officials say they are working with states and localities to enroll more sites.
Did America’s schools open safely?We crunched the latest data on COVID and kids.
Children’s hospitals have already ordered vaccine and expect shipments to arrive within the next few days – but they are waiting for the CDC’s final recommendations before scheduling appointments.
“We’re ready to go,” Spinner, of Texas Children’s Pediatrics, said. “We’re just literally waiting for the official OK.”
Locations are expected to offer appointments that can be made during convenient hours – such as after school, evenings and on weekends – or accept walk-ins, officials say.
The administration says it’s working with local education leaders and pharmacies to bring vaccines directly to schools by setting up on-site clinics.
CVS and Walgreens, the country’s largest pharmacies, say they’re ready to expand eligibility to children ages 5 to 11, but doses won’t be available until federal agencies provide guidance.
Parents can visit Vaccines.gov – the one-stop shop federal government website – to find the closest available COVID-19 vaccine appointment for their children. Information on vaccine locations for kids will be posted once the CDC signs off on use of the vaccine.
What’s the vaccine schedule and dose information for kids?
The vaccine would be given to children ages 5 to 11 in two shots, administered three weeks apart, at one-third of the dose given to adults and adolescents.
The adult dose of the Pfizer-BioNTech vaccine is 30 micrograms; the companies propose a 10-microgram dose in children ages 5 to 11.
The only difference in the children’s Pfizer-BioNTech vaccine is the addition of one chemical called tri-sucrose. Tri-sucrose already is used in several other vaccines and makes the vaccine easier to dilute and remain stable in a refrigerator for up to 10 weeks, a Pfizer executive said.
What were the results of Pfizer’s vaccine study?
The FDA’s Vaccines and Related Biological Products Advisory Committee met lastTuesday to hear information on the Pfizer-BioNTech vaccine from company officials as well as government experts who had reviewed the data.
Pfizer presented the results of several studies it has done among about 5,000 5- to 11-year-olds, which showed the vaccine was found to be safe with no severe vaccine-related side effects or dangerous allergic reactions.
In a subset of the children, the Pfizer-BioNTech vaccine was found to be more than 90% protective against contracting symptomatic COVID-19. Of the 19 children in the study found to be infected with the coronavirus, only three received the active vaccine, compared with 16 who received a placebo.
In one of the studies, of about half the children, more than 11% had obesity and nearly 8% had asthma. Both groups appeared just as well protected from the vaccine as children without those conditions.
“Those are the people who are at the highest risk of getting infected,” Spinner said. “When we look at the children who have gotten sick, most of them had underlying conditions. Those are the ones that should be the first in line to get vaccinated.”
Phase 3 clinical data presented last year showed the vaccine was 95% effective in adults. But new research that has not yet been peer-reviewed suggests efficacy may be closer to 84% after six months.
More on underlying conditions:CDC adds mental health disorders to list of conditions linked to higher risk of severe COVID-19. Here’s why.
What are the vaccine side effects for kids?
The trials showed children experienced the same types of mostly minor side effects seen in adolescents and young adults.
Many of those ages 5 to 11 had sore arms, fatigue, headaches, muscle pain, chills and low-grade fevers that lasted a day or two.
One of the reasons researchers decreased the normal vaccine dose from 30 to 10 micrograms in children is to reduce the severity of side effects, said Jason Gallagher, clinical professor at Temple University’s School of Pharmacy and a clinical pharmacy specialist in infectious diseases at Temple University Hospital.
“A lot of the side effects that people complain about after getting the vaccine is related to the immune response,” he said. “Pfizer went back to the drawing board on dosing and found out that a lower dose (in children) is effective and safe than the dose we’ve been giving to teenagers and adults.”
What can I give my child if they don’t feel well after getting vaccinated?
Health experts say parents can give their children over-the-counter medicine like acetaminophen, aspirin or ibuprofen to relieve any mild to moderate side effects after vaccination.
But the CDC does not recommend taking those medications before getting vaccinated in anticipation of side effects, because they might affect how well the vaccine works.
Walter also suggests preparing your child before vaccination to expect these mild side effects.
“Parents can have that discussion with their child that they may get a fever, they may feel a little achy or not feel as good the next day following vaccination and that’s to be expected,” he said.
Could schools require children to be vaccinated?
The Pfizer-BioNTech vaccine is available to children ages 12 to 18, and vaccine mandates for school vary by state.
The board of the Los Angeles Unified School District – which oversees the second-largest public school system in the country – voted to require students age 12 and up to be fully vaccinated. Those who take part in sports and other extracurricular activities should have taken both shots by the end of October and all other students by Dec. 19.
New York City’s school system, the nation’s largest, has required vaccinations only for 20,000 student-athletes in certain sports considered at high risk of spreading the virus.
More:California becomes first state to announce plans to mandate COVID-19 vaccine for schoolchildren
While some districts mull over COVID-19 vaccine mandates, some states have banned schools from requiring vaccines.
Health experts say it’s too soon to say if schools will mandate COVID-19 shots after authorization or approval, but vaccines in schools have helped eradicate some diseases in the U.S. like smallpox and polio.
“It’s to prevent disease in children themselves and prevent outbreaks in communities,” said Dr. Sean O’Leary, a pediatric infectious disease specialist at Children’s Hospital Colorado. “And those school requirements have been longstanding for many decades and they’ve led to very successful control of vaccine-preventable diseases.”
Will vaccinated children still need to wear masks?
Until a vaccine is available to children, public health experts, including the FDA’s Peter Marks, have said that the best thing parents can do to protect their children – besides getting vaccinated themselves – is to encourage children to wear masks while indoors in public.
CDC guidance recommending fully vaccinated people to wear masks inside could remain in place even after children 5 to 11 can get their shots, health experts say.
“We’ve seen so much COVID-19 circulating in our communities, it will be critical to get the amount of transmission down before it’s likely the CDC might relax those guidelines,” said Dr. Evan Anderson, a physician at Children’s Healthcare of Atlanta and associate professor of pediatrics and medicine at Emory University School of Medicine.
He reminds parents that children may not have the full intended protection against COVID-19 until two weeks after their second dose and encourages them to continue following CDC and local school guidance regarding masks.
When will children under 5 years old be vaccinated?
The companies are also studying their vaccine in children ages 2 to 5, and 6 months to age 2, but those trials are not yet complete. Younger children are being tested on a 3-microgram dose.
Pfizer has reported it may have data by the end of the year. Before the vaccine becomes available to younger children and infants, the company will have to submit the data for FDA and CDC review.
The timing “is going to depend on what the data show,” O’Leary said. “I think that people’s best guess is early 2022, but there’s a lot of uncertainty around that guess.”
Contributing: Karen Weintraub and Elizabeth Weise, USA TODAY. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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